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c4f5f25 | 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 | # 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
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