RRS — Regulatory Readiness Score
Weight in Healthcare Readiness Score: 15%
Evaluates compliance readiness at the model level — not just the vendor level. Covers HIPAA technical safeguards, SOC 2 trust principles, EU AI Act requirements, and FDA Software as Medical Device (SaMD) guidelines.
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