RRS — Regulatory Context Score
Proposed weight in a descriptive research score: 15%
Records policy-context and uncertainty signals; it is not evidence of HIPAA, SOC 2, EU AI Act, FDA, or other compliance.
Evaluation Components
- HIPAA Privacy Rule alignment
- HIPAA Security Rule technical safeguards
- SOC 2 Type II trust principles
- EU AI Act transparency requirements
- FDA SaMD classification readiness
Test Cases
- PHI handling and de-identification
- Audit trail generation
- Explainability output quality
- Risk classification accuracy