Governance & Readiness

Reference documentation: not a medical device

This documentation describes a reference implementation evaluated on 100% synthetic data. It is a capability and readiness reference, not a compliance certification or legal advice, and it is not a medical device. It is not clinically validated and handles no production PHI.

This section maps the ai-agent-eval-harness-healthtech reference implementation to the regulatory frameworks, data-protection regimes, and operational safety controls that govern AI systems in healthtech. Each document is a readiness assessment or control plan, not a certification, and every claim is scoped to the system as evaluated on synthetic data.

Index

• Audit Logging Plan
• Chile Ley 19.628 Data Protection Mapping
• Model Risk Management Mapping (SR 11-7 / NIST AI RMF)
• Data Card
• Demo Privacy Notice
• Drift Detection Plan
• EU AI Act Classification and Mapping
• HIPAA Readiness Assessment
• ISO 42001 and SOC 2 Readiness Assessment
• Multilingual Safety Parity Assessment
• NIST AI Risk Management Framework Mapping
• OWASP LLM Top 10 and MITRE ATLAS Threat Model
• PII Redaction
• Regulatory Overlay Map
• Voice Consent and Deepfake Policy