Sector Guide · HIGH_RISK_ANNEX_III
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.
01 / Baseline ClassificationHIGH_RISK_ANNEX_III
Statutory Risk Posture
Default classification under Regulation (EU) 2024/1689 (EU AI Act) and Regulation (EU) 2016/679 (GDPR).
- Default EU AI Act Tier: HIGH_RISK_ANNEX_III
- GDPR Article 35 DPIA: Mandatory Prior Assessment
- EU Data Act Chapter VI Cloud Switching Clause
02 / Required Deliverables.DOCX Pack
Statutory Artifacts Generated for AI Clinical Documentation & Medical Scribes
Compiled automatically by the Locus Labs deterministic rule engine in 90 seconds.
- EU AI Act Annex IV Technical Documentation
- Article 9 Continuous Risk Management Framework
- Article 14 Human Oversight & Stop-Switch Protocol
- Article 27 Fundamental Rights Impact Assessment (FRIA)
- Article 35 DPIA (Necessity, Proportionality & Risk)
- Article 30 Record of Processing Activities (RoPA)
- Article 28 Sub-Processor DPA Schedule