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| # ADR-010: HIPAA Compliance Strategy | |
| ## Status | |
| Accepted | |
| ## Context | |
| MediGuard AI processes Protected Health Information (PHI) and must comply with HIPAA (Health Insurance Portability and Accountability Act) requirements. Key compliance needs include: | |
| - Data encryption at rest and in transit | |
| - Access controls and audit logging | |
| - Data minimization and retention policies | |
| - Business Associate Agreement (BAA) with cloud providers | |
| - Secure development practices | |
| ## Decision | |
| Implement a comprehensive HIPAA compliance strategy: | |
| ### 1. Data Protection | |
| - **Encryption**: AES-256 encryption for data at rest, TLS 1.3 for data in transit | |
| - **Key Management**: Use AWS KMS or similar for key rotation | |
| - **Data Masking**: Mask PHI in logs and monitoring | |
| - **Minimal Data Storage**: Only store necessary PHI with automatic deletion | |
| ### 2. Access Controls | |
| - **Authentication**: Multi-factor authentication for admin access | |
| - **Authorization**: Role-based access control (RBAC) | |
| - **Audit Logging**: Comprehensive audit trail for all data access | |
| - **Session Management**: Secure session handling with timeouts | |
| ### 3. Infrastructure Security | |
| - **Network Security**: VPC with private subnets, security groups | |
| - **Container Security**: Non-root containers, security scanning | |
| - **Secrets Management**: AWS Secrets Manager or HashiCorp Vault | |
| - **Backup Security**: Encrypted backups with secure retention | |
| ### 4. Development Practices | |
| - **Code Review**: Security-focused code reviews | |
| - **Static Analysis**: Automated security scanning (Bandit, Semgrep) | |
| - **Dependency Scanning**: Regular vulnerability scans | |
| - **Penetration Testing**: Annual security assessments | |
| ## Consequences | |
| ### Positive | |
| - **Compliance**: Meets HIPAA requirements for healthcare data | |
| - **Trust**: Builds trust with healthcare providers and patients | |
| - **Security**: Robust security posture beyond HIPAA minimums | |
| - **Market**: Enables entry into healthcare market | |
| - **Risk**: Reduced risk of data breaches and penalties | |
| ### Negative | |
| - **Complexity**: Additional security measures increase complexity | |
| - **Cost**: Higher infrastructure and compliance costs | |
| - **Performance**: Security measures may impact performance | |
| - **Development**: Slower development due to security requirements | |
| ## Implementation | |
| ### Encryption Example | |
| ```python | |
| class PHIEncryption: | |
| def __init__(self, key_manager): | |
| self.key_manager = key_manager | |
| def encrypt_phi(self, data: str) -> str: | |
| key = self.key_manager.get_latest_key() | |
| return AES.encrypt(data, key) | |
| def decrypt_phi(self, encrypted_data: str) -> str: | |
| key_id = extract_key_id(encrypted_data) | |
| key = self.key_manager.get_key(key_id) | |
| return AES.decrypt(encrypted_data, key) | |
| ``` | |
| ### Audit Logging | |
| ```python | |
| class HIPAAAuditMiddleware: | |
| async def log_access(self, user_id: str, resource: str, action: str): | |
| audit_entry = { | |
| "timestamp": datetime.utcnow(), | |
| "user_id": self.hash_user_id(user_id), | |
| "resource": resource, | |
| "action": action, | |
| "ip_address": self.get_client_ip() | |
| } | |
| await self.audit_logger.log(audit_entry) | |
| ``` | |
| ### Data Minimization | |
| ```python | |
| class DataRetentionPolicy: | |
| def __init__(self): | |
| self.retention_periods = { | |
| "analysis_results": timedelta(days=365), | |
| "user_sessions": timedelta(days=30), | |
| "audit_logs": timedelta(days=2555) # 7 years | |
| } | |
| async def cleanup_expired_data(self): | |
| for data_type, retention in self.retention_periods.items(): | |
| cutoff = datetime.utcnow() - retention | |
| await self.delete_data_before(data_type, cutoff) | |
| ``` | |
| ## Notes | |
| - All cloud providers must sign BAAs | |
| - Regular compliance audits (at least annually) | |
| - Incident response plan for data breaches | |
| - Employee training on HIPAA requirements | |
| - Business continuity planning for disaster recovery | |
| - Legal review of all compliance measures | |