← Back to Free Compliance AssessmentEU AI Act & GDPR Use-Case Compliance Guide
EU AI Act & GDPR Compliance Checklist for AI Clinical Documentation & Medical Scribes
Clinical documentation AI processes GDPR Article 9 special category health data, requiring an exhaustive Article 35 DPIA and Annex IV technical documentation.
Statutory Baseline Classification
Default EU AI Act TierHIGH_RISK_ANNEX_III
GDPR Article 35 DPIAMandatory Prior Assessment
Required Regulatory Deliverables for AI Clinical Documentation & Medical Scribes:
- EU AI Act Annex IV Technical Documentation
- Article 9 Continuous Risk Management Framework
- Article 14 Human Oversight System & Kill-Switch Spec
- Article 27 Fundamental Rights Impact Assessment (FRIA)
- Article 35 DPIA (Necessity, Proportionality & Residual Risk)
- Article 30 Record of Processing Activities (RoPA) Entry
- Article 28 Data Processing Agreement & Sub-processor Audit
Generate Your AI Clinical Documentation & Medical Scribes Compliance Pack in 3 Minutes →100% Free Diagnostic • Zero Cost