What evidence does a healthcare SaaS need beyond SOC 2?
Evidence Beyond SOC 2
| Evidence Type | SOC 2 Covers? | HIPAA Requires? | What to Provide |
|---|---|---|---|
| Access controls | Yes | Yes | Already have from SOC 2 |
| Encryption | Yes | Yes | Already have from SOC 2 |
| Audit logging | Yes | Yes | Already have from SOC 2 |
| Business Associate Agreements | No | Yes | Signed BAAs with customers and vendors |
| PHI data flow map | No | Yes | Diagram showing where PHI enters, is stored, and exits |
| Breach notification process | Partial | Yes (60-day rule) | Specific process for PHI breaches |
| Minimum necessary access | No | Yes | Documentation showing PHI access limited to need |
| Patient rights procedures | No | Yes | How patients request data access, amendments |
| Subprocessor BAAs | Partial | Yes | BAAs with every vendor touching PHI |
| Privacy impact assessment | No | Yes | Assessment of privacy risks for PHI handling |
HIPAA-Specific Evidence Checklist
Business Associate Agreements
- Template BAA reviewed by healthcare lawyer
- Signed BAA with each healthcare customer
- Signed BAA with each vendor handling PHI (database, hosting, analytics)
PHI Data Mapping
- Data flow diagram showing PHI lifecycle
- List of all systems storing PHI
- Documentation of PHI encryption methods
- Data retention and disposal policies for PHI
Privacy Controls
- Minimum necessary access policy
- Patient data access request process
- PHI de-identification procedures (if applicable)
- Marketing use restrictions for PHI
Breach Response
- HIPAA-specific breach notification procedure (60-day timeline)
- HHS notification process for breaches affecting 500+ individuals
- Media notification process (if required)
- Breach risk assessment methodology
The Healthcare SaaS Compliance Stack
- SOC 2 Type II (security foundation)
- HIPAA compliance (PHI-specific requirements)
- HITRUST (if selling to large health systems — optional)
- State privacy laws (California, Texas, New York have additional requirements)