{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 6)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nch a premarket submission is not required (e.g., for 510(k)-exempt devices). This guidance also applies to cyber devices, as defined in section 524B of the FD&C Act, which are a subset of devices.\nGenerally, the recommendations in this guidance apply to the device constituent part of a combination product 2 (such as drug-device and biologic-device combination products) when the device constituent part presents cybersecurity considerations, 3 including but not limited to\n\n1 For the purposes of this guidance, 'device software function' means a software function that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For the purposes of this guidance, the term 'function' is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. For more information, see FDA's guidance 'Multiple Function Device Products: Policy and Considerations.'\n\n2 21 CFR 3.2(e). 3 21 CFR 4.2. ## Contains Nonbinding Recommendations\n\ndevices that include a device software function or that contain software (including firmware) or programmable logic. For more information, contact the FDA review division that will have the lead review for the combination product. 4\n\nAs IDE submissions have a different benefit-risk threshold and are not marketing authorizations, specific recommendations for IDE submission documentation are provided in Appendix 3. Additionally, Appendix 5 contains terminology used throughout the guidance. ## III. Background\n\nFDA recognizes that medical device cybersecurity is a shared responsibility among interested parties throughout the use environment of the medical device system, including healthcare facilities, patients, healthcare providers, and manufacturers of medical devices."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 5}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.522(a)(1) require?"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n§164.522(a)(1)(i)(B), the right to request restrictions applies to disclosures to persons assisting in the individual's care under "}], "metadata": {"source": "privacy_rule_2000", "cfr_section": "§164.522(a)(1)", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 419)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ncontract between a covered entity and its business associate should stipulate that the business associate is required to amend protected health information in accordance with the amendment provisions.\nOtherwise, these commenters argued, there would be a gap in the individual's right to have erroneous information corrected, because the covered entity could deny a request for amendment of information created by a business associate. Response: We agree that information created by the covered entity or by the covered entity's business associates should be subject to amendment. This requirement is consistent with the requirement to make information created by a business associate available for inspection and copying. We have revised the rule to require covered entities to specify in the business associate contract that the business associate will make protected health information available for amendment and will incorporate amendments accordingly. (See § 164.504(e).)\n\nComment: One commenter argued that covered entities should be required to presume information must be corrected where an individual informs the entity that an adjudicative process has made a finding of medical identity theft. Response: Identity theft is one of many reasons why protected health information may be inaccurate, and is one of many subjects that may result in an adjudicative process relevant to the accuracy of protective health information. We believe that this provision accommodates this situation without a special provision for identity theft. Comment: Some commenters asserted that the proposed rule's requirement that action must be taken on individuals' requests within 60 days of the receipt of the request was unreasonable and burdensome. A few commenters proposed up to three 30day extensions for ''extraordinary'' (as defined by the entity) requests. Response: We agree that 60 days will not always be a sufficient amount of time to adequately respond to these requests."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 418}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 8)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nions. The quality systems requirements are found in the QS regulation in 21 CFR Part 820. Depending on the device, QS requirements may be relevant at the premarket stage, postmarket stage, 15 or both.\nIn the premarket context, in order to demonstrate a reasonable assurance of safety and effectiveness for certain devices with cybersecurity risks, documentation outputs related to the ongoing requirements of the QS regulation may be one source of documentation to include as\n\n13  While section 524B(b)(4) of the FD&C Act authorizes FDA to promulgate additional cybersecurity requirements via regulation, FDA is not required to promulgate a regulation to elaborate on the new requirements specified in section 524B of the FD&C Act. 14 In addition to the cybersecurity requirements set forth in section 524B(b) of the FD&C Act, section 524B(b)(4) of the FD&C Act requires cyber device manufacturers to comply with any other such requirements FDA sets forth in regulations 'to demonstrate reasonable assurance that the device and related systems are cybersecure.'\n\n15 In the postmarket context, design controls may also be important to ensure medical device cybersecurity and maintain medical device safety and effectiveness. FDA recommends that device manufacturers implement comprehensive cybersecurity risk management programs and documentation consistent with the QS regulation, including but not limited to complaint handling (21 CFR 820.198), quality audit (21 CFR 820.22), corrective and preventive action (21 CFR 820.100), software validation and risk analysis (21 CFR 820.30(g)), and servicing (21 CFR 820.200). ## Contains Nonbinding Recommendations\n\npart of the premarket submission. 16 This guidance is intended to explain how such documentation that may be relevant for QS regulation compliance can also be used to show how a sponsor or manufacturer is addressing cybersecurity considerations relevant to a device."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 7}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 51)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nKey activities, descriptions, and sample questions for the Workstation Use standard | Key Activities | Description | Sample Questions | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 50}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 112)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nreplaced with the word ''specifications.''\n\n## IV. Final Regulatory Impact Analysis\n\nFederal law (5 U.S.C. 804(2), as added by section 251 of Pub. L. No.\n104-21), specifies that a ''major rule'' is any rule that the Office of Management and Budget finds is likely to result in:\n\n- A major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or\n- An annual effect on the economy of $100 million or more;\n- Significant adverse effects in competition, employment, investment productivity, innovation, or on the ability of United States based enterprises to compete with foreignbased enterprises in domestic and export markets. The impact of the modifications adopted in this rulemaking will have an annual effect on the economy of at least $100 million. Therefore, this Rule is a major rule as defined in 5 U.S.C. 804(2). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). According to Executive Order 12866, a regulatory action is ''significant'' if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million or more, adversely affecting in a material way a sector of the economy, competition, or jobs, or if it raises novel legal or policy issues. The purpose of the regulatory impact analysis is to assist decisionmakers in understanding the potential ramifications of a regulation as it is being developed. The analysis is also intended to assist the public in understanding the general economic ramifications of the regulatory changes."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 111}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the administrative safeguards under HIPAA?"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron Applied Cybersecurity Division Information Technology Laboratory\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\nFebruary 2024\n\n<!-- image -->\n\nU.S. Department of Commerce Gina M. Raimondo, Secretary\n\nNational Institute of Standards and Technology\n\nCertain commercial equipment, instruments, software, or materials, commercial or non-commercial, are identified in this paper in order to specify the experimental procedure adequately. Such identification does not imply recommendation or endorsement of any product or service by NIST, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose. There may be references in this publication to other publications currently under development by NIST in accordance with its assigned statutory responsibilities. The information in this publication, including concepts and methodologies, may be used by federal agencies even before the completion of such companion publications. Thus, until each publication is completed, current requirements, guidelines, and procedures, where they exist, remain operative. For planning and transition purposes, federal agencies may wish to closely follow the development of these new publications by NIST. Organizations are encouraged to review all draft publications during public comment periods and provide feedback to NIST."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_type": "administrative", "implementation_spec": "both", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 147)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nsures, and to only use or disclose genetic information as required or expressly permitted by the Rule, or as otherwise authorized by the individual who is the subject of the genetic information. ## 2.\nSection 160.101-Statutory Basis and Purpose\n\nWe have revised § 160.101, which describes the statutory basis of the HIPAA Rules, to include a reference to section 1180 of the Social Security Act,\n\nVerDate Mar&lt;15&gt;2010\n\nas added by section 105 of GINA (Pub. L. 110-233). ## 3. Section 160.103-Definitions\n\nThe final rule modifies § 160.103 of the Privacy Rule to: (1) Revise the definition of ''health information'' to make clear that the term includes ''genetic information;'' (2) add definitions for the GINA-related terms of ''family member,'' ''genetic information,'' ''genetic services,'' ''genetic test,'' and ''manifestation or manifested;'' and (3) make technical corrections to the definition of ''health plan.'' With respect to the GINA-related terms, the final rule adopts definitions that are generally consistent with the definitions of such terms promulgated in the implementing regulations for sections 101-103 of GINA. This will facilitate compliance for those health plans subject to both the privacy as well as the nondiscrimination provisions of GINA. a. Definition of ''Health information'' Proposed Rule\n\nPrior to enactment of GINA, the Department issued guidance that genetic information is health information protected by the Privacy Rule to the extent that such information is individually identifiable and held by a covered entity (subject to the general exclusions from the definition of ''protected health information''). 17 Section 105 of GINA requires the Secretary to revise the Privacy Rule to make clear that genetic information is health information under the Rule. Thus, the Department proposed to modify the definition of ''health information'' at § 160.103 to explicitly provide that such term includes genetic information."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 146}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 342)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nNPRM provision allowing disclosure without authorization to coroners and medical examiners. Response: The final rule retains the NPRM's basic approach to disclosure of coroners and medical examiners.\nIt allows covered entities to disclose protected health information without authorization to coroners and medical examiners, for identification of a deceased person, determining cause of death, or other duties authorized by law. Comment: In the preamble to the NPRM, we said we had considered but rejected the option of requiring covered entities to redact from individuals' medical records any information identifying other persons before disclosing the record to a coroner or medical examiner. We solicited comment on whether health care providers routinely identify other persons specifically in an individual's medical record and if so, whether in the final rule we should require health care providers to redact information about the other person before providing it to a coroner or medical examiner. A few commenters said that medical records typically do not include information about persons other than the patient. One commenter said that patient medical records occasionally reference others such as relatives or employers. These commenters recommended requiring redaction of such information in any report sent to a coroner or medical examiner. On the other hand, other commenters said that redaction should not be required. These commenters generally based their recommendation on the burden and delay associated with redaction. In addition to citing the complexity and time involved in redaction of medical records provided to coroners, one commenter said that health plans and covered health care providers were not trained to determine the identifiable information necessary for coroners and medical examiners to do thorough investigations."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 341}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 465)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhey will be of comparable responsibility, and therefore comparable pay, in larger institutions. The initial year cost for privacy officials will be $723 million; the tenyear cost will be $5.9 billion.\n## Internal Complaints\n\nThe final rule requires each covered entity to have an internal process to allow an individual to file a complaint concerning the covered entity's compliance with its privacy policies and procedures. The requirement includes designating a contact person or office responsible for receiving complaints and documenting the disposition of them, if any. This function may be performed by the privacy official, but because it is a distinct right under the final rule and may be performed by someone else, we are costing it separately. The covered entity only is required to receive and document a complaint (no response is required), which we assume will take, on average, ten minutes (the complaint can be oral or in writing). The Department believes that such complaints will be uncommon. We have assumed that one in every thousand patients will file a complaint, which is approximately 10.6 million complaints over ten years. Based on a weightedaverage hourly wage of $47.28 at ten minutes per complaint, the cost of this policy is $6.6 million in the first year. Using wage growth and patient growth assumptions, the cost of this policy is $103 million over ten years. ## Disclosure Tracking and History\n\nThe final rule requires providers to be able to produce a record of all disclosures of protected health information, except in certain circumstances. The exceptions include disclosures for treatment, payment, health care operations, or disclosures to an individual. This requirement will require a notation in the record (electronic or paper) of when, to whom, and what information was disclosed, as well as the purpose of such disclosure or a copy of an individual's written authorization or request for a disclosure."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 464}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 89)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nce acknowledgment requirement be modified to allow for an individual's oral acknowledgment of the notice, so long as the provider maintained a record that the individual's acknowledgment was obtained.\nSome commenters did not support the proposal's written notice acknowledgment as a suitable alternative to the consent requirement, stating that such a requirement would not provide individuals with\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00059\n\ncomparable privacy protections or rights. It was stated that there are a number of fundamental differences between a consent and an acknowledgment of the notice. For example, one commenter argued that asking individuals to acknowledge receipt of the notice does not provide a comparable ''initial moment'' between the provider and the individual, especially when the individual is only asked to acknowledge receipt of the notice, and not whether they have read or understood it, or have questions. Further, commenters argued that the notice acknowledgment process would not be the same as seeking the individual's permission through a consent process. Some of these commenters urged that the Department retain the consent requirements and make appropriate modifications to fix the known operational problems associated with the requirement. A few commenters urged that the Department strengthen the notice acknowledgment process. Some commenters suggested that the Department do so by eliminating the ''good faith'' aspect of the standard and simply requiring certain health care providers to obtain the written acknowledgment, with appropriate exceptions for emergencies and other situations where it may not be practical to do so. It was also suggested that the Department require providers to ensure that the consumer has an understanding of the information provided in the notice."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 88}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 277)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhem from the authorized disclosures in the contract. In addition, the commenter expressed concern that the proposal did not authorize business partners and their employees to engage in whistleblowing.\nThe commenter concluded that this omission was unintended since the proposal's provision at proposed §164.518(c)(4) relieved the covered entity, covered entity's employees, business partner, and the business partner's employees from liability for disclosing protected health information to law enforcement and to health oversight agencies when reporting improper activities, but failed to specifically authorize business partners and their employees to engage in whistleblowing in proposed §164.510(f), ''Disclosures for law enforcement.''\n\nResponse: Under our statutory authority, we cannot directly regulate entities that are not covered entities; thus, we cannot regulate most business associates, or 'authorize' them to use or disclose protected health information. We agree with the result sought by the commenter, and accomplish it by ensuring that such whistle blowing disclosures by business associates and others do not constitute a violation of this rule on the part of the covered entity. Comment: Some commenters suggested that the need to terminate contracts that had been breached would be particularly problematic when the contracts were with single-source business partners used by health care providers. For example, one commenter explained that when the Department awards single-source contracts, such as to a Medicare carrier acting as a fiscal intermediary that then becomes a business partner of a health care provider, the physician is left with no viable alternative if required to terminate the contract. Response: In most cases, we expect that there will be other entities that could be retained by the covered entity as a business associate to carry out those functions on its behalf or provide the necessary services."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 276}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 48)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nnt believes that narrowing the definition of ''health care operations'' will place serious burdens on covered entities and impair their ability to conduct legitimate business and management functions.\nComment: Some commenters requested that the regulation text state more specifically that a voluntary consent cannot substitute for an authorization when an authorization is otherwise required under the Privacy Rule. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nResponse: The Department agrees and modifies the regulation text, at §164.506(b)(2), to make this clear. As stated in the preamble to the NPRM, the Department intends to enforce strictly the requirement for obtaining an individual's authorization, in accordance with § 164.508, for uses and disclosures of protected health information for purposes not otherwise permitted or required by the Privacy Rule. A consent obtained voluntarily would not be sufficient to permit a use or disclosure which, under the Privacy Rule, requires an authorization or is otherwise expressly conditioned under the Rule. For example, a consent under §164.506 could not be obtained in lieu of an authorization required by §164.508 or a waiver of authorization by an IRB or Privacy Board under §164.512(i) to disclose protected health information for research purposes. Comment: Some commenters requested that, if the Department decides to allow consent on a voluntary basis, the Privacy Rule include requirements for those covered entities that voluntarily choose to obtain consents. Response: The goal of the NPRM approach was to enhance flexibility for covered entities by allowing them to design a consent process that best matches their needs. The Department learned over the past year that no single consent process works for all covered entities."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 47}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 145)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nof an individual may exercise the rights of the individual, including the right to inspect and copy protected health information about the individual that is relevant to such person's representation.\nThe provision permits covered entities to refuse to treat a personal representative as the individual, generally, if the covered entity has a reasonable belief that the individual has been or will be subjected to domestic violence, abuse or neglect by the personal representative, or that treating the personal representative as the individual may endanger the individual and, in its professional judgment, the covered entity decides that it is not in the best interest of the individual to treat such person as the personal representative. In addition to that provision, we add a new provision at § 164.524(a)(3)(iii) to clarify that a covered entity may deny a request to inspect or copy protected health information if the information is requested by a personal representative of the individual and a licensed health care professional has determined that, in the exercise of professional judgment, such access is reasonably likely to cause substantial harm to the individual who is the subject of the information or to another person. The health care professional need not have a reasonable belief that the personal representative has abused or neglected the individuals and the harm that is likely to result need not be limited to the individual who is the subject of the requested protected health information. Therefore, a covered entity can recognize a person as a personal representative but deny such person access to protected health information as a personal representative. We do not intend these provisions to create a legal duty for the covered entity to review all of the relevant protected health information before releasing it. Rather, we are preserving the flexibility and judgment of covered entities to deny access under appropriate circumstances."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 144}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the differences between covered entity and business associate obligations under HIPAA?"}, {"role": "assistant", "content": "According to 45cfr162:\n\n[Skip to main content](#main-content)\n\nMenu\n\n[![GovInfo logo](/media/GovInfo_logo_gray.png)](/)\n[Search](#searchHolder)\n\n* Browse\n  + [A to Z](/browse-a-z)\n  + [Category](/app/browse/category)\n  + [Date](/app/browse/date)\n  + [Committee](/browse/committee)\n  + [Author](/app/browse/author)\n* About\n  + [About](/about)\n  + [Policies](/about/policies)\n  + [Authentication](/about/authentication)\n  + [Digital Preservation](/about/digital-preservation)\n  + [History](/about/history)\n  + [Agency Submission](/about/agency-submission)\n  + [U.S. Government Information](/about/us-gov-info)\n  + [FDsys Retirement](/about#fdsys-transition)\n* Developers\n  + [Developer Hub](/developers)\n  + [API](https://api.govinfo.gov/docs)\n  + [Bulk Data Repository](%20/bulkdata)\n  + [Link Service](/link-docs)\n  + [Feeds](/feeds)\n  + [Sitemaps](/sitemaps)\n  + [System Design](/developers/system-design)\n* Features\n  + [All Features](/features)\n  + [Featured Content](/features/featured-content)\n  + [News](/features/news)\n  + [Release Notes](/features/release-notes)\n  + [Finding Publications](/features/finding-publications)\n* Help\n  + [Help](/help)\n  + [Finding Information](%20/help/finding-info)\n  + [What's Available](/help/whats-available)\n  + [Tutorials and Handouts](/help/tutorials-handouts)\n  + [Other Resources](%20/help/other-resources)\n* Feedback\n  + [Submit Feedback](https://www.surveymonkey.com/r/govinfo-feedback-survey)\n  + [Contact Us](/contact)\n\n* [Toggle the Search Widget\n  Search](#searchHolder)\n\n# Page Not Found\n\n![Icon: Share using Facebook](/sites/default/files/fb-icon-white.png)\n![Icon: Share using Email](/sites/default/files/email-icon-white.png)\n![Icon: Copy Link URL](/sites/default/files/link-icon-white.png)\n\n[Help](/help/other)\n\n---\n\n**Error occurred."}], "metadata": {"source": "45cfr162", "entity_type": "both", "safeguard_types": ["unknown"], "type": "entity_obligations"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 122)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ne members be available to serve in assignments throughout the world. The final rule permits disclosures to officials who need protected health information to determine availability for duty worldwide.\nSection 101(b)(5) of the Foreign Service Act requires the Department of State to mitigate the impact of hardships, disruptions, and other unusual conditions on families of Foreign Service Officers. Section 904 requires the Department to establish a health care program to promote and maintain the physical and mental health of Foreign Service member family members. The final rule permits disclosure of protected health information to officials who need protected health information for a family member to accompany a Foreign Service member abroad. This exemption does not permit the disclosure of specific medical conditions, diagnoses, or other specific medical information. It permits only the disclosure of the limited information needed to determine whether the individual should be granted a security clearance or whether the Foreign Service member of his or her family members should be posted to a certain overseas assignment. ## Application to Correctional Facilities\n\nThe NPRM would have excluded the individually identifiable health information of correctional facility inmates and detention facility detainees from the definition of protected health information. Thus, none of the NPRM's\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nproposed privacy protections would have applied to correctional facility inmates or to detention facility detainees while they were in these facilities or after they had been released. The final rule takes a different approach."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 121}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 167)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\ne those costs. The interim final rule estimated that it would cost approximately $240 to publish a public notice in a newspaper. Assuming the covered entity will publish two notices, the cost is $480.\n32 This number includes all individuals affected by breaches involving 500 or more individuals\n\nVerDate Mar&lt;15&gt;2010\n\nMultiplying this amount by the 1,190 estimated breaches yields $571,200. Also, as noted in the interim final rule, if a HIPAA covered entity has a Web site, we assume there will be no cost to post the notice to the Web site. We believe this overestimates the overall cost of publishing a notice, as many covered entities will elect to post the public notice only on their Web site, and not in a newspaper. As outlined in the interim final rule, the cost of setting up a toll-free phone number is a straight forward process of contacting any one of a number of service providers who offer toll-free service. The interim final rule found that the prices for toll-free service range from $0.027 per minute for a basic mail box arrangement to $0.07 per minute. A major, national phone service company offers toll-free service for $15 per month per toll-free number and per minute charge of $0.07. There is a one-time charge of $15. As in the interim final rule, we use the costs of $15 per month plus $15 activation fee and $0.07 per minute. Since the regulation requires providers to maintain a toll-free number for three months, the monthly charge plus initial fee per breach will be $60. To estimate the number of calls to the toll-free number, the interim final rule assumed that more individuals than those affected by the breach requiring substitute notice would call out of concern that their protected health information might have been compromised. The interim final rule estimated that a number equal to all affected individuals of all breaches would call the toll-free number."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 166}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 508)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n(B). Protected health information means individually identifiable health information:\n\n- (1) Except as provided in paragraph (2) of this definition, that is:\n2. (i) Transmitted by electronic media;\n3.\n(ii) Maintained in any medium described in the definition of electronic media at § 162.103 of this subchapter; or\n4. (iii) Transmitted or maintained in any other form or medium. - (2) Protected health information excludes individually identifiable health information in:\n6. (i) Education records covered by the Family Educational Right and Privacy Act, as amended, 20 U.S.C. 1232g; and\n7. (ii) Records described at 20 U.S.C. 1232g(a)(4)(B)(iv). Psychotherapy notes means notes recorded (in any medium) by a health care provider who is a mental health professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint, or family counseling session and that are separated from the rest of the individual's medical record. Psychotherapy notes excludes medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: Diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date. Public health authority means an agency or authority of the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. Required by law means a mandate contained in law that compels a covered entity to make a use or disclosure of protected health information and that is enforceable in a court of law."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 507}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 547)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nlosure for purposes of that project, provided that the covered entity complies with all limitations placed by the consent, authorization, or other express legal permission obtained from an individual.\n(ii) If the consent, authorization, or other express legal permission obtained from an individual is a general consent to participate in the project, and a covered entity is conducting or participating in the research, such covered entity may, with respect to protected health information that it created or received as part of the project before or after the applicable compliance date of this subpart, make a use or disclosure for purposes of that project, provided that the covered entity complies with all limitations placed by the consent, authorization, or other express legal permission obtained from an individual. (4) If, after the applicable compliance date of this subpart, a covered entity agrees to a restriction requested by an individual under § 164.522(a), a subsequent use or disclosure of\n\nFrm 00368\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nprotected health information that is subject to the restriction based on a consent, authorization, or other express legal permission obtained from an individual as given effect by paragraph (b) of this section, must comply with such restriction. ## §164.534 Compliance dates for initial implementation of the privacy standards. - (a) Health care providers. A covered health care provider must comply with the applicable requirements of this subpart no later than February 26, 2003. - (b) Health plans. A health plan must comply with the applicable requirements of this subpart no later than the following date, as applicable:\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00369\n\nFmt 4701\n\nSfmt 4700\n\n- (1) Health plans other than small health plans -February 26, 2003. - (2) Small health plans -February 26, 2004. 3. (c) Health care clearinghouses."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 546}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 43)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n---------------------------------------------------------------------------|\n|                  | • Have the results of each test been documented and any problems with the test reviewed and corrected?\n• If full testing is infeasible, has a tabletop scenario (e.g., a classroom-like exercise) been considered? • How frequently will the plan be tested (e.g., annually)? • When should the plan be revised? |\n\n## 5.1.8. Evaluation (§ 164.308(a)(8)) 78\n\nHIPAA Standard: Perform a periodic technical and nontechnical evaluation, based initially upon the standards implemented under this rule and subsequently, in response to environmental or operational changes affecting the security of electronic protected health information, that establishes the extent to which a covered entity's or business associate's security policies and procedures meet the requirements of this subpart. Table 15."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 42}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 331)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ne intrusive in state functions. At least one commenter argued that the requirement for prior process places unreasonable restrictions on the right of the states to regulate law enforcement activities.\nResponse: This rule regulates the ability of health care clearinghouses, health plans, and covered health care providers to use and disclose health information. It does not regulate the behavior of law enforcement officials or the courts, nor does it prevent states from regulating law enforcement officials. All regulations have some effects on entities that are not directly regulated. We have considered those effects in this instance and have determined that the provisions of the rule are necessary to protect the privacy of individuals. Comment: One commenter argued that state licensing boards should be exempt from restrictions placed on law enforcement officials, because state licensing and law enforcement are different activities. Response: Each state's law determines what authorities are granted to state licensing boards. Because state laws differ in this regard, we cannot make a blanket determination that state licensing officials are or are not law enforcement officials under this regulation. We note, however, that the oversight of licensed providers generally is included as a health oversight activity at § 164.512(d). ## Relationship to Existing Rules and Practices\n\nComment: Many commenters expressed concern that the proposed rule would have expanded current law enforcement access to protected health information. Many commenters said that the NPRM would have weakened their current privacy practices with respect to law enforcement access to health records."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 330}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 472)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhours for hospitals and health plans. The larger figure for hospitals and health plans reflects the fact that they are likely to have a more extensive array of relationships with business associates.\nThe cost for the changes in business associate contracts is estimated to be $103 million. This will be an initial year cost only because the Department assumes that this contract language will become standard in future contracts. In addition, the Department has estimated the cost for business associates to comply with the minimum necessary provisions. As part of the minimum necessary provisions, covered entities will have to establish policies to ensure that only the minimum necessary protected health information is shared with business associates. To the extent that data are exchanged, covered entities will have to review the data and systems programs to assure compliance. For non-hospital providers, we estimate that the first year will require an average of three hours to review existing agreements, and thereafter, they will require an additional hour to assure business associate compliance. We estimate that hospitals will require an additional 200 hours the first year and 16 hours in subsequent years; health plans will require an additional 112 hours the first year and 8 hours in subsequent years. As in other areas, we have assumed a weighted average wage for the respective sectors. The cost of the covered entities assuring business associates' complying with the minimum necessary is $197 million in the first year, and a total of $697 million over ten years. (These estimates include the both the cost for the covered entity and the business associates.)\n\n## Inspection and Copying\n\nIn the NPRM estimate, inspection and copying were a major cost. Based on data and information from the public comments and further fact-finding, however, the Department has re- estimated these policies and found them to be much less expensive."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 471}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 178)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nusively provide health insurance, even if limited in scope. Comment: One commenter recommended that the Secretary clarify that ''health plan'' does not include property and casualty benefit providers.\nThe commenter stated that the clarifying language is needed given the ''catchall'' category of entities defined as ''any other individual plan or group health plan, or combination thereof, that\n\nFrm 00117\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nprovides or pays for the cost of medical care,'' and asserted that absent clarification there could be serious confusion as to whether property and casualty benefit providers are ''health plans'' under the rule. Response: We agree and as described above have added language to the final rule to clarify that the ''excepted benefits'' as defined under 42 U.S.C. 300gg-91(c)(1), which includes liability programs such as property and casualty benefit providers, are not health plans for the purposes of this rule. Comment: Some commenters recommended that the Secretary replace the term ''medical care'' with ''health care.'' It was observed that ''health care'' was defined in the proposal, and that this definition was used to define what a health care provider does. However, they observed that the definition of ''health plan'' refers to the provision of or payment for ''medical care,'' which is not defined. Another commenter recommended that HHS add the parenthetical phrase ''as such term is defined in section 2791 of the Public Health Service Act'' after the phrase ''medical care.''\n\nResponse: We disagree with the first recommendation. We understand that the term ''medical care'' can be easily confused with the term ''health care.'' However, the two terms are not synonymous. The term ''medical care'' is a statutorily defined term and its use is critical in making a determination as to whether a health plan is considered a ''health plan'' for purposes of administrative simplification."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 177}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 170)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nion revised NPPs over and above their existing printing obligations (4/12 × 613 million = 204 million). Printing costs for 204 million NPPs will be $20.4 million (204 million × $0.10 = $20.4 million).\nTherefore, the total cost for providers is approximately $40.4 million ($20 million + $20.4 million = $40.4 million). For health plans, the costs related to the NPP consist of developing and drafting the revised NPP, and, for certain health plans, the costs of printing and mailing the notice out-ofcycle because the revision is a material change. See § 164.520(c)(1)(v)(A). With the exception of a few large health plans, most health plans do not selfadminister their plans. Most plans are either health insurance issuers (approximately 730) or utilize third party administrators that act on their behalf in the capacity of business associates. We identified approximately 750 third party administrators acting as business associates for ERISA plans. We\n\n37 We identified 698,238 entities that must prepare and deliver NPPs that are shown in Table 1 above. This includes 696,758 HIPAA covered entities that are health care providers, including hospitals, nursing facilities, doctor offices, outpatient care centers, medical diagnostic, imaging service, home health service and other ambulatory care service covered entities, medical equipment suppliers, and pharmacies. For the purposes of our calculation, we have rounded this number to 697,000. Table 1 also includes 730 health insurance carriers and 750 third party administrators working on behalf of covered health plans. The cost estimates for these entities are addressed later. 18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00111\n\nhave revised our earlier estimate of 3,500 third party administrators after learning that the majority of these entities act as welfare administrators and do not administer health plans. In addition, some public non-Federal health plans may use third party administrators."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 169}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.514(e)(3)(ii) require?"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\n§164.514(e)(3)(ii) to make clear that a covered entity may engage a business associate to create a limited data set, in the same way it can use a business associate to create de-identified data. As with de-identified data, a business associate relationship arises even if the limited data set is not being created for the covered entity's own use. For instance, if a researcher needs county data, but the covered entity's data contains only the postal address of the individual, a business associate may be used to convert the covered entity's geographical information into that needed by the researc"}], "metadata": {"source": "privacy_mod_2002", "cfr_section": "§164.514(e)(3)(ii)", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 57)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nthe entire customer base. ## 4. System Vendors\n\nSystems vendors that provide computer software applications to health care providers and other billers of health care services would likely be affected.\nThese vendors would have to develop software solutions that would allow health plans, providers, and other users of electronic transactions to protect these transactions and the information in their databases from unauthorized access to their systems. Their costs would also probably be passed along to their customer bases. ## F. Factors in Establishing the Security Standard\n\n## 1. General Effect\n\nIn assessing the impact of these standards, it is first necessary to focus on the general nature of the standards, their scalability, and the fact that they are not dependent upon specific technologies. These factors will make it possible for covered entities to implement them with the least possible impact on resources. Because there is no national security standard in widespread use throughout the industry, adopting any of the candidate standards would require most health care providers, health plans, and health care clearinghouses to at least conduct\n\n17:54 Feb 19, 2003\n\nPO 00000\n\nFrm 00040\n\nan assessment of how their current security measures conform to the new standards. However, we assume that most, if not all, covered entities already have at least some rudimentary security measures in place. Covered entities that identify gaps in their current measures would need to establish or revise their security precautions. It is also important to note that the standards specify what goals are to be achieved, but give the covered entity some flexibility to determine how to meet those goals. This is different from the transaction standards, where all covered entities must use the exact same implementation guide. With respect to security, covered entities will be able to blend security processes now in place with new processes. This should significantly reduce compliance costs."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 56}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 4)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\nalthough that covered entity may be in compliance with the Security Rule, following a breach of this information, the covered entity would have to provide breach notification to affected individuals.\nFor example, a covered entity that has a large database of protected health information may choose, based on their risk assessment under the Security Rule, to rely on firewalls and other access controls to make the information inaccessible, as opposed to encrypting the information. While the Security Rule permits the use of firewalls and access controls as reasonable and appropriate safeguards, a covered entity that seeks to ensure breach notification is not required in the event of a breach of the information in the database would need to encrypt the information pursuant to the guidance. We also received several comments asking for clarification and additional detail regarding the forms of information and the specific devices and protocols described in the guidance. As a result, we provide clarification regarding the forms of information addressed in the National Institute of Standards and Technology (NIST) publications referenced in the guidance. We clarify that ''data in motion'' includes data that is moving through a network, including wireless transmission, whether by e-mail or structured electronic interchange, while ''data at rest'' includes data that resides in databases, file systems, flash drives, memory, and any other structured storage method. ''Data in use'' includes data in the process of being created, retrieved, updated, or deleted, and ''data disposed'' includes discarded paper records or recycled electronic media. Additionally, many commenters suggested that access controls be included in the guidance as a method for rendering protected health information unusable, unreadable, or indecipherable to unauthorized individuals."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 3}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "How should organizations implement physical controls?"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\n## Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions\n\n## Guidance for Industry and Food and Drug Administration Staff\n\nDocument issued on June 27, 2025. A draft select update to this document was issued on March 13, 2024. This document supersedes 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,' issued September 27, 2023. For questions about this document regarding CDRH-regulated devices, contact CyberMed@fda.hhs.gov. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at industry.biologics@fda.hhs.gov. <!-- image -->\n\nU.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research\n\n## Public Comment\n\nYou may submit electronic comments and suggestions at any time for Agency consideration to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2021-D-1158. Comments may not be acted upon by the Agency until the document is next revised or updated. ## Additional Copies\n\n## CDRH\n\nAdditional copies are available from the Internet. You may also send an email request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number GUI00001825 and complete title of the guidance in the request."}], "metadata": {"source": "fda_premarket_2023", "safeguard_type": "physical", "implementation_spec": "required", "entity_type": "covered_entity", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 30)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nthe amount of a civil money penalty within the penalty range. The Department did not propose to modify the Secretary's discretion in how to apply the factors-i.e., as either mitigating or aggravating.\n## Overview of Public Comments\n\nWe received one comment requesting that the Department limit the number of mitigating factors it will consider when determining penalty amounts and apply\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with civil money penalties in every case of noncompliance, including where resolution and compliance have been achieved by informal means. The commenter also argued that a covered entity's or business associate's financial condition or financial difficulties should not be considered as mitigating factors in determining the amount of civil money penalties. The commenter recommended that penalties should apply to all violators except those who despite due diligence could not discover the violation, who reported the violation immediately, and who fully corrected the problem within 30 days of discovery. We received two comments in support of considering reputational harm in the computation of civil money penalties. One commenter emphasized that reputational harm addresses harm to individuals' dignity interest and recommended the inclusion of ''other'' harm as well. However, another covered entity expressed concern that damages for reputational harm are difficult to quantify and, therefore, claims might lead to protracted litigation and expensive settlements, ultimately increasing the costs of health care. Finally, we received one comment requesting examples of situations involving a cognizable claim of reputational harm. We also received several comments requesting that the Department continue to consider the degree of culpability when determining the amount of a civil money penalty."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 29}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 253)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nrequire authorization. The relationship between the covered entity and the TPA may be subject to the business associate requirements of §§ 164.502 and 164.504.\nDisclosures by covered entities to plan sponsors, including employers, for the purpose of plan administration are addressed in § 164.504. Comment: Commenters suggested that as disease management is defined only as an element of treatment, it could only be carried out by health care providers, and not health plans. They opposed this approach because health plans also conduct such programs, and are indeed required to do it by accreditation standards and HCFA Managed Care Organization standards. Response: We agree that the placement of disease management in the proposed definition of treatment suggested that health plans could not conduct such programs. We revise the final rule to clarify that health plans may conduct population based care management programs as a health care operation activity. Comment: Some commenters stated that the rule should require that disease management only be done with the approval of the treating physician or at least with the knowledge of the physician. Response: We disagree with this comment because we do not believe that this privacy rule is an appropriate venue for setting policies regarding the management of health care costs or treatment. Comment: Some industry groups stated that if an activity involves selling products, it is not disease management. They asked for a definition that differentiates use of information for the best interests of patient from uses undertaken for ''ulterior purposes'' such as advertising, marketing, or promoting separate products. Response: We eliminate the definition of ''disease management'' from the rule. Often however, treatment decisions involve discussing the relevant advantages and disadvantages of products and services."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 252}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.520(c)(1)(v) require?"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\n§164.520(c)(1)(v)(A). We anticipate that most, if not all, affected entities will take advantage of this option and will not send the NPP in a separate mailing. As such, we expect that the vast majority of health insurers will not incur any out-of-cycle NPP dissemination costs.\n\nNonetheless, to account for any costs that might be incurred by a small\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with minority of health insurers to distribute the revised NPPs in a separate mailing, we have calculated the costs to these entities of doing so. We describe"}], "metadata": {"source": "hitech_omnibus_2013", "cfr_section": "§164.520(c)(1)(v)", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 16)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nification were concerned that a covered entity may abuse its access to the individually identifiable health information in its employment records by using that information for discriminatory purposes.\nMany commenters expressed concern that an employee's health information created, maintained, or transmitted by the covered entity in its health care capacity would be considered an employment record and, therefore, would not be considered protected health information. Some of these commenters argued for the inclusion of special provisions, similar to the ''adequate separation'' requirements for disclosure of protected health information from group health plan to plan sponsor functions (§ 164.504(f)), to heighten the protection for an employee's individually identifiable health information when moving between a covered entity's\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nhealth care functions and its employer functions. A number of commenters also suggested types of records that the Department should consider to be ''employment records'' and, therefore, excluded from the definition of ''protected health information.'' The suggested records included records maintained under the FMLA or the Americans with Disabilities Act (ADA), as well as records relating to occupational injury, disability insurance eligibility, sick leave requests and justifications, drug screening results, workplace medical surveillance, and fitness-for-duty test results. One commenter suggested that health information related to professional athletes should qualify as an employment record. Final Modifications."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 15}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 293)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nthorizations described in §§ 164.506 and 164.508 should not be construed as waivers of a patient's evidentiary privilege. See the discussions under § 164.506 and ''Relationship to Other Laws,'' above.\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\n## Research Information Unrelated to Treatment\n\n## Definition of Research Information Unrelated to Treatment\n\nComment: The majority of commenters, including many researchers and health care providers, objected to the proposed definition of research information unrelated to treatment, asserting that the privacy rule should not distinguish research information unrelated to treatment from other forms of protected health information. Even those who supported the proposed distinction between research information related and unrelated to treatment suggested alternative definitions for research information unrelated to treatment. A large number of commenters were concerned that the definition of research information unrelated to treatment was vague and unclear and, therefore, would be difficult or impossible to apply. These commenters asserted that in many instances it would not be feasible to ascertain whether research information bore some relation to treatment. In addition, several commenters asserted that the need for distinguishing research information unrelated to treatment from other forms of protected health information was not necessary because the proposed rule's general restrictions for the use and disclosure of protected health information and the existing protections for research information were sufficiently strong. Of the commenters who supported the proposed distinction between research information related and unrelated to treatment, very few supported the proposed definition of research unrelated to treatment."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 292}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 437)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nprocedures. It does not apply to medical records. Comments: Comments on the six year retention period were mixed. Some commenters endorsed the six-year retention period for maintaining documentation.\nOne of the comments stated this retention period would assist physicians legally. Other commenters believed that the retention period would be an undue burden. One commenter noted that most State Board of Pharmacy regulations require\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\npharmacies to keep records for two years, so the six year retention period would triple document retention costs. Response: We established the retention period at six years because this is the statute of limitations for the civil monetary penalties. This rule does not apply to all pharmacy records, but only to the documentation required by this rule. ## Section 164.530(k)-Group Health Plans\n\nThere were no comments directly about this section because it was not included in the proposed rule. ## Section 164.532-Transition Provisions\n\nComment: Commenters urged the Department to clarify whether the ''reach of the transition requirement'' is limited to a particular time frame, to the provider's activities in a particular job, or work for a particular employer. For example, one commenter questioned how long a nurse is a covered entity after she moves from a job reviewing files with protected health information to an administrative job that does not handle protected health information; or whether an occupational health nurse who used to transmit first reports of injury to her company's workers' compensation carrier last year but no longer does so this year because of a carrier change still is a covered entity. Response: Because this comment addresses a question of enforcement, we will address it in the enforcement regulation."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 436}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 205)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nsociate to carry out a health care operations function and the covered entity has a data use agreement with the business associate that complies with § 164.514(e)(4) and §164.314(a)(1), if applicable.\n- (4) Implementation specifications: Other requirements for contracts and other arrangements. (i) The contract or other arrangement between the covered entity and the business associate may permit the business associate to use the protected health information received by the business associate in its capacity as a business associate to the covered entity, if necessary:\n- (A) For the proper management and administration of the business associate; or\n- (B) To carry out the legal responsibilities of the business associate. - (ii) The contract or other arrangement between the covered entity and the business associate may permit the business associate to disclose the protected health information received by the business associate in its capacity as a business associate for the purposes described in paragraph (e)(4)(i) of this section, if:\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00134\n\n- (A) The disclosure is required by law; or\n- (B)( 1 ) The business associate obtains reasonable assurances from the person to whom the information is disclosed that it will be held confidentially and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person; and\n- ( 2 ) The person notifies the business associate of any instances of which it is aware in which the confidentiality of the information has been breached. - (5) Implementation specifications: Business associate contracts with subcontractors. The requirements of §164.504(e)(2) through (e)(4) apply to the contract or other arrangement required by § 164.502(e)(1)(ii) between a business associate and a business associate that is a subcontractor in the same manner as such requirements apply to contracts or other arrangements between a covered entity and business associate."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 204}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 518)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\norganized health care arrangement and that have a joint notice under §164.520(d) may comply with this section by a joint consent. - (2) Implementation specifications: Requirements for joint consents.\n(i) A joint consent must:\n- (A) Include the name or other specific identification of the covered entities, or classes of covered entities, to which the joint consent applies; and\n- (B) Meet the requirements of this section, except that the statements required by this section may be altered to reflect the fact that the consent covers more than one covered entity. - (ii) If an individual revokes a joint consent, the covered entity that receives the revocation must inform the other entities covered by the joint consent of the revocation as soon as practicable. ## § 164.508 Uses and disclosures for which an authorization is required. - (a) Standard: Authorizations for uses and disclosures. (1) Authorization required: General rule. Except as otherwise permitted or required by this subchapter, a covered entity may not use or disclose protected health information without an authorization that is valid under this section. When a covered entity obtains or receives a valid authorization for its use or disclosure of protected health information, such use or disclosure must be consistent with such authorization. - (2) Authorization required: psychotherapy notes."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 517}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 117)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nd entities and business associates, we have removed the harm standard and modified the risk assessment to focus more objectively on the risk that the protected health information has been compromised.\nThus, breach notification is not required under the final rule if a covered entity or business associate, as applicable, demonstrates through a risk assessment that there is a low probability that the protected health information has been compromised, rather than demonstrate that there is no significant risk of harm to the individual as was provided under\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with the interim final rule. The final rule also identifies the more objective factors covered entities and business associates must consider when performing a risk assessment to determine if the protected health information has been compromised and breach notification is necessary. Although some commenters urged us to implement a bright line standard, requiring notification for all impermissible uses and disclosures without any assessment of risk, we believe that a risk assessment is necessary. The statute acknowledges, by including a specific definition of breach and identifying exceptions to this definition, as well as by providing that an unauthorized acquisition, access, use, or disclosure of protected health information must compromise the security or privacy of such information to be a breach, that there are several situations in which unauthorized acquisition, access, use, or disclosure of protected health information is so inconsequential that it does not warrant notification. In addition to the statutory exceptions that have been included in both the interim final rule and this final rule, there may be other similar situations that do not warrant breach notification."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 116}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 264)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nate protected health information over which the minor maintains control from protected health information with respect to which the minor's parent has rights as a personal representative of the minor.\nA covered provider may disclose protected health information to a parent, regardless of a confidentiality agreement, if there is an imminent threat to the minor or another person, in accordance with § 164.512(j)(1)(i). Comment: Several commenters suggested that we add a provision in the final rule to provide minors and parents with concurrent rights under certain circumstances, particularly when the minor reaches 16 years of age or when a parent authorizes his or her minor child to exercise these rights concurrently. Response: We do not add such provision in the final rule. We believe that establishing concurrent rights through this rule could result in problems that effect the quality of health care if the minor and the parent were to disagree on the exercise of their rights. The rule would not prevent a parent from allowing a minor child to make decisions about his or her protected health information and acting consistently with the minor's decision. In all cases, either the parent has the right to act for the individual with respect to protected health information, or the minor has the right to act for himself or herself. The rule does not establish concurrent rights for parents and minors. Comment: Commenters requested clarification about the rights of an adult or emancipated minor with respect to protected health information concerning health care services rendered while the person was an unemancipated minor. 7 Confidentiality in Adolescent Health Care, a joint policy statement of the American Academy of Pediatrics; the American Academy of Family Physicians; the American College of Obstetricians and Gynecologists; NAACOG-The Organization for Obstetric, Gynecologic, and Neonatal Nurses; and the National Medical Association."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 263}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 513)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nunctions of a health plan, health care provider, or health care clearinghouse, the affiliated covered entity complies with paragraph (g) of this section. (e)(1) Standard: Business associate contracts.\n(i) The contract or other arrangement between the covered entity and the business associate required by §164.502(e)(2) must meet the requirements of paragraph (e)(2) or (e)(3) of this section, as applicable. (ii) A covered entity is not in compliance with the standards in §164.502(e) and paragraph (e) of this section, if the covered entity knew of a pattern of activity or practice of the business associate that constituted a material breach or violation of the business associate's obligation under the contract or other arrangement, unless the covered entity took reasonable steps to cure the breach or end the violation, as applicable, and, if such steps were unsuccessful:\n\n(A) Terminated the contract or arrangement, if feasible; or\n\n(B) If termination is not feasible, reported the problem to the Secretary. (2) Implementation specifications: Business associate contracts. A contract between the covered entity and a business associate must:\n\n(i) Establish the permitted and required uses and disclosures of such information by the business associate. The contract may not authorize the business associate to use or further disclose the information in a manner that would violate the requirements of this subpart, if done by the covered entity, except that:\n\n(A) The contract may permit the business associate to use and disclose protected health information for the proper management and administration of the business associate, as provided in paragraph (e)(4) of this section; and\n\n(B) The contract may permit the business associate to provide data aggregation services relating to the health care operations of the covered entity."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 512}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "When must a HIPAA breach be reported to HHS?"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron Applied Cybersecurity Division Information Technology Laboratory\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\nFebruary 2024\n\n<!-- image -->\n\nU.S. Department of Commerce Gina M. Raimondo, Secretary\n\nNational Institute of Standards and Technology\n\nCertain commercial equipment, instruments, software, or materials, commercial or non-commercial, are identified in this paper in order to specify the experimental procedure adequately. Such identification does not imply recommendation or endorsement of any product or service by NIST, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose. There may be references in this publication to other publications currently under development by NIST in accordance with its assigned statutory responsibilities. The information in this publication, including concepts and methodologies, may be used by federal agencies even before the completion of such companion publications. Thus, until each publication is completed, current requirements, guidelines, and procedures, where they exist, remain operative. For planning and transition purposes, federal agencies may wish to closely follow the development of these new publications by NIST. Organizations are encouraged to review all draft publications during public comment periods and provide feedback to NIST."}], "metadata": {"source": "nist_sp800-66r2", "type": "breach_notification", "cfr_section": "§164.400-414"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 14)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nthis proposal. Additional comments received on this issue are discussed below in the section entitled, ''Response to Other Public Comments.''\n\nNumerous commenters supported the proposed modifications.\nGenerally, these commenters claimed the modifications would prevent inconvenience to consumers, and facilitate timely access to health care. Specifically, these commenters indicated that health care would be delayed and consumers would be inconvenienced if covered entities were required to obtain individual consent or\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00010\n\nauthorization before they could access health records that are newly acquired assets resulting from the sale, transfer, merger, or consolidation of all or part of a covered entity. Commenters further claimed that the administrative burden of acquiring individual permission and culling records of consumers who do not give consent would be too great, and would cause some entities to simply store or destroy the records instead. Consequently, health information would be inaccessible, causing consumers to be inconvenienced and health care to be delayed. Some commenters noted that the proposed modifications recognize the realities of business without compromising the availability or quality of health care or diminishing privacy protections one would expect in the handling of protected health information during the course of such business transactions. Opposition to the proposed modifications was limited, with commenters generally asserting that the transfer of records in such circumstances would not be in the best interests of individuals. Final Modifications. The Department agrees with the commenters that supported the proposed modifications and, therefore, adopts the modifications to the definition of health care operations."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 13}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 53)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nte subcontractors with the requirements for covered entities with regard to their business associates. We also proposed changes to the specific business associate agreement provisions at § 164.504(e).\nFirst, we proposed to revise § 164.504(e)(2)(ii)(B) through (D) to provide that the contract will require that: in (B), business associates comply, where applicable, with the Security Rule with regard to electronic protected health information; in (C), business associates report breaches of unsecured protected health information to covered entities, as required by § 164.410; and in (D), in accordance with § 164.502(e)(1)(ii), business associates ensure that any subcontractors that create or receive protected health information on behalf of the business associate agree to the same restrictions and conditions that apply to the business associate with respect to such information. These revisions were proposed to align the requirements for the business associate agreement with the requirements in the HITECH Act and elsewhere within the HIPAA Rules. Additionally, we proposed to add a new agreement provision at §164.504(e)(2)(ii)(H) (and to renumber the current paragraphs (H) and (I) accordingly) to requires that, to the extent the business associate is to carry out a covered entity's obligation under this subpart, the business associate must comply with the requirements of the Privacy Rule that apply to the covered entity in the performance of such obligation. This provision would clarify that when a covered entity delegates a responsibility under the Privacy Rule to the business associate, the business associate would be contractually required to comply with the requirements of the Privacy Rule in the same manner as they apply to the covered entity."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 52}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 40)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nt or omission complained of occurred, unless this time limit is waived by the Secretary for good cause shown. Sixth, §160.310(b) requires cooperation with investigations as well as compliance reviews.\nSeventh, § 160.310 (c)(1) provides that the Secretary must be provided access to a covered entity's facilities, books, records, accounts, and other sources of information, including\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00027\n\nprotected health information, at any time and without notice where exigent circumstances exist, such as where documents might be hidden or destroyed. Eighth, the provision proposed at § 164.522(d) that would prohibit covered entities from taking retaliatory action against individuals for filing a complaint with the Secretary or for certain other actions has been changed and moved to §164.530. Ninth, §160. 312(a)(2) deletes the reference in the proposed rule to using violation findings as a basis for initiating action to secure penalties. This deletion is not a substantive change. This language was removed because penalties will be addressed in the enforcement regulation. As in the NPRM, the Secretary may promulgate alternative procedures for complaints relating to national security. For example, to protect classified information, we may promulgate rules that would allow an intelligence community agency to create a separate body within that agency to receive complaints. The Department plans to issue an Enforcement Rule that applies to all of the regulations that the Department issues under the Administrative Simplification provisions of HIPAA. This regulation will address the imposition of civil monetary penalties and the referral of criminal cases where there has been a violation of this rule. Penalties are provided for under section 262 of HIPAA. The Enforcement Rule would also address the topics covered by Subpart C below. It is expected that this Enforcement Rule would replace Subpart C."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 39}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 170)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ne describe and delimit the exact nature of the exemption in the regulatory text. See § 164.500(b). We will monitor developments in this sector should the basic business-tobusiness relationship change.\nComment: A number of comments relate to the proposed definition of health care clearinghouse. Many commenters suggested that we expand the definition. They suggested that additional types of entities be included in the definition of health care clearinghouse, specifically medical transcription services, billing services, coding services, and ''intermediaries.'' One commenter suggested that the definition be expanded to add entities that receive standard transactions, process them and clean them up, and then send them on, without converting them to any standard format. Another commenter suggested that the health care clearinghouse definition be expanded to include entities that do not perform translation but may receive protected health information in a standard format and have access to that information. Another commenter stated that the list of covered entities should include any organization that receives or maintains individually identifiable health information. One organization recommended that we expand the health care clearinghouse definition to include the concept of a research data clearinghouse, which would collect individually identifiable health information from other covered entities to generate research data files for release as de-identified data or with appropriate confidentiality safeguards. One commenter stated that HHS had gone beyond Congressional intent by including billing services in the definition. Response: We cannot expand the definition of ''health care clearinghouse'' to cover entities not covered by the definition of this term in the statute. In the final regulation, we\n\nFrm 00112\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nmake a number of changes to address public comments relating to definition."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 169}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 13)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nsupport the risk analysis activities. As part of the risk assessment, FDA recommends threat modeling be performed throughout the design process and be inclusive of all medical device system elements.\n30 Details on the content for security risk management plans and reports beyond those specifically identified can be found in AAMI TIR57 Principles for medical device security-Risk management and ANSI/AAMI SW96 Standard for medical device security - Security risk management for device manufacturers . https://doi.org/10.2345/9781570208621.ch1\n\n31 While security architecture is likely captured as a component of the security risk management process, it is discussed separately for the purposes of this guidance due to the level of detail recommended to be provided by manufacturers in order to facilitate FDA review of the safety and effectiveness of the device. ## The threat model should:\n\n- Identify medical device system risks and mitigations as well as inform the pre- and post-mitigation risks considered as part of the cybersecurity risk assessment;\n- State any assumptions about the medical device system or environment of use (e.g., hospital networks are inherently hostile, therefore manufacturers are recommended to assume that an adversary controls the network with the ability to alter, drop, and replay packets); and\n- Capture cybersecurity risks introduced through the supply chain, manufacturing, deployment, interoperation with other devices, maintenance/update activities, and decommission activities that might otherwise be overlooked in a traditional safety risk assessment process. FDA recommends that premarket submissions include threat modeling documentation to demonstrate how the medical device system has been analyzed to identify potential security risks that could impact safety and effectiveness. There are a number of methodologies and/or combinations of methods for threat modeling that manufacturers may choose to use."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 12}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 31)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nituation will determine whether reputational harm has occurred, such as whether the unlawful disclosure resulted in adverse effects on employment, standing in the community, or personal relationships.\nWith respect to requests to consider\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00021\n\n''other'' harm or whether unauthorized access has occurred, we reiterate that, in determining the nature and extent of the harm involved, we may consider all relevant factors, not just those expressly included in the text of the regulation. Regarding the shift in terminology from ''history of violations'' to ''prior indications of noncompliance,'' we note that use of the terms ''violation'' or ''violate'' generally indicates that the Department has made a formal finding of a violation through a notice of proposed determination. Because the Department has a number of enforcement tools, such as informal resolution through a corrective action plan, the number of ''violations'' incurred by a covered entity or business associate does not constitute an accurate picture of a covered entity's or business associate's general history of compliance with all HIPAA Rules, which is relevant in determining the amount of a civil money penalty within the penalty range. See 71 FR 8390, 8408. As such, the Department modified the provision to reflect the Department's policy of considering the covered entity's or business associate's general history of compliance with the HIPAA Rules when determining a civil money penalty. With regard to the phrase ''indications of noncompliance,'' we first clarify that a mere complaint does not constitute an indication of noncompliance. Instead, prior indications of noncompliance may refer to the number of times the Department has investigated an entity in the past and discovered indications of noncompliance that the Department resolved by informal means, such as satisfactory corrective action voluntarily taken by the covered entity."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 30}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "When must a HIPAA breach be reported to HHS?"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\n## Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions\n\n## Guidance for Industry and Food and Drug Administration Staff\n\nDocument issued on June 27, 2025. A draft select update to this document was issued on March 13, 2024. This document supersedes 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,' issued September 27, 2023. For questions about this document regarding CDRH-regulated devices, contact CyberMed@fda.hhs.gov. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at industry.biologics@fda.hhs.gov. <!-- image -->\n\nU.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research\n\n## Public Comment\n\nYou may submit electronic comments and suggestions at any time for Agency consideration to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2021-D-1158. Comments may not be acted upon by the Agency until the document is next revised or updated. ## Additional Copies\n\n## CDRH\n\nAdditional copies are available from the Internet. You may also send an email request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number GUI00001825 and complete title of the guidance in the request."}], "metadata": {"source": "fda_premarket_2023", "type": "breach_notification", "cfr_section": "§164.400-414"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 302)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nJkt 194001\n\nPO 00000\n\nFrm 00200\n\nof the authorization. For example, a valid authorization could expire upon the individual's disenrollment from a health plan or upon termination of a research project.\nWe prohibit an authorization from having an indeterminate expiration date. These changes were intended to address situations in which a specific date for the termination of the purpose for the authorization is difficult to determine. An example may be a research study where it may be difficult to predetermine the length of the project. Comment: A few commenters requested that the named insured be permitted to sign an authorization on behalf of dependents. Response: We disagree with the commenter that a named insured should always be able to authorize uses and disclosures for other individuals in the family. Many dependents under group health plans have their own rights under this rule, and we do not assume that one member of a family has the authority to authorize uses or disclosures of the protected health information of other family members. A named insured may sign a valid authorization for an individual if the named insured is a personal representative for the individual in accordance with § 164.502(g). The determination of whether an individual is a personal representative under this rule is based on other applicable law that determines when a person can act on behalf of an individual in making decisions related to health care. This rule limits a person's rights and authorities as a personal representative to only the protected health information relevant to the matter for which he or she is a personal representative under other law. For example, a parent may be a personal representative of a child for most health care treatment and payment decisions under state law. In that case, a parent, who is a named insured for her minor child, would be able to provide authorization with respect to most protected health information about her dependent child."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 301}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 187)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nmmon for new federal requirements to necessitate an examination by the regulated entities of the interaction between existing state law and the federal requirements incident to coming into compliance.\nWe agree, however, that the case is different where the Secretary has affirmatively acted, either through granting an exception under section 1178(a)(2)(A) or by making a specific determination about the effect of a particular state privacy law in, for example, the course of determining an entity's compliance with the privacy standards. As is discussed below, the Department intends to make notice of exception determinations that it makes routinely available. We do not agree with the comments suggesting that compliance by covered entities be delayed pending completion of an analysis by the Secretary and that states be required to certify agreement with the Secretary's analysis, as we are not institutionalizing the advisory opinion/analysis process upon which these comments are predicated. Fmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nFurthermore, with respect to the suggestion regarding delaying the compliance date, Congress provided in section 1175(b) of the Act for a delay in when compliance is required to accommodate the needs of covered entities to address implementation issues such as those raised by these comments. With respect to the suggestion regarding requiring states to certify their agreement with the Secretary's analysis, we have no authority to do this. Comment: Several commenters criticized the proposed provision for annual publication of determinations and advisory opinions in the Federal Register as inadequate. They suggested that more frequent notices should be made and the regulation be changed accordingly, to provide for publication either quarterly or within a few days of a determination."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 186}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 213)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nts whenever possible, which includes allowing covered entities a reasonable amount of time to work with the Secretary to come into compliance before initiating action to seek civil monetary penalties.\nSection 160.306(b)(3)-Requiring That Complaints Be Filed With the Secretary Within a Certain Period of Time\n\nComment: A number of commenters, primarily privacy and disability advocacy organizations, suggested that\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nthe regulation require that complaints be filed with the Secretary by a certain time. These commenters generally recommended that the time period for filing a complaint should commence to run from the time when the individual knew or had reason to know of the violation or omission. Another comment suggested that a requirement to file a complaint with the Secretary within 180 days of the alleged noncompliance is a problem because a patient may, because of his or her medical condition, be unable to access his or her records within that time frame. Response: We agree with the commenters that complainants should generally be required to submit complaints in a timely fashion. Federal regulations implementing Title VI of the Civil Rights Act of 1964 provide that ''[a] complaint must be filed not later than '180 days from the date of the alleged discrimination' unless the time for filing is extended by the responsible Department official or his designee.'' 45 CFR 80.7(b). Other civil rights laws, such as the Age Discrimination Act, section 504 of the Rehabilitation Act, and Title II of the Americans with Disabilities Act (ADA) (state and local government services), also use this approach. Under civil rights laws administered by the EEOC, individuals have 180 days of the alleged discriminatory act to file a charge with EEOC (or 300 days if there is a state or local fair employment practices agency involved)."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 212}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 71)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nn. Most group health plans are also regulated under the Employee Retirement Income Security Act of 1974 (ERISA). Under ERISA, a group health plan must be a separate legal entity from its plan sponsor.\nERISA-covered group health plans usually do not have a corporate presence, in other words, they may not have their own employees and sometimes do not have their own assets ( i.e., they may be fully insured or the benefits may be funded through the general assets of the plan sponsor, rather than through a trust). Often, the only tangible evidence of the existence of a group health plan is the contractual agreement that describes the rights and responsibilities of covered participants, including the benefits that are offered and the eligible recipients. ERISA requires the group health plan to identify a ''named fiduciary,'' a person responsible for ensuring that the plan is operated and administered properly and with ultimate legal responsibility for the plan. If the plan documents under which the group health plan was established and is maintained permit, the named fiduciary may delegate certain responsibilities to trustees and may hire advisors to assist it in carrying out its functions. While generally the named fiduciary is an individual, it may be another entity. The plan sponsor or employees of the plan sponsor are often the named fiduciaries. These structural and operational relationships present a problem in our ability to protect health information from being used inappropriately in employment-related decisions. On the one hand, the group health plan, and any health insurance issuer or HMO providing health insurance or health coverage to the group health plan, are covered entities under the regulation and may only disclose protected health information as authorized under the\n\nFrm 00047\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nregulation or with individual consent."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 70}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 228)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nnformation created or received by a researcher. They reasoned that it is important to ensure that researchers using personally identifiable health information are subject to federal privacy standards.\nThey also stated that if information created by a school regarding the health status of its students could be labeled ''health information,'' then information compiled by a clinical researcher regarding an individual also should be considered health information. Response: We are restricted to the statutory limits of the terms. The Congress did not include information created or received by a researcher in either definition, and, consequently, we do not include such language in the rule's definitions. Comment: Several commenters suggested modifying the definition of individually identifiable health information to state as a condition that the information provide a direct means of identifying the individual. They commented that the rule should support the need of those ( e.g., researchers) who need ''ready access to health information * * * that remains linkable to specific individuals.''\n\nResponse: The Congress included in the statutory definition of individually identifiable health information the modifier ''reasonable basis'' when describing the condition for determining whether information can be used to identify the individual. Congress thus intended to go beyond ''direct'' identification and to encompass circumstances in which a reasonable likelihood of identification exists. Even after removing ''direct'' or ''obvious'' identifiers of information, a risk or probability of identification of the subject of the information may remain; in some instances, the risk will not be inconsequential. Thus, we agree with the Congress that ''reasonable basis'' is the appropriate standard to adequately protect the privacy of individuals' health information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 227}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 32)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nor example, ''Partition rulebased access controls,'' and the development of new access control technology. Response: We agree with the commenters that other types of access controls should be allowed.\nThere was no intent to limit the implementation features to the named technologies and this final rule has been reworded to make it clear that use of any appropriate access control mechanism is allowed. Proposed implementation features titled ''Context-based access,'' ''Role-based access,'' and ''User-based access'' have been deleted and the access control standard at § 164.312(a)(1) states the general requirement. b. Comment: A large number of comments were received objecting to the identification of ''Automatic logoff'' as a mandatory implementation feature. Generally the comments asked that we not be so specific and allow other forms of inactivity lockout, and that this type\n\nVerDate Jan&lt;31&gt;2003\n\nof feature be made optional, based more on the particular configuration in use and a risk assessment/analysis. Response: We agree with the comments that mandating an automatic logoff is too specific. This final rule has been written to clarify that the proposed implementation feature of automatic logoff now appears as an addressable access control implementation specification and also permits the use of an equivalent measure. c. Comment: We received comments asking that encryption be deleted as an implementation feature and stating that encryption is not required for ''data at rest.''\n\nResponse: The use of file encryption is an acceptable method of denying access to information in that file. Encryption provides confidentiality, which is a form of control. The use of encryption, for the purpose of access control of data at rest, should be based upon an entity's risk analysis. Therefore, encryption has been adopted as an addressable implementation specification in this final rule. d."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 31}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 23)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nll impose a civil money penalty upon a covered entity if the Secretary determines that the covered entity violated an\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00016\n\nadministrative simplification provision.\nSection 164.402, in paragraphs (b) and (c), provides the basis for a civil money penalty against a covered entity where more than one covered entity is responsible for a violation, where an affiliated covered entity is responsible for a violation, and where an agent of a covered entity is responsible for a violation. The proposed rule proposed to remove the exception at § 160.402(c) for covered entity liability for the acts of its agent in cases where the agent is a business associate, the relevant contract requirements have been met, the covered entity did not know of a pattern or practice of the business associate in violation of the contract, and the covered entity did not fail to act as required by the Privacy or Security Rule with respect to such violations. The proposed rule also proposed to add a parallel provision in a new paragraph (2) at § 160.402(c) that would provide for civil money penalty liability against a business associate for the acts of its agent. The existing language of §160.402(c) regarding the liability of covered entities for the acts of their agents would be re-designated as paragraph (1). These proposed changes would make covered entities and business associates liable under § 160.402(c) for the acts of their business associate agents, in accordance with the Federal common law of agency, regardless of whether the covered entity has a compliant business associate agreement in place."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 22}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "How should organizations implement administrative controls?"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\n<!-- image -->\n\n## NIST Special Publication 800 NIST SP 800-66r2\n\n## Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule\n\nA Cybersecurity Resource Guide\n\nJeffrey A. Marron Applied Cybersecurity Division Information Technology Laboratory\n\nThis publication is available free of charge from: https://doi.org/10.6028/NIST.SP.800-66r2\n\nFebruary 2024\n\n<!-- image -->\n\nU.S. Department of Commerce Gina M. Raimondo, Secretary\n\nNational Institute of Standards and Technology\n\nCertain commercial equipment, instruments, software, or materials, commercial or non-commercial, are identified in this paper in order to specify the experimental procedure adequately. Such identification does not imply recommendation or endorsement of any product or service by NIST, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose. There may be references in this publication to other publications currently under development by NIST in accordance with its assigned statutory responsibilities. The information in this publication, including concepts and methodologies, may be used by federal agencies even before the completion of such companion publications. Thus, until each publication is completed, current requirements, guidelines, and procedures, where they exist, remain operative. For planning and transition purposes, federal agencies may wish to closely follow the development of these new publications by NIST. Organizations are encouraged to review all draft publications during public comment periods and provide feedback to NIST."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_type": "administrative", "implementation_spec": "both", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 179)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhus, the WIC program is not a health plan for purposes of this rule. The program of health care services for individuals detained by the INS provides health care directly, and so is not a health plan.\nSimilarly, the family planning program authorized by Title X of the Public Health Service Act pays for care exclusively through grants, and so is not a health plan under this rule. These programs (the grantees under the Title X program) may be or include health care\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00118\n\nproviders and may be covered entities if they conduct standard transactions. We further clarify that, where a public program meets the definition of ''health plan,'' the government agency that administers the program is the covered entity. Where two agencies administer a program jointly, they are both a health plan. For example, both the Health Care Financing Administration and the insurers that offers a Medicare+Choice plan are ''health plans'' with respect to Medicare beneficiaries. An agency that does not administer a program but which provides services for such a program is not a covered entity by virtue of providing such services. Whether an agency providing services is a business associate of the covered entity depends on whether its functions for the covered entity meet the definition of business associate in § 164.501 and, in the example described by this comment, in particular on whether the arrangement falls into the exception in §164.504(e)(1)(ii)(C) for government agencies that collect eligibility or enrollment information for covered government programs. Comment: Some commenters expressed support for retaining the category in paragraph (16) of the proposal's definition: ''Any other individual or group health plan, or combination thereof, that provides or pays for the cost of medical care.'' Others asked that the Secretary clarify this category."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 178}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 433)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ng complaints, for at least six years from the date of creation. Comments: Some commenters objected to the need for covered entities to have at least one employee, if not more, to deal with complaints.\nThey felt that this would be costly and is redundant in light of the designation of a contact person to receive complaints. Response: We do not require assignment of dedicated staff to handle complaints. The covered entity can determine staffing based on its needs and business practices. We believe that consumers need one clear point of contact for complaints, in order that this provision effectively inform consumers how to lodge complaints and so that the compliant will get to someone who knows how to respond. The contact person (or office) is for receipt of complaints, but need not handle the complaints. ## Section 164.530(e)-Sanctions\n\nComment: Commenters argued that most covered entities already have strict sanctions in place for violations of a patient's privacy, either due to current laws, contractual obligations, or good operating practices. Requiring covered entities to create a formal sanctioning process would be superfluous. Response: We believe it is important for the covered entity to have these sanction policies and procedures documented so that employees are aware of what actions are prohibited and punishable. For entities that already have sanctions policies in place, it should not be problematic to document those policies. We do not define the particular sanctions that covered entities must impose. Comment: Several commenters agreed that training should be provided and expectations should be clear so that individuals are not sanctioned for doing things that they did not know were wrong or inappropriate. A good faith exception should be included in the final rule to protect these individuals. Response: We agree that employees should be trained to understand the covered entity's expectations and understand the consequences of any violation."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 432}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 2)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\ne frequently than once every 12 months. However, modifications are permitted during the first year after adoption of the standards if the changes are necessary to permit compliance with the standards.\nHIPAA also provides that compliance with modifications to standards or implementation specifications must be accomplished by a date designated by the Secretary, which may not be earlier than 180 days after the adoption of the modification. ## B. Regulatory and Other Actions to Date\n\nHHS published a proposed Rule setting forth privacy standards for individually identifiable health information on November 3, 1999 (64 FR 59918). The Department received more than 52,000 public comments in response to the proposal. After reviewing and considering the public comments, HHS issued a final Rule (65 FR 82462) on December 28, 2000, establishing ''Standards for Privacy of Individually Identifiable Health Information'' (''Privacy Rule''). In an era where consumers are increasingly concerned about the privacy of their personal information, the Privacy Rule creates, for the first time, a floor of national protections for the privacy of their most sensitive information-health information. Congress has passed other laws to protect consumers' personal information contained in bank, credit card, other financial records, and even video rentals. These health privacy protections are intended to provide consumers with similar assurances that their health information, including genetic information, will be properly protected. Under the Privacy Rule, health plans, health care clearinghouses, and certain health care providers must guard against misuse of individuals' identifiable health information and limit the sharing of such information, and consumers are afforded significant new rights to enable them to understand and control how their health information is used and disclosed."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 1}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 314)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nity to comply with its existing legal obligations. Comment: A number of commenters recommended that the rule compel covered entities to use or disclose protected health information as required by law.\nThey expressed concern that covered entities could refuse or delay compliance with legally mandated disclosures by misplaced reliance on a rule that permits, but does not require, a use or disclosure required by other law. Response: We do not agree that the final rule should require covered entities to comply with uses or disclosures of protected health information mandated by law. The\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\npurpose of this rule is to protect privacy, and to allow those disclosures consistent with sound public policy. Consistent with this purpose, we mandate disclosure only to the individual who is the subject of the information, and for purposes of enforcing the rule. Where a law imposes a legal duty on the covered entity to use or disclose protected health information, it is sufficient that the privacy rule permit the covered entity to comply with such law. The enforcement of that legal duty, however, is a matter for that other law. ## Section 164.512(b)-Uses and Disclosures for Public Health Activities\n\nComment: Several non-profit entities commented that medical records research by nonprofit entities to ensure public health goals, such as diseasespecific registries, would not have been covered by this provision. These organizations collect information without relying on a government agency or law. Commenters asserted that such activities are essential and must continue. They generally supported the provisions allowing the collection of individually identifiable health information without authorization for registries. One stated that both governmental and non-governmental cancer registries should be exempt from the regulation."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 313}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 100)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nthat the final rule make it the priority of the business associate to inform the provider that they are acting as the business associate of the health plan to ensure provider compliance with the rule.\nOther comments misconstrued the preamble statements on this issue and commented that a provider should be allowed to provide restricted protected health information to its own business associates. Response: A provider that is prohibited from disclosing protected health information to a health plan may not disclose such information to the health plan's business associate. We do not include a requirement that the business associate inform the provider that they are acting as a business associate of the health plan as it is the provider's responsibility to know to whom and for what purposes it is making a disclosure. We also clarify that a provider is not prohibited from disclosing protected health information restricted from a health plan to its own business associates for the provider's own purposes. Comment: One commenter expressed concern about the number of workforce members who must know about the restriction and indicated that this may create a risk for potential error with regard to the information. Response: Covered entities must identify those workforce members or class of persons who need access to particular protected health information, and appropriately train their workforce members as necessary to comply with these new requirements. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with\n\n10. Section 164.524-Access of Individuals to Protected Health Information\n\n## Proposed Rule\n\nSection 164.524 of the Privacy Rule currently establishes, with limited exceptions, an enforceable means by which individuals have a right to review or obtain copies of their protected health information to the extent such information is maintained in the designated record set(s) of a covered entity."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 99}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 44)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nduring evaluation. | • Has the organization documented policies and procedures for conducting the evaluation of security controls? • Have management, operational, and technical issues been considered?\n• Do the elements of each evaluation procedure (e.g., questions, statements, or other components) address individual, measurable security safeguards for ePHI? • Has the organization developed evaluation procedures that capture any desired metrics or measurements? |\n\n78 See Sec. 5.2.1, HIPAA Standard: Facility Access Controls , and Sec. 5.3.1, HIPAA Standard: Access Control. 79  Organizations may wish to review and employ, where reasonable and appropriate, security control assessment procedures found in NIST [SP 800-53A], Rev.5, Assessing Security and Privacy Controls in Information Systems and Organizations . 80 See Sec. 5.5.1, HIPAA Standard: Policies and Procedures."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 43}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 340)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nalance between protecting victims and providing law enforcement access to information about potential crimes that cause harm to individuals, by waiving the requirement for agreement in two situations.\nIn allowing covered entities to disclose protected health information about a crime victim pursuant to a state or other mandatory reporting law, we defer to other governmental bodies' judgments on when certain public policy objectives are important enough to warrant mandatory disclosure of protected health information to law enforcement. While some mandatory reporting laws are written more broadly than others, we believe that it is neither appropriate nor practicable to distinguish in federal regulations between what we consider overly broad and sufficiently focused mandatory reporting laws. The final rule waives the requirement for agreement if the covered entity is unable to obtain the individual's agreement due to incapacity or other emergency circumstance, and (1) the law enforcement official represents that the information is needed to determine whether a violation of law by a person other than the victim has occurred and the information is not intended to be used against the victim; (2) the law enforcement official represents that immediate law enforcement activity that depends on the disclosure would be materially and adversely affected by waiting until the individual is able to agree to the disclosure; and (3) the covered entity determines, in the exercise of professional judgment, that the disclosure is in the individual's best interests. By allowing covered entities, in the exercise of professional judgment, to determine whether such disclosures are in the individual's best interests, the final rule recognizes the importance of the provider-patient relationship."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 339}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 75)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\no respond to actual issues that may arise during the implementation of these provisions and to provide the guidance necessary to address concerns of IRBs, Privacy Boards, and researchers in this area.\nComment: A few commenters requested elimination of the waiver element at § 164.512(i)(2)(ii)(A)(2) that would require the IRB or Privacy Board to determine that ''there is an adequate plan to destroy identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for their retention or such retention is required by law.'' These commenters argued that this requirement may lead to premature destruction of the data, which may hinder investigations of defective data analysis or research misconduct. Response: The waiver element at §164.512(i)(2)(ii)(A)(2) accounts for these concerns by permitting the retention of identifiers if there is a health or research justification, or if such retention is required by law. It is expected that IRBs and Privacy Boards will consider the need for continued analysis of the data, research, and possible investigations of research misconduct when considering whether this waiver element has been met. In addition, destroying identifiers at the\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00050\n\nearliest opportunity helps to ensure that the use or disclosure of protected health information will indeed pose no more than ''minimal risk to the privacy of individuals.'' Requiring the researcher to justify the need to retain patient identifiers provides needed flexibility for research, while maintaining the goal of protecting individuals' privacy interests. If additional issues arise after implementation, the Department can most appropriately address them through guidance."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 74}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "How should organizations implement physical controls?"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n## 45 CFR Parts 160 and 164\n\nRIN 0991-AB14\n\n## Standards for Privacy of Individually Identifiable Health Information\n\nAGENCY: Office for Civil Rights, HHS. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (''HHS'' or ''Department'') modifies certain standards in the Rule entitled ''Standards for Privacy of Individually Identifiable Health Information'' (''Privacy Rule''). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The purpose of these modifications is to maintain strong protections for the privacy of individually identifiable health information while clarifying certain of the Privacy Rule's provisions, addressing the unintended negative effects of the Privacy Rule on health care quality or access to health care, and relieving unintended administrative burdens created by the Privacy Rule. DATES: This final rule is effective on October 15, 2002. FOR FURTHER INFORMATION CONTACT: Felicia Farmer, 1-866-OCR-PRIV (1866-627-7748) or TTY 1-866-7884989. ## SUPPLEMENTARY INFORMATION:\n\nAvailability of copies, and electronic access. Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-866-5121800) or by fax to (202) 512-2250. The cost for each copy is $10.00."}], "metadata": {"source": "privacy_mod_2002", "safeguard_type": "physical", "implementation_spec": "required", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 398)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nd entity arranges for another person or entity to distribute the covered entity's notice on its behalf and individuals do not receive such notice, the covered entity would be in violation of the rule.\nComment: Some comments stated that covered providers without direct patient contact, such as clinical laboratories, might not have sufficient patient contact information to be able to mail the notice. They suggested we require or allow such providers to form agreements with referring providers or other entities to distribute notices on their behalf or to include their practices in the referring entity's own notice. Response: We agree with commenters' concerns about the potential administrative and financial burdens of requiring covered providers that have indirect treatment relationships with individuals, such as clinical laboratories, to distribute the notice. Therefore, we require these covered providers to provide the notice only upon request. In addition, these covered providers may elect to reach agreements with other entities distribute their notice on their behalf, or to participate in an organized health care arrangement that produces a joint notice. See §164.520(d) and the corresponding preamble discussion of joint notice requirements. Comment: Some commenters requested that covered health care providers be permitted to distribute their notice prior to an individual's initial visit so that patients could review the information in advance of the visit. They suggested that distribution in advance would reduce the amount of time covered health care providers' staff would have to spend explaining the notice to patients in the office."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 397}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 446)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\naccurate estimate of the costs likely to be borne as a result of the final regulation. Comment: One commenter estimated that simply training an employee could have a burdensome impact on his company.\nHe argued, for example, a 10hour annual requirement takes 0.5% of an employee's time if they work a 2000hour year, but factoring in sick and vacation leave, the effects of industry turnover could significantly increase the effect. Response: In the analysis below, the Department has factored in turnover rates, employment growth and greater utilization based on data obtained from broad-based surveys and a public comment. Comment: Some commenters felt that the regulatory training provisions are overly burdensome. Specific concerns centered around the requirement to train all individuals who may come in contact with protected health information and the requirement to have such individuals sign a new certifying statement at least every three years. Some commenters felt that the content of the training program should be left to the discretion of the covered entity. Response: Changes and clarifications in the training requirements are made in the final regulation, explained below. For example, the certification requirement has been eliminated. As in the NPRM, the content of the training program is left to the discretion of the covered entity. These changes are expected to lessen the training burden and are reflected in the final cost estimates. ## Compliance and Enforcement\n\nComment: A Member of Congress and a number of privacy and consumer groups expressed their concern with whether the Office for Civil Rights (OCR) in HHS has adequate funding to carry out the major responsibility of enforcing the complaint process established by this rule. The Member stated that ''[d]ue to the limited enforcement ability allowed for in this rule by HIPAA, it is essential that OCR have the capacity to enforce the regulations."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 445}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 22)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\njoint enterprise involving the covered entity. The change clarifies that in either instance the person performing the function or activity (or providing the specified service) is a business associate.\nWe also add language to the final rule that clarifies that the mere fact that two covered entities participate in an organized health care arrangement does not make either of the covered entities a business associate of the other covered entity. The fact that the entities participate in joint health care operations or other joint activities, or pursue common goals through a joint activity, does not mean that one party is performing a function or activity on behalf of the other party (or is providing a specified services to or for the other party). In general under this provision, actions relating to the protected health information of an individual undertaken by a business associate are considered, for the purposes of this rule, to be actions of the covered entity, although the covered entity is subject to sanctions under this rule only if it has knowledge of the wrongful activity and fails to take the required actions to address the wrongdoing. For example, if a business associate maintains the medical records or manages the claims system of a covered entity, the covered entity is considered to have protected health information and the covered entity must ensure that individuals who are the subject of the information can have access to it pursuant to § 164.524. The business associate relationship does not describe all relationships between covered entities and other persons or organizations."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 21}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 38)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\nough e-mail or postal mail, the interim final rule requires the\n\n15 Department of Labor, Occupational Employment Statistics; Healthcare Practitioner and Technical Occupations. http://www.bls.gov/oes/.\nVerDate Nov&lt;24&gt;2008\n\n15:01 Aug 21, 2009\n\nJkt 217001\n\nPO 00000\n\nentity to (1) publish a notice in the media (newspaper, television, or radio) containing the information contained in the mailed notice or post a notice on its Web site, and (2) set up a toll-free number. The toll-free number is to be included in the public notice and Web site. Based on the cost for publishing a public notice in the two leading newspapers, in the Washington, DC area, rates range between $2.91 and $15.23 per line. Based on these numbers, we estimate the cost of a public notice will cost between $80 and $400. Taking the mean of the range, we estimate an average price of $240 per notice. If we assume that a provider will publish two notices, the cost will be $480. Multiplying this amount by the number of breaches reported in 2008 for\n\nFrm 00025\n\nthe 10 to 499 and 500 or more groupings (70), yields $33,600. It is conceivable that some breaches involving more than 10 but fewer than 500 individuals may require notices in several states or jurisdictions. The probability of this event occurring, however, we believe, is low and we did not attempt to estimate the costs of such an event. If a HIPAA covered entity has a Web site, we assume there will be no cost to post the notice to the Web site. The cost of setting up a toll-free phone number is a straight forward process of contacting any one of a number of service providers who offer toll-free service. In checking the internet, we found prices for toll-free service ranging from $0.027 per minute for a basic mail box arrangement to $0.07 per minute. Some require a\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\24AUR2.SGM\n\n24AUR2\n\nerowe on DSK5CLS3C1PROD with RULES\\_2\n\nmonthly fee ranging from $10 to $15 per month."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 37}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 27)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nices must 'design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure . . .' (section 524B(b)(2) of the FD&amp;C Act).\nFDA considers related systems to include, among other things, manufacturer-controlled elements, such as other devices, software that performs 'other functions' as described in FDA's Guidance 'Multiple Function Device Products: Policy and Considerations,' software/firmware update servers, and connections to healthcare facility networks. In the design, development and maintenance of a cyber device, manufacturers should consider the cybersecurity risks of related systems to the cyber device and implement appropriate security controls to mitigate those risks. The documentation recommendations identified in this guidance and summarized in Appendix 4 should be considered and used to demonstrate reasonable assurance that the device and related systems are cybersecure as required by section 524B(b)(2) of the FD&amp;C Act. 66  See section 524B(b)(1) of the FD&amp;C Act. 67  See section 524B(b)(2) of the FD&amp;C Act. 68  See section 524B(b)(1) of the FD&amp;C Act. 69  See section 524B(b)(2) of the FD&amp;C Act. ## Contains Nonbinding Recommendations\n\n## 3. Software Bill of Materials (SBOM) (Section 524B(b)(3))\n\nSection 524B(b)(3) of the FD&amp;C Act requires manufacturers of cyber devices to provide an SBOM, including commercial, open-source, and off-the-shelf software components. To assist with complying with this requirement, we recommend that a cyber device provide SBOMs that contain the information recommended in Section V.A.4.b. ## D. Modifications\n\nAs previously stated, the requirements under section 524B of the FD&amp;C Act apply to a manufacturer who submits an application or submission under any of the following pathways510(k), PMA, PDP, De Novo or HDE-for a device that meets the definition of a cyber device."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 26}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 74)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n| Health Information Technology for Economic and Clinical Health (HITECH Act), title XIII of division A and title IV of division B of the American Recovery and Reinvestment Act of 2009 (ARRA), Pub. L.\n111-5, https://www.congress.gov/bill/111th-congress/house-bill/1/text                                                                                                                 |\n| [OMNIBUS]  | 'Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule,' Volume 78, Issue 17 (January 25, 2013), https://www.govinfo.gov/content/pkg/FR-2013-01-25/pdf/2013- 01073.pdf |\n| [Sec_3542] | 'Definitions,' Title 44 U.S. Code, Sec. 3542. 2011 ed. https://www.govinfo.gov/app/details/USCODE-2011-title44/USCODE-2011- title44-chap35-subchapIII-sec3542                                                                                                                                                                                                                                |\n| [Sec_Rule] | 45 CFR Part 160 and Part 164 Subparts A and C. Originally published as: 'Health Insurance Reform: Security Standards,' Volume 68, Issue 34, 8333 (February 20, 2003), https://www.govinfo.gov/app/details/FR-2003-02-20/03-3877. |\n\n## Appendix A. List of Symbols, Abbreviations, and Acronyms\n\nSelected acronyms and abbreviations used in this paper are defined below."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 73}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 9)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nty outputs of activities that are part and parcel of QS regulation compliance, and explain how the QS regulation can be leveraged to demonstrate these performance outputs. 17  See 21 CFR 820.30. ## B.\nDesigning for Security\n\nWhen reviewing premarket submissions, FDA intends to assess device cybersecurity based on a number of factors, including, but not limited to, the device's ability to provide and implement the security objectives below throughout the device architecture. The security objectives below generally may apply broadly to devices within the scope of this guidance, including, but not limited to, devices containing artificial intelligence (AI) and cloud-based services. ## Security Objectives:\n\n- Authenticity, which includes integrity;\n- Authorization;\n- Availability;\n- Confidentiality; and\n- Secure and timely updatability and patchability. Premarket submissions should include information that describes how the above security objectives are addressed by and integrated into the device design. The extent to which security requirements, architecture, supply chain, and implementation are needed to meet these objectives will depend on but may not be limited to:\n\n- The device's intended use, indications for use, and reasonably foreseeable misuse;\n- The presence and functionality of its electronic data interfaces;\n- Its intended and actual environment of use; 18\n- The risks presented by cybersecurity vulnerabilities;\n- The exploitability of the vulnerabilities; and\n- The risk of patient harm due to vulnerability exploitation. SPDF processes aim to reduce the number and severity of vulnerabilities and thereby reduce the exploitability of a medical device system and the associated risk of patient harm. Because exploitation of known vulnerabilities or weak cybersecurity controls should be considered reasonably foreseeable failure modes for medical device systems, these factors should be addressed in the device design."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 8}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 34)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nlop and test the original product to ensure updates and patches may be applied safely and in a timely manner. - Maintain necessary third-party licenses throughout the supported lifespan of the device.\nDevelop contingency plans for the possibility that a third-party company goes out of business or stops supporting a licensed product. Modular designs should be considered such that third-party solutions could be readily replaced. - Implement a secure process and mechanism for providing validated software updates and patches for users. ## Appendix 2. Submission Documentation for Security Architecture Flows\n\nIn premarket submissions, FDA recommends that manufacturers provide detailed information for the views identified in Section V.B.2. Methods for providing the views and the recommendations for the level of detail to provide are discussed in the sections below. In addition to diagrams and explanatory text, call-flow views can be provided to convey some of the information details expected to be addressed in the architecture views. ## A. Diagrams\n\nFDA recommends that manufacturers provide diagrams to help describe the medical device system architecture, interfaces, communication protocols, threats, and cybersecurity controls used throughout the system. Different diagramming methods can be used to describe the architecture, including data flow diagrams, state diagrams, swim-lane diagrams, and call-flow diagrams, among others. Architecture views should include diagram(s) with explanatory text that describes the sequence of process or protocol steps in explicit detail for an associated use case. Architecture views should provide specific protocol details of the communication pathways between parts of the medical device system, to include authentication or authorization procedures and session management techniques."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 33}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.404 require?"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\n§164.404(a)(1).\n\n## Breaches Treated as Discovered\n\nSection 164.404(a)(2) states that a breach shall be treated as discovered by a covered entity as of the first day the breach is known to the covered entity, or by exercising reasonable diligence would have been known to the covered entity. Thus, a covered entity is not liable for failing to provide notification in cases in which it is not aware of a breach unless the covered entity would have been aware of the breach had it exercised reasonable diligence. Section 164.404(a)(2) further provides that a covered entity is deemed to have knowledge"}], "metadata": {"source": "breach_notification_2009", "cfr_section": "§164.404", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 47)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ne made the following changes to the provisions of the August 12, 1998 proposed rule. Specifically, we have-\n\n- Removed information throughout the document pertaining to electronic signature standards.\nElectronic signature standards will be published in a separate final rule. - Changed the CFR part from 142 to 164. - Replaced the word ''requirement,'' when referring to a standard, with ''standard.'' Replaced ''Implementation feature'' with ''Implementation specification.''\n- Modified numerous implementation features so that they are now addressable rather than mandatory. - Made minor modifications to the text throughout the document for purposes of clarity. - Removed the word ''formal'' when referring to documentation. - •\n- Revised the phrase ''health information pertaining to an individual'' to ''electronic protected health information.''\n- Added the following definitions to §160.103: ''Disclosure,'' ''Electronic protected health information,'' ''Electronic media,'' ''Organized health care arrangement,'' and ''Use.''\n- Removed the following definitions from proposed § 142.103 since they are pertinent to other administrative simplification regulations and are defined elsewhere: code set, health care clearinghouse, health care provider, health information, health plan, medical care, small health plan, standard, and transaction. - Removed proposed §142.101 as this information is conveyed in § 160.101 and §160.102 of the Privacy Rule (65 FR 82798). Removed proposed §142.102 as it is redundant. - Moved the following definitions from § 164.501 to § 164.103 (proposed §142.103): '' ''Plan sponsor'' and ''Protected health information.'' Added definitions of ''Covered functions'' and ''Required by law.''\n- Removed proposed §142.106, ''Effective dates of a modification to a standard or implementation specification,'' since this information is\n\n17:54 Feb 19, 2003\n\nPO 00000\n\nFrm 00033\n\n- covered in the ''Standards for Electronic Transactions'' final rule (65 FR 50312)."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 46}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 77)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nst of, healthcare; or\n- (B) Whose principal activity is:\n- (1) The direct provision of healthcare to persons; or\n- (2) The making of grants to fund the direct provision of healthcare to persons. [Sec.\nRule, §160.103]\n\n## hybrid entity\n\nA single legal entity:\n\n- (1) That is a covered entity;\n- (2) Whose business activities include both covered and non-covered functions; and\n- (3) That designates healthcare components in accordance with paragraph § 164.105(a)(2)(iii)(D). ## implementation specification\n\nSpecific requirements or instructions for implementing a standard. [Sec. Rule, §160.103]\n\n## individually identifiable health information (IIHI)\n\nInformation that is a subset of health information, including demographic information collected from an individual, and:\n\n- (1) Is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and\n- (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual; and\n3. (i) That identifies the individual; or\n4. (ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual. [Sec. Rule, §160.103]\n\n## information security\n\nProtecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide-\n\n- (A) integrity, which means guarding against improper information modification or destruction, and includes ensuring information non-repudiation and authenticity;\n- (B) confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and\n- (C) availability, which means ensuring timely and reliable access to and use of information. [44 U.S.C., Sec."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 76}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 17)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\nthat the notification should describe the steps the covered entity is taking to mitigate potential harm to the individual resulting from the breach and that such harm is not limited to economic loss.\nUnder these content requirements, for example, and depending on the\n\nVerDate Nov&lt;24&gt;2008\n\ncircumstances, the notice to the individual may include recommendations that the individual contact his or her credit card company and information about how to contact the credit bureaus and obtain credit monitoring services (if credit card information was breached); information about steps the covered entity is taking to retrieve the breached information, such as filing a police report (if a suspected theft of unsecured protected health information occurred); information about steps the covered entity is taking to improve security to prevent future similar breaches; and information about sanctions the covered entity imposed on workforce members involved in the breach. Some commenters recommended that we impose a page limitation on the length of the notice (e.g., one page in length) and ensure the content of the notice is non-technical and noncomplex so individuals can easily understand the information being provided. We agree that it is important for individuals to be able to understand the information being provided to them in the breach notifications and thus, at §164.404(c)(2) of the interim final rule, include a requirement that such notifications be written in plain language. To satisfy this requirement, the covered entity should write the notice at an appropriate reading level, using clear language and syntax, and not include any extraneous material that might diminish the message it is trying to convey. We do not impose a page limitation, however, so as not to constrain covered entities in including in the notifications the information they believe could be helpful to individuals."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 16}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 38)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nbject to ADA confidentiality restrictions, as well as this privacy regulation. See Carparts Distribution Center, Inc. v. Automotive Wholesaler's\n\nAssociation of New England, Inc., 37 F.3d 12 (1st Cir.\n1994)(setting forth three bases for ADA Title I jurisdiction over an employer-provided medical reimbursement plan, in a discrimination challenge to the plan's HIV/AIDS cap). Transmission of applicant or employee health information by the employer's management to the group health plan may be permitted under the ADA standards as the use of medical information for insurance purposes. Similarly, disclosure of such medical information by the group health plan, under the limited circumstances permitted by this privacy regulation, may involve use of the information for insurance purposes as broadly described in the ADA discussion above. Entities that receive federal financial assistance, which may also be covered entities under the privacy regulation, are subject to section 504 of the Rehabilitation Act (29 U.S.C. 794) and its implementing regulations. Each federal agency has promulgated such regulations that apply to entities that receive financial assistance from that agency (''recipients''). These regulations may limit the disclosure of medical information about persons who apply to or participate in a federal financially assisted program or activity. For example, the Department of Labor's section 504 regulation (found at 29 CFR part 32), consistent with the ADA standards, requires recipients that conduct employment-related programs, including employment training programs, to maintain confidentiality regarding any information about the medical condition or history of applicants to or participants in the program or activity. Such information must be kept separate from other information about the applicant or participant and may be provided to certain specified individuals and entities, but only under certain limited circumstances described in the regulation."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 37}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 20)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nthat has only a USB interface. ## (a) Global System View\n\nA global system view should describe the overall medical device system, including the device itself and all internal and external connections.\nFor interconnected and networked devices, this view should identify all interconnected elements, including any software update infrastructure(s),\n\n## Contains Nonbinding Recommendations\n\nhealthcare facility network impacts, intermediary connections or devices, cloud connections, and patient home network impact. Depending on the complexity of the medical device system, it may not be feasible to include all data flow specifics in a singular global system view. Additional views can be provided that detail the communication specifics as recommended in Appendix 2 and do not need to be duplicated if captured in one of the other types of views detailed below. ## (b) Multi-Patient Harm View\n\nWhen devices are capable of connecting (wired or wirelessly) to another medical or non-medical product, to a network, or to the Internet, there is the possibility that multiple devices can be compromised simultaneously. Because of that connectivity, if a device is compromised, or if a non-device function (i.e., any function that does not fall within section 201(h) of the FD&amp;C Act) that could impact the device function is compromised, the device may introduce a safety risk to patients through security risk. This may change the device's functionality. For example, a nondevice function could be hacked to perform a device function and ultimately harm patients. Depending on the device risk and use environment, a multiple-device compromise may have severe impacts for multiple patients, either through impact to the device itself and/or to healthcare facility operations (e.g., multiparameter bedside monitors all restarting at once, leaving all monitors connected to the same network no longer monitoring patient vitals and staffing levels not able to monitor all patient vitals)."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 19}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 66)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n| Key Activities | Description | Sample Questions | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 3."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 65}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 12)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nrketing. The covered entity needs the individual's authorization to use or disclose protected health information for marketing communications, regardless of whether clinical information is to be used.\nComment: The proposed modification eliminated the § 164.514 requirements that permitted the use of protected health information to market healthrelated products and services without an authorization. In response to that proposed modification, many commenters asked whether covered entities would be allowed to make communications about ''health education'' or ''health promoting'' materials or services without an authorization under the modified Rule. Examples included communications about health improvement or disease prevention, new developments in the diagnosis or treatment of disease, health fairs, health/wellness-oriented classes or support groups. Response: The Department clarifies that a communication that merely promotes health in a general manner\n\nVerDate Aug&lt;2,&gt;2002\n\nand does not promote a specific product or service from a particular provider does not meet the general definition of ''marketing.'' Such communications may include population-based activities to improve health or reduce health care costs as set forth in the definition of ''health care operations'' at § 164.501. Therefore, communications, such as mailings reminding women to get an annual mammogram, and mailings providing information about how to lower cholesterol, about new developments in health care (e.g., new diagnostic tools), about health or ''wellness'' classes, about support groups, and about health fairs are permitted, and are not considered marketing. Comment: Some commenters asked whether they could communicate with beneficiaries about government programs or government-sponsored programs such as information about SCHIP; eligibility for Medicare/Medigap (e.g., eligibility for limited, six-month open enrollment period for Medicare supplemental benefits)."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 11}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 77)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nerned by other provisions of the Privacy Rule. We decline to include language in the final rule placing the burden of proof on the requestor to demonstrate they were involved in the individual's care.\nIn some cases, it will be readily apparent to the covered entity that a person is a family member or was involved in the individual's care prior to death because the person would have made themselves known to the covered entity prior to the individual's death by either visiting with or inquiring about the individual, or the individual would have identified such person as being involved in their care or payment for care to a member of the covered entity's workforce. In other cases, the covered entity need just have reasonable assurance that the person is a family member of the decedent or other person who was involved in the individual's care or payment for care prior to death. For example, the person may indicate to the covered entity how he or she is related to the decedent or offer sufficient details about the decedent's circumstances prior to death to indicate involvement in the decedent's care prior to death. As stated above, a covered entity that is uncomfortable disclosing protected health information under this provision because of questions about the person's\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with relationship to the decedent is not required to do so. Comment: Several commenters requested and offered suggested clarifications on the scope of the terms ''personal representative'' and ''family member.''\n\nResponse: The Privacy Rule already identifies the persons who qualify as a personal representative of a decedent at §164.502(g)(4). Further, this final rule includes a definition of ''family member'' at § 160.103."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 76}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 270)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\npport services would be a business associate of the Medicaid agency, but was unclear as to whether it would also constitute a health care component within its own agency. Response: We generally agree.\nWe expect that in most cases, government agencies that run health plans or provide health care services would typically meet the definition of a ''hybrid entity'' under § 164.504(a), so that such an agency would be required to designate the health care component or components that run the program or programs in question under §164.504(c)(3), and the rules would not apply to the remainder of the agency's operations, under § 164.504(b). In addition, we have created an exception to the business associate contract requirement for government agencies who perform functions on behalf of other government agencies. Government agencies can enter into a memorandum of understanding with another government entity or adopt a regulation that applies to the other government entity in lieu of a business associate contract, as long as the memorandum or regulation contains certain terms. See\n\n§164.504(e). Comment: One commenter representing an insurance company stated that different product lines should be treated separately under the rule. For example, the commenter argued, because an insurance company offers both life insurance and health insurance, it does not mean that the insurance company itself is a covered entity, rather only the health insurance component is a covered entity. Another commenter requested clarification of the use of the term ''product line'' in the proposed rule. This commenter stated that product line should differentiate between different lines of coverage such\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00179\n\nas life vs. health insurance, not different variations of the same coverage, such as HMO vs. PPO."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 269}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 405)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nare required to establish policies and procedures for providing individuals the right to request restrictions, including policies for who may agree to such restrictions on the covered entity's behalf.\nHospitals and other large entities that are concerned about employees agreeing to restrictions on behalf of the organization will have to make sure that their policies are communicated appropriately to those employees. The circumstances under which members of a covered entity's workforce can bind the covered entity are a function of other law, not of this regulation. Comment: Commenters expressed confusion about the intended effect of any agreed-upon restrictions on downstream covered entities. They asserted that it would be extremely difficult for a requested restriction to be followed through the health care system and that it would be unfair to hold covered entities to a restriction when they did not agree to such restriction. Specifically, commenters asked whether a covered provider that receives protected health information in compliance with this rule from a physician or medical group that has agreed to limit certain uses of the information must comply with the original restriction. Other commenters expressed concern that not applying a restriction to downstream covered entities is a loophole and that all downstream covered providers and health plans should be bound by the restrictions. Response: Under the final rule, a restriction that is agreed to between an individual and a covered entity is only binding on the covered entity that agreed to the restriction and not on downstream entities. It would also be binding on any business associate of the covered entity since a business associate can not use or disclose protected health information in any manner that a covered entity would not be permitted to use or disclose such information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 404}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 243)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nrule are more appropriate for protecting health information. However, we add provisions to the definition of payment which should address these concerns. See the definition of 'payment' in § 164.501.\nComment: An insurance company recommended that the rule require that medical records containing protected health information include a notation on a cover sheet on such records. Response: Since we have expanded the scope of protected health information, there is no need for covered entities to distinguish among their records, and such a notation is not needed. This uniform coverage eliminates the mixed record problem and resultant potential for confusion. Comment: A government agency requested clarification of the definition to address the status of information that flows through dictation services. Response: A covered entity may disclose protected health information for transcription of dictation under the definition of health care operations, which allows disclosure for ''general administrative'' functions. We view transcription and clerical services generally as part of a covered entity's general administrative functions. An entity transcribing dictation on behalf of a covered entity meets this rule's definition of business associate and may receive protected health information under a business associate contract with\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00161\n\nthe covered entity and subject to the other requirements of the rule. Comment: A commenter recommended that information transmitted for employee drug testing be exempted from the definition. Response: We disagree that is necessary to specifically exclude such information from the definition of protected health information. If a covered entity is involved, triggering this rule, the employer may obtain authorization from the individuals to be tested."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 242}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 110)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nrding health care fraud from the law enforcement section, because all disclosures that would have been allowed under that provision are allowed under § 164.512(d) of the final rule (health oversight).\nSimilarly, in the final rule, we eliminate proposed\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\n§164.510(f)(5)(iii) on disclosure of protected health information to law enforcement officials regarding criminal activity witnessed by a member of a health plan workforce. All disclosures that would have been permitted by that provision are included in §164.512(f)(5), which allows disclosure of information to report a crime committed on the covered entity's premises, and by § 164.502, which provides that a covered entity is not in violation of the rule when a member of its workforce or person working for a business associate uses or discloses protected health information while acting as a ''whistle blower.'' Thus, §164.512(f)(5) allows covered entities to disclose health information only on the good faith belief that it constitutes evidence of a crime on their premises. The preamble to the NPRM said that if the covered entity disclosed protected health information in good faith but was wrong in its belief that the information was evidence of a violation of law, the covered entity would not be subject to sanction under this regulation. The final rule retains this approach. ## Reporting Crime in Emergencies\n\nThe proposed rule did not address disclosures by emergency medical personnel to a law enforcement official intended to alert law enforcement about the commission of a crime. Because the provisions of proposed rule were limited to individually identifiable health information that was reduced to electronic form, many communications that occur between emergency medical personnel and law enforcement officials at the scene of a crime would not have been covered by the proposed provisions."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 109}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 529)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nview procedure if the research involves no more than minimal risk to the privacy of the individuals who are the subject of the protected health information for which use or disclosure is being sought.\nIf the privacy board elects to use an expedited review procedure, the review and approval of the alteration or waiver of authorization may be carried out by the chair of the privacy board, or by one or more members of the privacy board as designated by the chair; and\n- (v) Required signature. The documentation of the alteration or\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\n- waiver of authorization must be signed by the chair or other member, as designated by the chair, of the IRB or the privacy board, as applicable. - (j) Standard: Uses and disclosures to avert a serious threat to health or safety. (1) Permitted disclosures. A covered entity may, consistent with applicable law and standards of ethical conduct, use or disclose protected health information, if the covered entity, in good faith, believes the use or disclosure:\n- (i)(A) Is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and\n- (B) Is to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat; or\n- (ii) Is necessary for law enforcement authorities to identify or apprehend an individual:\n- (A) Because of a statement by an individual admitting participation in a violent crime that the covered entity reasonably believes may have caused serious physical harm to the victim; or\n- (B) Where it appears from all the circumstances that the individual has escaped from a correctional institution or from lawful custody, as those terms are defined in § 164.501. - (2) Use or disclosure not permitted."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 528}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.512(i)(2)(i) require?"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n§164.512(i)(2)(i) and (v).\n\n- (ii) Identity of public officials. A covered entity may rely, if such reliance is reasonable under the circumstances, on any of the following to verify identity when the disclosure of protected health information is to a public official or a person acting on behalf of the public official:\n- (A) If the request is made in person, presentation of an agency identification badge, other official credentials, or other proof of government status;\n- (B) If the request is in writing, the request is on the appropriate government letterhead; or\n\n(C) If the disclosure is to a "}], "metadata": {"source": "privacy_rule_2000", "cfr_section": "§164.512(i)(2)(i)", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 17)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nAssessment scale for overall likelihood | Likelihood | Likelihood that Threat Events Result in Adverse Impacts | Likelihood that Threat Events Result in Adverse Impacts | Likelihood that Threat Events Result in Adverse Impacts | Likelihood that Threat Events Result in Adverse Impacts | Likelihood that Threat Events Result in Adverse Impacts | |------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------| | of Threat Event Initiation or Occurrence | Very Low | Low | Moderate | High | Very High | | Very High | Low | Moderate | High | Very High | Very High | | High | Low | Moderate | Moderate | High | Very High | | Moderate | Low | Low | Moderate | Moderate | High | | Low | Very Low | Low | Low | Moderate | Moderate | | Very Low | Very Low | Very Low | Low | Low | Low | The regulated entity could perform this likelihood assessment for each threat/vulnerability pairing."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 16}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 488)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nA case law describes such activities as settlor functions. For example a plan sponsor may want to change its contract from a preferred provider organization to a health maintenance organization (HMO).\nIn order to obtain premium information, the health plan sponsor may need to provide the HMO with aggregate claims information. Under the rule, the health plan sponsor can obtain summary information with certain identifiers removed, in order to provide it to the HMO and receive a premium rate. The Department assumes that most health plan sponsors who are small employers (those with 50 or fewer employees) will elect not to receive individually identifiable health information because they will have\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nlittle, if any, need for such data. Any needs that sponsors of small group health plans may have for information can be accomplished by receiving the information in summary form from their health insurance issuers. ## 3. The Burden on a Typical Small Business\n\nThe Department expects small entities to face a cost burden as a result of complying with the proposed regulation. We estimate that the burden of developing privacy policies and procedures is lower in dollar terms for small businesses than for large businesses, but we recognize that the cost of implementing privacy provisions could be a larger burden to small entities as a proportion of total revenue. Due to these concerns, we have relied on the principle of scalability throughout the rule, and have based our cost estimates on the expectation that small entities will develop less expensive and less complex privacy measures that comply with the rule than large entities. In many cases, we have specifically considered the impact that rule may have on solo practitioners or rural health care providers. If a health care provider only maintains paper records and does not engage in any electronic transactions, the regulation would not apply to such provider."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 487}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 39)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nDevelop and Implement Policy and Procedures to Respond to and Report Security Incidents Implementation Specification (Required) | • Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity or business associate; and document security incidents and their outcomes. • Ensure that an organizational incident response policy 70 is in place that addresses all parts of the organization in which ePHI is created, stored, processed, or transmitted. • Document incident response procedures that can provide a single point of reference to guide the day-to-day operations of the incident response team. • Review incident response procedures with staff who have roles and responsibilities related to incident response; solicit suggestions for improvements; and make changes to reflect input, if reasonable and appropriate. • Consider conducting tests of the incident response plan. • Update the procedures as required based on changing organizational needs. 71 | • Has the organization determined that maintaining a staffed security incident hotline would be reasonable and appropriate? • Has the organization developed processes for documenting and tracking incidents? • Has the organization determined reasonable and appropriate mitigation options for security incidents? • Has the organization developed standardized incident report templates to record necessary information related to incidents? • Has the organization determined that information captured in the reporting templates is reasonable and appropriate to investigate an incident? • Has the organization determined the conditions under which information related to a security breach will be disclosed to the media? • Have appropriate (internal and external) persons who should be informed of a security breach been identified? Has a contact information list been prepared?"}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 38}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 212)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nresult in abuse. Finally, upholding privacy protections benefits all persons who have or may be served by the covered entity as well as the general public, and not only the subject of the information.\nIf a complaint is received from someone who is not the subject of protected health information, the person who is the subject of this information may be concerned with the Secretary's investigation of this complaint. While we did not receive comments on this issue, we want to protect the privacy rights of this individual. This might\n\nFrm 00140\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\ninvolve the Secretary seeking to contact the individual to provide information as to how the Secretary will address individual's privacy concerns while resolving the complaint. Contacting all individuals may not be practicable in the case of allegations of systemic violations (e.g., where the allegation is that hundreds of medical records were wrongfully disclosed). Requiring That a Complainant Exhaust the Covered Entity's Internal Complaint Process Prior to Filing a Complaint With the Secretary\n\nComment: A number of commenters, primarily health plans, suggested that individuals should not be permitted to file a complaint with the Secretary until they exhaust the covered entity's own complaint process. Commenters stated that covered entities should have a certain period of time, such as ninety days, to correct the violation. Some commenters asserted that providing for filing a complaint with the Secretary will be very expensive for both the public and private sectors of the health care industry to implement. Other commenters suggested requiring the Secretary to inform the covered entity of any complaint it has received and not initiate an investigation or ''take enforcement action'' before the covered entity has time to address the complaint. Response: We have decided, for a number of reasons, to retain the approach as presented in the proposed rule."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 211}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 426)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nated that a hospital medical records department generally makes notations regarding information it releases, but that these notations do not include disclosures that the emergency department may make.\nSeveral commenters proposed that the rule provide for patients to receive only an accounting of disclosures made by medical records departments or some other central location, which would relieve the burden of centralizing accounting for those entities who depend on paper records and tracking systems. Response: We disagree with commenters' arguments that covered entities should not be held accountable for the actions of their subdivisions or workforce members. Covered entities are responsible for accounting for the disclosures of protected health information made by the covered entity, in accordance with this rule. The particular person or department within the entity that made the disclosure is immaterial to the covered entity's obligation. In the final rule, we require covered entities to document each disclosure that is required to be included in an accounting. We do not, however, require this documentation to be maintained in a central registry. A covered hospital, for example, could maintain separate documentation of disclosures that are made from the medical records department and the emergency department. At the time an individual requests an accounting, this documentation could be integrated to provide a single accounting of disclosures made by the covered hospital. Alternatively, the covered hospital could centralize its processes\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00282\n\nfor making and documenting disclosures. We believe this provision provides covered entities with sufficient flexibility to meet their business needs without compromising individuals' rights to know how information about them is disclosed."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 425}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 536)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nve date. The notice must contain the date on which the notice is first in effect, which may not be earlier than the date on which the notice is printed or otherwise published. - (2) Optional elements.\n(i) In addition to the information required by paragraph (b)(1) of this section, if a covered entity elects to limit the uses or disclosures that it is permitted to make under this subpart, the covered entity may describe its more limited uses or disclosures in its notice, provided that the covered entity may not include in its notice a limitation affecting its right to make a use or disclosure that is required by law or permitted by § 164.512(j)(1)(i). - (ii) For the covered entity to apply a change in its more limited uses and disclosures to protected health information created or received prior to issuing a revised notice, in accordance with § 164.530(i)(2)(ii), the notice must include the statements required by paragraph (b)(1)(v)(C) of this section. - (3) Revisions to the notice. The covered entity must promptly revise and distribute its notice whenever there is a material change to the uses or disclosures, the individual's rights, the covered entity's legal duties, or other privacy practices stated in the notice. Except when required by law, a material change to any term of the notice may not be implemented prior to the effective date of the notice in which such material change is reflected. - (c) Implementation specifications: Provision of notice. A covered entity must make the notice required by this\n\nFrm 00361\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nsection available on request to any person and to individuals as specified in paragraphs (c)(1) through (c)(4) of this section, as applicable. (1) Specific requirements for health plans."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 535}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 168)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\n................ | 660,550                  | $2,052,665 |\n| Total .......................................................................................................... | ........................\n| ........................ | ........................ | $3,869,044 |\n\nAs in the interim final rule, we have also imputed a cost to the time individuals will spend calling the tollfree number. In estimating the time involved, we assumed that a person will spend five minutes per call. However, the person may not get through the first time and thus may have to call back a second time which could add another 5 minutes. Taking the average between 5 and 10 minutes, we used an average time of 7.5 minutes per caller. For purposes of imputing cost to an individual's time, we took the median compensation amount from the Bureau of Labor Statistics of $24.86 33 for all occupations. Dividing 60 by 7.5 minutes yields 8 calls per hour. Dividing the number of calls per hour into 660,550 calls and then multiplying by $24.86, gives us a cost of $2,052,665. ## Cost of Breaches Involving More Than 500 Individuals\n\nIf a covered entity experiences a breach of protected health information affecting more than 500 individuals of a State or jurisdiction, § 164.406 of the rule requires the entity to notify the media in the jurisdiction or State in which the individuals reside. In addition, § 164.408 of the rule requires the entity to notify the Secretary contemporaneously with notice to affected individuals in cases where 500 or more individuals are affected by a breach. As stated in the interim final rule, we anticipate that a covered entity will issue a press release when it must notify the media under § 164.406. The tasks involved in issuing the press release will be the drafting of the statement and clearing it through the entity."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 167}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 319)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ne of protected health information and the reuse of this information by other agencies covered in proposed § 164.510, the President should issue an Executive Order barring such re-disclosure and reuse.\nOne of these groups specified that the Executive Order should bar re-use and re-disclosure of protected health information in actions against individuals. In contrast, some commenters advocated information-sharing between law enforcement and oversight agencies. Most of these commenters recognized that the NPRM would have allowed reuse and re-disclosure of protected health information from oversight to law\n\nFrm 00211\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nenforcement agencies, and they supported this approach. Response: We believe that the language we have added to the rule, at §164.512(d)(2) and the corresponding explanation in the preamble, to clarify the boundary between disclosures for health oversight and for law enforcement purposes should partially address the concern expressed by some that oversight agencies will be the back door for access by law enforcement. In situations when the individual is the subject of an investigation or activity and the investigation or activity is not related to health care fraud, the requirements for disclosure to law enforcement must be met, and an oversight agency cannot request the information under its more general oversight authority. We acknowledge, however, that there will be instances under the rule when a health oversight agency (or a law enforcement agency in its oversight capacity) that has obtained protected health information appropriately will be able to redisclose the information to a law enforcement agency for law enforcement purposes. Under HIPAA, we have the authority to restrict redisclosure of protected health information only by covered entities. Re-disclosures by public agencies such as oversight agencies are not within the purview of this rule."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 318}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 92)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nplex, while several commenters recommended that\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00061\n\nthe final rule require NPPs to be shortened, simplified, and written in a clear, easily understandable manner.\nIn addition, while a few commenters suggested that HHS provide a sample or standard NPP, many more commenters requested flexibility in developing the content of their respective NPPs. Response: We believe that the additions to the NPP required by the final rule are necessary to fully inform individuals of the covered entity's privacy practices and their rights. The NPP should be provided in a clear, concise, and easy to understand manner, and we clarify that covered entities may use a ''layered notice'' to implement the Rule's provisions, so long as the elements required at §164.520(b) are included in the document that is provided for the individual. For example, a covered entity may satisfy the NPP provisions by providing the individual with both a short notice that briefly summarizes the individual's rights, as well as other information, and a longer notice, layered beneath the short notice that contains all the elements required by the Rule. Additionally, the Privacy Rule requires that the NPP be written in plain language, and we note that some covered entities may have obligations under other laws with respect to their communication with affected individuals. For example, to the extent a covered entity is obligated to comply with Title VI of the Civil Rights Act of 1964, the covered entity must take reasonable steps to ensure meaningful access for Limited English Proficient persons to the services of the covered entity, which could include translating the NPP into frequently encountered languages. In addition, we agree with the commenters who suggested that covered entities have flexibility and discretion to determine how to draft and prepare their NPPs."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 91}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 87)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nhas a right to opt out of receiving such communications. The final rule does not require covered entities to send pre-solicitation opt outs to individuals prior to the first fundraising communication.\nWe believe that because the individual will be on notice of the opportunity to opt out of receiving fundraising communications through the notice of privacy practices and the first fundraising communication itself will contain a clear and conspicuous opportunity to opt out, there is no need to require covered entities to incur the additional burden and cost of sending pre-solicitation opt outs. Under the Privacy Rule fundraising communications can take many forms, including communications made over the phone. Despite the fact that the HITECH Act refers only to written fundraising communications, because the Privacy Rule applies to communications made over the phone, we believe it would be counterintuitive to apply the strengthened opt out requirement to only written fundraising communications. Therefore, like fundraising communications made in writing, covered entities that make fundraising communications over the phone must clearly inform individuals that they have a right to opt out of further solicitations. Accordingly, to make clear that the opt out requirement applies to fundraising solicitations made over the phone, the final rule provides that the opt out requirement applies to each fundraising communication ''made'' rather than ''sent'' to an individual. We also emphasize that the notice and opt out requirements for fundraising communications apply only where the covered entity is using or disclosing protected health information to target the fundraising communication. If the covered entity does not use protected health information to send fundraising materials, then the notice and opt out requirements do not apply."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 86}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 436)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nwell within this mandate. Comments: Several commenters suggested that the documentation requirements not be established as a standard under the regulation, because standards are subject to penalties.\nThey recommend we delete the documentation standards and instead provide specific guidance and technical assistance. Several commenters objected to the suggestion in the NPRM that professional associations assist their members by developing appropriate policies for their membership. Several commentators representing professional associations believed this to be an onerous and costly burden for the associations, and suggested instead that we develop specific models which might require only minor modification. Some of these same associations were also concerned about liability issues in developing such guidelines. One commenter argued that sample forms, procedures, and policies should be provided as part of the Final Rule, so that practitioners would not be overburdened in meeting the demands of the regulations. They urged us to apply this provision only to larger entities. Response: The purpose of requiring covered entities to develop policies and procedures for implementing this regulation is to ensure that important decisions affecting individuals' rights and privacy interests are made thoughtfully, not on an ad hoc basis. The purpose of requiring covered entities to maintain written documentation of these policies is to facilitate workforce training, and to facilitate creation of the required notice of information practices. We further believe that requiring written documentation of key decisions about privacy will enhance accountability, both within the covered entity and to the Department, for compliance with this regulation. We do not include more specific guidance on the content of the required policies and procedures because of the vast difference in the size of covered entities and types of covered entities' businesses."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 435}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 30)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nseveral methods including the use of cryptographic nonces (an arbitrary number used only once in a cryptographic communication);\n\n75 See the definition of security strength in Appendix 5, Terminology.\n## Contains Nonbinding Recommendations\n\n- Provide mechanisms for verifying the authenticity of information originating from the device, such as telemetry. This is especially important for data that, if spoofed or otherwise modified, could result in patient harm, such as the link between a clinician programmer or monitoring device and an implanted device like a pacemaker, defibrillator, or neurostimulator; or the link between a continuous glucose monitor system and an automated insulin pump;\n- Do not rely on cyclic redundancy checks (CRCs) as security controls. CRCs do not provide integrity or authentication protections in a security environment. While CRCs are an error detecting code and provide integrity protection against environmental factors (e.g., noise or EMC), they do not provide protections against an intentional or malicious actor; and\n- Consider how the device and/or system should respond in event of authentication failure(s). ## Authorization\n\nFor the purposes of this guidance, authorization is the right or a permission that is granted to a system entity (e.g., a device, server, or software function) to access a system resource. More specifically, as a defensive measure, an authorization scheme enforces privileges (i.e., 'rights' associated with authenticated sessions, identities and/or roles). These privileges either permit allowed behavior, or refuse disallowed behavior in order to ensure that system resources are only accessed in accepted ways, by accepted parties. Within an adequately designed authorization scheme, the principle of least privileges 76 should be applied to users, system functions, and others, to only allow those entities the levels of system access necessary to perform a specific function."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 29}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 341)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhe proposed rule would have provided open-ended access by law enforcement to victims' medical records because of this difficulty in evaluating law enforcement claims of their need for the information.\nResponse: We modify the NPRM in several ways that reduce covered entities' decisionmaking burdens. The final rule clarifies that covered entities may disclose protected health information about a victim of crime where a report is required by state or other law, and it requires the victim's agreement for disclosure in most other instances. The covered entity must make the decision whether to disclose only in limited circumstances: when there is no mandatory reporting law; or when the victim is unable to provide agreement and the law enforcement official represents that: the protected health information is needed to determine whether a violation of law by a person other than the victim has occurred, that the information will not be used against the victim, and that immediate law enforcement activity that depends on such information would be materially and adversely affected by waiting until the individual is able to agree to the disclosure. In these circumstances, we believe it is appropriate to rely on the covered entity, in the exercise of professional judgment, to determine whether the disclosure is in the individual's best interests. Other sections of this rule allow covered entities to reasonably rely on certain representations by law enforcement officials (see § 164.514, regarding verification,) and require disclosure of the minimum necessary protected health information for this purpose. Together, these provisions do not allow open-ended access or place undue responsibility on providers."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 340}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 5)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nent more of the HITECH Act's changes to HIPAA enforcement. In addition to the proposed modifications to implement the HITECH Act, the NPRM also proposed certain other modifications to the HIPAA Rules.\nThe NPRM proposed to permit the use of compound authorizations for conditioned and unconditioned research activities and requested comment regarding permitting authorizations for future research. Additionally, the NPRM proposed to modify the Privacy Rule's application to the individually identifiable health information of decedents and to permit covered entities that obtain the agreement of a parent to provide proof of immunization without written authorization to schools that are required to have such information. ## iii. The Genetic Information Nondiscrimination Act\n\nThe Genetic Information Nondiscrimination Act of 2008 (''GINA''), Pub. L. 110-233, 122 Stat. 881, prohibits discrimination based on an individual's genetic information in both the health coverage (Title I) and employment (Title II) contexts. In addition to the nondiscrimination provisions, section 105 of Title I of GINA contains new privacy protections for genetic information, which require the Secretary of HHS to revise the Privacy Rule to clarify that genetic information is health information and to prohibit group health plans, health insurance issuers (including HMOs), and issuers of Medicare supplemental policies from using or disclosing genetic information for underwriting purposes. On October 7, 2009, the Department published a proposed rule to strengthen the privacy protections for genetic information under the HIPAA Privacy Rule by implementing the protections for genetic information required by GINA and making related changes to the Rule. The 60-day public comment period for the proposed rule closed on December 7, 2009. The Department received about 25 comments on the proposed rule. ## II."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 4}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 22)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nce security.'' This is addressable because in certain circumstances, for example, a solo physician practice whose staff consists only of the physician's spouse, formal procedures may not be necessary.\nThe proposed ''Personnel security policy/procedure'' and ''record of access authorizations'' implementation features have been removed from this final rule, as they have been determined to be redundant. Implementation of the balance of the ''Workforce security'' implementation specifications and the\n\nVerDate Jan&lt;31&gt;2003\n\nother standards contained within this final rule will result in assurance that all personnel with access to electronic protected health information have the required access authority as well as appropriate clearances. a. Comment: The majority of comments concerned the supervision of maintenance personnel by an authorized knowledgeable person. Commenters stated this would not be feasible in smaller settings. For example, the availability of technically knowledgeable persons to ensure this supervision would be an issue. We were asked to either reword this implementation feature or delete it. Response: We agree that a ''knowledgeable'' person may not be available to supervise maintenance personnel. We have accordingly modified this implementation specification so that, in this final rule, we are adopting an addressable implementation specification titled, ''Authorization and/or supervision,'' requiring that workforce members, for example, operations and maintenance personnel, must either be supervised or have authorization when working with electronic protected health information or in locations where it resides (see §164.308(a)(3)(ii)(A)). Entities can decide on the feasibility of meeting this specification based on their risk analysis. b."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 21}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the differences between covered entity and business associate obligations under HIPAA?"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n## 45 CFR Parts 160 and 164\n\nRIN 0991-AB14\n\n## Standards for Privacy of Individually Identifiable Health Information\n\nAGENCY: Office for Civil Rights, HHS. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (''HHS'' or ''Department'') modifies certain standards in the Rule entitled ''Standards for Privacy of Individually Identifiable Health Information'' (''Privacy Rule''). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The purpose of these modifications is to maintain strong protections for the privacy of individually identifiable health information while clarifying certain of the Privacy Rule's provisions, addressing the unintended negative effects of the Privacy Rule on health care quality or access to health care, and relieving unintended administrative burdens created by the Privacy Rule. DATES: This final rule is effective on October 15, 2002. FOR FURTHER INFORMATION CONTACT: Felicia Farmer, 1-866-OCR-PRIV (1866-627-7748) or TTY 1-866-7884989. ## SUPPLEMENTARY INFORMATION:\n\nAvailability of copies, and electronic access. Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-866-5121800) or by fax to (202) 512-2250. The cost for each copy is $10.00."}], "metadata": {"source": "privacy_mod_2002", "entity_type": "both", "safeguard_types": ["physical", "technical", "administrative"], "type": "entity_obligations"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 7)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nf processes that reduces the number and severity of vulnerabilities in products throughout the device lifecycle. Examples of such frameworks exist in many sectors, including the medical device sector.\nRisk management for device manufacturers is the essential systematic practice of identifying, analyzing, evaluating, controlling, and monitoring risk throughout the product lifecycle to ensure that the devices they manufacture are safe and effective. The Quality System (QS) regulation in 21 CFR Part 820 explicitly addresses risk management activities in 21 CFR 820.30(g). FDA issued a final rule 11 amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world, and the final rule incorporates risk management throughout its requirements. 12\n\nThe recommendations contained in this guidance are intended to supplement FDA's Postmarket Cybersecurity Guidance, and 'Content of Premarket Submissions for Device Software Functions,' hereafter referred to as the 'Premarket Software Guidance.' This guidance replaces the 2014 final guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'\n\nThe recommendations in this guidance also generally align with or expand upon the recommendations in the Pre-Market Considerations for Medical Device Cybersecurity section of the International Medical Device Regulators Forum (IMDRF) final guidance 'Principles and Practices for Medical Device Cybersecurity,' issued in March 2020. Additionally, section 3305 of the Food and Drug Omnibus Reform Act of 2022 ('FDORA'), enacted on December 29, 2022, added section 524B 'Ensuring Cybersecurity of Medical Devices' to the FD&amp;C Act."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 6}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the administrative safeguards under HIPAA?"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n## 45 CFR Parts 160 and 164\n\nRIN 0991-AB14\n\n## Standards for Privacy of Individually Identifiable Health Information\n\nAGENCY: Office for Civil Rights, HHS. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (''HHS'' or ''Department'') modifies certain standards in the Rule entitled ''Standards for Privacy of Individually Identifiable Health Information'' (''Privacy Rule''). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The purpose of these modifications is to maintain strong protections for the privacy of individually identifiable health information while clarifying certain of the Privacy Rule's provisions, addressing the unintended negative effects of the Privacy Rule on health care quality or access to health care, and relieving unintended administrative burdens created by the Privacy Rule. DATES: This final rule is effective on October 15, 2002. FOR FURTHER INFORMATION CONTACT: Felicia Farmer, 1-866-OCR-PRIV (1866-627-7748) or TTY 1-866-7884989. ## SUPPLEMENTARY INFORMATION:\n\nAvailability of copies, and electronic access. Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-866-5121800) or by fax to (202) 512-2250. The cost for each copy is $10.00."}], "metadata": {"source": "privacy_mod_2002", "safeguard_type": "administrative", "implementation_spec": "required", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 134)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nauthorization was obtained as a condition of obtaining insurance coverage, other law provides the insurer with the right to contest a claim under the policy or the policy itself. - (6) Documentation.\nA covered entity must document and retain any signed authorization under this section as required by § 164.530(j). - (c) Implementation specifications: Core elements and requirements.-(1) Core elements. A valid authorization under this section must contain at least the following elements:\n- (i) A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion. - (ii) The name or other specific identification of the person(s), or class\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00089\n\n- of persons, authorized to make the requested use or disclosure. - (iii) The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure. - (iv) A description of each purpose of the requested use or disclosure. The statement ''at the request of the individual'' is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose. - (v) An expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure. The statement ''end of the research study,'' ''none,'' or similar language is sufficient if the authorization is for a use or disclosure of protected health information for research, including for the creation and maintenance of a research database or research repository. - (vi) Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual must also be provided. - (2) Required statements."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 133}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 89)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhold the information may not be providing the long term care and may not, therefore, be aware of the individual's coverage under the policy or that the individual is receiving long term care services.\nAn authorization obtained by the long term care insurer will help to demonstrate these facts to the providers holding the information, which will make them more confident that the individual intends for the information to be shared. Similarly, an insurer with subrogation obligations may need health information from the enrollee's providers to assess or prosecute the claim. A patient's new\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00059\n\nphysician may also need medical records from the patient's prior providers in order to treat the patient. Without an authorization that demonstrates the patient's intent for the information to be shared, the covered entity that maintains the protected health information may be reluctant to provide the information, even if that covered entity's consent permits such disclosure to occur. These authorizations may also be useful to accomplish clinical coordination and integration among covered entities that do not meet the definitions of affiliated covered entities or organized health care arrangements. For example, safety-net providers that participate in the Community Access Program (CAP) may not qualify as organized health care arrangements but may want to share protected health information with each other in order to develop and expand integrated systems of care for uninsured people. An authorization under this section would permit such providers to receive protected health information from other CAP participants to engage in such activities. Because of such concerns, we permit a covered entity to request the individual's authorization to obtain protected health information from another covered entity to carry out treatment, payment, and health care operations."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 88}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 59)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nxact words do not need to be used in the statement. We provide discretion for covered entities to craft appropriate language that reflects, for example, the specific type of remuneration they receive.\nAs we explained in the NPRM, with respect to the recipient of the information, if protected health information is\n\nVerDate Mar&lt;15&gt;2010\n\ndisclosed for remuneration by a covered entity or business associate to another covered entity or business associate in compliance with the authorization requirements at proposed §164.508(a)(4)(i), the recipient covered entity or business associate could not redisclose the protected health information in exchange for remuneration unless a valid authorization was obtained in accordance with proposed §164.508(a)(4)(i). We requested comment on these provisions. At proposed § 164.508(a)(4)(ii), we set forth the exceptions to the authorization requirement. We proposed the exceptions provided for by section 13405(d)(2) of the HITECH Act, and also proposed to exercise the authority granted to the Secretary in section 13405(d)(2)(G) to include additional exceptions that we deemed to be similarly necessary and appropriate. These exceptions are discussed below. We requested comment on whether there were additional exceptions that should be included in the final regulation. First, we proposed to include an exception to cover exchanges for remuneration for public health activities pursuant to §§ 164.512(b) or 164.514(e). We added the reference to § 164.514(e) of the Privacy Rule to ensure that disclosures of protected health information for public health activities in limited data set form would also be excepted from the authorization requirement, in addition to disclosures that may occur under § 164.512(b) with more identifiable information."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 58}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 13)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\nses of the statute, means an individual who is authorized to access protected health information, and thus, for clarity, we have substituted this language for the statutory language in the regulation.\nThus, a person who is authorized to access protected health information is similarly situated, for purposes of this regulation, to another person at the covered entity, business associate of the covered entity, or organized health care arrangement in which the covered entity participates, who is also authorized to access protected health information (even if the two persons may not be authorized to access the same types of protected health information). For example, a physician who has authority to use or disclose protected health information at a hospital by virtue of participating in an organized health care arrangement with the hospital is similarly situated to a nurse or billing employee at the hospital. In contrast, the physician is not similarly situated to an employee at the hospital who is not authorized to access protected health information. Additionally, we have interpreted ''same facility'' to mean the same covered entity, business associate, or organized health care arrangement in which the covered entity participates and have substituted this language in the regulation. By focusing on the legal entity or status of the entities as an organized health care arrangement when interpreting ''same facility,'' we believe we have more clearly captured the intent of the statute and have also alleviated commenter concerns that the term ''facility'' was too narrow. Therefore, the size of the covered entity,\n\n10 45 CFR 160.103 also defines ''organized health care arrangement'' to include ''an organized system of health care in which more than one covered entity participates'' and in which the participating covered entities engage in certain joint utilization review, quality assessment and improvement, or payment activities."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 12}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 346)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ntions that must be met before a covered entity may use or disclose protected health information. Those conditions are in addition to any conditions required of research entities under the Common Rule.\nCovered entities will certainly be subject to laws and regulations in addition to the rule, but the rule does not require compliance with these other laws or regulations. For covered health care providers and health plans that are subject to both the final rule and the Common Rule, both sets of regulations will need to be followed. Comment: A few commenters suggested that the Common Rule should be extended to all research, regardless of funding source. Response: We generally agree with the commenters on the need to provide protections to all human subjects research, regardless of funding source. HIPAA, however, did not provide the Department with authority to extend the Common Rule beyond its current purview. For research that relies on the use or disclosure of protected health information by covered entities without authorization, the final rule applies the Common Rule's principles for protecting research subjects by, in most instances, requiring documentation of independent board review, and a finding that specified criteria designed to protect the privacy of prospective research subjects have been met. Comment: A large number of commenters agreed that the research use and disclosure of protected health information should not require authorization. Of these commenters, many supported the proposed rule's approach to research uses and disclosures without authorization, including many from health care provider organizations, the mental health community, and members of Congress. Others, while they agreed that the research use and disclosure should not require authorization disagreed with the NPRM's approach and proposed alternative models."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 345}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 9)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n0 for the patient records of a family practice in South Carolina. Among the businessman's uses of the purchased records was selling them back to the former patients. (New York Times, August 14, 1991).\n- A few weeks after an Orlando woman had her doctor perform some routine tests, she received a letter from a drug company promoting a treatment for her high cholesterol. (Orlando Sentinel, November 30, 1997). No matter how or why a disclosure of personal information is made, the harm to the individual is the same. In the face of industry evolution, the potential benefits of our changing health care system, and the real risks and occurrences of harm, protection of privacy must be built into the routine operations of our health care system. ## Privacy Is Necessary To Secure Effective, High Quality Health Care\n\nWhile privacy is one of the key values on which our society is built, it is more than an end in itself. It is also necessary for the effective delivery of health care, both to individuals and to populations. The market failures caused by the lack\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00007\n\nof effective privacy protections for health information are discussed below (see section V.C below). Here, we discuss how privacy is a necessary foundation for delivery of high quality health care. In short, the entire health care system is built upon the willingness of individuals to share the most intimate details of their lives with their health care providers. The need for privacy of health information, in particular, has long been recognized as critical to the delivery of needed medical care. More than anything else, the relationship between a patient and a clinician is based on trust. The clinician must trust the patient to give full and truthful information about their health, symptoms, and medical history."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 8}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the differences between covered entity and business associate obligations under HIPAA?"}, {"role": "assistant", "content": "According to 45cfr160:\n\n[Skip to main content](#main-content)\n\nMenu\n\n[![GovInfo logo](/media/GovInfo_logo_gray.png)](/)\n[Search](#searchHolder)\n\n* Browse\n  + [A to Z](/browse-a-z)\n  + [Category](/app/browse/category)\n  + [Date](/app/browse/date)\n  + [Committee](/browse/committee)\n  + [Author](/app/browse/author)\n* About\n  + [About](/about)\n  + [Policies](/about/policies)\n  + [Authentication](/about/authentication)\n  + [Digital Preservation](/about/digital-preservation)\n  + [History](/about/history)\n  + [Agency Submission](/about/agency-submission)\n  + [U.S. Government Information](/about/us-gov-info)\n  + [FDsys Retirement](/about#fdsys-transition)\n* Developers\n  + [Developer Hub](/developers)\n  + [API](https://api.govinfo.gov/docs)\n  + [Bulk Data Repository](%20/bulkdata)\n  + [Link Service](/link-docs)\n  + [Feeds](/feeds)\n  + [Sitemaps](/sitemaps)\n  + [System Design](/developers/system-design)\n* Features\n  + [All Features](/features)\n  + [Featured Content](/features/featured-content)\n  + [News](/features/news)\n  + [Release Notes](/features/release-notes)\n  + [Finding Publications](/features/finding-publications)\n* Help\n  + [Help](/help)\n  + [Finding Information](%20/help/finding-info)\n  + [What's Available](/help/whats-available)\n  + [Tutorials and Handouts](/help/tutorials-handouts)\n  + [Other Resources](%20/help/other-resources)\n* Feedback\n  + [Submit Feedback](https://www.surveymonkey.com/r/govinfo-feedback-survey)\n  + [Contact Us](/contact)\n\n* [Toggle the Search Widget\n  Search](#searchHolder)\n\n# Page Not Found\n\n![Icon: Share using Facebook](/sites/default/files/fb-icon-white.png)\n![Icon: Share using Email](/sites/default/files/email-icon-white.png)\n![Icon: Copy Link URL](/sites/default/files/link-icon-white.png)\n\n[Help](/help/other)\n\n---\n\n**Error occurred."}], "metadata": {"source": "45cfr160", "entity_type": "both", "safeguard_types": ["unknown"], "type": "entity_obligations"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 432)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nundant or conflicting requirements. Response: Unlike the proposed regulation, the final regulation covers all protected health information, not just information that had at some point been electronic.\nThus, these commenters' assumption that the proposed Privacy Rule and the proposed Security Rule covered the same information is not the case, and taking the approach suggested by these comments would leave a significant number of health records unprotected. The safeguards required by this regulation are appropriate for both paper and electronic information. We will take care to ensure that the final Security Rule works in tandem with these requirements. Comments: One commenter requested that the final privacy rule be published before the final Security Rule, recognizing that the privacy policies must be in place before the security technology used to implement them could be worked out. Another\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00286\n\ncommenter asked that the final Security Rule be published immediately and not wait for an expected delay while privacy policies are worked out. Response: Now that this final privacy rule has been published in a timely manner, the final Security Rule can be harmonized with it and published soon. Comments: Several commenters echoed an association recommendation that, for those organizations that have implemented a computer based patient record that is compliant with the requirements of the proposed Security Rule, the minimum necessary rule should be considered to have been met by the implementation of role-based access controls. Response: The privacy regulation applies to paper records to which the proposed Security Rule does not apply. Thus, taking the approach suggested by these comments would leave a significant number of health records unprotected."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 431}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 450)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nterprises in domestic and export markets. The impact of this final rule will be over $1 billion in the first year of implementation. Therefore, this rule is a major rule as defined in 5 U.S.C. 804(2).\nExecutive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). According to Executive Order 12866, a regulatory action is ''significant'' if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million or more adversely affecting in a material way a sector of the economy, competition, or jobs, or if it raises novel legal or policy issues. The purpose of the regulatory impact analysis is to assist decisionmakers in understanding the potential ramifications of a regulation as it is being developed. The analysis is also intended to assist the public in understanding the general economic ramifications of a regulation, both in the aggregate as well as the major policy areas of a regulation and how they are likely to affect the major industries or sectors of the economy covered by it. In accordance with the Small Business Regulatory Enforcement and Fairness Act (Pub. L. 104-121), the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB) has determined that this rule is a major rule for the purpose of congressional review. The proposal for the privacy regulation included a preliminary regulatory impact analysis (RIA) which estimated the cost of the rule at $3.8 billion over five years. The preliminary\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nanalysis also noted that a number of significant areas were not included in the estimate due to inadequate information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 449}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 160)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\ne lack data, and the rule may produce savings that may offset some or all of the added costs. We discuss these unquantified costs and benefits of the rule at the end of the Regulatory Impact Analysis.\nAs a result of the economic impact, and other costs that are described but not quantified in the regulatory analysis below, OMB has determined that this rule is an economically significant regulatory action within the meaning of section 3(f)(4) of Executive Order 12866. We present our analysis of the costs and benefits of the rule in sections C and D below. ## 2. Entities Subject to the Rule\n\nThis rule impacts covered health care providers, health insurance issuers, and third party administrators acting on behalf of health plans, which we estimate to total 698,238 entities. The rule also applies to approximately 1-2\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with million business associates and an unknown number of subcontractors. 23\n\nTable 1 below shows the number of covered entities by class of provider and insurer that will be affected by the Rule."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 159}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 111)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n.g. , as permitted by § 164.512(j) to avert an imminent threat to health or safety, for health oversight activities, to coroners or medical examiners, and in other circumstances permitted by the rule.\nFor\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00073\n\nadditional provisions permitting covered entities to disclose protected health information to law enforcement officials, see § 164.512(j)(1)(i) and (ii). Under the NPRM and under the final rule, to obtain protected health information, law enforcement officials must comply with whatever other law is applicable. In certain circumstances, while this provision could authorize a covered entity to disclose protected health information to law enforcement officials, there could be additional applicable statutes or rules that further govern the specific disclosure. If the preemption provisions of this regulation do not apply, the covered entity must comply with the requirements or limitations established by such other law, regulation or judicial precedent. See §§ 160.201 through 160.205. For example, if state law permits disclosure only after compulsory process with court review, a provider or payor is not allowed to disclose information to state law enforcement officials unless the officials have complied with that requirement. Similarly, disclosure of substance abuse patient records subject to, 42 U.S.C. 290dd-2, and the implementing regulations, 42 CFR part 2, continue to be governed by those provisions. In some instances, disclosure of protected health information to law enforcement officials will be compelled by other law, for example, by compulsory judicial process or compulsory reporting laws (such as laws requiring reporting of wounds from violent crimes, suspected child abuse, or suspected theft of controlled substances). As discussed above, disclosure of protected health information under such other mandatory law is permitted under §164.512(a)."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 110}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 520)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nrequested by a covered entity for its own use or disclosure of protected health information that it maintains, the covered entity must comply with the following requirements. - (1) Required elements.\nThe authorization for the uses or disclosures described in this paragraph must, in addition to meeting the requirements of paragraph (c) of this section, contain the following elements:\n- (i) For any authorization to which the prohibition on conditioning in paragraph (b)(4) of this section applies, a statement that the covered entity will not condition treatment, payment, enrollment in the health plan, or eligibility for benefits on the individual's providing authorization for the requested use or disclosure;\n- (ii) A description of each purpose of the requested use or disclosure;\n- (iii) A statement that the individual may:\n- (A) Inspect or copy the protected health information to be used or disclosed as provided in § 164.524; and\n- (B) Refuse to sign the authorization; and\n- (iv) If use or disclosure of the requested information will result in\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\ndirect or indirect remuneration to the covered entity from a third party, a statement that such remuneration will result. - (2) Copy to the individual. A covered entity must provide the individual with a copy of the signed authorization. 2. (e) Implementation specifications: Authorizations requested by a covered entity for disclosures by others. If an authorization is requested by a covered entity for another covered entity to disclose protected health information to the covered entity requesting the authorization to carry out treatment, payment, or health care operations, the covered entity requesting the authorization must comply with the following requirements. - (1) Required elements. The authorization for the disclosures described in this paragraph must, in addition to meeting the requirements of paragraph (c) of this section, contain the following elements:\n4."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 519}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 50)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\n(e)(2)(ii) and reworded to enhance flexibility and scalability. - Removed proposed §142.310, ''Electronic signature,'' and all subheadings. This section will be issued as a separate future regulation.\n- Moved proposed §142.312, ''Effective date of the implementation of the security and electronic signature\n\n17:54 Feb 19, 2003\n\nPO 00000\n\nFrm 00035\n\n- standards,'' to § 164.318 and retitled as ''Compliance dates for the initial implementation of the security standards.'' Reworded and retitled subsections. - Added §164.310(d)(2)(ii), ''Media re-use procedures,'' implementation specification. - Added §164.105, ''Organizational requirements,'' with two standards, ''Health care component and ''Affiliated covered entities'' with related implementation specifications. - Added §164.312, ''Technical safeguards,'' encompassing the combined technical services and technical mechanisms standards (proposed § 142.308(c) and (d)). - Added §164.314(a)(1), ''Business associate contracts or other arrangements'' standard and related implementation specifications. - Added §164.314, ''Organizational requirements.''\n- Added §164.314(b)(1), ''Requirements for group health plans'' standard and related implementation specifications. - Added §164.316(a), ''Policies and procedures'' standard. - Added §164.316, ''Policies and procedures and documentation requirements.''\n- Added §164.316(b)(1), ''Documentation'' standard and related implementation specifications. - Renamed Addendum 1 as Appendix A. - Added §164.318, ''Compliance dates for the initial implementation of the security standards.''\n- Removed Addendum 2. Definitions of terms used in this final rule are now incorporated into § 164.103 and §164.304, or within the rule itself. - Removed Addendum 3. ## V."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 49}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 496)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ncy Rule, and it adheres to section 4(a) of Executive Order 13132, which expressly contemplates preemption when there is a conflict between exercising state and federal authority under federal statute.\nSection 262 of HIPAA enacted Section 1178 of the Social Security Act, developing a ''general rule'' that state laws or provisions that are contrary to the provisions or requirements of Part C of Title XI, or the standards or implementation specifications adopted, or established thereunder are preempted. Several exceptions to this rule exist, each of which is designed to maintain a high degree of state autonomy. Moreover, section 4(b) of the Executive Order authorizes preemption of state law in the federal rule making context when there is ''the exercise of state authority is directly conflicts with the exercise of federal authority under federal statute * * *.'' Section 1178 (a)(2)(B) of HIPAA specifically preempts state laws related to the privacy of individually identifiable health information unless the state law is more stringent. Thus, we have interpreted state and local laws and regulations that would impose less stringent requirements for protection of individually identifiable health information as undermining the\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00337\n\nagency's goal of ensuring that all patients who receive medical services are assured a minimum level of personal privacy. Particularly where the absence of privacy protection undermines an individual's access to health care services, both the personal and public interest is served by establishing federal rules. The final rule would establish national minimum standards with respect to the collection, maintenance, access, use, and disclosure of individually identifiable health information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 495}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 116)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\ntil April 14, 2004, whichever is earlier. The effect of this proposal is to spread first-year costs over an additional year, with a corresponding postponement of the costs estimated for the out years.\nHowever, the Department has no reliable information as to the number of contracts potentially affected by the modification or the average delay that will occur. Therefore, the Department is uncertain about the extent of the cost savings attributable to this modification. ## Response to Public Comments\n\nComment: While many commenters supported the business associate transition provisions as helpful to reducing the administrative burden and cost of compliance, commenters argued that the business associate provisions would still be very burdensome and costly to implement, especially for small and solo businesses. Response: The Department acknowledges that there are compliance costs associated with the business associate standards. However, no commenters supplied empirical, direct evidence in support of or contradictory to the Department's estimates of the cost savings associated with the business associate transition provisions. Therefore, our estimates remain unchanged. Comment: Some commenters disputed the estimated costs of complying with the business associate requirements based on the quantity of contracts (with suppliers, physicians, local agencies and national concerns), and the number of hours necessary to individually tailor and renegotiate all of these contracts. Response: These comments address the underlying costs of the business associate requirements and do not address the reduction in costs afforded through the sample business associate agreement language. Moreover, no empirical, direct evidence, based on accomplished workload rather than extrapolations of singular events, were provided to contradict the Department's calculations. Therefore, our estimates remain unchanged. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\n## 4."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 115}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 47)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nd authorization under § 164.508. This includes making clear in the authorization that the individual may revoke the authorization at any time he or she wishes to stop receiving the marketing material.\nBecause the final rule will treat all subsidized treatment communications as marketing communications for which an authorization is required, the final rule also removes the language at proposed §164.514(f)(2), which proposed to require that such communications be accompanied by a statement in the notice and an opportunity for the individual to opt out of receiving such communications. We believe that the removal of the notice and opt out requirements for such communications and the addition of the requirement to obtain an authorization will provide covered entities with a more uniform system for treating all remunerated communications. Because the individual must now sign an authorization before the covered entity can make subsidized treatment communications, there is no longer any need to require each such communication to contain a clear and conspicuous opportunity for the individual to elect not to receive any more of these communications. Where the individual signs an authorization to receive such communications, the covered entity may use and disclose the individual's protected health information for the purposes of making such communications unless or until the individual revokes the authorization pursuant to § 164.508(a)(5). If the individual does not authorize the covered entity to use and disclose the individual's protected health information for the purposes of making subsidized treatment communications, then the covered entity is prohibited from doing so. We clarify that the final rule does nothing to modify the exceptions to the authorization requirement for marketing communications at § 164.508(a)(3)(i)(A) and (B)."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 46}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 385)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ngovernment requests from this standard, other than when a disclosure is required by law. (See preamble to § 164.512(a) for the\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nrationale behind this policy).\nWhen a disclosure is required by law, the minimum necessary standard does not apply, whether the recipient of the information is a government official or a private individual. At the same time, we understand that when certain government officials make requests for protected health information, some covered entities might feel pressure to comply that might not be present when the request is from a private individuals. For this reason, we allow (but do not require) covered entities to reasonably rely on the representations of public officials as to the minimum necessary information for the purpose. Comment: Some commenters argued that requests under proposed § 164.510 should not be subject to the minimum necessary standard, whether or not they are ''authorized by law.'' Others argued that for disclosures made for administrative proceedings pursuant to proposed §164.510, the minimum necessary standard should apply unless they are subject to a court order. Response: We found no compelling reason to exempt disclosures for purposes listed in the regulation from this standard, other than for disclosures required by law. When there is no such legal mandate, the disclosure is voluntary on the part of the covered entity, and it is therefore reasonable to expect the covered entity to make some effort to protect privacy before making such a disclosure. If the covered entity finds that redacting unnecessary information, or extracting the requested information, prior to making the disclosure, is too burdensome, it need not make the disclosure. Where there is ambiguity regarding what information is needed, some effort on the part of the covered entity can be expected in these circumstances."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 384}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 195)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\n*\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with\n\n- ■ 21. Revise § 160.410 to read as follows:\n\n## §160.410 Affirmative defenses. - (a) The Secretary may not:\n- (1) Prior to February 18, 2011, impose a civil money penalty on a covered entity or business associate for an act that violates an administrative simplification provision if the covered entity or business associate establishes that the violation is punishable under 42 U.S.C. 1320d-6. - (2) On or after February 18, 2011, impose a civil money penalty on a covered entity or business associate for an act that violates an administrative simplification provision if the covered entity or business associate establishes that a penalty has been imposed under 42 U.S.C. 1320d-6 with respect to such act. - (b) For violations occurring prior to February 18, 2009, the Secretary may not impose a civil money penalty on a covered entity for a violation if the covered entity establishes that an affirmative defense exists with respect to the violation, including the following:\n- (1) The covered entity establishes, to the satisfaction of the Secretary, that it did not have knowledge of the violation, determined in accordance with the Federal common law of agency, and by exercising reasonable diligence, would not have known that the violation occurred; or\n- (2) The violation is-\n- (i) Due to circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the administrative simplification provision violated and is not due to willful neglect; and\n- (ii) Corrected during either:\n- (A) The 30-day period beginning on the first date the covered entity liable for the penalty knew, or by exercising reasonable diligence would have known, that the violation occurred; or\n- (B) Such additional period as the Secretary determines to be appropriate based on the nature and extent of the failure to comply."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 194}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 371)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nnformation of intelligence community employees and their dependents being considered for postings overseas, on the grounds that the scope of permissible disclosure without authorization was too broad.\nWhile acknowledging that the intelligence community may have legitimate needs for its employees' protected health information, the commenters believed that the NPRM\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nfailed to provide adequate procedural protections for the employees' information. A few comments also said that the intelligence community should be able to obtain their employees' health information only with authorization. In addition, commenters said that the intelligence community should make disclosure of protected health information a condition of employment. Response: Again, we agree that the NPRM's provision allowing disclosure of the protected health information of intelligence community employees without authorization was overly broad. Thus we eliminate it in the final rule. The intelligence community can obtain this information with authorization (pursuant to § 164.508), for example, when employees or their family members are being considered for an oversees assignment and when individuals are applying for employment with or seeking a contract from an intelligence community agency. ## National Security and Intelligence Activities and Protective Services for the President and Others\n\nComment: A number of comments opposed the proposed ''intelligence and national security activities'' provision of the law enforcement section (§ 164.510(f)(4)), suggesting that it was overly broad. These commenters were concerned that the provision lacked sufficient procedural safeguards to prevent abuse of protected health information. The Central Intelligence Agency (CIA) and the Department of Defense (DoD) also expressed concern over the provision's scope."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 370}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 44)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\ndoctors, hospital, labs, etc., speak with patients by telephone, identify treatment options, and develop\n\nVerDate Aug&lt;2,&gt;2002\n\npreliminary treatment plans, all before the initial patient visit.\nThe prior consent requirement would prevent all of these important preliminary activities before the first patient visit, which would delay treatment in cases in which such delay cannot be tolerated. Other commenters continued to strongly support a consent requirement, consistent with their views expressed during the comment period in March 2001. Some argued that the NPRM approach would eliminate an important consumer protection and that such a ''radical'' approach to fixing the workability issues was not required. They recommended a targeted approach to fixing each problem, and suggested ways to fix each unintended consequence of the consent requirement, in lieu of removing the requirement to obtain consent. A few commenters argued for reinstating a consent requirement, but making it similar to the proposal for acknowledgment of notice by permitting flexibility and including a ''good faith'' standard. They also urged the Department to narrow the definition of health care operations and require that de-identified information be used where possible for health care operations. Finally, a few commenters continued to assert that consent should be strengthened by applying it to more covered entities, requiring it to be obtained more frequently, or prohibiting the conditioning of treatment on the obtaining of consent. Final Modifications. The Department continues to be concerned by the multitude of comments and examples demonstrating that the consent requirements would result in unintended consequences that would impede the provision of health care in many critical circumstances. We are also concerned that other such unintended consequences may exist which have yet to be brought to our attention."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 43}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What's the difference between required and addressable implementation specifications?"}, {"role": "assistant", "content": "According to 45cfr164:\n\n[Skip to main content](#main-content)\n\nMenu\n\n[![GovInfo logo](/media/GovInfo_logo_gray.png)](/)\n[Search](#searchHolder)\n\n* Browse\n  + [A to Z](/browse-a-z)\n  + [Category](/app/browse/category)\n  + [Date](/app/browse/date)\n  + [Committee](/browse/committee)\n  + [Author](/app/browse/author)\n* About\n  + [About](/about)\n  + [Policies](/about/policies)\n  + [Authentication](/about/authentication)\n  + [Digital Preservation](/about/digital-preservation)\n  + [History](/about/history)\n  + [Agency Submission](/about/agency-submission)\n  + [U.S. Government Information](/about/us-gov-info)\n  + [FDsys Retirement](/about#fdsys-transition)\n* Developers\n  + [Developer Hub](/developers)\n  + [API](https://api.govinfo.gov/docs)\n  + [Bulk Data Repository](%20/bulkdata)\n  + [Link Service](/link-docs)\n  + [Feeds](/feeds)\n  + [Sitemaps](/sitemaps)\n  + [System Design](/developers/system-design)\n* Features\n  + [All Features](/features)\n  + [Featured Content](/features/featured-content)\n  + [News](/features/news)\n  + [Release Notes](/features/release-notes)\n  + [Finding Publications](/features/finding-publications)\n* Help\n  + [Help](/help)\n  + [Finding Information](%20/help/finding-info)\n  + [What's Available](/help/whats-available)\n  + [Tutorials and Handouts](/help/tutorials-handouts)\n  + [Other Resources](%20/help/other-resources)\n* Feedback\n  + [Submit Feedback](https://www.surveymonkey.com/r/govinfo-feedback-survey)\n  + [Contact Us](/contact)\n\n* [Toggle the Search Widget\n  Search](#searchHolder)\n\n# Page Not Found\n\n![Icon: Share using Facebook](/sites/default/files/fb-icon-white.png)\n![Icon: Share using Email](/sites/default/files/email-icon-white.png)\n![Icon: Copy Link URL](/sites/default/files/link-icon-white.png)\n\n[Help](/help/other)\n\n---\n\n**Error occurred. The page you requested cannot be found.**\n\nPlease report this error to [askGPO.](https://www.gpo.gov/error-pages/askgpo)\n\nProvide the following information to help us resolve this problem: the URL of the page you were trying to acce"}], "metadata": {"source": "45cfr164", "implementation_spec": "both", "safeguard_types": ["unknown"], "type": "implementation"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 275)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nfere with the attorney-client relationship, nor does it override professional judgement of business associates regarding the protected health information they need to discharge their responsibilities.\nWe do not require covered entities to second guess their professional business associates' reasonable requests to use or disclose protected health information in the course of the relationship. The attorney-client privilege covers only a small portion of information provided to attorneys and so is not a substitute for this requirement. More important, attorney-client privilege belongs to the client, in this case the covered entity, and not to the individual who is the subject of the information. The business associate requirements are intended to protect the subject of the information. With regard to government attorneys and other government agencies, we recognize that federal and other law often does not allow standard legal contracts among governmental entities, but instead requires agreements to be made through the Economy Act or other mechanisms; these are generally reflected in a memorandum of understanding (MOU). We therefore modify the proposed requirements to allow government agencies to meet the required ''satisfactory assurance'' through such MOUs that contain the same provisions required of business associate contracts. As discussed elsewhere, we believe that direct regulation of entities receiving protected health information can be as or more effective in protecting health\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\ninformation as contracts. We therefore also allow government agencies to meet the required ''satisfactory assurances'' if law or regulations impose requirements on business associates consistent with the requirements specified for business associate contracts."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 274}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 153)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nicy includes discounts, rebates, payments in kind, or other premium differential mechanisms in return for activities such as completing a health risk assessment or participating in a wellness program.\nFinally, we proposed a provision within the\n\nVerDate Mar&lt;15&gt;2010\n\ndefinition to clarify that ''underwriting purposes'' does not include determinations of medical appropriateness where an individual seeks a benefit under the plan, coverage, or policy. ## Overview of Public Comments\n\nAbout ten commenters addressed the proposed definition of ''underwriting purposes.'' Four commenters generally supported the proposed definition. Other commenters expressed concern with the definition's inclusion of discounts, rebates, payments in kind, or other premium differential mechanisms in return for activities such as completing a health risk assessment (HRA) or participating in a wellness program. These commenters were concerned that prohibiting the use of genetic information, particularly family health history, for such purposes would have a detrimental impact on wellness and disease management programs. One commenter was concerned that the definition would prohibit dental insurance plans from offering preventive prognostic features to enrollees as part of the plan that test for susceptibility to dental decay and periodontal diseases. Enrollees that test positive would be provided with additional plan benefits as a supplement to the standard benefits to cover more aggressive preventive services. Finally, a few commenters were concerned that the broad definition of ''underwriting purposes'' would preclude plans from using HRAs and offering wellness programs even if no genetic information is requested or used. For example, one commenter was concerned that the definition would prohibit the use of ''personal habit'' information, such as information about smoking, or alcohol or drug use."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 152}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 236)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nlowed to be\n\nFrm 00156\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\ndisclosed for banking and payment processes rule would stifle innovation in continually evolving payment systems.\nThus, the commenter recommended that in the final rule, we eliminate the minimum necessary requirement for banking and payment processing and that we do not include a list of specific types of information allowed to be disclosed for banking and payment processes. On the other hand, several other commenters supported applying the minimum necessary standard to covered entities' disclosures to financial institutions for payment processing. In addition, these groups said that because financial institutions are not covered entities under the proposed rule, they urged Congress to enact comprehensive privacy legislation to limit financial institutions' use and re-disclosure of the minimally necessary protected health information they could receive under the proposed rule. Several of these commenters said that, in light of the increased ability to manipulate data electronically, they were concerned that financial institutions could use the minimal protected health information they received for making financial decisions. For example, one of these commenters said that a financial institution could identify an individual who had paid for treatment of domestic violence injuries and subsequently could deny the individual a mortgage based on that information. Response: We agree with the commenters who were concerned that a finite list of information could hamper systems innovation, and we eliminate the proposed list of data items. However, we disagree with the commenters who argued that the requirement for minimum necessary disclosures not apply to disclosures to financial institution or for payment activities."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 235}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 106)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nealth information held by a business associate, or receive an accounting of disclosures by a business associate, as provided for by the Privacy Rule's requirements at §§ 164.524, 164.526, and 164.528.\nIn addition, unlike the proposed Rule, the final Rule at §164.532(e)(3) explicitly provides that with respect to those business associate contracts that qualify for the transition period as described above, a covered entity is not relieved of its obligation\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nunder §164.530(f) to mitigate, to the extent practicable, any harmful effect that is known to the covered entity of a use or disclosure of protected health information by its business associate in violation of the covered entity's policies and procedures or the requirements of this subpart, as required by § 164.530(f). The Department does not believe that a covered entity should be relieved during the transition period of its responsibilities with respect to cooperating with the Secretary or fulfilling an individual's rights with respect to protected health information held by the business associate, or mitigating any harmful effects of an inappropriate use or disclosure by the business associate. The transition period is intended to alleviate some of the burden on covered entities, but not at the expense of individuals' privacy rights. Eliminating these privacy protections and rights would severely weaken the Rule with respect to those covered entities with contracts that qualify for the transition period. Further, the Rule provides covered entities some discretion in implementing these requirements with respect to their business associates. For example, a covered entity does not need to provide an individual with access to protected health information held by a business associate if the only information the business associate holds is a duplicate of what the covered entity maintains and to which it has provided the individual access."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 105}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 70)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ntrative costs to providers and health plans compared to the alternatives, and the standard is promulgated in accordance with the rulemaking procedures of subchapter III of chapter 5 of title 5, U.S.C.\nSection 1172 of the Act also sets forth consultation requirements that must be met before the Secretary may adopt standards. In the case of a standard that is developed, adopted, or modified by an SSO, the SSO must consult with the following Data Content Committees (DCCs) in the course of the development, adoption, or modification of the standard: The National Uniform Billing Committee (NUBC), the National Uniform Claim Committee (NUCC), the Workgroup for Electronic Data Interchange (WEDI), and the American Dental Association (ADA). In the case of any other standard, the Secretary is required to consult with each of the above-named groups before adopting the standard and must also comply with the provisions of section 1172(f) of the Act regarding consultation with the National Committee on Vital and Health Statistics (NCVHS). Section 1173 of the Act requires the Secretary to adopt standards for transactions, and data elements for such transactions, to enable the electronic exchange of health information. Section\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\nJkt 200001"}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 69}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 40)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ndetermine that, in order to do business with it, a business associate must also employ equivalent measures. This would be a business decision and would not be governed by the provisions of this rule.\nSecurity mechanisms relative to the transmission of electronic protected health information between entities may need to be agreed upon by\n\n17:54 Feb 19, 2003\n\nPO 00000\n\nFrm 00028\n\nboth parties in order to successfully complete the transmission. However, the determination of the specific transmission mechanisms and the specific security features to be implemented remains a business decision. d. Comment: Several commenters asked whether existing contracts could be used to meet the requirement for a trading partner agreement, or does the rule require entry into a new contract specific to this purpose. Also, the commenters want to know about those whose working agreements do not involve written contractual agreement: Do they now need to set up formal agreements and incur the additional expense that would entail? Response: This final rule requires written agreements between covered entities and business associates. New contracts do not have to be entered into specifically for this purpose, if existing written contracts adequately address the applicable requirements (or can be amended to do so). e. Comment: Several commenters asked whether covered entities are responsible for the security of all individual health information sent to them, or only information sent by chain of trust partners. They also asked if they can refuse to process standard transactions sent to them in an unsecured fashion. In addition, they inquired if they can refuse to send secured information in standard transactions to entities not required by law to secure the information. One commenter asked if there is a formula for understanding in any particular set of relationships where the ultimate responsibility for compliance with the standards would lie."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 39}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance?"}, {"role": "assistant", "content": "According to security_rule_2003:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160, 162, and 164 [CMS-0049-F] RIN 0938-AI57\n\n## Health Insurance Reform: Security Standards\n\nAGENCY: Centers for Medicare &amp; Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses, and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and otherFederal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general by establishing a level of protection for certain electronic health information. This final rule implements some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability andAccountability Act of 1996 (HIPAA). DATES: Effective Date: These regulations are effective on April 21, 2003. Compliance Date: Covered entities, with the exception of small health plans, must comply with the requirements of this final rule by April 21, 2005. Small health plans must comply with the requirements of this final rule by April 21, 2006. FOR FURTHER INFORMATION CONTACT: William Schooler, (410) 786-0089. SUPPLEMENTARY INFORMATION:\n\n## Availability of Copies and Electronic Access\n\nTo order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 5122250. The cost for each copy is $10."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 0}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 445)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nes of close to $2.0 billion nationally. Another commenter indicated that authorization costs will be at least double the notice dissemination costs due to the cost of both outbound and return postage.\nResponse: Public commenters and subsequent factfinding clearly indicate that most providers with patient contact already obtain authorizations for release of records, so for them there is virtually no new cost. Further, this comment does not reflect the actual regulatory requirement. For example, there is no need to engage in mailing and remailing of forms, and we do not foresee any reason why there should be any significant calls involved. Comment: A commenter criticized the percentage (1%) that we used to calculate the number of health care encounters expected to result in requests to withhold the release of protected information. This respondent postulates that even if one in six patients who encounter the U.S. health care system opt to restrict access to their records, the total expected national cost per year could rise to $900 million. Response: The final regulation requirements regarding the release of protected health information has been substantially changed, thereby greatly reducing the potential cost burden. A fuller explanation of the cost is provided below in the regulatory impact analysis. Comment: An additional issue raised by commenters was the added cost of seeking authorizations for health promotion and disease management activities, health care operations that traditionally did not require such action. Response: In the final regulation, a covered entity can use medical information collected for treatment or operations for its own health promotion and disease management efforts without obtaining additional authorization. Therefore, there is no additional cost incurred. ## Business Associates\n\nComment: A number of commenters were concerned about the cost of monitoring business partners."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 444}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 64)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\n05(d)(2)(B) of the HITECH Act clearly states that any remuneration received in exchange for research disclosures must reflect only the cost of preparation and transmittal of the data for such purpose.\nIn response to comments about the types of costs that are permitted in the reasonable cost-based fee to prepare and transmit the data, we clarify that this may include both direct and indirect costs, including labor, materials, and supplies for generating, storing, retrieving, and transmitting the protected health information; labor and supplies to ensure the protected health information is disclosed in a permissible manner; as well as related capital and overhead costs. However, fees charged to incur a profit from the disclosure of protected health information are not allowed. We believe allowing a profit margin would not be consistent with the language contained in Section 13405 of the HITECH Act. We intend to work with the research community to provide guidance and help the research community reach a common understanding of appropriate cost-based limitations on remuneration. We retain the exceptions proposed for treatment and payment disclosures without modification and agree with commenters that these exceptions are necessary to make clear that these core health care functions may continue. Similarly, we retain the exception to the remuneration prohibition for disclosures for the transfer, merger, or consolidation of all or part of a covered entity with another covered entity, or an entity that following such activity will become a covered entity, and related due diligence, to ensure that such disclosures may continue to occur in accordance with the Privacy Rule. We retain the proposed exception for\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00043\n\ndisclosures that are otherwise required by law to ensure a covered entity can continue to meet its legal obligations without imposing an authorization requirement."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 63}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the required HIPAA security measures?"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160 and 164\n\nRIN 0991-AB56\n\n## Breach Notification for Unsecured Protected Health Information\n\nAGENCY: Office for Civil Rights, Department of Health and Human Services.\n\nACTION: Interim final rule with request for comments.\n\nSUMMARY: The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to require notification of breaches of unsecured protected health information. Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA) that was enacted on February 17, 2009, requires HHS to issue interim final regulations within 180 days to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide notification in the case of breaches of unsecured protected health information. For purposes of determining what information is ''unsecured protected health information,'' in this document HHS is also issuing an update to its guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.\n\nDATES: Effective Date: This interim final rule is effective September 23, 2009.\n\nComment Date: Comments on the provisions of this interim final rule are due on or before October 23, 2009. Comments on the information collection requirements associated with this rule are due on or before September 8, 2009.\n\nADDRESSES: You may submit comments, identified by RIN 0991-AB56, by any of the following methods (please do not submit duplicate comments):\n\n- Regular, Express, or Overnight Mail: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: HITECH Breach Notification, Hubert H. Humphrey Building, Room\n- Federal eRulemaking Portal: http:// "}], "metadata": {"source": "breach_notification_2009", "implementation_spec": "required", "safeguard_types": ["physical", "technical", "administrative"], "type": "implementation"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 479)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nivacy concerns that led these individuals to respond affirmatively. However, for the purposes of this estimate, we assume that privacy concerns were responsible for the majority of positive responses.\nBased on the Harris-Equifax survey estimate that seven percent of people did not seek services for physical or mental health conditions due to fears about job prospects or other opportunities, we assume that the proportion of people diagnosed with cancer who did not seek earlier treatment due to these fears is also seven percent. Applying this seven percent figure to the estimated number of total cancer cases (8.37 million) gives us an estimate of 586,000 people who did not seek earlier cancer treatment due to privacy concerns. We estimate annual lost wages due to cancer morbidity and mortality per cancer patient by dividing total lost wages ($68.7 billion) by the number of cancer patients (8.37 million), which rounds to $8,200. We then assume that cancer patients who seek earlier treatment would achieve a one-third reduction in cancer mortality and morbidity due to earlier treatment. The assumption of a one-third reduction in mortality and morbidity is derived from a study showing a one-third reduction in colorectal cancer mortality due to colorectal cancer screening. 63 We could have chosen a lower or higher treatment success rate. By multiplying 586,000 by $8,200 by one-third, we calculate that $1.6 billion in lost wages could be saved each year by encouraging more people to seek early cancer treatment through enhanced privacy protections. This estimate illustrates the potential savings\n\n63 Jack S. Mandel, et al., ''Reducing Mortality from Colorectal Cancer by Screening for Fecal Occult Blood,'' The New England Journal of Medicine, May 13, 1993, Vol, 328, No. 19. E:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nin lost wages due to cancer that could be achieved with greater privacy protections."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 478}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 19)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nan incidental use or disclosure as a secondary use or disclosure that cannot reasonably be prevented, is limited in nature, and that occurs as a by-product of an otherwise permitted use or disclosure.\nThe Department proposed that an incidental use or disclosure be permissible only to the extent that the covered entity had applied reasonable safeguards as required by § 164.530(c), and implemented the minimum necessary standard, where applicable, as required by §§ 164.502(b) and 164.514(d). Overview of Public Comments. The following discussion provides an overview of the public comment received on this proposal. Additional comments received on this issue are discussed below in the section entitled, ''Response to Other Public Comments.''\n\nThe Department received many comments on its proposal to permit certain incidental uses and disclosures, the majority of which expressed strong support for the proposal. Many of these commenters indicated that such a policy would help to ensure that essential health care communications and practices are not chilled by the Privacy Rule. A few commenters opposed the Department's proposal to permit certain incidental uses and disclosures, one of whom asserted that the burden on medical staff to take precautions not to be overheard is minimal compared to the potential harm to patients if incidental disclosures were to be considered permissible. Final Modifications. In response to the overwhelming support of commenters on this proposal, the Department adopts the proposed provision at § 164.502(a)(1)(iii), explicitly permitting certain incidental uses and disclosures that occur as a byproduct of a use or disclosure otherwise permitted under the Privacy Rule."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 18}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 429)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nor the purpose of establishing or checking a computer system. Response: This activity falls within the definition of health care operations and is, therefore, excluded from the accounting requirement.\n## Section 164.530-Administrative Requirements\n\nSection 164.530(a)-Designation of a Privacy Official and Contact Person\n\nComment: Many of the commenters on this topic objected to the cost of establishing a privacy official, including the need to hire additional staff, which might need to include a lawyer or other highly paid individual. Response: We believe that designation of a privacy official is essential to ensure a central point of accountability within each covered entity for privacyrelated issues. The privacy official is charged with developing and implementing the policies and procedures for the covered entity, as required throughout the regulation, and for compliance with the regulation generally. While the costs for these activities are part of the costs of compliance with this rule, not extra costs associated with the designation of a privacy official, we do anticipate that there will be some cost associated with this requirement. The privacy official role may be an additional responsibility given to an existing employee in the\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00284\n\ncovered entity, such as an office manager in a small entity or an information officer or compliance official in a larger institution. Cost estimates for the privacy official are discussed in detail in the overall cost analysis. Comment: A few commenters argued for more flexibility in meeting the requirement for accountability. One health care provider maintained that covered entities should be able to establish their own system of accountability."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 428}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 304)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nthat will receive direct\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nor indirect remuneration from a third party for the use or disclosure, to state that fact in the authorization.\nRemuneration from a third party includes payments such as a fixed price per disclosure, compensation for the costs of compiling and sending the information to be disclosed, and, with respect to marketing communications, a percentage of any sales generated by the marketing communication. For example, a device manufacturer may offer to pay a fixed price per name and address of individuals with a particular diagnosis, so that the device manufacturer can market its new device to people with the diagnosis. The device manufacturer may also offer the covered entity a percentage of the profits from any sales generated by the marketing materials sent. If a covered entity seeks an authorization to make such a disclosure, the authorization must state that the remuneration will occur. We believe individuals should have the opportunity to weigh the covered entity's potential conflict of interest when deciding to authorize the covered entity's use or disclosure of protected health information. We believe that the term ''remuneration from a third party'' clarifies our intent to describe a direct, tangible exchange, rather than the mere fact that parties intend to profit from their enterprises. Comment: One commenter suggested we require covered entities to request authorizations in a manner that does not in itself disclose sensitive information. Response: We agree that covered entities should make reasonable efforts to avoid unintentional disclosures. In §164.530(c)(2), we require covered entities to have in place appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 303}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 127)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nlimit the amount of protected health information used/disclosed. g. The cost of limiting the use/ disclosure. h. Any other factors that the covered entity believed were relevant to the determination.\nThe proposal shifted the ''minimum necessary'' burden off of covered providers when they were being audited by a health plan. The preamble explained that the duty would have been shifted to the payor to request the minimum necessary information for the audit purpose, although the regulatory text did not include such a requirement. Outside of the audit context, the preamble stated that a health plan would be required, when requesting a disclosure, to limit its requests to the information required to achieve the purpose of the request; the regulation text did not include this requirement. The preamble stated that disclosure of an entire medical record, in response to a request for something other than the entire medical record, would presumptively violate the minimum necessary standard. This final rule significantly modifies the proposed requirements for implementing the minimum necessary standard. For all uses and many disclosures and requests for disclosures from other covered entities, we require covered entities to implement policies and procedures for ''minimum necessary'' uses and disclosures. Implementation of such policies and procedures is required in lieu of making the ''minimum necessary'' determination for each separate use or disclosure as discussed in the proposal. Disclosures to or requests by a health care provider for treatment purposes are not subject to the standard (see §164.502). Specifically (and as further described below), the proposed requirement for individual review of all uses of protected health information is replaced with a requirement for covered entities to implement policies and procedures that restrict access and uses based on the specific roles of members of the covered entity's workforce."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 126}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 134)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nst of the rule, we specify minimum requirements, not best practices. Covered entities may want to include more detail. We note that all federal agencies must still comply with the Privacy Act of 1974.\nThis means that federal agencies that are covered entities or have covered health care components must comply with the notice requirements of the Privacy Act as well as those included in this rule. In addition, covered entities may want or be required to produce more than one notice in order to satisfy the notice content requirements under this rule. For example, a covered entity that conducts business in multiple states with different laws regarding the uses and disclosures that the covered entity is permitted to make without authorization may be required to produce a different notice for each state. A covered entity that conducts business both as part of an organized health care arrangement or affiliated covered entity and as an independent enterprise (e.g., a physician who sees patients through an on-call arrangement with a hospital and through an independent private practice) may want to adopt different privacy practices with respect to each line of business; such a covered entity would be required to produce a different notice describing the practices for each line of business. Covered entities must produce notices that accurately describe the privacy practices that are relevant to the individuals receiving the notice. ## Required Elements\n\n## Plain Language\n\nAs in the proposed rule, we require the notice to be written in plain language. A covered entity can satisfy the plain language requirement if it makes a reasonable effort to: organize material to serve the needs of the reader; write short sentences in the active voice, using ''you'' and other pronouns; use common, everyday words in sentences; and divide material into short sections."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 133}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 19)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nty testing, see Section V.C, below. Manufacturers may include the demonstration of security controls that are comparable or in addition to those described in Appendix 1 in their premarket submissions.\nIf using alternate controls that are not described in this document, manufacturers should provide documentation and tracing of specific design features and security controls to the associated risks in order to demonstrate that they provide appropriate levels of safety and effectiveness. As cybersecurity design controls are established early in the development phase, FDA recommends that device manufacturers utilize the FDA Q-submission process to discuss design considerations for cybersecurity risk management throughout the device lifecycle with the agency. 43 Additional information on premarket documentation recommendations for design controls are discussed in the Security Architecture Views section below. ## 2. Security Architecture Views\n\nIn addition to the design control requirements, 44 21 CFR 820.100 requires that manufacturers establish and maintain procedures for implementing corrective and preventive action, which must include, among other things, requirements for analyzing quality data to identify existing and potential causes of quality problems. FDA recommends that manufacturers develop and maintain security architecture view documentation as a part of the process for the design, development, and maintenance of the medical device system. If corrective and preventive actions are identified, these views can be used to help identify impacted functionality and solutions that address the risks. FDA recommends that premarket submissions include the architecture views described in this section. These architecture views can contribute to the demonstration of safety and effectiveness in premarket submissions by illustrating how the controls to address cybersecurity risks have been applied to the medical device system."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 18}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 60)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ntected health information created or received by such health insurance issuers or HMOs that relates to individuals who are or have been participants or beneficiaries in any of such group health plans.\nProtected health information means individually identifiable health information:\n\n- (1) Except as provided in paragraph (2) of this definition, that is:\n2. (i) Transmitted by electronic media;\n3. (ii) Maintained in electronic media; or\n4. (iii) Transmitted or maintained in any other form or medium. - (2) Protected health information excludes individually identifiable health information in:\n6. (i) Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g;\n7. (ii) Records described at 20 U.S.C. 1232g(a)(4)(B)(iv); and\n8. (iii) Employment records held by a covered entity in its role as employer. *\n\n*\n\n*\n\n*\n\n*\n\nUse means, with respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within an entity that maintains such information. *\n\n*\n\n*\n\n*\n\n*\n\n## PART 162-ADMINISTRATIVE REQUIREMENTS\n\n1. The authority citation for part 162 is revised to read as follows:\n\nAuthority: Secs. 1171 through 1179 of the Social Security Act (42 U.S.C. 1320d-1320d8), as added by sec. 262 of Pub. L. 104-191, 110 Stat. 2021-2031, and sec. 264 of Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)). ## §162.103 [Amended]\n\n2. In § 162.103, the definition of ''electronic media'' is removed. ## PART 164-SECURITY AND PRIVACY\n\n1. The authority citation for part 164 is revised to read as follows:\n\nAuthority: Secs. 1171 through 1179 of the Social Security Act (42 U.S.C. 1320d-1320d8), as added by sec. 262 of Pub. L. 104-191, 110 Stat. 2021-2031, and 42 U.S.C. 1320d2 and 1320d-4, sec. 264 of Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)). 2. A new § 164.103 is added to read as follows:\n\n## §164.103 Definitions."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 59}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 157)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nexcept to the extent doing so would be inconsistent with the prohibition in GINA and this final rule at §164.502(a)(5)(i) against using or disclosing genetic information for underwriting purposes. 9.\nSection 164.520-Notice of Privacy Practices for Protected Health Information\n\n## Proposed Rule\n\nAs discussed above in Section IV with regard to the changes made to § 164.520 pursuant to the HITECH Act, § 164.520 of the Privacy Rule sets out the requirements for most covered entities to have and distribute a Notice of Privacy Practices (NPP). With respect to the NPP, the Department believes that\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with individuals should be informed of their rule with respect to genetic information in the health coverage context. Thus, the\n\nnew rights and protections under this Department proposed in §164.520(b)(1)(iii)(D) to require health plans that use or disclose protected health information for underwriting to include a statement in their NPP that they are prohibited from using or disclosing protected health information that is genetic information about an individual for such purposes. Without such a specific statement, individuals would not be aware of this restriction and the general statements regarding permitted uses and disclosures for treatment, payment, and health care operations in the NPP of a health plan that performs underwriting would not be accurate (i.e., the NPP would state that the health plan may use or disclose PHI for purposes of payment and health care operations, which would not be true with respect to genetic information when the use or disclosure is for underwriting purposes)."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 156}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 143)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\notifications were provided. ## VI. Modifications to the HIPAA Privacy Rule Under GINA\n\n## A. Background\n\nThe Genetic Information Nondiscrimination Act of 2008 (''GINA''), Public Law 110-233, 122 Stat.\n881, prohibits discrimination based on an individual's genetic information in both the health coverage and employment contexts. With respect to health coverage, Title I of GINA generally prohibits discrimination in premiums or contributions for group coverage based on genetic information, proscribes the use of genetic information as a basis for determining eligibility or setting premiums in the individual and Medicare supplemental (Medigap) insurance markets, and limits the ability of group health plans, health insurance issuers, and Medigap issuers to collect genetic information or to request or require that individuals undergo genetic testing. Title II of GINA generally prohibits use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with information, and strictly limits such entities from disclosing genetic information. The Departments of Labor, Treasury, and Health and Human Services (HHS) are responsible for administering and enforcing the GINA Title I nondiscrimination provisions, and the Equal Employment Opportunity Commission (EEOC) is responsible for administering and enforcing the GINA Title II nondiscrimination provisions."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 142}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 54)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nFinally, several commenters requested that the Department provide a model business associate agreement. ## Final Rule\n\nThe final rule adopts the proposed modifications to §§ 164.502(e) and 164.504(e).\nAs we discussed above, while section 13404 of the HITECH Act provides that business associates are now directly liable for civil money penalties under the HIPAA Privacy Rule for impermissible uses and disclosures and for the additional HITECH requirements in Subtitle D that are made applicable to covered entities, it does not apply all of the requirements of the Privacy Rule to business associates and thus, the final rule does not. Therefore, business associates are not required to comply with other provisions of the Privacy Rule, such as providing a notice of privacy practices or designating a privacy official, unless the covered entity has chosen to delegate such a responsibility to the business associate, which would then make it a contractual requirement for which contractual liability would attach. Concerning commenters' questions about the continued need for business associate agreements given the new direct liability on business associates for compliance, we note that section 13404 of the HITECH Act expressly refers and ties business associate liability to making uses and disclosures in accordance with the uses and disclosures laid out in such agreements, rather than liability for compliance with the Privacy Rule generally. Further, section 13408 of the HITECH Act requires certain data transmission and personal health record vendors to have in place business associate agreements with the covered entities they serve."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 53}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_postmarket_2016 say about HIPAA compliance? (Part 13)"}, {"role": "assistant", "content": "According to fda_postmarket_2016:\n\nommendations\n\n- A device manufacturer is notified of an open, unused communication port by the U.S. Department of Homeland Security Industrial Control Systems-Cyber Emergency Response Team (ICS-CERT).\nSubsequent analyses show that a design feature of the device prevents unauthorized remote firmware download onto the device. The threat is mitigated substantially by the need for physical access due to this device feature and the residual risk of patient harm is considered 'acceptable.' The manufacturer takes steps to further enhance the device's security by taking steps to close the unused communication port(s) and provide adequate communication to device users (e.g., user facilities) to facilitate the patch. If the manufacturer closes the open communication ports, the change would be considered a cybersecurity routine update or patch, a type of device enhancement. The change does not require reporting under 21 CFR part 806 (see the 'Distinguishing Medical Device Recalls from Medical Enhancements Guidance' [http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedo cuments/ucm418469.pdf] for additional clarity of reporting requirements and recommendations for device enhancements). - A device manufacturer receives a user complaint that a recent security software scan of the PC component of a class III medical device has indicated that the PC is infected with malware. The outcome of a manufacturer investigation and impact assessment confirms the presence of malware and that the primary purpose of the malware is to collect internet browsing information. The manufacturer also determines that the malware has actively collected browsing information, but that the device's safety and essential performance is not and would not be impacted by such collection. The manufacturer's risk assessment determines that the risk of patient harm due to the vulnerability is controlled."}], "metadata": {"source": "fda_postmarket_2016", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 12}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 16)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nedia'' that house electronic data. Second, we proposed to add to paragraph (2) of the definition of ''electronic media'' a reference to intranets, to clarify that intranets come within the definition.\nThird, we proposed to change the word ''because'' to ''if'' in the final sentence of paragraph (2) of the definition of ''electronic media.'' The definition assumed that no transmissions made by voice via telephone existed in electronic form before transmission; the evolution of technology has made this assumption obsolete since some voice technology is digitally produced from an information system and transmitted by phone. ## Overview of Public Comments\n\nThe Department received comments in support of the revised definition and the flexibility created to account for later technological developments. Certain other commenters raised concerns that changes to the definition could have unintended impacts when applied to the administrative transaction and code set requirements. One commenter specifically supported the change in language from ''because'' to ''if,'' noting the distinction was important to provide protection for digital audio recordings containing protected health information. One commenter suggested including the\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with word ''immediately'' in the final sentence of paragraph (2) to indicate that fax transmissions are excluded from the definition of electronic media if the information being exchanged did not exist in electronic form immediately before the transmission. Several commenters sought clarification as to whether data that is retained in office machines, such as facsimiles and photocopiers, is subject to the Privacy and Security Rules. ## Final Rule\n\nThe final rule adopts the definition as proposed with two additional modifications."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 15}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 356)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nvacy board members have varying backgrounds and appropriate professional competency as necessary to review the effect of the research protocol on the individual's privacy rights and related interests.\nWe believe that this criterion for privacy board membership requires that members already have the necessary knowledge or that they be trained to address privacy issues that arise in the conduct of research that involves the use of protected health information. In addition, we note that the Common Rule (§ /�������������������������\u000f����/�������������������������\u000f���� .107(a)) already imposes a general requirement that IRB members posses adequate training and experience to adequately evaluate the research which it reviews. IRBs are also authorized to obtain the services of consultants (§ /�������������������������\u000f����/�������������������������\u000f���� .107(f)) to provide expertise not available on the IRB. We believe that these existing requirements in the Common Rule already require that an IRB have the necessary privacy expertise. ## Waiver Criteria\n\nComment: A large number of comments supported the proposed rule's criteria for the waiver of authorization by an IRB or privacy board. Response: While we agree that several of the waiver criteria should be retained in the final rule, we have made changes to the waiver criteria to address some of the comments we received on specific criteria. These reason for these changes are discussed in the response to comments below. Comment: In addition to the proposed waiver criteria, several commenters recommended that the final rule also instruct IRBs and privacy boards to consider the type of protected health information and the sensitivity of the information to be disclosed in determining whether to grant a waiver, in whole or in part, of the authorization requirements."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 355}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 389)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ns or receives protected health information other than as a business associate of a covered entity, it is permitted and required to obtain authorizations to the same extent as any other covered entity.\nComment: A few commenters suggested we require covered entities to publicly disclose, on the covered entity's website or upon request, all of their marketing arrangements. Response: While we agree that such a requirement would provide individuals with additional information about how their information would be used, we do not feel that such a significant intrusion into the business practices of the covered entity is warranted. Comment: Some commenters argued that if an activity falls within the scope of payment, it should not be considered marketing. Commenters strongly supported an approach which would bar an activity from being construed as ''marketing'' even if performing that activity would result in financial gain to the covered entity. In a similar vein, we were urged to adopt the position that if an activity was considered payment, treatment or health care operations, it could not be further evaluated to determine whether it should be excluded as marketing. Response: We considered the approach offered by commenters but decided against it. Some activities, such as the marketing of a covered entity's own health-related products or services, are now included in the definition of health care operations, provided certain requirements are met. Other types of activities, such as the sale of a patient list to a marketing firm, would not be permitted under this rule without authorization from the individual. We do not believe that we can envision every possible disclosure of health information that would violate the privacy of an individual, so any list would be incomplete."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 388}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 113)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nry in guidance'' and provides that the guidance specify the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.\nCovered entities and business associates that implement the specified technologies and methodologies with respect to protected health information are not required to provide notifications in the event of a breach of such informationthat is, the information is not considered ''unsecured'' in such cases. As required by the Act, the Secretary initially issued this guidance on April\n\nVerDate Mar&lt;15&gt;2010\n\n17, 2009 (it was subsequently published at 74 FR 19006 on April 27, 2009). The guidance listed and described encryption and destruction as the two technologies and methodologies for rendering protected health information unusable, unreadable, or indecipherable to unauthorized individuals. In cases in which notification is required, the Act at section 13402 prescribes the timeliness, content, and methods of providing the breach notifications. Section 13402 required HHS to issue within 180 days of enactment interim final regulations to implement these breach notification requirements. The Department issued an interim final rule on August 24, 2009, with a 60-day public comment period (74 FR 42740). The interim final rule became effective on September 23, 2009. In the preamble to the interim final rule, the Department also re-issued without substantive change its Guidance Specifying the Technologies and Methodologies That Render Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals that was initially issued on April 17, 2009. The Guidance continues to specify encryption and destruction as the two methods for rendering protected health information unusable, unreadable, or indecipherable to unauthorized individuals-or ''secured''-and thus, exempt from the breach notification obligations. See 74 FR 42741-43. ## B."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 112}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the physical safeguards under HIPAA?"}, {"role": "assistant", "content": "According to security_rule_2003:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160, 162, and 164 [CMS-0049-F] RIN 0938-AI57\n\n## Health Insurance Reform: Security Standards\n\nAGENCY: Centers for Medicare &amp; Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses, and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and otherFederal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general by establishing a level of protection for certain electronic health information. This final rule implements some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability andAccountability Act of 1996 (HIPAA). DATES: Effective Date: These regulations are effective on April 21, 2003. Compliance Date: Covered entities, with the exception of small health plans, must comply with the requirements of this final rule by April 21, 2005. Small health plans must comply with the requirements of this final rule by April 21, 2006. FOR FURTHER INFORMATION CONTACT: William Schooler, (410) 786-0089. SUPPLEMENTARY INFORMATION:\n\n## Availability of Copies and Electronic Access\n\nTo order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 5122250. The cost for each copy is $10."}], "metadata": {"source": "security_rule_2003", "safeguard_type": "physical", "implementation_spec": "both", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 87)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nst inform the individual that, when the information is used or disclosed pursuant to the authorization, it may be subject to re-disclosure by the recipient and may no longer be protected by this rule.\nSeventh, the authorization must include the individual's signature and the date of the signature. Once we adopt the standards for electronic signature, another of the required administrative simplification standards we are required to adopt under HIPAA, an electronic signature that meets those standards will be sufficient under this rule. We do not require verification of the individual's identity or authentication of the individual's signature. Finally, if the authorization is signed by a personal representative of the individual, the representative must indicate his or her authority to act for the individual. As in the proposed rule, the authorization must be written in plain language. See the preamble discussion regarding notice of privacy practices (§ 164.520) for a discussion of the plain language requirement. We do not provide a model authorization in this rule. We will provide further guidance on this issue prior to the compliance date. ## Section 164.508(d)-Authorizations Requested by a Covered Entity for Its Own Uses and Disclosures\n\nWe proposed to require covered entities to include additional elements in authorizations initiated by the covered entity."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 86}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 163)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nd concern that clergy, religious practitioners, and other faith-based service providers would have to abide by the rule and asked that the Department exempt prayer healing and non-medical health care.\nResponse: The Secretary provides the following clarifications in response to these comments. To the extent that a ''department-operated hospital'' meets the definition of a ''health care provider'' and conducts any of the standard transactions, it is a covered entity for the purposes of this rule. We agree that a state Crime Victim Compensation Program is not a covered entity if it is not a health care provider that conducts standard transactions, health plan, or health care clearinghouse. Further, as described above, employers are not covered entities. In addition, we agree that workers' compensation insurers, property and casualty insurers, reinsurers, and stoploss insurers are not covered entities, as they do not meet the statutory definition of ''health plan.'' See further discussion in the preamble on § 160.103 regarding the definition of ''health plan.'' However, activities related to ceding, securing, or placing a contract for reinsurance, including stop-loss insurance, are health care operations in the final rule. As such, reinsurers and stop-loss insurers may obtain protected health information from covered entities. Also, in response to the comment regarding religious practitioners, the Department clarifies that ''health care'' as defined under the rule does not include methods of healing that are solely spiritual. Therefore, clergy or other religious practitioners that provide solely religious healing services are not health care providers within the meaning of this rule, and consequently not covered entities for the purposes of this rule. Comment: A few commenters expressed general uncertainty and requested clarification as to whether certain entities were covered entities for the purposes of this rule."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 162}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 223)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nnsidered health care operations. Others questioned whether such studies or research performed internal to a covered entity are ''health care operations'' even if generalizable results may be produced.\nResponse: We agree that some health care operations have many of the characteristics of research studies and in the NPRM asked for comments on how to make this distinction. While a clear answer was not suggested in any of the comments, the comments generally together with our fact finding lead to the provisions in the final rule. The distinction between health care operations and research rests on whether the primary purpose of the study is to produce ''generalizable knowledge.'' We have modified the definition of health care operations to include ''quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities. '' If the primary purpose of the activity is to produce generalizable knowledge, the activity fits within this rule's definition of ''research'' and the covered entity must comply with §§164.508 or 164.512, including obtaining an authorization or the approval of an institutional review board or privacy board. If not and the activity otherwise meets the definition of health care operations, the activity is not research and may be conducted under the health care operations provisions of this rule. In some instances, the primary purpose of the activity may change as preliminary results are analyzed. An activity that was initiated as an internal outcomes evaluation may produce information that the covered entity wants to generalize. If the purpose of a study changes and the covered entity does intend to generalize the results, the covered entity should document the change in status of the activity to establish that they did not violate the requirements of this rule."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 222}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 43)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nle position of having to decide whether to withhold treatment when an individual did not provide consent or proceed to use information to treat the individual in violation of the consent requirements.\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00029\n\n- The transition provisions would have resulted in significant operational problems, and the inability to access health records would have had an adverse effect on quality activities, because many providers currently are not required to obtain consent for treatment, payment, or health care operations. - could have hampered treatment and resulted in large institutional providers deciding that it would be necessary to obtain consent at each patient encounter instead. - Providers that are required by law to treat were concerned about the mixed messages to patients and interference with the physician-patient relationship that would have resulted because they would have had to ask for consent to use or disclose protected health information for treatment, payment, or health care operations, but could have used or disclosed the information for such purposes even if the patient said ''no.''\n\nAs a result of the large number of treatment-related obstacles raised by various types of health care providers that would have been required to obtain consent, the Department became concerned that individual fixes would be too complex and could possibly overlook important problems. Instead, the Department proposed an approach designed to protect privacy interests by affording patients the opportunity to engage in important discussions regarding the use and disclosure of their health information through the strengthened notice requirement, while allowing activities that are essential to quality health care to occur unimpeded (see section III.H. of the preamble for a discussion of the strengthened notice requirements)."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 42}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 449)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ned relevance to the regulation actually proposed. The following are examples of assumptions and costs in the analysis that do not match privacy policies or requirements stated in the proposed rule. 1.\nAuthorizations: The study assumed rules requiring new authorizations from current subscribers to use their data for treatment, payment of claims, or other health plan operations. The proposed rule would have prohibited providers or plans from obtaining patient authorization to use data for treatment, payment or health care operations, and the final rule makes obtaining consent for these purposes voluntary for all health plans and for providers that do not have direct treatment relationships with individuals. 2. Disclosure History: The study assumes that providers, health plans, and clearinghouses would have to track all disclosures of health information. Under the NPRM and the final rule, plans, providers and clearinghouses are only required to account for disclosures that are not for treatment, payment, and health care operations, a small minority of all disclosures. 3. Inspection, Copying, and Amendment: The study assumed requirements to allow patients and their subscribers to inspect, copy, and amend all information that includes their name, social security number or other identifying feature ( e.g. customer service calls, internal memorandum, claim runs). However, the study assumed broader access than provided in the rule, which requires access only to information in records used to make decisions about individuals, not all records with identifiable information. 4. Infrastructure development: The study attributed significant costs to infrastructure implementation of (computer systems, training, and other compliance costs). As explained below, the compliance requirements are much less extensive than assumed in this study."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 448}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 51)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nd entity implement policies and procedures to document repairs and modifications to the physical components of a facility that are related to security (for example, hardware, walls, doors, and locks).\nWe believe that 15,500 entities will have to repair or modify physical components, most of which will need to be done in the first year of implementation. In the following years, we estimate that 500 entities will need to make repairs or modifications. We estimate that it will take 10 minutes to document each repair or modification for a burden of 2,583 hours the first year and 83 hours annually subsequently. This section requires that a covered entity create a retrievable, exact copy of electronic protected health information, where needed, before movement of equipment. We believe that the burden associated with this requirement is not subject to the PRA. It is good business practice for entities to backup their data files, and as such is usual and customary among the entities subject to them. A burden associated with a requirement conducted in the normal course of business is exempt from the PRA as defined in 5 CFR 1320.3(b)(2). ## Section 164.314 Organizational Requirements\n\nThis section requires that a covered entity report to the Secretary problems with a business associate's pattern of an activity or practice of the business associate that constitute a material breach or violation of the business associate's obligation under the contract or other arrangement if it is not feasible to terminate the contract or arrangement. We believe that 10 entities will need to comply with this reporting requirement and that it will take them 60 minutes to comply with this requirement for an annual burden of 10 hours."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 50}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 10)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nding specifically anti-kickback, fraud and abuse, or self-referral statutes or regulations, or to authorize or permit any activity or transaction currently proscribed by such statutes and regulations.\nExamples of such laws include the anti-kickback statute (section 1128B(b) of the Social Security Act), safe harbor regulations (42 CFR part 1001), Stark law (section 1877 of the Social Security Act) and regulations (42 CFR parts 411 and 424), and HIPAA statute on self-referral (section 1128C of the Social Security Act). The definition\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nof ''marketing'' is solely applicable to the Privacy Rule and the permissions granted by the Rule are only for a covered entity's use or disclosure of protected health information. In particular, although this regulation defines the term ''marketing'' to exclude communications to an individual to recommend, purchase, or use a product or service as part of the treatment of the individual or for case management or care coordination of that individual, such communication by a ''white coat'' health care professional may violate the anti-kickback statute. Similar examples for pharmacist communications with patients relating to the marketing of products on behalf of pharmaceutical companies were identified by the OIG as problematic in a 1994 Special Fraud Alert (December 19, 1994, 59 FR 65372). Other violations have involved home health nurses and physical therapists acting as marketers for durable medical equipment companies. Although a particular communication under the Privacy Rule may not require patient authorization because it is not marketing, or may require patient authorization because it is ''marketing'' as the Rule defines it, the arrangement may nevertheless violate other statutes and regulations administered by HHS, the Department of Justice, or other Federal or State agency."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 9}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 65)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nThis standard does not apply with respect to-\n- (i) The transmission by a covered entity of electronic protected health information to a health care provider concerning the treatment of an individual.\n- (ii) The transmission of electronic protected health information by a group health plan or an HMO or health insurance issuer on behalf of a group health plan to a plan sponsor, to the extent that the requirements of §164.314(b) and § 164.504(f) apply and are met; or\n- (iii) The transmission of electronic protected health information from or to other agencies providing the services at §164.502(e)(1)(ii)(C), when the covered entity is a health plan that is a government program providing public\n\nVerDate Jan&lt;31&gt;2003\n\n- benefits, if the requirements of §164.502(e)(1)(ii)(C) are met. - (3) A covered entity that violates the satisfactory assurances it provided as a business associate of another covered entity will be in noncompliance with the standards, implementation specifications, and requirements of this paragraph and § 164.314(a). - (4) Implementation specifications: Written contract or other arrangement (Required). Document the satisfactory assurances required by paragraph (b)(1) of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of § 164.314(a). ## §164.310 Physical safeguards. A covered entity must, in accordance with § 164.306:\n\n- (a)(1) Standard: Facility access controls. Implement policies and procedures to limit physical access to its electronic information systems and the facility or facilities in which they are housed, while ensuring that properly authorized access is allowed. - (2) Implementation specifications:\n- (i) Contingency operations (Addressable). Establish (and implement as needed) procedures that allow facility access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 64}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 47)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\ne options, we do not believe that any would address all of the issues that were brought to the Department's attention during the comment process or would be the best approach for regulating this area.\nFor example, the suggestion to treat pharmacists as indirect treatment providers would not be consistent with the current regulatory definition of that term and would not have addressed\n\nVerDate Aug&lt;2,&gt;2002\n\nother referral situations. This approach was also rejected by some pharmacists who view themselves as providing treatment directly to individuals. The suggestion to allow certain uses and disclosures prior to first patient encounter would not address concerns of tracking consents, use of historical data for quality purposes, or the concerns of emergency treatment providers. The Department desired a global approach to resolving the problems raised by the prior consent requirement, so as not to add additional complexity to the Privacy Rule or apply different standards to different types of direct treatment providers. This approach is consistent with the basic goal of the Rule to provide flexibility as necessary for the standards to work for all sectors of the health care industry. More global approaches suggested were carefully considered, but each had some flaw or failed to address all of the treatment-related concerns brought to our attention. For example, those who suggested that the Rule be modified to require a good faith effort to obtain consent at first service delivery failed to explain how that approach would provide additional protection than the approach we proposed. The Department also decided against eliminating the consent requirement only for uses and disclosures for treatment, or only for uses of protected health information but not for disclosures, because these options fall short of addressing all of the problems raised."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 46}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 122)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\npersons who need access to protected health information to carry out their duties and to disclose an amount of protected health information reasonably necessary to achieve the purpose of a disclosure.\nThe Privacy Rule requires covered entities to determine and define in their policies and procedures how the minimum necessary standard applies to their own uses and disclosures. Thus, covered entities are in a good position to know when such policies and procedures have been violated and to assess the probability that the incident has compromised the security or privacy of the information. Finally, we will consider including further guidance regarding the interaction between the minimum necessary standard and the breach notification requirements in the guidance required by section 13405(b)(1)(B) of the HITECH Act. Comment: Several commenters asked that we clarify the differences between ''acquisition,'' ''access,'' ''use,'' and ''disclosure'' in the exceptions in the final rule. These commenters expressed confusion regarding the use of these terms in the first two exceptions to the definition of breach, stating that the term ''acquisition'' connotes a disclosure of information, and thus, the exception regarding unintentional acquisition, access, or use of protected health information by a workforce member or person acting under the authority of a covered entity or business associate implicitly includes disclosures of protected health information. Response: While the Privacy Rule uses the terms ''use'' and ''disclosure,'' we included both ''acquisition'' and ''access'' in the regulatory text for consistency with the statutory language. We interpret ''acquisition'' and ''access''\n\nVerDate Mar&lt;15&gt;2010\n\nto information based on their plain meanings and believe that both terms are encompassed within the current definitions of ''use'' and ''disclosure'' in the HIPAA Rules."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 121}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 285)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ndisclose protected health information for treatment, payment, and health care operations. In addition, we have eliminated the provision prohibiting other covered entities from obtaining such consents.\nWe note that the consents that covered entities are permitted to obtain relate to their own uses and disclosures of protected health information for treatment, payment, and health care operations and not to the practices of others. If a covered entity wants to obtain the individual's permission to receive protected health information from another covered entity, it must do so using an authorization under § 164.508. ## ''Consent'' versus ''Authorization''\n\nComment: In general, commenters did not distinguish between ''consent'' and ''authorization.'' Commenters used both terms to refer to the individual's giving permission for the use and disclosure of protected health information by any entity. Response: In the final rule we have made an important distinction between consent and authorization. Under the final rule, we refer to the process by which a covered entity seeks agreement from an individual regarding how it will use and disclose the individual's protected health information for treatment, payment, and health care operations as ''consent.'' The provisions in the final rule relating to consent are largely contained in § 164.506. The process by which a covered entity seeks agreement from an individual to use or disclose protected health information for other purposes, or to authorize another covered entity to disclose protected health information to the requesting covered entity, are termed ''authorizations'' and the provisions relating to them are found in § 164.508. ## Consent Requirements\n\nComment: Many commenters believed that consent might be problematic in that it could allow covered entities to refuse enrollment or services if the individual does not grant the consent."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 284}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 156)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nnst individuals who exercise any right, or participate in any process established by the privacy rule (Part 164 Subpart E), and include as an example the filing of a complaint with the covered entity.\n## Waiver of Rights\n\nIn the final regulation, but not in the proposed regulation, we provide that a covered entity may not require individuals to waive their rights to file a complaint with the Secretary or their other rights under this rule as a condition of the provision of treatment, payment, enrollment in a health plan or eligibility for benefits. This provision ensures that covered entities do not take away the rights that individuals have been provided in Parts 160 and 164. ## Requirements for Policies and Procedures, and Documentation Requirements\n\nIn § 164.520 of the NPRM, we proposed to require covered entities to develop and document their policies and procedures for implementing the requirements of the rule. In the final regulation we retain this approach, but specify which standards must be documented in each of the relevant sections. In this section, we state the general administrative requirements applicable to all policies and procedures required throughout the regulation. In § 164.530(i), (j), and (k) of the final rule, we amend the NPRM language in several respects. In § 164.530(i) we require that the policies and procedures be reasonably designed to comply with the standards, implementation specifications, and other requirements of the relevant part of the regulation, taking into account the size of the covered entity and the nature of the activities undertaken by the covered entity that relate to protected health information. However, we clarify that the requirements that policies and procedures be reasonably designed may not be interpreted to permit or excuse any action that violates the privacy regulation."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 155}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 368)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nustrative only, and it was not intended to limit the types of\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\npersons who could make such a credible representation to a covered entity.\nComment: One commenter questioned under what circumstances proposed §164.510(k) would apply instead of proposed §164.510(f)(5), ''Urgent Circumstances,'' which permitted covered entities to disclose protected health information to law enforcement officials about individuals who are or are suspected to be victims of a crime, abuse, or other harm, if the law enforcement official represents that the information is needed to determine whether a violation of law by a person other than the victim has occurred and immediate law enforcement activity that depends upon obtaining such information may be necessary. Response: First, we note that inclusion of this provision as §164.510(f)(5) was a drafting error which subsequently was clarified in technical corrections to the NPRM. In fact, proposed § 164.510(f)(3) addressed the identical circumstances, which in this subsection were titled ''Information about a Victim of Crime or Abuse.'' The scenarios described under §164.510(f)(3) may or may not involve serious and imminent threats to health or safety. Second, as discussed in the main section of the preamble to § 164.512(j), we recognize that in some situations, more than one section of this rule potentially could apply with respect to a covered entity's potential disclosure of protected health information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 367}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 41)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\n| Key Activities | Description | Sample Questions | |----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • Consider whether any vendor/service provider arrangements are critical to operations and address them as appropriate to ensure availability and reliability."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 40}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.504(c)(2) require?"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n§164.504(c)(2).\n\nThe term ''primary functions'' in the definition of ''hybrid entity'' is not meant to operate with mathematical precision. Rather, we intend that a more common sense evaluation take place: Is most of what the covered entity does related to its health care functions? If so, then the whole entity should be covered. Entities with different insurance lines, if not separately incorporated, present a particular issue with respect to this analysis. Because the definition of ''health plan'' excludes many types of insurance products (in the exclusion under paragraph (2)(i) of the defin"}], "metadata": {"source": "privacy_rule_2000", "cfr_section": "§164.504(c)(2)", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 507)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nThe communication is made orally; or\n8. (ii) The communication is in writing and the covered entity does not receive direct or indirect remuneration from a third party for making the communication. 9.\nOrganized health care arrangement means:\n- (1) A clinically integrated care setting in which individuals typically receive health care from more than one health care provider;\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\n- (2) An organized system of health care in which more than one covered entity participates, and in which the participating covered entities:\n2. (i) Hold themselves out to the public as participating in a joint arrangement; and\n3. (ii) Participate in joint activities that include at least one of the following:\n4. (A) Utilization review, in which health care decisions by participating covered entities are reviewed by other participating covered entities or by a third party on their behalf;\n5. (B) Quality assessment and improvement activities, in which treatment provided by participating covered entities is assessed by other participating covered entities or by a third party on their behalf; or\n6. (C) Payment activities, if the financial risk for delivering health care is shared, in part or in whole, by participating covered entities through the joint arrangement and if protected health information created or received by a covered entity is reviewed by other participating covered entities or by a third party on their behalf for the purpose of administering the sharing of financial risk."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 506}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 38)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nDetermine the Goals of an Incident Response                                                         | • Gain an understanding as to what constitutes a true security incident. Under the HIPAA Security Rule, a security incident is the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system (45 CFR § 164.304). • Ensure that the incident response program covers all parts of the organization in which ePHI is created, stored, processed, or transmitted. • Determine how the organization will respond to a security incident. • Establish a reporting mechanism and a process to coordinate responses to the security incident. • Provide direct technical assistance, advise vendors to address product-related problems, and provide liaisons to legal and criminal investigative groups, as needed. | • Has the HIPAA-required security risk assessment resulted in a list of potential physical or technological events that could lead to a breach of security? • Is there a procedure in place for reporting and handling incidents? • Has an analysis been conducted that relates reasonably anticipated organizational threats (that could result in a security incident) to the methods that would be used for mitigation? • Have the key functions of the organization been prioritized to determine what would need to be restored first in the event of a disruption? 69 |\n| 2. Develop and Deploy an Incident Response Team or Other Reasonable and Appropriate Response Mechanism | • Determine whether the size, scope, mission, and other aspects of the organization justify the reasonableness and appropriateness of maintaining a standing incident response team. • Identify appropriate individuals to be part of a formal incident response team if the organization has determined that implementing an incident response team is reasonable and appropriate."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 37}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 24)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nr premarket submissions so that FDA can assess whether the manufacturer has sufficiently addressed how to maintain the safety and effectiveness of the device after marketing authorization is achieved.\nFor cyber devices, 'a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures' is required (see section 524B(b)(1) of the FD&amp;C Act and Section VII.C.1 of this guidance). Cybersecurity management plans should include the following elements:\n\n- Personnel responsible;\n- Sources, methods, and frequency for monitoring and identifying vulnerabilities (e.g., researchers, NIST national vulnerability database (NIST NVD), third-party software manufacturers);\n- Identify and address vulnerabilities identified in CISA's Known Exploited Vulnerabilities Catalog;\n- Periodic security testing;\n- Timeline to develop and release patches;\n- Update processes;\n- Patching capability (i.e., rate at which update can be delivered to devices);\n- Description of their coordinated vulnerability disclosure process; and\n- Description of how the manufacturer intends to communicate forthcoming remediations, patches, and updates to customers. Additional recommendations on coordinated vulnerability disclosure plans may be found in FDA's Postmarket Cybersecurity Guidance. ## VII. Cyber Devices\n\nThis section identifies the cybersecurity information FDA considers to generally be necessary to support obligations under section 524B of the FD&amp;C Act for cyber devices. This section provides recommendations specifically for cyber devices. Manufacturers of cyber devices should also consider the recommendations throughout this guidance to help meet their obligations under section 524B of the FD&amp;C Act. ## A."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 23}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 53)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nproposal in a number of ways. For example, a number of health plans and others requested that the Department eliminate the condition that both covered entities have a relationship with the individual.\nSome of these commenters explained that such a restriction would impede some fraud and abuse activities, credentialing investigations, and quality assurance research and outcome studies. Some commenters asked that the Department clarify that the condition that both covered entities have a relationship with the individual would not be limited to a current relationship, but also would include a past relationship with the individual. VerDate Aug&lt;2,&gt;2002\n\nIn addition, many commenters requested that the Department expand the proposed provision to allow for disclosures for any type of health care operation of another covered entity, or at least additional activities beyond those specified in the proposal. Some health plans commented that they may need information from a health care provider in order for the health plan to resolve member or internal grievances, provide customer service, arrange for legal services, or conduct medical review or auditing activities. A number of commenters requested that the proposal be expanded to allow for disclosures for another covered entity's underwriting or premium rating. Some commenters also requested that the Department expand the provision to allow for disclosures to non-covered entities. In particular, a number of these commenters urged that the Department allow disclosures to non-covered insurers for fraud and abuse purposes. Some of these commenters specifically requested that the Department allow for disclosures to affiliated entities or nonhealth care components of the covered entity for purposes of investigating fraud and abuse. A few commenters requested that the Rule allow for disclosures to a non-covered health care provider for that provider's operations."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 52}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 167)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nheck, or electronic funds transfer; (e) for reporting to consumer reporting agencies; or (f) for complying with: (i) a civil or criminal subpoena; or (ii) a federal or state law regulating the entity.\nThese companies expressed concern that the proposed rule did not include the full text of section 1179 when discussing the list of activities that were exempt from the rule's requirements. Accordingly, they recommended including in the final rule either a full listing of or a reference to section 1179's full list of exemptions. Furthermore, these firms opposed applying the proposed rule's minimum necessary standard for disclosure of protected health information to financial institutions because of section 1179. These commenters suggest that in light of section 1179, HHS lacks the authority to impose restrictions on financial institutions and other entities when they engage in activities described in that section. One commenter expressed concern that even though proposed §164.510(i) would have permitted covered entities to disclose certain information to financial institutions for banking and payment processes, it did not state clearly that financial institutions and other entities described in section 1179 are exempt from the rule's requirements. Response: We interpret section 1179 of the Act to mean that entities engaged in the activities of a financial institution, and those acting on behalf of a financial institution, are not subject to this regulation when they are engaged in authorizing, processing, clearing, settling, billing, transferring, reconciling, or collecting payments for a financial institution. The statutory reference to 12 U.S.C."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 166}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "How should organizations implement physical controls?"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\n## Office of the Secretary\n\n## 45 CFR Parts 160 and 164\n\nRin: 0991-AB08\n\n## Standards for Privacy of Individually Identifiable Health Information\n\nAGENCY : Office of the Assistant Secretary for Planning and Evaluation, DHHS. ACTION\n\n: Final rule. SUMMARY : This rule includes standards to protect the privacy of individually identifiable health information. The rules below, which apply to health plans, health care clearinghouses, and certain health care providers, present standards with respect to the rights of individuals who are the subjects of this information, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards will improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections will begin to address growing public concerns that advances in electronic technology and evolution in the health care industry are resulting, or may result, in a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and\n\nAccountability Act of 1996. DATES : The final rule is effective on February 26, 2001. ## FOR FURTHER INFORMATION CONTACT :\n\nKimberly Coleman, 1-866-OCR-PRIV (1-866-627-7748) or TTY 1-866-7884989. ## SUPPLEMENTARY INFORMATION :\n\nAvailability of copies, and electronic access. Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954."}], "metadata": {"source": "privacy_rule_2000", "safeguard_type": "physical", "implementation_spec": "required", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 59)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nexternal groups included the NCVHS Workgroup on Standards and Security, the Workgroup for Electronic Data Interchange, the National Uniform Claim Committee, and the National Uniform Billing Committee.\nMost of these groups have State officials as members. We also received comments on the proposed regulation from these organizations. In accordance with the provisions of Executive Order 12866, this rule has been reviewed by the Office of Management and Budget. ## List of Subjects\n\n## 45 CFR Part 160\n\nElectronic transactions, Employer benefit plan, Health, Health care, Health facilities, Health insurance, Health\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\nJkt 200001\n\nrecords, Medicaid, Medical research, Medicare, Privacy, Reporting and record keeping requirements. ## 45 CFR Part 162\n\nAdministrative practice and procedure, Health facilities, Health insurance, Hospitals, Medicaid, Medicare, report and recordkeeping requirement. ## 45 CFR Part 164\n\nAdministrative practice and procedure, Health facilities, Health insurance, Hospitals, Medicaid, Medicare, Electronic Information System, Security, Report and recordkeeping requirement. For the reasons set forth in the preamble, the Department of Health and Human Services amends title 45, subtitle A, subchapter C, parts 160, 162, and 164 as set forth below:\n\n## PART 160-GENERAL ADMINISTRATIVE REQUIREMENTS\n\n1. The authority citation for part 160 continues to read as follows:\n\nAuthority: Sec. 1171 through 1179 of the Social Security Act, (42 U.S.C. 1320d1329d-8) as added by sec. 262 of Pub. L. 104-191, 110 Stat. 2021-2031 and sec. 264 of Pub. L. 104-191 (42 U.S.C. 1320d-2(note)). 2. In § 160.103, the definitions of ''disclosure'', ''electronic media'', ''electronic protected health health care arrangement'', ''protected health information,'' and ''use'' are added in alphabetical order to read as\n\ninformation,'' ''individual,'' ''organized follows:\n\n## §160.103 Definitions."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 58}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 75)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nUnited States\n\n## US-CERT\n\nUnited States Computer Emergency Readiness Team\n\n## VPN\n\nVirtual Private Network\n\n## Appendix B. Glossary\n\nThis appendix provides definitions for terms within this document that are defined principally in the HIPAA Security Rule. ## addressable\n\nTo meet the addressable implementation specifications, a covered entity or business associate must (i) assess whether each implementation specification is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting the electronic protected health information; and (ii) as applicable to the covered entity or business associate - (A) Implement the implementation specification if reasonable and appropriate; or (B) if implementing the implementation specification is not reasonable and appropriate-(1) document why it would not be reasonable and appropriate to implement the implementation specification; and (2) implement an equivalent alternative measure if reasonable and appropriate. [Sec. Rule, §164.306(d)(3)]\n\n## administrative safeguards\n\nAdministrative actions, and policies and procedures, to manage the selection, development, implementation, and maintenance of security measures to protect electronic protected health information and to manage the conduct of the covered entity's or business associate's workforce in relation to the protection of that information. [Sec. Rule, §164.304]\n\n## affiliated covered entities\n\nLegally separate covered entities that are affiliated may designate themselves as a single covered entity for the purposes of this part. [Sec. Rule, §164.105(b)]\n\n## authentication\n\nThe corroboration that a person is the one claimed. [Sec. Rule, §164.304]\n\n## availability\n\nThe property that data or information is accessible and usable upon demand by an authorized person. [Sec."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 74}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 3)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\n|\n| 3. | 3. | Interoperability Considerations ..................................................................................\n| 14                                                                                                                                                                                                                        |\n| 4. | 4. | Third-Party Software Components............................................................................. | 15                                                                                                                                                                                                                        |\n| 5. | 5. | Security Assessment of Unresolved Anomalies......................................................... | 18                                                                                                                                                                                                                        |\n| 6. | 6. | TPLC Security Risk Management.............................................................................. | 18                                                                                                                                                                                                                        |\n| B. | B. | Security Architecture...................................................................................................... | 19                                                                                                                                                                                                                        |\n| 1. | 1. | Implementation of Security Controls ........................................................................."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 2}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 10)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nprivacy concerns and another 87 percent reported having had a patient request to withhold information from their records. For an example of this phenomenon in a particular demographic group, see Drs.\nBearman, Ford, and Moody, ''Foregone Health Care among Adolescents,'' JAMA, vol. 282, no. 23 (999); Cheng, T.L., et al., ''Confidentiality in Health Care: A Survey of Knowledge, Perceptions, and Attitudes among High School Students,'' JAMA, vol. 269, no. 11 (1993), at 1404-1407. The absence of strong national standards for medical privacy has widespread consequences. Health care professionals who lose the trust of their patients cannot deliver high-quality care. In 1999, a coalition of organizations representing various stakeholders including health plans, physicians, nurses, employers, disability and mental health advocates, accreditation organizations as well as experts in public health, medical ethics, information systems, and health policy adopted a set of ''best principles'' for health care privacy that are consistent with the standards we lay out here. (See the Health Privacy Working Group, ''Best Principles for Health Privacy''\n\n## (July, 1999) (Best Principles Study). The Best Principles Study states that-\n\nTo protect their privacy and avoid embarrassment, stigma, and discrimination, some people withhold information from their health care providers, provide inaccurate information, doctor-hop to avoid a consolidated medical record, pay out-ofpocket for care that is covered by insurance, and-in some cases-avoid care altogether. Best Principles Study, at 9. In their comments on our proposed rule, numerous organizations representing health plans, health providers, employers, and others acknowledged the value of a set of national privacy standards to the efficient operation of their practices and businesses."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 9}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 55)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nnsible for coordinating the disposal of data and the reuse of the hardware and software? • Are workforce members appropriately trained on the security risks to ePHI when reusing software and hardware?\n102                                                                                                                            |\n| 3. Maintain Accountability for Hardware and Electronic Media Implementation Specification (Addressable)       | • Maintain a record of the movements of hardware and electronic media and any person responsible for them. • Ensure that ePHI is not inadvertently released or shared with any unauthorized party. | • Have policies and procedures been implemented that govern the receipt and removal of hardware and electronic media that contain ePHI into and out of a facility and the movement of these items within the facility? |\n\n102  See Sec. 5.1.5, HIPAA Standard: Security Awareness and Training."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 54}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 486)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n. Individuals routinely request copies of such information, in whole or in part, for purposes that include providing health information to another health care provider or as part of legal proceedings.\nThe amount of inspection and copying of individually identifiable health information that occurs for these purposes is not expected to change as a result of the final regulation. The final regulation establishes the right of individuals to inspect and copy protected health information about them. Although this is an important right, the Department does not expect it to result in dramatic increases in requests from individuals. We assume that most health care providers currently have procedures for allowing patients to inspect and copy this information. The economic impact on small businesses of requiring covered entities to provide individuals with access to protected health information should be relatively small. Moreover, entities can recoup the costs of copying such information by charging reasonable cost-based fees. ## Amendments to Protected Health Information\n\nMany health care providers and health plans currently make provisions to help patients expedite amendments and corrections of their medical record where appropriate. If an error exists, both the patient and the health care provider on health plan benefit from the correction. However, as with inspection and copying, a person's right to request amendment and correction of individually identifiable health information about them is not guaranteed by all states. Based on these assumptions, the Department concludes that the principal economic effect of the final rule will be to expand the right to request amendments to protected health information held by health plans and covered health care providers to those who are currently granted such right by state law. In addition, the rule may draw additional attention to the issue of record inaccuracies and stimulate patient demand for amendment of medical records."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 485}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 57)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nganized health care arrangement.'' The group health plan (or the HMO with respect to the group health plan) may disclose protected health information to a plan sponsor in accordance with § 164.504(f).\nComment: Several commenters requested that the Department expand the definition of ''payment'' to include disclosures to a responsible party. Additionally, these commenters urged that the Department permit covered entities (and their business associates) to use and disclose protected health information as permitted by other law, rather than only as required by law. These commenters were concerned that the Privacy Rule would impede the ability of first-party billing companies, collection agencies, and accounts receivable management companies to continue to bill and communicate, on behalf of a health care provider, with the responsible party on an account when that person is different from the individual to whom health care services were provided; report outstanding receivables owed by the responsible party on an account to a credit reporting agency; and perform collection litigation services. Response: The Department does not believe a modification to the definition of ''payment'' is necessary. The Privacy Rule permits a covered entity, or a business associate acting on behalf of a covered entity ( e.g., a collection agency),\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nto disclose protected health information as necessary to obtain payment for health care, and does not limit to whom such a disclosure may be made. See the definition of ''payment'' in § 164.501. Therefore, a collection agency, as a business associate of a covered entity, is permitted to contact persons other than the individual to whom health care is provided as necessary to obtain payment for such services."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 56}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 123)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nity to another; (5) law enforcement on the premises of the correctional institution; and (6) the administration and maintenance of the safety, security, and good order of the correctional institution.\nThis section is intended to allow, for example, a prison's doctor to disclose to a van driver transporting a criminal that the individual is a diabetic and frequently has seizures, as well as information about the appropriate action to take if the individual has a seizure while he or she is being transported. We permit covered entities to disclose protected health information about these individuals if the correctional institution or law enforcement official represents that the protected health information is necessary for these purposes. Under 164.514(h), a covered entity may reasonably rely on the representation of such public officials. ## Application to Public Benefits Programs Required to Share Eligibility Information\n\nWe create a new provision for covered entities that are a government program providing public benefits. This provision allows the following disclosures of protected health information. First, where other law requires or expressly authorizes information relating to the eligibility for, or enrollment in more than one public program to be shared among such public programs and/or maintained in a single or combined data system, a public agency that is administering a health plan may maintain such a data base and may disclose information relating to such eligibility or enrollment in the health plan to the extent authorized by such other law. Where another public entity has determined that the appropriate balance between the need for efficient administration of public programs and public funds and individuals' privacy\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00081\n\ninterests is to allow information sharing for these limited purposes, we do not upset that determination."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 122}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 292)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\novision of law requires the disclosure of these notes, a covered entity may make the disclosure under § 164.512(a). The final rule, however, does not require the disclosure of these notes to Medicare.\nComment: One commenter expressed concern that by filing a complaint an\n\nFrm 00193\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nindividual would be required to reveal sensitive information to the public. Another commenter suggested that complaints regarding noncompliance in regard to psychotherapy notes should be made to a panel of mental health professionals designated by the Secretary. This commenter also proposed that all patient information would be maintained as privileged, would not be revealed to the public, and would be kept under seal after the case is reviewed and closed. Response: We appreciate this concern and the Secretary will ensure that individually identifiable health information and other personal information contained in complaints will not be available to the public. This Department seeks to protect the privacy of individuals to the fullest extent possible, while permitting the exchange of records required to fulfill its administrative and program responsibilities. The Freedom of Information Act, 5 U.S.C. 552, and the HHS implementing regulation, 45 CFR part 5, protect records about individuals if the disclosure would constitute an unwarranted invasion of their personal privacy, as does the Privacy Act, 5 U.S.C. 552a. See the discussion of FOIA and the Privacy Act in the ''Relationship to Other Federal Laws'' section of the preamble. Information that the Secretary routinely withholds from the public in its current enforcement activities includes individual names, addresses, and medical information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 291}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 164)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nand are therefore in the baseline. We did not include these costs in our analysis of the annual costs. We have followed the same approach to estimating the costs as outlined in the interim final rule.\nWe examined the cost of notifying affected individuals by first class mail, issuing substitute notice in major media or on a Web site along with a toll-free phone number, notifying prominent media in the event of a\n\n31 Department of Labor, Occupational Employment Statistics; Healthcare Practitioner and\n\nVerDate Mar&lt;15&gt;2010\n\nbreach involving more than 500 individuals, and notifying the Secretary of a breach, as well as the costs of investigating and documenting breaches. Some commenters requested that we include the cost of modifying contracts with business associates to potentially define the breach notification obligations between the parties. We note that costs to modify business associate agreements generally to comply with the new HITECH provisions are discussed elsewhere in this impact analysis. ## Cost of Notifying Affected Individuals by First Class Mail or Email\n\nSection 164.404 requires all covered entities to notify affected individuals of a breach either by first class mail, or if the individual has agreed, by email. In the interim final rule, we assumed that approximately one half of notices sent to affected individuals would be sent via first-class mail, while the rest would be sent via email. By comparison, in the Federal Trade Commission's (FTC) final breach notification rule, the FTC assumed that 90 percent of the notices sent to individuals affected by a breach requiring notification under the FTC rule would be emailed and only 10 percent would be sent by regular first class mail. Since the firms that the FTC regulates are primarily web-based, assuming that the vast majority of communications would be conducted through email is a reasonable assumption."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 163}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 67)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\n(a)(2)(i)(D) of this section if such authorization is inconsistent with the statutory obligations of the covered entity or its business associate. (b)(1) Standard: Requirements for group health plans.\nExcept when the only electronic protected health information disclosed to a plan sponsor is disclosed pursuant to\n\n18:40 Feb 19, 2003\n\nPO 00000\n\nFrm 00047\n\n§164.504(f)(1)(ii) or (iii), or as authorized under § 164.508, a group health plan must ensure that its plan documents provide that the plan sponsor will reasonably and appropriately safeguard electronic protected health information created, received, maintained, or transmitted to or by the plan sponsor on behalf of the group health plan. - (2) Implementation specifications (Required). The plan documents of the group health plan must be amended to incorporate provisions to require the plan sponsor to-\n2. (i) Implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits on behalf of the group health plan;\n3. (ii) Ensure that the adequate separation required by §164.504(f)(2)(iii) is supported by reasonable and appropriate security measures;\n\n(iii) Ensure that any agent, including a subcontractor, to whom it provides this information agrees to implement reasonable and appropriate security measures to protect the information; and\n\n(iv) Report to the group health plan any security incident of which it becomes aware. ## §164.316 Policies and procedures and documentation requirements. A covered entity must, in accordance with § 164.306:\n\n- (a) Standard: Policies and procedures. Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in § 164.306(b)(2)(i), (ii), (iii), and (iv)."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 66}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 439)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nt § 164.524 below. Section 164.524 below has also been reorganized to follow the organization of the analogous provisions of the Transactions Rule. The underlying policy, however, remains as proposed.\n## Extend the Compliance Date\n\nComment: Some commenters recommended that the compliance date be extended. A number of comments objected that the time frame for compliance with the proposed standards is unrealistically short. It was pointed out that providers and others would have to do the following, among other things, prior to the applicable compliance date: assess their current systems and departments, determine which state laws were preempted and which were not, update and reprogram computer systems, train workers, create and implement the required privacy policies and procedures, and create or update contracts with business partners. One comment also noted that the task of coming into compliance during the same time period with the other regulations being issued under HIPAA would further complicate the task. These comments generally supported an extension of the compliance dates by one or more years. Other comments supported extending the compliance dates on the ground that the complexity of the tasks involved in implementing the regulation would be a heavy financial burden for providers and others, and that they should be given more time to comply, in order to spread the associated capital and workforce costs over a longer period. It was also suggested that there be provision for granting extensions of the compliance date, based on some criteria, such as a good faith effort to comply or that the compliance dates be extended to two years following completion of a ''stateby-state preemption analysis'' by the Department. Response: The Secretary acknowledges that covered entities will have to make changes to their policies and procedures during the period between the effective date of the rules below and the applicable compliance dates."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 438}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 180)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nn order to ensure an individual's restriction request is honored. Rather, the final rule leaves it to the discretion of the provider as to how to flag information that is the subject of a restriction.\nFurther, the final rule provides flexibility as to how restriction requests for certain services, such as bundled services, are to be handled, as well as what reasonable efforts should be made to obtain payment from an individual whose original form of payment has been dishonored, prior to resorting to billing the health plan for the service. Finally, in response to comments regarding the potential burden and cost of doing so, the final rule does not require health care providers to inform downstream providers who may receive the individual's protected health information, such as a pharmacy or specialist, of a restriction, given the lack of automated technologies to support such a requirement. Notwithstanding the above, we acknowledge that there will be some additional burden on certain health care providers to ensure an individual's request to restrict a disclosure to a health plan is honored where such a request would not have been honored in the past. However, we do not have data to inform quantifying an estimated cost in this area. For example, we do not have data on the number of providers that currently accommodate requests from self-pay patients to restrict disclosures versus those that do not, the number of requests that covered health care providers receive today that would now require a restriction, nor even the number of requests for restrictions generally that covered health care providers currently receive. ## e."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 179}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 35)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\n- For every communication path that exists between any two assets in the security use case view (and/or explanatory text), including indirect connections when there is at least one intermediate asset (e.g., an app), the following details should be provided: - A list of the communication interfaces and paths, including communication paths (e.g., between two assets through an intermediary), and any unused interfaces; - An indication of whether the path is used for data, code, and/or commands, and type of data/information/code being transferred; - Protocol name(s), version number(s), and ports/channels/frequencies; - Detailed descriptions of the primary and all available functionality for each medical device system asset, including assessment of any functionality that is built in but not currently used or enabled (e.g., dormant application functionality or ports), including assurance that this functionality cannot be activated and/or misused; - Access control models or features (if any) for every asset (such as privileges, user accounts/groups, passwords); - Users' roles and levels of responsibility if they interact with the assets and communication channels; - Any 'handoff' sequences from one communication path to another (e.g., from asset to asset, network to network, or Bluetooth to Wi-Fi), and how the data, code, and/or commands are"}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 34}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 51)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nlth care operations, the Department also received comments about the difficulty that the Privacy Rule would place on health plans trying to obtain information needed for quality assessment activities.\nHealth plans informed the Department that they need to obtain individually identifiable health information from health care providers for the plans' quality-related activities, accreditation, and performance measures, such as Health Plan Employer Data and Information Set\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\n(HEDIS). Commenters explained that the information provided to plans for payment purposes ( e.g. , claims or encounter information) may not be sufficient for quality assessment or accreditation purposes. The NCVHS, in response to public testimony on this issue at its August 2001 hearing, also recommended that the Department amend the Privacy Rule to allow for uses and disclosures for quality-related activities among covered entities, without the individual's written authorization. Based on these concerns, the Department proposed to modify §164.506 to permit a covered entity to disclose protected health information for the payment activities of another covered entity or any health care provider, and also for certain types of health care operations of another covered entity. The proposal would broaden the uses and disclosures that are permitted without authorization as part of treatment, payment, and health care operations so as not to interfere inappropriately with access to quality and effective health care, while limiting this expansion in order to continue to protect the privacy expectations of the individual. Specifically, the Department proposed the following. First, the Department proposed to add to § 164.506(c)(1) language stating that a covered entity may use or disclose protected health information for its own treatment, payment, or health care operations without prior permission."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 50}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 35)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nConduct a Training Needs Assessment                | • Determine the training needs of the organization. • Interview and involve key personnel in assessing security training needs. • Use feedback and analysis of past events to help determine training needs. • Review organizational behavior issues, past incidents, and/or breaches to determine what training is missing or needs reinforcement, improvement, or periodic reminders. | • What awareness, training, and education programs are needed? Which are required? • Is the organization monitoring current threats to determine possible areas of training needs? • Are there current, relevant threats (e.g., phishing, ransomware) about which personnel need training? • Do workforce members need training on any particular organization devices (e.g., IoT devices) or technology that pose a risk to ePHI? • What is the current status regarding how these needs are being addressed (e.g., how well are current efforts working)? • Where are the gaps between the needs and what is being done (e.g., what more needs to be done)? • What are the training priorities in terms of content and audience? |\n| 2. Develop and Approve a Training Strategy and a Plan | • Address the specific HIPAA policies that require security awareness and training in the security awareness and training program. • Set organizational expectations for protecting ePHI. • In the security awareness and training program, outline the program's scope, goals, target audiences, learning objectives, deployment methods, and evaluation and measurement techniques, as well as the frequency of training. | • Is there a procedure in place to ensure that everyone in the organization receives security awareness training, including teleworkers and remote personnel? • What type of security training is needed to address specific technical topics based on job responsibility? • When should training be scheduled to ensure that compliance deadlines are met?"}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 34}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 73)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nn addition to or not directly related to the provision of insurance, the health insurance issuer or HMO may be a business associate with respect to those additional functions, activities, or services.\nIn addition, group health plans that provide health benefits only through an insurance contract and do not create, maintain, or receive protected health information (except for summary information described below or information that merely states whether an individual is enrolled in or has been disenrolled from the plan) do not have to meet the notice requirements of § 164.520 or the administrative requirements of §164.530, except for the documentation requirement in § 164.530(j), because these requirements are satisfied by the issuer or HMO that is providing benefits under the group health plan. A group health plan, however, may not permit a health insurance issuer or HMO to disclose protected health information to a plan sponsor unless the notice required in 164.520 indicate such disclosure may occur. The final rule also permits a health plan that is providing insurance to a group health plan to provide summary information to the plan sponsor to permit the plan sponsor to solicit premium bids from other health plans or for the purpose of modifying, amending, or terminating the plan. The rule provides that summary information is information that summarizes claims history, claims expenses, or types of claims experienced by individuals for whom the plan sponsor has provided health benefits under a group health plan, provided that specified identifiers are not included. Summary information may be disclosed under this provision even if it does not meet the definition of de-identified information. As part of the notice requirements in § 164.520, health plans must inform individuals that they may disclose protected health information to plan sponsors."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 72}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 104)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ne central to the purpose of health care oversight agencies (covered under proposed §164.510(c)). In the final rule, we make substantial changes to these provisions, in an attempt to prevent confusion.\nIn § 164.512(d)(2), we include explicit decision rules indicating when an investigation is considered law enforcement and when an investigation is considered oversight under this regulation. An investigation or activity is not considered health oversight for purposes of this rule if: (1) The individual is the subject of the investigation or activity; and (2) The investigation or activity does not arise out of and is not directly related to: (a) The receipt of health care; (b) a claim for public benefits related to health; or (c) qualification for, or receipt of public benefits or services where a patient's health is integral to the claim for benefits or services. In such cases, where the individual is the subject of the investigation and the investigation does not relate to issues (a) through (c), the rules regarding disclosure for law enforcement purposes (see § 164.512(f)) apply. For the purposes of this rule, we intend for investigations regarding issues (a) through (c) above to mean investigations of health care fraud. Where the individual is not the subject of the activity or investigation, or where the investigation or activity relates to the subject matter in (a) through (c) of the preceding sentence, a covered entity may make a disclosure pursuant to § 164.512(d)(1). For example, when the U.S. Department of Labor's Pension and Welfare Benefits Administration (PWBA) needs to analyze protected health information about health plan enrollees in order to conduct an audit or investigation of the health plan ( i.e., the enrollees are not subjects of the investigation) to investigate potential fraud by the plan, the health plan may disclose protected health information to the PWBA under the health oversight rules."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 103}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 163)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\ns, we rely entirely on our experience with breach notifications received by the Secretary during calendar years 2010 and 2011, for projecting the ongoing, annual costs of the breach notification rule.\nBased on our experience in those years, we project the likely number of breaches, number of affected individuals, and costs associated with this regulation. We have not attempted to predict future costs because, as discussed above, while we anticipate the overall number of breaches and the overall costs of implementing the breach notification provisions to fall over time, we do not currently have enough data to establish such a trend. ## Affected Entities\n\nThe entities affected by the breach notification regulation are outlined in the impact statement of the interim final\n\nVerDate Mar&lt;15&gt;2010\n\nrule. HIPAA covered entities and their business associates must comply with these regulations. We estimate that approximately 700,000 HIPAA covered entities will be subject to the final rule, although many fewer will experience a breach requiring them to fulfill the breach notification requirements. How many breaches will require notification? Although this final rule modifies the definition of breach at § 164.402 to remove the harm standard, we do not believe that this will have a significant effect on the number of breaches reported to HHS or on the number of individuals affected. As discussed in Section V above, this final rule removes the harm standard and implements a more objective risk assessment for evaluating whether an impermissible use or disclosure is a breach. As a result,\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00107\n\ncovered entities must still perform a risk assessment following an impermissible use or disclosure of protected health information to determine the probability that the protected health information has been compromised."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 162}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 93)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nformation. Under the final rule, we also establish provisions for disclosure of directory information to clergy that are slightly different from those which apply for disclosure to the general public.\nSubject to the individual's right to object or restrict the disclosure, the final rule permits a covered entity to disclose to a member of the clergy: (1) The individual's name; (2) the individual's general condition in terms that do not communicate specific medical information about the individual; (3) the individual's location in the facility; and (4) the individual's religious affiliation. A disclosure of directory information may be made to members of the clergy even if they do not inquire about an individual by name. We note that the rule in no way requires a covered health care provider to inquire about the religious affiliation of an individual, nor must individuals supply that information to the facility. Individuals are free to determine whether they want their religious affiliation disclosed to clergy through facility directories. We believe that allowing clergy to access patient information pursuant to this section does not violate the Establishment Clause of the First Amendment, which prohibits laws ''respecting an establishment of religion.'' Courts traditionally turn to the Lemon test when evaluating laws that might raise Establishment Clause concerns. A law does not violate the Clause if it has a secular purpose, is not primarily to advance religion, and does not cause excessive government entanglement with religion. The privacy regulation passes this test because its purpose is to protect the privacy of individuals-regardless of their religious affiliation-and it does not cause excessive government entanglement. More specifically, although this section provides a special rule for members of the clergy, it does so as an accommodation to patients who seek to engage in religious conduct."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 92}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 274)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nitly detailed in its contract. However, the final rule expands the proposed exception for disclosures of protected health information by a covered health care provider to another health care provider.\nThe final rule allows such disclosures without a business associate contract for any activities that fall under the definition of ''treatment.'' We agree with the commenter that the administrative burdens of requiring contracts in staff privileges arrangements would not be outweighed by any potential privacy enhancements from such a requirement. Although the exception for disclosure of protected health information for treatment could be sufficient to relieve physicians and hospitals of the contract requirement, we also believe that this arrangement does not meet the true meaning of ''business associate,'' because both the hospital and physician are providing services to the patient, not to each other. We therefore also add an exception to § 164.502(e)(1) that explicitly states that a contract is not required when the association involves a health care facility and another health care provider with privileges at that facility, if the purpose is providing health care to the individual. We have also added other exceptions in §164.502(e)(1)(ii) to the requirement to obtain ''satisfactory assurances'' under §164.502(e)(1)(i). We do not require a business associate arrangement between group health plans and their plan sponsors because other, albeit analogous, requirements apply under §164.504(f) that are more tailored to the specifics of that legal relationship. We do not require business associate arrangements between government health plans providing public benefits and other agencies conducting certain functions for the health plan, because these arrangements are typically very constrained by other law. Comment: Many commenters expressed concern that required contracts for federal agencies would adversely affect oversight activities, including investigations and audits."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 273}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 39)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nse covered entities must already conform to the regulation\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\nJkt 200001\n\nrequirements, a ''chain of trust'' agreement does not add to overall security.\nCompliance with the regulation should be sufficient. Response: We believe the commenters are correct that the rule as proposed would-(1) not allow for scalability; and (2) would lead an entity to believe it is responsible, and liable, for making sure all entities down the line maintain the same level of security. The confusion here seems to come from the phrase ''same level of security.'' Our intention was that each trading partner would maintain reasonable and appropriate safeguards to protect the information. We did not mean that partners would need to implement the same security technology or measures and procedures. We have replaced the proposed ''Chain of trust'' standard with a standard for ''Business associate contracts and other arrangements.''\n\nWhen another entity is acting as a business associate of a covered entity, we require the covered entity to require the other entity to protect the electronic protected health information that it creates, receives, maintains or transmits on the covered entity's behalf. The level of security afforded particular electronic protected health information should not decrease just because the covered entity has made the business decision to entrust a business associate with using or disclosing that information in connection with the performance of certain functions instead of doing those functions itself. Thus, the rule below requires covered entities to require their business associates to implement certain safeguards and take other measures to ensure that the information is safeguarded (see § 164.308(b)(1) and §164.314(a)(1))."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 38}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 33)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ncovered entities may be required by other Federal law to adhere to additional, or more stringent security measures. Section 1178(a)(2) of the statute provides several exceptions to this general rule.\nWith regard to protected health information, the preemption of State laws and the relationship of the Privacy Rule to other Federal laws is discussed in the Privacy Rule beginning at 65 FR 82480; the preemption provisions of the rule are set out at 45 CFR part 160, subpart B. It should be noted that although the Privacy Rule does not incorporate a requirement for an ''audit trail'' function, it does call for providing an accounting of certain disclosures of protected health information to an\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\nJkt 200001\n\nindividual upon request. There has been a tendency to assume that this Privacy Rule requirement would be satisfied via some sort of process involving audit trails. We caution against assuming that the Security Rule's requirement for an audit capability will satisfy the Privacy Rule's requirement regarding accounting for disclosures of protected health information. The two rules cover overlapping, but not identical information. Further, audit trails are typically used to record uses within an electronic information system, while the Privacy Rule requirement for accounting applies to certain disclosures outside of the covered entity (for example, to public health authorities). ## 3. Integrity (§ 164.312(c)(1))\n\nWe proposed under the ''Data authentication'' requirement, that each organization be required to corroborate that data in its possession have not been altered or destroyed in an unauthorized manner and provided examples of mechanisms that could be used to accomplish this task. We adopt the proposed requirement for data authentication in the final rule as an addressable implementation specification ''Mechanism to authenticate data,'' under the ''Integrity'' standard. a."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 32}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 36)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nvered, the entity need not become a hybrid entity so as to avoid applying the Privacy Rule to health information the entity holds in its role as employer, such as sick leave requests of its employees.\nSuch information is already excluded from the definition of ''protected health information'' as employment records and thus, the Privacy Rule does not apply to this information. However, the identifiable health information the entity holds as a covered health care provider (e.g., the information the clinic holds about employees who have received treatment) is protected health information and generally may not be shared with the employer for employment purposes without the individual's authorization. ## ii. Section 164.105(a)(2)(iii)(C)\n\nWe proposed to modify this section to re-designate § 164.105(a)(2)(iii)(C) as (D), and to include a new paragraph (C), which makes clear that, with respect to a hybrid entity, the covered entity itself, and not merely the health care component, remains responsible for complying with §§164.314 and 164.504 regarding business associate arrangements and other organizational requirements. Hybrid entities may need to execute legal contracts and conduct other organizational matters at the level of the legal entity rather than at the level of the health care component. The final rule adopts this change. ## iii. Section 164.105(b)(1)\n\nThe final rule fixes a minor typographical error in this paragraph by redesignating the second paragraph (1) as paragraph (2). ## iv. Section 164.105(b)(2)(ii)\n\nThe final rule simplifies this paragraph by collapsing subparagraphs (A), (B), and (C) regarding the obligations of an affiliated entity to comply with the Privacy and Security Rules into one provision. ## d. Section 164.106-Relationship to Other Parts\n\nThe final rule adds a reference in this provision to business associates, consistent with their inclusion elsewhere throughout the other HIPAA Rules. VerDate Mar&lt;15&gt;2010\n\n2."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 35}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 55)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nthan 10 percent higher in 2002 than it was in 1998. This increase is mainly driven by more active threats and increased personnel costs offsetting decreases in technology costs over the past 4 years.\nHowever, spending by companies who have anticipated the security rule or who have independently made business decisions to implement security policies and procedures as good business practice(s) has already occurred, and probably will cancel out the increased costs of implementation. Therefore, Gartner expects the cost of complying with the HIPAA security standards to be about the same now as it was in 1998. ## 2. Synchronizing Standards\n\nThe timelines for the implementation of the initial HIPAA standards (transactions, identifiers, and security) are no longer closely synchronized. However, we do not believe that this lack of synchronization will have a significant impact on the cost of implementing security. The analysis provided by the Gartner group indicated that implementing security standards is being viewed by entities as a separate task from implementing the transaction standards, and that this is not having a significant impact on costs. As with other HIPAA standards, most current entities will have a 2-year implementation period before compliance with the standards is required. Covered entities will develop their own implementation schedules, and may phase in various security measures over that time period. ## 3. Relationship to Privacy Standards\n\nThe publication of the final Privacy Rules (45 CFR parts 160 and 164) on December 28, 2000 in the Federal Register (65 FR 82462) and on August 14, 2002 (67 FR 53182) has affected the impact of this regulation significantly. Covered entities must implement the privacy standards by April 14, 2003 (April 14, 2004 for small health plans). The implementation of privacy standards reduces the cost of implementing the security standards in two significant areas."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 54}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the technical safeguards under HIPAA?"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160 and 164\n\n## RIN 0945-AA03\n\nModifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules\n\nAGENCY: Office for Civil Rights, Department of Health and Human Services. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (HHS or ''the Department'') is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (''the HITECH Act'' or ''the Act'') to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities. DATES: Effective date: This final rule is effective on March 26, 2013. Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013. FOR FURTHER INFORMATION CONTACT: Andra Wicks 202-205-2292. SUPPLEMENTARY INFORMATION:\n\nVerDate Mar&lt;15&gt;2010\n\n18:57 Jan 24, 2013\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with\n\n## I."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_type": "technical", "implementation_spec": "required", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 97)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nSimilarly, the Department believes that it is impracticable to account for incidental disclosures, which by their very nature, may be uncertain or unknown to the covered entity at the time they occur.\nIncidental disclosures are permitted as long as reasonable safeguards and minimum necessary standards have been observed for the underlying communication. Moreover, incidental disclosures may most often happen in the context of a communication that relates to treatment or health care operations. In that case, the underlying disclosure is not subject to an accounting and it would be arbitrary to require an accounting for a disclosure that was merely incidental to such a communication. The Department however disagrees with commenters who requested that other public purpose disclosures not be subject to the accounting requirement. Although the Rule permits disclosure for a variety of public purposes, they are not routine disclosures of the individual's information. The accounting requirement was designed as a means for the individual to find out the non-routine purposes for which his or her protected health information was disclosed by the covered entity, so as to increase the individual's awareness of persons or entities other than the individual's health care provider or health plan in possession of this information. To eliminate some or all of these public purposes would defeat the core purpose of the accounting requirement. The Department disagrees with commenters' proposal to exempt all research disclosures made pursuant to a waiver of authorization from the accounting requirement. Individuals have a right to know what information about them has been disclosed without their authorization, and for what purpose(s). However, the Department agrees that the Rule's accounting requirements could have the undesired effect of causing covered entities to halt disclosures of protected health information for research."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 96}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 72)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nffect, whichever is later. | Security Rule documented as appropriate? • Have documentation retention requirements under HIPAA been aligned with the organization's other data retention policies? |\n| 3.\nEnsure That Documentation is Available to Those Responsible for Implementation Implementation Specification (Required) | • Make documentation available to those persons responsible for implementing the procedures to which the documentation pertains. | • Is the location of the documentation known to all staff who need to access it? • Is availability of the documentation made known as part of education, training, and awareness activities? 149                                                                                                                                                                                                                                                                                                                                                                                                 |\n\n149  See Sec. 5.1.5, HIPAA Standard: Security Awareness and Training."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 71}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_postmarket_2016 say about HIPAA compliance? (Part 10)"}, {"role": "assistant", "content": "According to fda_postmarket_2016:\n\nng the temperature reading of a thermometer may have different risks than a cybersecurity vulnerability affecting the dosage of an insulin infusion pump because of the severity of patient harm. ## VI.\nMedical Device Cybersecurity Risk Management\n\nAs part of their risk management process consistent with 21 CFR part 820, a manufacturer should establish, document, and maintain throughout the medical device lifecycle an ongoing process for identifying hazards associated with the cybersecurity of a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls. This process should include risk analysis, risk evaluation, risk control, and incorporation of production and post-production information. Elements identified in the Appendix of this guidance should be included as part of the manufacturer's cybersecurity risk management program to support an effective risk management process. Manufacturers should have a defined process to systematically conduct a risk evaluation and determine whether a cybersecurity vulnerability affecting a medical device presents an acceptable or unacceptable risk. It is not possible to describe all hazards, associated risks, and/or controls associated with medical device cybersecurity vulnerabilities in this guidance. It is also not possible to describe all scenarios where risk is controlled or uncontrolled. Rather, FDA recommends that manufacturers define and document their process for objectively assessing the cybersecurity risk for their device(s). As outlined below, it is recommended that such a process focus on assessing the risk of patient harm by considering:\n\n- 1) The exploitability of the cybersecurity vulnerability, and\n- 2) The severity of patient harm if the vulnerability were to be exploited. Such analysis should also incorporate consideration of compensating controls and risk mitigations. ## A."}], "metadata": {"source": "fda_postmarket_2016", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 9}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_premarket_2023 say about HIPAA compliance? (Part 31)"}, {"role": "assistant", "content": "According to fda_premarket_2023:\n\nich it operates:\n\n- Select industry-standard cryptographic algorithms and protocols, and select appropriate key generation, distribution, management and protection, as well as robust nonce mechanisms.\n- Use current NIST recommended standards for cryptography (e.g., FIPS 140-3 78 ) or equivalent-strength cryptographic protection that are expected to be considered cryptographically strong throughout the service life of the device. - Manufacturers should not implement cryptographic algorithms that have been deprecated or disallowed in applicable standards or best practices (e.g., NIST SP 800-131A, Transitioning the Use of Cryptographic Algorithms and Key Lengths). Implementation of algorithms with a status of 'legacy use' should be discussed with FDA during a pre-submission meeting. - Design a system architecture and implement security controls to prevent a situation where the full compromise of any single device can result in the ability to reveal keys for other devices. - For example, avoid using master-keys stored on device, or key derivation algorithms based solely on device identifiers or other readily discoverable information. - For example, avoid using device serial numbers as keys or as part of keys. Device serial numbers may be disclosed by patients seeking additional information on their device or might be disclosed during a device recall to identify affected\n\n78  See NIST FIPS 140-3 Security Requirements for Cryptographic Modules . https://doi.org/10.6028/NIST.FIPS.1403\n\n## Contains Nonbinding Recommendations\n\nproducts and should be avoided as part of the key generation process (e.g., publickey cryptography can be employed to help meet this objective). - Implement cryptographic protocols that permit negotiated parameters/versions such that the most recent, secure configurations are used, unless otherwise necessary. - Do not allow downgrades, or version rollbacks, unless absolutely necessary for safety reasons, and log and document the event."}], "metadata": {"source": "fda_premarket_2023", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 30}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What is considered a breach under HIPAA?"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nmay wish to closely follow the development of these new publications by NIST. Organizations are encouraged to review all draft publications during public comment periods and provide feedback to NIST.\nMany NIST cybersecurity publications, other than the ones noted above, are available at https://csrc.nist.gov/publications. ## Authority\n\nThis publication has been developed by NIST in accordance with its statutory responsibilities under the Federal Information Security Modernization Act (FISMA) of 2014, 44 U.S.C. § 3551 et seq., Public Law (P.L.) 113-283. NIST is responsible for developing information security standards and guidelines, including minimum requirements for federal information systems, but such standards and guidelines shall not apply to national security systems without the express approval of appropriate federal officials exercising policy authority over such systems. This guideline is consistent with the requirements of the Office of Management and Budget (OMB) Circular A-130. Nothing in this publication should be taken to contradict the standards and guidelines made mandatory and binding on federal agencies by the Secretary of Commerce under statutory authority. Nor should these guidelines be interpreted as altering or superseding the existi"}], "metadata": {"source": "nist_sp800-66r2", "type": "breach_notification", "cfr_section": "§164.400-414"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 528)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nllowing:\n- (i) Identification and date of action. A statement identifying the IRB or privacy board and the date on which the alteration or waiver of authorization was approved;\n- (ii) Waiver criteria.\nA statement that the IRB or privacy board has determined that the alteration or waiver, in whole or in part, of authorization satisfies the following criteria:\n- (A) The use or disclosure of protected health information involves no more than minimal risk to the individuals;\n- (B) The alteration or waiver will not adversely affect the privacy rights and the welfare of the individuals;\n- (C) The research could not practicably be conducted without the alteration or waiver;\n- (D) The research could not practicably be conducted without access to and use of the protected health information;\n- (E) The privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to the anticipated benefits if any to the individuals, and the importance of the knowledge that may reasonably be expected to result from the research;\n- (F) There is an adequate plan to protect the identifiers from improper use and disclosure;\n- (G) There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; and\n- (H) There are adequate written assurances that the protected health\n\nFrm 00356\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\ninformation will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart. - (iii) Protected health information needed."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 527}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 86)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\n'laboratory results from July 1998'' or ''all laboratory results'' or ''results of MRI performed in July 1998.'' The covered entity can then use or disclose that information and only that information.\nIf the covered entity does not understand what information is covered by the authorization, the use or disclosure is not permitted unless the covered entity clarifies the request. There are no limitations on the information that can be authorized for disclosure. If an individual wishes to authorize a covered entity to disclose his or her entire medical record, the authorization can so specify. In order for the covered entity to disclose the entire medical record, the authorization must be specific enough to ensure that the individual has a clear understanding that the entire record will be disclosed. For example, if the Social Security Administration seeks authorization for release of all health information to facilitate the processing of benefit applications, then the description on the authorization form must specify ''all health information'' or the equivalent. In some instances, a covered entity may be reluctant to undertake the effort to review the record and select portions relevant to the request (or redact portions not relevant). In such circumstances, covered entities may provide the entire record to the individual, who may then redact and release the more limited information to the requestor. This rule does not require a covered entity to disclose information pursuant to an individual's authorization. Second, the authorization must include the name or other specific identification of the person(s) or class of persons that are authorized to use or disclose the protected health information."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 85}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 105)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\n2003, rather than the effective date of the modification, or, even less so, to any\n\nVerDate Aug&lt;2,&gt;2002\n\nbusiness associate arrangement regardless of whether a written contract currently exists.\nA covered entity that does not have a written contract with a business associate prior to the effective date of this modification does not encounter the same burdens described by other commenters associated with having to reopen and renegotiate many existing contracts at once. The Department believes that such a covered entity should be able to enter into a compliant business associate contract by the compliance date of the Rule. Further, those covered entities whose business associate contracts come up for renewal or modification prior to the compliance date have the opportunity to bring such contracts into compliance by April 14, 2003. Thus, a covered entity that enters into a business associate contract after the effective date of this modification, or that has a contract that is renewed or modified prior to the compliance date of the Rule, is not eligible for the transition period and is required to have a business associate contract in place that meets the applicable requirements of §§164.502(e) and 164.504(e) by the Privacy Rule's compliance date of April 14, 2003. Further, as in the proposed Rule, the transition provisions apply only to written contracts or other written arrangements. Oral contracts or other arrangements are not eligible for the transition period. The Department clarifies, however, that nothing in these provisions requires a covered entity to come into compliance with the business associate contract provisions prior to April 14, 2003."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 104}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 476)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nhealth information, either under permissible exceptions to the disclosure rules or through an individual's expressed authorization, will likely incur some costs complying with provisions of this rule.\nSamples of state and local agencies or programs encompassed by the broad scope of this rule include: Medicaid, State Children's Health Insurance Programs, county hospitals, state mental health facilities, state or local nursing facilities, local health clinics, and public health surveillance activities, among others. We have included state and local costs in the estimation of total costs in this section. The greatest cost and administrative burden on the state and local government will fall to agencies and programs that act as covered entities, by virtue of being either a health plan or provider, such as Medicaid, State Children's Health Insurance Programs, and county hospitals. These and other health insurance or provider programs operated by state and local government are subject to requirements placed on covered entities under this rule, including, but not limited to, those outlined in this section (Section E) of the impact analysis. Many of these state and local programs already afford privacy protections for individually identifiable health information through the Privacy Act. For example, state governments often become subject to Privacy Act requirements when they contract with the federal government. This rule is expected to create additional requirements beyond those covered by the Privacy Act. Furthermore, we anticipate that most state and local health programs will, to some extent, need to modify their existing Privacy Act practices to fully comply with this rule. The cost to state\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nand local programs that function as health plans will be different than the private sector, much as the federal costs vary from private health plans."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 475}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the physical safeguards under HIPAA?"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160 and 164\n\n## RIN 0945-AA03\n\nModifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules\n\nAGENCY: Office for Civil Rights, Department of Health and Human Services. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (HHS or ''the Department'') is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (''the HITECH Act'' or ''the Act'') to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effectiveness and to increase flexibility for and decrease burden on the regulated entities. DATES: Effective date: This final rule is effective on March 26, 2013. Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013. FOR FURTHER INFORMATION CONTACT: Andra Wicks 202-205-2292. SUPPLEMENTARY INFORMATION:\n\nVerDate Mar&lt;15&gt;2010\n\n18:57 Jan 24, 2013\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with\n\n## I."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_type": "physical", "implementation_spec": "required", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 121)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nation to Intelligence Community\n\nThe NPRM would have provided an exemption from its proposed requirements to the intelligence community. As defined in section 4 of the National Security Act, 50 U.S.C.\n401a, the intelligence community includes: the Office of the Director of Central Intelligence Agency; the Office of the Deputy Director of Central Intelligence; the National Intelligence Council and other such offices as the Director may designate; the Central Intelligence Agency; the National Security Agency; the Defense Intelligence Agency; the National Imagery and Mapping Agency ; the National Reconnaissance Office; other offices within the DOD for the collection of specialized national intelligence through reconnaissance programs; the intelligence elements of the Army, the Navy, the Air Force, the Marine Corps, the Federal Bureau of Investigation, the Department of the Treasury, and the Department of Energy; the Bureau of Intelligence and Research of the Department of State; and such other elements of any other department or agency as may be designated by the President, or designated jointly by the Director of Central Intelligence and the head of the department or agency concerned, as an element of the intelligence community. It would have allowed a covered entity to use without individual authorization protected health information of employees of the intelligence community, and of their dependents, if such dependents were being considered for posting abroad. The final rule does not include such an exemption. Rather, the final rule does not except intelligence community employees and their dependents from the general rule requiring an authorization in order for protected health information to be used and disclosed."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 120}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 85)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\ndditionally, the Privacy Rule has always required that such communications contain a description of how the individual may opt out of receiving further fundraising communications (§164.514(f)(2)(ii)).\nWith respect to the proposed requirement that the method for an individual to elect not to receive further fundraising communications should not cause the individual to incur an undue burden or more than a nominal cost, we generally agree with the commenters who suggested that the final rule be flexible and not prescriptive. Under the final rule, covered entities are free to decide what methods individuals can use to opt out of receiving further fundraising communications, as long as the chosen methods do not impose an undue burden or more than a nominal cost on individuals. Covered entities should consider the use of a toll-free phone number, an email address, or similar opt out mechanisms that provide individuals with simple, quick, and inexpensive ways to opt out of receiving further fundraising communications. Covered entities may employ multiple opt out methods, allowing individuals to determine which opt out method is the simplest and most convenient for them, or a single method that is reasonably accessible to all individuals wishing to opt out. In response to commenters who expressed concern about the cost of setting up a toll-free phone number, we clarify that covered entities may require individuals who wish to opt out of further fundraising communications to do so through other methods, (e.g., through the use of a local phone number), where appropriate, as long as the method or methods adopted do not impose an undue burden or cost on the individual. We encourage covered entities to consider the size of the population to which they are sending the communications, the geographic distribution, and any other factors that may help determine which opt out method(s) is most appropriate and least burdensome to individuals."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 84}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 444)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ns regardless of storage medium, HHS must make a distinction in its cost estimates between records stored electronically and those which must be accessed by manual means, since these costs will differ.\nResponse: The cost estimates made for regulations are not intended to provide such refined gradations; rather, they are intended to show the overall costs for the regulation as a whole and its major components. For inspections and copying (and virtually all other areas for which estimates are made) estimates are based on averages; particular providers may experience greater or lesser costs than the average cost used in this analysis. Comment: Several commenters noted that the Department did not appear to include the cost of establishing storage systems, retrieval fees and the cost of searching for records, and that these costs, if included, would significantly increase the Department's estimate. Response: Currently, providers keep and maintain medical records and often provide copies to other providers and patients. Therefore, much of the cost of maintaining records already exists. Indeed, based on public comments, the Department has concluded that there will be relatively few additional copies requested as the result of this regulation (see below). We have measured and attributed to this regulation the incremental cost, which is the standard for conducting this kind of analysis. Comment: A federal agency expressed concern over the proposal to allow covered entities to charge a fee for copying personal health information based on reasonable costs. The agency requests personal health information from many covered entities and pays a fee that it establishes. Allowing covered entities to establish the fee, the agency fears, may cost them significantly more than the current amounts they pay and as a result, could adversely affect their program."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 443}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 286)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nn for these purposes, including if the covered entity is required to do so by other law. Though we do not believe any states currently require such authorizations, we wanted to avoid future conflicts.\nThese changes should resolve the concerns raised by commenters regarding conflicts with state laws that require consent, authorization, or other types of written legal permission for uses and disclosures of protected health information. Frm 00189\n\nFmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nComment: Some commenters noted that there would be circumstances when consent is impossible or impractical. A few commenters suggested that in such situations patient information be deidentified or reviewed by an objective third party to determine if consent is necessary. Response: Covered health care providers with direct treatment relationships are required to obtain consent to use or disclose protected health information to carry out treatment, payment, and health care operations. In certain treatment situations where the provider is permitted or required to treat an individual without the individual's written consent to receive health care, the provider may use and disclose protected health information created or obtained in the course of that treatment without the individual's consent under this rule (see § 164.506(a)(3)). In these situations, the provider must attempt to obtain the individual's consent and, if the provider is unable to obtain consent, the provider must document the attempt and the reason consent could not be obtained. Together with the uses and disclosures permitted under §§ 164.510 and 164.512, the concerns raised regarding situations in which it is impossible or impractical for covered entities to obtain the individual's permission to use or disclose protected health information about the individual have been addressed."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 285}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does fda_postmarket_2016 say about HIPAA compliance? (Part 5)"}, {"role": "assistant", "content": "According to fda_postmarket_2016:\n\ne, or recover from the effects of cyber threats, or voluntarily disseminate critical infrastructure information to its members or others involved in the detection and response to cybersecurity issues.\n6\n\nThe ISAOs (https://www.dhs.gov/isao) are intended to be: Inclusive (groups from any and all sectors, both non-profit and for-profit, expert or novice, should be able to participate in an ISAO); Actionable (groups will receive useful and practical cybersecurity risk, threat indicator, and incident information via automated, real-time mechanisms if they choose to participate in an ISAO); Transparent (groups interested in an ISAO model will have adequate understanding of how that model operates and if it meets their needs); and Trusted (participants in an ISAO can request that their information be treated as Protected Critical Infrastructure Information (https://www.dhs.gov/pcii-program). Such information is shielded from any release otherwise required by the Freedom of Information Act or State Sunshine Laws and is exempt from regulatory use and civil litigation if the information satisfies the requirements of the Critical Infrastructure Information Act of 2002 (6 U.S.C. §§ 131 et seq.)). The FDA Center for Devices and Radiological Health has entered into a Memorandum of Understanding with one such ISAO, the National Health Information Sharing &amp; Analysis Center, (NH-ISAC) 7 in order to assist in the creation of an environment that fosters stakeholder collaboration and communication, and encourages the sharing of information about cybersecurity threats and vulnerabilities that may affect the safety, effectiveness, integrity, and security of the medical devices and the surrounding Health IT infrastructure. 6 See Homeland Security Act (https://www.dhs.gov/xlibrary/assets/hr\\_5005\\_enr.pdf), 6 U.S.C. § 212 (2002). 7 See Memorandum of Understanding between the National Health Information Sharing &amp; Analysis Center, Inc."}], "metadata": {"source": "fda_postmarket_2016", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 4}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 46)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nress legal permission obtained for uses and disclosures of protected health information for treatment, payment, and health care operations prior to the compliance date of the Privacy Rule are deleted.\nThe proposal to permit a covered entity to use or disclose protected health information for these purposes without consent or authorization would apply to any protected health information held by a covered entity whether created or received before or after the compliance date. Therefore, transition provisions are not necessary. This final Rule also includes conforming changes to the definition of ''more stringent'' in § 160.202; the text of § 164.500(b)(1)(v), §§ 164.508(a)(2)(i) and (b)(3)(i), and § 164.520(b)(1)(ii)(B); the introductory text of §§ 164.510 and 164.512, and the title of § 164.512 to eliminate references to required consent. ## Response to Other Public Comments\n\nComment: There were three categories of commenters with respect to the Rule's general approach to consentthose that supported the changes proposed in the NPRM provisions, those that requested targeted changes to the consent requirement, and those that requested that the consent requirement be strengthened. Many commenters supported the NPRM approach to consent, making consent to use or disclose protected health information for treatment, payment, and health care operations voluntary for all covered entities. These commenters said that this approach provided flexibility for covered entities to address consent in a way that is consistent with their practices. These commenters also stated that the NPRM approach assured that the Privacy Rule would not interfere with or delay necessary treatment."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 45}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 20)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ncovered entities have the flexibility to implement the standard in a manner consistent with numerous factors, including such things as, but not limited to, their size, degree of risk, and environment.\nWe have deleted the implementation specification calling for an organizational security policy, as it duplicated requirements of the security management and training standard. We note that the implementation specification for a risk analysis at §164.308(a)(1)(ii)(A) does not specifically require that a covered entity perform a risk analysis often enough to ensure that its security measures are adequate to provide the level of security required by § 164.306(a). In the proposed rule, an assurance of adequate security was framed as a requirement to keep security measures ''current.'' We continue to believe that security measures must remain current, and have added regulatory language in §164.306(e) as a more precise way of communicating that security measures\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\nJkt 200001\n\nin general that must be periodically reassessed and updated as needed. The risk analysis implementation specification contains other terms that merit explanation. Under §164.308(a)(1)(ii)(A), the risk analysis must look at risks to the covered entity's electronic protected health information. A thorough and accurate risk analysis would consider ''all relevant losses'' that would be expected if the security measures were not in place. ''Relevant losses'' would include losses caused by unauthorized uses and disclosures and loss of data integrity that would be expected to occur absent the security measures. b. Comment: Relative to the development of an entity's sanction policy, one commenter asked that we describe the sanction penalties for breach of security."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 19}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 50)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ned rule. We define the term in order to describe certain arrangements in which participants need to share protected health information about their patients to manage and benefit the common enterprise.\nTo allow uses and disclosures of protected health information for these arrangements, we also add language to the definition of ''health care operations.'' See discussion of that term above. We include five arrangements within the definition of organized health care arrangement. The arrangements involve clinical or operational integration among legally separate covered entities in which it is often necessary to share protected health information for the joint management and operations of the arrangement. They may range in legal structure, but a key component of these arrangements is that individuals who obtain services from them have an expectation that these arrangements are integrated and that they jointly manage their operations. We include within the definition a clinically integrated care setting in which individuals typically receive health care from more than one health care provider. Perhaps the most common example of this type of organized health care arrangement is the hospital setting, where a hospital and a physician with staff privileges at the hospital together provide treatment to the individual. Participants in such clinically integrated settings need to be able to share health information freely not only for treatment purposes, but also to improve their joint operations. For example, any physician with staff privileges at a hospital must be able to participate in the hospital's morbidity and mortality reviews, even when the particular physician's patients are not being discussed. Nurses and other hospital personnel must also be able to participate. These activities benefit the common enterprise, even when the benefits to a particular participant are not evident."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 49}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 81)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nities must obtain the individual's authorization before using or disclosing protected health information for marketing purposes. In the final rule, we add a new definition of marketing (see §164.501).\nFor more detail on what activities constitute marketing, see §164.501, definition of ''marketing,'' and §164.514(e). ## Pre-Enrollment Underwriting\n\nAs in the proposed rule, covered entities must obtain the individual's authorization to use or disclose protected health information for the purpose of making eligibility or enrollment determinations relating to an individual or for underwriting or risk rating determinations, prior to the individual's enrollment in a health plan (that is, for purposes of pre-enrollment underwriting). For example, if an individual applies for new coverage with a health plan in the non-group market and the health plan wants to review protected health information from the individual's covered health care providers before extending an offer of coverage, the individual first must authorize the covered providers to share the information with the health plan. If the individual applies for renewal of existing coverage, however, the health plan would not need to obtain an authorization to review its existing claims records about that individual, because this activity would come within the definition of health care operations and be permissible. We also note that under §164.504(f), a group health plan and a health insurance issuer that provides benefits with respect to a group health plan are permitted in certain circumstances to disclose summary health information to the plan sponsor for the purpose of obtaining premium bids. Because these disclosures fall within the definition of health care operations, they do not require authorization. ## Employment Determinations\n\nAs in the proposed rule, covered entities must obtain the individual's authorization to use or disclose protected health information for employment determinations."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 80}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 28)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nost logical reading of the HITECH Act, which provides the Secretary with discretion to impose penalties for each category of culpability up to the maximum amount described in the highest penalty tier.\nWith respect to those comments expressing concern about the discretion available to the Secretary under the adopted scheme we emphasize again that the Department will not impose the maximum penalty amount in all cases but will rather determine the amount of a penalty on a case-by-case basis, depending on the nature and extent of the violation and the nature and extent of the resulting harm, as required by the HITECH Act, as well as the other factors\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00019\n\nset forth at § 160.408. In response to those commenters particularly concerned about the impact of penalties on smaller entities, we note that the other factors include both the financial condition and size of the covered entity or business associate. These factors are discussed more fully below. In addition, with respect to comments expressing specific concern about fairness regarding those violations of which an entity did not know or by exercising reasonable diligence would not have known or for which there was a reasonable cause and not willful neglect, we note that in both cases an entity may establish that an affirmative defense applies under § 160.410, where the entity corrects the violation within 30 days from the date the entity had knowledge of the violation or with the exercise of reasonable diligence would have had knowledge of the violation, or during a period determined appropriate by the Secretary based upon the nature and extent of the entity's failure to comply. These affirmative defenses are described more fully below. In addition, Section 13410(d) of the HITECH Act and Section 1176(a) of the Social Security Act, give the Secretary further ability to waive a civil money penalty, in whole or in part, under certain circumstances."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 27}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 124)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ncare services. To carry out their insurance functions, these non-covered insurers typically seek individually identifiable health information from covered health care providers and group health plans.\nIn drafting the proposed rule, the Secretary was faced with the challenge of trying to carry out the statutory mandate of safeguarding the privacy of individually identifiable health information by regulating the flow of such information from covered entities while at the same time respecting the Congressional intent to shield workers' compensation carriers and other excepted benefit plans from regulation as covered entities. In the proposed rule we allowed covered entities to disclose protected health information without individual consent for purposes of treatment, payment or health care operationseven when the disclosure was to a noncovered entity such as a workers' compensation carrier. In addition, we allowed protected health information to be disclosed if required by state law for purposes of determining eligibility for coverage or fitness for duty. The proposed rule also required that whenever a covered entity disclosed protected health information to a noncovered entity, even though authorized under the rule, the individual who was the subject of the information must be informed that the protected health information was no longer subject to privacy protections. Like other disclosures under the proposed rule, the information provided to workers' compensation carriers for treatment, payment or health care operations was subject to the minimum necessary standard. However, to the extent that protected health information was disclosed to the carrier because it was required by law, it was not subject to the minimum necessary standard. In addition, individuals were entitled to an accounting when protected health information was disclosed for purposes other than treatment, payment or health care operations."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 123}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 19)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nement provisions of the IFR and the NPRM, responds to public comment received by the Department on both rules, and describes the final modifications to the Enforcement Rule adopted by this final rule.\nIn addition to the modifications discussed below, this final rule also adopts the NPRM proposal to add the term ''business associate'' to the following provisions of the Enforcement Rule: §§ 160.300; 160.304; 160.306(a) and (c); 160.308; 160.310; 160.312; 160.316; 160.401; 160.402; 160.404(b); 160.406; 160.408(c) and (d); and 160.410(a) and (c). This is done to implement sections 13401 and 13404 of the Act, which impose direct civil money penalty liability on business associates for their violations of certain provisions of the HIPAA Rules. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with\n\n1. Subpart C of Part 160-Compliance and Investigations a. Sections 160.304, 160.306, 160.308, and 160.312-Noncompliance Due to Willful Neglect\n\n## Proposed Rule\n\nSection 13410(a) of the HITECH Act adds a new subsection (c) to section 1176 of the Social Security Act, which requires the Department to formally investigate a complaint if a preliminary investigation of the facts of the complaint indicates a possible violation due to willful neglect (section 1176(c)(2)) and to impose a civil money penalty for a violation due to willful neglect (section 1176(c)(1)). The Department proposed a number of modifications to Subpart C of the Enforcement Rule to implement these provisions. First, § 160.306(c) of the Enforcement Rule currently provides the Secretary with discretion to investigate HIPAA complaints through the use of the word ''may.'' As a practical matter, however, the Department currently conducts a preliminary review of every complaint received and proceeds with the investigation in every eligible case where its preliminary review of the facts indicates a possible violation of the HIPAA Rules."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 18}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 64)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nparagraph (a)(4) of this section, and to prevent those workforce members who do not have access under paragraph (a)(4) of this section from obtaining access to electronic protected health information.\n- (ii) Implementation specifications:\n- (A) Authorization and/or supervision (Addressable). Implement procedures for the authorization and/or supervision of workforce members who work with electronic protected health information or in locations where it might be accessed. - (B) Workforce clearance procedure (Addressable). Implement procedures to determine that the access of a workforce member to electronic protected health information is appropriate. - (C) Termination procedures (Addressable). Implement procedures for terminating access to electronic protected health information when the employment of a workforce member ends or as required by determinations made as specified in paragraph (a)(3)(ii)(B) of this section. - (4)(i) Standard: Information access management. Implement policies and procedures for authorizing access to\n\nPO 00000\n\nFrm 00045\n\n- electronic protected health information that are consistent with the applicable requirements of subpart E of this part. - (ii) Implementation specifications :\n- (A) Isolating health care clearinghouse functions (Required). If a health care clearinghouse is part of a larger organization, the clearinghouse must implement policies and procedures that protect the electronic protected health information of the clearinghouse from unauthorized access by the larger organization. - (B) Access authorization (Addressable). Implement policies and procedures for granting access to electronic protected health information, for example, through access to a workstation, transaction, program, process, or other mechanism. - (C) Access establishment and modification (Addressable)."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 63}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 35)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nut which are governed by various federal laws (such as Medicare, Medicaid, and ERISA). Congress explicitly included some of these programs in HIPAA, subjecting them directly to the privacy regulation.\nSection 1171 of the Act defines the term ''health plan'' to include the following federally conducted, regulated, or funded programs: Group plans under ERISA that either have 50 or more participants or are administered by an entity other than the employer who established and maintains the plan; federally qualified health maintenance organizations; Medicare; Medicaid; Medicare supplemental policies; the health care program for active military personnel; the health care program for veterans; the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); the Indian health service program under the Indian Health Care Improvement Act, 25 U.S.C. 1601, et seq. ; and the Federal Employees Health Benefits Program. There also are many other federally conducted, regulated, or funded programs in which individually identifiable health information is created or maintained, but which do not come within the statutory definition of ''health plan.'' While these latter types of federally conducted, regulated, or assisted programs are not explicitly covered by part C of title XI in the same way that the programs listed in the statutory definition of ''health plan'' are covered, the statute may nonetheless apply to transactions and other activities conducted under such programs. This is likely to be the case when the federal entity or federally regulated or funded entity provides health services; the requirements of part C may apply to such an entity as a ''health care provider.'' Thus, the issue of how different federal requirements apply is likely to arise in numerous contexts."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 34}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 46)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nivity of the ePHI controlled by the organization as well as the organization's size, complexity, and environmental and/or operational changes (e.g., other relevant laws or accreditation requirements).\n• In addition to periodic reevaluations, consider repeating evaluations when environmental and operational changes that affect the security of ePHI are made to the organization (e.g., if new technology is adopted or if there are newly recognized risks to the security of ePHI). | • Do security policies specify that evaluations will be repeated when environmental and operational changes are made that affect the security of ePHI? • Do policies on the frequency of security evaluations reflect any and all relevant federal or state laws that bear on environmental or operational changes affecting the security of ePHI? • Has the organization explored the use of automated tools to support periodic evaluations? |\n\n81 See Sec. 5.5.2, HIPAA Standard: Documentation . ## 5.1.9. Business Associate Contracts and Other Arrangements (§ 164.308(b)(1)) 82\n\nHIPAA Standard: A covered entity may permit a business associate to create, receive, maintain, or transmit electronic protected health information on the covered entity's behalf only if the covered entity obtains satisfactory assurances, in accordance with § 164.314(a), that the business associate will appropriately safeguard the information. A covered entity is not required to obtain such satisfactory assurances from a business associate that is a subcontractor. Covered entities need to be cognizant of differentiating between best practices versus what the Security Rule requires. Vendor management and supply chain risks are important topics due to the potential they have to introduce new threats and risks to organizations. However, to the extent that such vendors and service providers are business associates, HIPAA treats them the same as covered entities with respect to Security Rule compliance."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 45}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 148)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nual's genetic tests; (2) the genetic tests of family members of such individual; and (3) the manifestation of a disease or disorder in family members of such individual (i.e., family medical history).\nGINA also provides that the term ''genetic information'' includes, with respect to any individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\25JAR2.SGM\n\n25JAR2\n\nJkt 229001\n\nsroberts on DSK5SPTVN1PROD with individual or family member of such individual. GINA expressly provides that the term ''genetic information'' shall not include information about the sex or age of any individual. This basic definition of ''genetic information'' in section 102(a)(4) of GINA (and that is to apply for purposes of section 105) is also expanded by section 102(a)(3), which provides that any reference to genetic information concerning an individual or family member in the PHSA shall include: with respect to an individual or family member of an individual who is a pregnant woman, the genetic information of any fetus carried by such pregnant woman; and with respect to an individual or family member utilizing an assisted reproductive technology, the genetic information of any embryo legally held by the individual or family member. The Department proposed to include this statutory definition of ''genetic information'' in § 160.103. ## Overview of Public Comments\n\nMost commenters did not address the proposed definition of ''genetic information'' in their comments on the proposed rule. However, one commenter stated that it was unclear what information may fall within the scope of the term ''genetic information'' and whether such term may be construed to include traditional medical information or medical tests used in underwriting today. ## Final Rule\n\nThe final rule adopts without modification the definition of ''genetic information'' proposed in the NPRM."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 147}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 44)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nhan the requirements outlined in the proposed rule may be imposed. VerDate Jan&lt;31&gt;2003\n\nResponse: The general rule is that the security standards in this final rule supersede contrary State law.\nOnly where the Secretary has granted an exception under section 1178(a)(2)(A) of the Act, or in situations under section 1178(b) or (c) of the Act, will the general rule not hold true. Covered entities may be required to adhere to stricter Stateimposed security measures that are not contrary to this final rule. ## 2. Enforcement\n\nThe proposed rule did not contain specific enforcement provisions. This final rule likewise does not contain specific enforcement provisions; it is expected that enforcement provisions applicable to all Administrative Simplification rules will be proposed in a future rulemaking. a. Comment: One commenter voiced support for the proposed rule's approach. Another stated that the process is poorly defined. One commenter stated that fines should be eliminated, or the scope of activity subject to fines should be more narrowly defined. While a number of commenters were of the opinion that HHS must retain enforcement responsibility, stating that it would be unconstitutional to give it to a private entity, several others stated that it may not be practical for HHS to retain the responsibility for determining violations and imposing penalties specified by the statute. A concern was voiced over HHS's ability to fairly and consistently apply the rules due to budget constraints. Several commenters support industry solutions to enforcement with some level of government involvement. One commenter recommended a single audit process using accrediting bodies already in place. Another stated that entities providing accreditation services should not be involved in enforcement as this would result in a conflict of interest."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 43}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 42)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ntical subdivision of a state or territory, or an Indian tribe, for the confinement or rehabilitation of persons charged with or convicted of a criminal offense or other persons held in lawful custody.\nOther persons held in lawful custody includes juvenile offenders adjudicated delinquent, aliens detained awaiting deportation, persons committed to mental institutions through the criminal justice system, witnesses, or others awaiting charges or trial. This language was necessary to explain the privacy rights and protections of inmates in this regulation. ## Covered Functions\n\nWe add a new term, ''covered functions,'' as a shorthand way of expressing and referring to the functions that the entities covered by section 1172(a) of the Act perform. Section 1171 defines the terms ''health plan'', ''health care provider'', and ''health care clearinghouse'' in functional terms. Thus, a ''health plan'' is an individual or group plan ''that provides, or pays the cost of, medical care * * *'', a ''health care provider'' ''furnish[es] health care services or supplies,'' and a ''health care clearinghouse'' is an entity ''that processes or facilitates the processing of * * * data elements of health information * * *''. Covered functions, therefore, are the activities that any such entity engages in that are directly related to operating as a health plan, health care provider, or health care clearinghouse; that is, they are the functions that make it a health plan, health care provider, or health care clearinghouse. The term ''covered functions'' is not intended to include various support functions, such as computer support, payroll and other office support, and similar support functions, although we recognize that these support functions must occur in order for the entity to carry out its health care functions."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 41}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 211)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nubstance abuse confidentiality regulations in the ''Relationship to Other Federal Laws'' preamble provides guidance that may be applied to the laws governing Veteran's Affairs (''VA'') health records.\nIn most cases, a conflict will not exist between these privacy rules and the VA programs. For example, some disclosures allowed without patient consent or authorization under the privacy regulation may not be within the VA statutory list of permissible disclosures without a written consent. In such circumstances, the covered entity would have to abide by the VA statute, and no conflict exists. If the disclosures permitted by the VA statute come within the permissible disclosures of our rules, no conflict exists. In some cases, our rules may demand additional requirements, such as obtaining the approval of a privacy board or Institutional Review Board if a covered entity seeks to disclose protected health information for research purposes without the individual's authorization. A covered entity subject to the VA statute will need to ensure that it meets the requirements of both that statute and the regulation below. If a conflict arises, the covered entity should evaluate the specific potential conflicting provisions under the implied repeal analysis set forth in the ''Relationship to Other Federal Laws'' discussion in the preamble. ## WIC\n\nComment: One comment called on other federal agencies to examine their regulations and policies regarding the use and disclosure of protected health information. The comment suggested that other agencies revise their regulations and policies to avoid duplicative, contradictory, or more stringent requirements. The comment noted that the U.S. Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children (''WIC'') does not release WIC data."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 210}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 156)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nformation for underwriting purposes. Such covered entities, in particular, should ensure that appropriate staff members are trained on the permissible and impermissible uses of genetic information. 6.\nSection 164.504(f)(1)(ii)Requirements for Group Health Plans\n\n## Proposed Rule\n\nSection 164.504(f)(1)(ii) permits a group health plan, or health insurance issuer or HMO with respect to the group health plan, to disclose summary health\n\nVerDate Mar&lt;15&gt;2010\n\ninformation to the plan sponsor if the plan sponsor requests the information for the purpose of obtaining premium bids from health plans for providing health insurance coverage under the group health plan, or for modifying, amending, or terminating the group health plan. As this provision permits activities that constitute ''underwriting purposes,'' as defined by GINA and the proposed rule, the Department proposed to modify § 164.504(f)(1)(ii) to clarify that § 164.504(f)(1)(ii) would not allow a disclosure of protected health information that is otherwise prohibited by the underwriting prohibition. ## Overview of Public Comments\n\nThe Department received one comment in support of this modification. ## Final Rule\n\nThe final rule adopts the modification to § 164.504(f)(1)(ii). 7. Section 164.506-Uses and Disclosures To Carry Out Treatment, Payment, or Health Care Operations Proposed Rule\n\nSection 164.506(a) of the Privacy Rule sets out the uses and disclosures a covered entity is permitted to make to carry out treatment, payment, or health care operations."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 155}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.502(b) require?"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\n§164.502(b) and 164.514(d).\n\nWe do not intend to interfere with research or public health activities that rely on dates of birth or zip codes. Uses and disclosures of limited data sets that include this information continue to be permissible under the Privacy Rule if the applicable requirements, such as a data use agreement, are satisfied. Further, we note that a covered entity or business associate is not responsible for a breach by a third party to whom it permissibly disclosed protected health information, including limited data sets, unless the third party received the information in its r"}], "metadata": {"source": "breach_notification_2009", "cfr_section": "§164.502(b)", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 74)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nhe earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and\n4.\n(c) Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the\n- The Department proposed to delete the criterion that ''the alteration or waiver will not adversely affect the privacy rights and the welfare of the individuals,'' because it may conflict\n\n19:04 Aug 13, 2002\n\nPO 00000\n\nFrm 00049\n\nFmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\14AUR4.SGM\n\npfrm17\n\nPsN: 14AUR4\n\nJkt 197001\n\nresearch project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;\n\n(2) The research could not practicably be conducted without the waiver or alteration; and\n\n(3) The research could not practicably be conducted without access to and use of the protected health information. Overview of Public Comments. The following discussion provides an overview of the public comment received on this proposal. Additional comments received on this issue are discussed below in the section entitled, ''Response to Other Public Comments.''\n\nThe overwhelming majority of commenters were supportive of the Department's proposed modifications to the Privacy Rule's waiver criteria. These commenters found that the proposed revisions adequately addressed earlier concerns that the waiver criteria in the December 2000 Rule were confusing, redundant, and internally inconsistent. However, a few commenters argued that some of the proposed criteria continued to be too subjective and urged that they be eliminated. Final Modifications. The Department agrees with the majority of commenters that supported the proposed waiver criteria, and adopts the modifications as proposed in the NPRM."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 73}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does §164.304 require?"}, {"role": "assistant", "content": "According to security_rule_2003:\n\n§164.304, as appropriate. We included only terms relevant to the particular standards and implementation specifications being adopted.\n\n3. Comment: Several commenters requested that the mapped matrix located in Addendum 3 of the proposed rule be included in this final rule, either as part of the rule or as an addendum, while others stated that it should not be part of this final rule. Several commenters cited items to be added to the mapped matrix.\n\nResponse: The mapped matrix was merely a snapshot of current standards and guidelines that the implementation team was able to obtain for review d"}], "metadata": {"source": "security_rule_2003", "cfr_section": "§164.304", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "cfr_section"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 265)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nlic or re-released after the initial whistleblowing event, and that this could put covered entities in violation of the law. Many commenters wanted to see the whistleblower provision deleted entirely.\nAccording to a number of health care associations who commented on this topic, current practices already include adequate mechanisms for informing law enforcement, oversight and legal counsel of possible violations without the need for patient identifiable information; thus, the provision allowing whistleblowers to share protected health information is unnecessary. Additionally, some commenters felt that the covered entity needs to be allowed to prohibit disclosures outside of legitimate processes. Some commenters were concerned about not having any recourse if the whistleblower's suspicions were unfounded. Response: In this rule, we do not regulate the activities of whistleblowers. Rather, we regulate the activities of covered entities, and determine when they may be held responsible under this rule for whistleblowing activities of their workforce or business associates when that whistleblowing involves the disclosure of protected health information. Similarly, we regulate when covered entities must and need not sanction their workforce who disclose protected health information in violation of the covered entity's policies and procedures, when that disclosure is for whistleblowing purposes. See §164.530(e). This rule does not address a covered entity's recourse against a whistleblower under other applicable law. We do not hold covered entities responsible under this rule for\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nwhistleblowing disclosures of protected health information under the circumstances described in § 164.502(j)."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 264}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 57)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nhow zero trust architecture principals can aid in the organization's approach to access control. See Appendix F for more information. 105 See Sec. 5.1.4, HIPAA Standard: Information Access Management.\n| Key Activities                                                                                                     | Description                                                                                                                                                                                                                                                                  | Sample Questions                                                                                                                                                                                                                                                                                                                        |\n|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|\n| 3. Ensure That All System Users Have Been Assigned a Unique Identifier 106 Implementation Specification (Required) | • Assign a unique name and/or number for identifying and tracking user identity. • Ensure that system activity can be traced to a specific user."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 56}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 205)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nDER2\n\nSfmt 4700\n\nComment: Several commenters expressed concern that the privacy regulation would eliminate the parents' ability to have access to information in their children's school health records.\nBecause the proposed regulation suggests that school-based clinics keep health records separate from other educational files, these comments argued that the regulation is contrary to the spirit of FERPA, which provides parents with access rights to their children's educational files. Response: As noted in the ''Relationship to Other Federal Laws'' provision of the preamble, to the extent information in school-based clinics is not protected health information because it is an education record, the FERPA access requirements apply and this regulation does not. For more detail regarding the rule's application to unemancipated minors, see the preamble discussion about ''Personal Representatives.''\n\n## Federal Employees Compensation Act\n\nComment: One comment noted that the Federal Employees Compensation Act (''FECA'') requires claimants to sign a release form when they file a claim. This commenter suggested that the privacy regulation should not place additional restrictions on this type of release form. Response: We agree. In the final rule, we have added a new provision, §164.512(l), that permits covered entities to make disclosures authorized under workers' compensation and similar laws. This provision would permit covered entities to make disclosures authorized under FECA and not require a different release form. ## Federal Employees Health Benefits Program\n\nComment: A few comments expressed concern about the preemption effect on FEHBP and wanted clarification that the privacy regulation does not alter the existing preemptive scope of the program. Response: We do not intend to affect the preemptive scope of the FEHBP. The Federal Employee Health Benefit Act of 1998 preempts any state law that ''relates to'' health insurance or plans. 5 U.S.C. 8902(m)."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 204}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 63)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\nards means the technology and the policy and procedures for its use that protect electronic protected health information and control access to it. User means a person or entity with authorized access.\nWorkstation means an electronic computing device, for example, a laptop or desktop computer, or any other device that performs similar functions, and electronic media stored in its immediate environment. ## §164.306 Security standards: General rules. (a) General requirements. Covered entities must do the following:\n\n- (1) Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity creates, receives, maintains, or transmits. - (2) Protect against any reasonably anticipated threats or hazards to the security or integrity of such information. - (3) Protect against any reasonably anticipated uses or disclosures of such information that are not permitted or required under subpart E of this part. - (4) Ensure compliance with this subpart by its workforce. 5. (b) Flexibility of approach. - (1) Covered entities may use any security measures that allow the covered entity to reasonably and appropriately implement the standards and implementation specifications as specified in this subpart. (2) In deciding which security measures to use, a covered entity must take into account the following factors:\n\n(i) The size, complexity, and capabilities of the covered entity. Fmt 4701\n\nSfmt 4700\n\nE:\\FR\\FM\\20FER2.SGM\n\n20FER2\n\n- (ii) The covered entity's technical infrastructure, hardware, and software security capabilities. - (iii) The costs of security measures. - (iv) The probability and criticality of potential risks to electronic protected health information. - (c) Standards. A covered entity must comply with the standards as provided in this section and in § 164.308, §164.310, § 164.312, § 164.314, and §164.316 with respect to all electronic protected health information. - (d) Implementation specifications."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 62}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 13)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nand Media Controls | 164.310(d)(1) | Accountability (A) | | Device and Media Controls | 164.310(d)(1) | Data Backup and Storage (A) | | Technical Safeguards | Technical Safeguards | Technical Safeguards | | Access Control | 164.312(a)(1) | Unique User Identification (R) | 15 See https://www.hhs.gov/hipaa/index.html and https://www.hhs.gov/hipaa/for-professionals/security/index.html."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 12}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 495)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\ns. An individual may request that a covered entity provide an accounting for disclosure for a period of time less than six years from the date of the individual's request, as outlined in this section.\n## Section 164.530-Administrative Requirements\n\nA covered entity must maintain such policies and procedures in written or electronic form where policies or procedures with respect to protected health information are required by this subpart. Where a communication is required by this subpart to be in writing, a covered entity must maintain such writing, or an electronic copy, as documentation; and where an action or activity is required by this subpart to be documented, it must maintain a written or electronic record of such action or activity. While these requirements are subject to the PRA, we believe the burden associated with these requirements is exempt from the PRA as stipulated under 5 CFR 1320.3(b)(2). Fmt 4701\n\nE:\\FR\\FM\\28DER2.SGM\n\npfrm08\n\nPsN: 28DER2\n\nSfmt 4700\n\nWe have submitted a copy of this rule to OMB for its review of the information collection requirements in §§ 160.204, 160.306, 160.310, 164.502, 164.504, 164.506, 164.508, 164.510, 164.512, 164.514, 164.520, 164.522, 164.524, 164.526, 164.528, and Sec. 164.530. These requirements are not effective until they have been approved by OMB. If you comment on any of these information collection and record keeping requirements, please mail copies directly to the following: Health Care Financing Administration, Office of Information Services, Division of HCFA Enterprise Standards, Room N214-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. ATTN: John Burke and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503. ATTN: Allison Herron Eydt, HCFA Desk Officer. ## IX."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 494}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 28)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\nand safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year).\nThis interim final rule is not an economically significant rule because we estimate that the breach notification requirements are not expected to cost more than $100 million per year. Nevertheless, because of the public interest in this rule, we have prepared an RIA that to the best of our ability presents the costs and benefits of the proposed rule. We request comments on the economic analysis provided in this proposed rule. The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The scope of the interim final rule will apply to all HIPAA covered entities and their business associates. Based on U.S. business census data provided to the Small Business Administration Office of Advocacy there were 605,845 entities classified under the North American Industrial Classification System (NAICS) 62. Code 62 encompasses physicians, dentists, ambulatory care centers, kidney dialysis centers, family planning clinics, home care services, mental health and drug rehabilitation centers, medical laboratories, hospitals and nursing facilities. In addition, based on data from the Centers for Medicare &amp; Medicaid Services, we estimate that there are 107,567 suppliers of durable medical equipment and prosthetics. Almost all of these health providers fall under the RFA's definition of a small entity by either meeting the Small Business Administration's (SBA's) size standard of a small business or by being a non-dominant nonprofit organization. The SBA's size standard for NAICS 62 ranges between $7 million and $34.5 million in annual receipts. Also covered under HIPAA are health insurance firms and third party administrators (NAICS codes 524114 and 524292)."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 27}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does security_rule_2003 say about HIPAA compliance? (Part 16)"}, {"role": "assistant", "content": "According to security_rule_2003:\n\ndata, with resulting loss of public trust, and potential legal action. For example, a covered entity with poor facility access controls and procedures would be susceptible to hacking of its databases.\nA provider with appropriate security protections already in place would only need to ensure that the protections are documented and are reassessed periodically to ensure that they continue to be appropriate and are actually being implemented. Our decision to classify many implementation specifications as addressable, rather than mandatory, provides even more flexibility to covered entities to develop costeffective solutions. We believe that insurers who already have effective security programs in place will have met many of the requirements of this regulation. c. Comment: One commenter believes the rule is arbitrary and capricious in its requirements without any justification that they will significantly improve the security of medical records and with the likelihood that their implementation may actually increase the vulnerability of the data. The commenter noted that the data backup requirements increase access to data and that security awareness training provides more information to employees. Response: The standards are based on generally accepted security procedures, existing industry standards and guidelines, and recommendations contained in the National Research Council's 1997 report For The Record:\n\nVerDate Jan&lt;31&gt;2003\n\nProtecting Electronic Health Information, Chapter 6. We also consulted extensively with experts in the field of security throughout the health care industry. The standards are consistent with generally accepted security principles and practices that are already in widespread use. Data backup need not result in increased access to that data. Backups should be stored in a secure location with controlled access. The appropriate secure location and access control will vary, based upon the security needs of the covered entity."}], "metadata": {"source": "security_rule_2003", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 15}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 380)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nsafe harbor standards, the number of demographic variables retained in the databases will be relatively small, so that it is appropriate to accept a relatively low number as a minimum geographic size.\nIn applying this provision, covered entities must replace the (currently 18) forbidden 3-digit zip codes with zeros and thus treat them as a single geographic area (with &gt;20,000 population). The list of the forbidden 3digit zip codes will be maintained as part of the updated Secretarial guidance referred to above. Currently, they are: 022, 036, 059, 102, 203, 555, 556, 692, 821, 823, 830, 831, 878, 879, 884, 893, 987, and 994. This will result in an average 3-digit zip code area population of 287,858 which should result in an average of about 4% unique records using the 6 variables described above from the Census Short Form. Although this level of unique records will be much higher in the smaller geographic areas, the actual risk of identification will be much lower because of the limited availability of comparable data in publically available, identified databases, and will be further reduced by the low probability that someone will expend the resources to try to identify records when the chance of success is so small and uncertain. We think this compromise will meet the current need for an easy method to identify geographic area while providing adequate protection from reidentification. If a greater level of geographical detail is required for a particular use, the information will have to be obtained through another permitted mechanism or be subjected to a specific de-identification determination as described above. We will monitor the availability of identified public data and the concomitant re-identification risks, both theoretical and actual, and adjust this safe harbor in the future as necessary."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 379}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 82)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\ndeletion in a multi-tenant environment. | Adversary obtains unauthorized information due to insecure or incomplete data deletion in a multi-tenant environment (e.g., in a cloud computing environment).\n|\n| Violate isolation in a multi-tenant environment. | Adversary circumvents or defeats isolation mechanisms in a multi-tenant environment (e.g., in a cloud computing environment) to observe, corrupt, or deny service to hosted services and information or data. |\n| Compromise critical information systems via physical access. | Adversary obtains physical access to organizational information systems and makes modifications. |\n| Compromise information systems or devices used externally and reintroduced into the enterprise. | Adversary installs malware on information systems or devices while the systems/devices are external to organizations in order to subsequently infect organizations when reconnected. |\n| Compromise the software of organizational critical information systems. | Adversary inserts malware or otherwise corrupts critical internal organizational information systems. |\n| Compromise organizational information systems to facilitate exfiltration of data or information. | Adversary implants malware into internal organizational information systems where the malware can identify and exfiltrate valuable information over time. |\n| Compromise mission-critical information. | Adversary compromises the integrity of mission-critical information, thus preventing or impeding the ability of organizations to which information is supplied from carrying out operations. |\n| Compromise the design, manufacturing, and/or distribution of information system components (including hardware, software, and firmware). | Adversary compromises the design, manufacturing, and/or distribution of critical information system components at selected suppliers. |\n| Conduct an attack (i.e., direct or coordinate attack tools or activities)."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 81}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 53)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\nIdentify All Methods of Physical Access to Workstations and Devices     | • Document the different ways that users access workstations and other devices that create, store, process, or transmit ePHI. Be sure to consider the multitude of computing devices (e.g., medical equipment, IoT devices, tablets, smart phones). • Consider any mobile devices that leave the physical facility as well as remote workers who access devices that create, store, process, or transmit ePHI. | • Is there an inventory of all current device locations? • Are any devices located in public areas? • Are laptops or other computing devices used as workstations to create, access, store, process, or transmit ePHI? |\n| 2. Analyze the Risks Associated with Each Type of Access 99                | • Determine which type of access identified in Key Activity 1 poses the greatest threat to the security of ePHI. | • Do any devices leave the facility? • Are any devices housed in areas that are more vulnerable to unauthorized use, theft, or viewing of the data they contain? • What are the options for modifying the current access configuration to protect ePHI? |\n| 3. Identify and Implement Physical Safeguards for Workstations and Devices | • Implement physical safeguards and other security measures to minimize the possibility of inappropriate access to ePHI through computing devices. • If there are impediments to physically securing devices and/or the facilities where devices are located, additional safeguards should be considered, such as: o Limiting device capabilities to access ePHI o Limiting user permissions to access ePHI o Device encryption o Stringent access controls (e.g., multi-factor authentication [MFA]) o Screen lock | • Are physical safeguards implemented for all devices that access ePHI to restrict access to authorized users?"}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 52}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 21)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\n§ 160.312 so that the Secretary may move directly to a civil money penalty without exhausting informal resolution efforts at her discretion, particularly in cases involving willful neglect violations.\n## Response to Other Public Comments\n\nComment: A number of commenters requested further clarification on the scope and depth of what constitutes a ''preliminary review of the facts'' for purposes of determining whether facts indicate a possible violation due to willful neglect and thus, warrant a formal complaint investigation or compliance review. Certain commenters suggested that a preliminary review of the facts should go beyond merely a\n\nVerDate Mar&lt;15&gt;2010\n\nreview of the allegations asserted in a complaint. Response: As noted above, currently the Department conducts a preliminary review of every complaint received and proceeds with the investigation in every eligible case where its preliminary review of the facts indicates a possible violation of the HIPAA Rules. The Department anticipates that some complaints, on their face, or reports or referrals that form the basis of a potential compliance review, will contain sufficient information to indicate a possible violation due to willful neglect, and some may not. In any event, the Department may on a case-by-case basis expand the preliminary review and conduct additional inquiries for purposes of identifying a possible violation due to willful neglect. Notwithstanding the scope of a preliminary review, OCR will determine if an indicated violation was due to willful neglect based on the evidence from its investigation of the allegations, even if a violation due to willful neglect was not indicated at the preliminary review stage. b. Section 160.310-Protected Health Information Obtained by the Secretary Proposed Rule\n\nSection 160.310 requires that covered entities make information available to and cooperate with the Secretary during complaint investigations and compliance reviews."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 20}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 35)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\nf the findings from the database for the year 2008, categorized by the number of individuals affected by each breach. We chose 2008 because it is the latest year for which we have a full year of data.\n## TABLE 3-NUMBER OF BREACHES BY NUMBER OF AFFECTED FOR 2008\n\n| Affected size                                                                                 | Data                                                                                                                                                                                    | Year 2008                   |\n|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|\n| Unknown ..................................................................................... | Breaches .................................................................................... Affected Individuals .................................................................... | 36 ........................"}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 34}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 39)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\n| ........................ | ........................ | $4,200    |\n| Direct Calling Charges @$.07/min × 5 minutes ................. | ........................ | ........................\n| 622                            | 1,010,461                          | 1,011,084 |\n| Labor cost @$30/hr × 5 min per call .................................. | ........................ | ........................ | 4,445                          | 7,217,580                          | 7,222,025 |\n| Total .............................................................................. | 840                              | 3,360                           | 5,067                          | 8,228,041                          | 8,237,309 |\n\nIn addition to the cost of the toll-free number and staff time answering calls, we also imputed a cost to the time individuals will spend calling the tollfree number. In estimating the time involved, we assumed that a person will spend five minutes per call. However, the person may not get through the first time and thus may have to call back a second time which could add another 5 minutes. Taking the average between 5 and 10 minutes, we used an average call time of 7.5 minutes. For purposes of imputing cost to an individual's time, we took the mean compensation amount from the Bureau of Labor Statistics of $20.32 for all occupations at http://www.bls.gov/oes/ current/oes \\_ nat.htm. Dividing 60 by 7.5 minutes yields 8 calls per hour. Dividing the number of calls per hour into 2,888,804 calls and then multiplying by $20, gives us a cost of $7,222,010. We invite the public to comment on our analysis and assumptions."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 38}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 210)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nprovisions of the preamble. ## Tribal Law\n\nComments: One commenter suggested that the consultation process with tribal governments described in the NPRM was inadequate under Executive Order No. 13084.\nIn addition, the commenter expressed concern that the disclosures for research purposes as permitted by the NPRM would conflict with a number of tribal laws that offer individuals greater privacy rights with respect to research and reflects cultural appropriateness. In particular, the commenter referenced the Health Research Code for the Navajo Nation which creates a entity with broader authority over research conducted on the Navajo Nation than the local IRB and requires informed consent by study participants. Other laws mentioned by the commenter included the Navajo Nation Privacy and Access to Information Act and a similar policy applicable to all health care providers within the Navajo Nation. The\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00139\n\ncommenter expressed concern that the proposed regulation research provisions would override these tribal laws. Response: We disagree with the comment that the consultation with tribal governments undertaken prior to the proposed regulation is inadequate under Executive Order No. 13084. As stated in the proposed regulation, the Department consulted with representatives of the National Congress of American Indians and the National Indian Health Board, as well as others, about the proposals and the application of HIPAA to the Tribes, and the potential variations based on the relationship of each Tribe with the IHS for the purpose of providing health services. In addition, Indian and tribal governments had the opportunity to, and did, submit substantive comments on the proposed rules. Additionally, disclosures permitted by this regulation do not conflict with the policies as described by this commenter."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 209}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What are the technical safeguards under HIPAA?"}, {"role": "assistant", "content": "According to security_rule_2003:\n\n&lt;unknown&gt;\n\n## DEPARTMENT OF HEALTH AND HUMAN SERVICES\n\nOffice of the Secretary\n\n45 CFR Parts 160, 162, and 164 [CMS-0049-F] RIN 0938-AI57\n\n## Health Insurance Reform: Security Standards\n\nAGENCY: Centers for Medicare &amp; Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses, and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and otherFederal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general by establishing a level of protection for certain electronic health information. This final rule implements some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability andAccountability Act of 1996 (HIPAA). DATES: Effective Date: These regulations are effective on April 21, 2003. Compliance Date: Covered entities, with the exception of small health plans, must comply with the requirements of this final rule by April 21, 2005. Small health plans must comply with the requirements of this final rule by April 21, 2006. FOR FURTHER INFORMATION CONTACT: William Schooler, (410) 786-0089. SUPPLEMENTARY INFORMATION:\n\n## Availability of Copies and Electronic Access\n\nTo order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 5122250. The cost for each copy is $10."}], "metadata": {"source": "security_rule_2003", "safeguard_type": "technical", "implementation_spec": "both", "entity_type": "both", "type": "safeguard"}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 8)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nen applying the Privacy Rule. PSQIA provides for the establishment of PSOs to receive reports of patient safety events or concerns from providers and provide analyses of events to reporting providers.\nA reporting provider may be a HIPAA\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00006\n\ncovered entity and, thus, information reported to a PSO may include protected health information that the PSO may analyze on behalf of the covered provider. The analysis of such information is a patient safety activity for purposes of PSQIA and the Patient Safety Rule, 42 CFR 3.10, et seq. While the HIPAA Rules as written would treat a PSO as a business associate when the PSO was performing quality analyses and other activities on behalf of a covered health care provider, we proposed this change to the definition of ''business associate'' to more clearly align the HIPAA and Patient Safety Rules. ## Overview of Public Comment\n\nCommenters on this topic supported the express inclusion of patient safety activities within the definition of ''business associate.''\n\n## Final Rule\n\nThe final rule adopts the proposed modification. ii. Inclusion of Health Information Organizations (HIO), E-Prescribing Gateways, and Other Persons That Facilitate Data Transmission; as Well as Vendors of Personal Health Records\n\n## Proposed Rule\n\nSection 13408 of the HITECH Act provides that an organization, such as a Health Information Exchange Organization, E-prescribing Gateway, or Regional Health Information Organization, that provides data transmission of protected health information to a covered entity (or its business associate) and that requires access on a routine basis to such protected health information must be treated as a business associate for purposes of the Act and the HIPAA Privacy and Security Rules."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 7}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_rule_2000 say about HIPAA compliance? (Part 462)"}, {"role": "assistant", "content": "According to privacy_rule_2000:\n\nDepartment considers the estimates to be averages across the entire class of health care providers, hospitals, or health plans in question. Underlying all annual cost estimates are growth projections.\nFor growth in the number of patients, the Department used data from the National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey, the National Home and Hospice Survey, the National Nursing Home Survey, and information from the American Hospital Association. For growth in the number of health care workers, the Department used data from the Bureau of Health Professions in the Department's Health Resources Services Administration (HRSA). For insurance coverage growth (private and military coverage), we used a five-year average\n\nVerDate 11&lt;MAY&gt;2000\n\n19:16 Dec 27, 2000\n\nJkt 194001\n\nPO 00000\n\nFrm 00306\n\nannual growth rate in employersponsored, individual, military, and overall coverage growth from the Census Bureau's CPS, 1995-1999. To estimate growth in the number of Medicare and Medicaid enrollees, the Department used the enrollment projections of the Health Care Financing Administration's Office of the Actuary. For growth in the number of hospitals, health care providers and health plans, trend rates were derived from the Census Bureau's Statistics of U.S. Businesses, using SIC code-specific five-year annual average growth rate from 1992-1997 (the most recent data available). For wage growth, the Department used the same assumptions made in the Medicare Trustees' Hospital Insurance Trust Fund report for 2000. In some areas, the Department was able to obtain very reliable data, such as survey data from the Statistics of U.S. Businesses and the Medical Expenditures Panel Survey (MEPS). In numerous areas, however, there was too little information or data to support quantitative estimates. As a result, the Department relied on data provided in the public comments or subsequent factfinding to provide a basis for making key assumptions."}], "metadata": {"source": "privacy_rule_2000", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 461}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 39)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nalable and flexible, so that entities of different types and sizes can implement the standards and implementation specifications in a manner that is reasonable and appropriate for their circumstances.\nWe do not mandate the use of specific technologies, or require uniform policies and procedures for compliance, because we recognize the diversity of regulated entities and appreciate the unique characteristics of their environments. Comment: Two commenters suggested providing subcontractors with additional time to comply with the provisions of the Security Rule. Response: We decline to delay application of the requirements under the Security Rule to subcontractors beyond the compliance dates provided by this final rule. As we emphasized above, the Security Rule already requires covered entities to establish business associate agreements that require business associates to ensure that their subcontractors implement reasonable and appropriate safeguards to protect the security of electronic protected health information they handle. Comment: A few commenters proposed alternative ways to apply security requirements to subcontractors, such as exempting subcontractors from compliance with the Security Rule if they have already completed security\n\nVerDate Mar&lt;15&gt;2010\n\nassessments and met the security requirements under other State and Federal laws or only requiring subcontractors to comply with the minimum necessary standard and to utilize ''reasonable'' security measures with regard to protected health information. Response: We decline to adopt an exemption or otherwise limit subcontractors' responsibility to safeguard individuals' electronic protected health information. To ensure appropriate and strong security protections for electronic protected health information, subcontractors are required to comply with the Security Rule to the same extent as business associates with a direct relationship with a covered entity. ## D."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 38}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 115)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nation where a covered entity or a business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.\nFor example, if\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00076\n\na covered entity, due to a lack of reasonable safeguards, sends a number of explanations of benefits (EOBs) to the wrong individuals and a few of the EOBs are returned by the post office, unopened, as undeliverable, the covered entity can conclude that the improper addressees could not reasonably have retained the information. The EOBs that were not returned as undeliverable, however, and that the covered entity knows were sent to the wrong individuals, should be treated as potential breaches. As another example, if a nurse mistakenly hands a patient the discharge papers belonging to another patient, but she quickly realizes her mistake and recovers the protected health information from the patient, this would not constitute a breach if the nurse can reasonably conclude that the patient could not have read or otherwise retained the information. With respect to any of the three exceptions discussed above, a covered entity or business associate has the burden of proof, pursuant to §164.414(b) (discussed below), for showing why breach notification was not required. Accordingly, the covered entity or business associate must document why the impermissible use or disclosure falls under one of the above exceptions. ## Overview of Public Comments\n\nOf the approximately 85 public comments received on the interim final rule addressing the definition of breach, approximately 70 of those comments addressed the harm standard and risk assessment approach in the interim final rule. We received approximately 60 comments in support of the harm standard and the risk assessment approach. The commenters in support of this approach included providers, health plans, professional associations, and certain members of Congress."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 114}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does nist_sp800-66r2 say about HIPAA compliance? (Part 63)"}, {"role": "assistant", "content": "According to nist_sp800-66r2:\n\ned as altered by unauthorized users or improperly altered by authorized users, is a process in place to respond? • Is this response process tied to organizational incident management processes? |\n| 6.\nEstablish a Monitoring Process to Assess How the Implemented Process is Working       | • Review existing processes to determine whether objectives are being addressed. 136 • Continually reassess integrity processes as technology and operational environments change to determine whether they need to be revised. 137        | • Are there reported instances of information integrity problems? Have they decreased since integrity procedures were implemented? 138 • Does the process, as implemented, provide a higher level of assurance that information integrity is being maintained? |\n\n136 See Sec. 5.1.8, HIPAA Standard: Evaluation. 137 See Sec. 5.1.8, HIPAA Standard: Evaluation. 138 See Sec. 5.1.6, HIPAA Standard: Security Incident Procedures. ## 5.3.4. Person or Entity Authentication (§ 164.312(d)) 139\n\nHIPAA Standard: Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed. Table 24."}], "metadata": {"source": "nist_sp800-66r2", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 62}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 6)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nes at § 164.514(e). Many also supported the requirement that authorizations notify the individual of marketing that results in direct or indirect remuneration to the covered entity from a third party.\nThey argued that for patients to make informed decisions, they must be notified of potential financial conflicts of interest. However, some commenters opposed the authorization requirement for marketing, arguing instead for the disclosure and opt-out requirements at §164.514(e) or for a one-time, blanket authorization from an individual for their marketing activities. Commenters were sharply divided on whether the Department had properly defined what is and what is not marketing. Most of those opposed to the Department's proposed definitions objected to the elimination of healthrelated communications for which the covered entity received remuneration from the definition of ''marketing.'' They argued that these communications would have been subject to the consumer protections in § 164.514(e) but, under the proposal, could be made without any protections at all. The mere presence of remuneration raised conflict of interest concerns for these commenters, who feared patients would be misled into thinking the covered entity was acting solely in the patients' best interest when recommending an alternative medication or treatment. Of particular concern to these commenters was the possibility of a third party, such as a pharmaceutical company, obtaining a health care provider's patient list to market its own products or services directly to the patients under the guise of recommending an ''alternative treatment'' on behalf of the provider."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 5}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does privacy_mod_2002 say about HIPAA compliance? (Part 68)"}, {"role": "assistant", "content": "According to privacy_mod_2002:\n\nmetimes be necessary to continue using and disclosing protected health information even after an individual has revoked his or her authorization in order to preserve the integrity of a research study.\nTherefore, the Department has clarified that the reliance exception at § 164.508(b)(5)(i) would permit the continued use and disclosure of protected health information already obtained pursuant to a valid authorization to the extent necessary to preserve the integrity of the research study. A requirement for documentation of IRB or Privacy Board review and approval of the continued use or disclosure of protected health information after an individual's authorization had been revoked could protect patient privacy. However, the Department believes that the additional burden on the IRB or Privacy Board could be substantial, and is not warranted at this time. Comment: A commenter requested clarification that the ''reliance exception'' does not permit covered entities as researchers to continue analyzing data once an individual has revoked his or her authorization. Response: As discussed above, the Department disagrees with this comment. Patient privacy must be balanced against other public goods, such as research and the risk of compromising such research projects if researchers could not continue to use such data. The Department determined that permitting continued uses and disclosures of protected health information already obtained to protect the integrity of research, even after an individual's authorization has been revoked, would pose minimal privacy risk to individuals without compromising research. Comment: Several commenters suggested permitting the proposed authorization requirement for a ''description of each purpose of the requested use or disclosure'' at §164.508 to be sufficiently broad to encompass future unspecified research."}], "metadata": {"source": "privacy_mod_2002", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 67}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does breach_notification_2009 say about HIPAA compliance? (Part 25)"}, {"role": "assistant", "content": "According to breach_notification_2009:\n\niate to temporarily delay a notification, notice, or posting if a law enforcement official states orally that a notification would impede a criminal investigation or cause damage to national security.\nHowever, in this case, the covered entity or business associate is required to document the statement and the identity of the official and delay notification for no longer than 30 days, unless a written statement meeting the above requirements is provided during that time. We interpret these provisions as tolling the time within which notification is required under §§164.404, 164.406, 164.408, and 164.410, as applicable. ## H. Administrative Requirements and Burden of Proof-164.414\n\nSection 164.414(a) requires covered entities to comply with the administrative requirements of §164.530(b), (d), (e), (g), (h), (i), and (j) of the Privacy Rule with respect to the breach notification provisions of this subpart. These provisions, for example, require covered entities and business\n\n15:01 Aug 21, 2009\n\nPO 00000\n\nFrm 00017\n\nassociates to develop and document policies and procedures, train workforce members on and have sanctions for failure to comply with these policies and procedures, permit individuals to file complaints regarding these policies and procedures or a failure to comply with them, and require covered entities to refrain from intimidating or retaliatory acts. Thus, a covered entity is required to consider and incorporate the requirements of this subpart with respect to its administrative compliance and other obligations. In addition to §164.414(a), to make clear that these provisions apply to this subpart as well as subpart E, we have made conforming modifications in each of the above sections of the Privacy Rule to include a reference to this subpart D."}], "metadata": {"source": "breach_notification_2009", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "covered_entity", "type": "semantic_chunk", "chunk_id": 24}}
{"messages": [{"role": "system", "content": "You are a HIPAA compliance expert with deep knowledge of the Security Rule, Privacy Rule, and Breach Notification Rule. You provide accurate, practical guidance on HIPAA requirements, implementation specifications, and compliance procedures. You cite specific CFR sections and distinguish between covered entity and business associate obligations."}, {"role": "user", "content": "What does hitech_omnibus_2013 say about HIPAA compliance? (Part 58)"}, {"role": "assistant", "content": "According to hitech_omnibus_2013:\n\nady have been renegotiated in good faith to meet the applicable provisions in the HITECH Act, covered entities should review such agreements to determine whether they meet the final rule's provisions.\nIf\n\n18:57 Jan 24, 2013\n\nPO 00000\n\nFrm 00039\n\nthey do not, these covered entities then have the transition period to make whatever additional changes are necessary to conform to the final rule. The transition period is also available to those agreements that require compliance with all applicable laws (to the extent the agreements were otherwise in compliance with the HIPAA Rules prior to this final rule), but that do not fully meet the new requirements in this final rule. However, we do not deem such contracts as compliant beyond the transition period because they would not sufficiently reflect the new requirements. 4. Section 164.508-Uses and Disclosures for Which an Authorization Is Required\n\na. Sale of Protected Health Information Proposed Rule\n\nSection 164.508 of the Privacy Rule permits a covered entity to use and disclose protected health information for purposes not otherwise permitted by the Rule if it has obtained a valid written authorization from the individual who is the subject of the information. This section also specifies two circumstances in which authorization from the individual must be obtained: (1) Most uses and disclosures of psychotherapy notes; and (2) uses and disclosures for marketing purposes. Section 13405(d) of the HITECH Act added a third circumstance that requires authorization, specifically the sale of protected health information. Section 13405(d)(1) prohibits a covered entity or business associate from receiving direct or indirect remuneration in exchange for the disclosure of protected health information unless the covered entity has obtained an individual's authorization pursuant to § 164.508 that states whether the protected health information can be further exchanged for remuneration by the entity receiving the information."}], "metadata": {"source": "hitech_omnibus_2013", "safeguard_types": ["physical", "technical", "administrative"], "entity_type": "both", "type": "semantic_chunk", "chunk_id": 57}}