EU AI Act Compliance
for Healthcare
Medical AI systems are among the most strictly regulated under the EU AI Act. Diagnosis support, patient risk scoring, and clinical workflow AI all carry Article 6 High-Risk classifications. Sentinel generates the audit evidence required by both the AI Act and the EU Medical Device Regulation (MDR).
Clinical Decision Support
Clinical decision support AI is listed in Annex III as a high-risk AI system. Sentinel provides structured audit logs per inference, enabling hospitals to demonstrate that AI recommendations were generated by a conforming system at every patient interaction.
Diagnostic Imaging AI
Radiology and pathology AI must maintain decision traces under both the EU AI Act and MDR Annex IX. Sentinel's D1 schema captures image hash, model version, and verdict in a single write — below the latency threshold for real-time diagnostic workflows.
Patient Risk Stratification
Patient-facing risk scores must be accompanied by an explanation of the factors that influenced them. Sentinel's compliance JSON provides a structured transparency artifact compliant with EHR audit requirements.
Hospital Resource Allocation AI
AI systems making resource allocation decisions affecting patient care require demonstrable human oversight capability. Sentinel's webhook integration triggers your clinical governance team whenever an allocation AI verdict is flagged as non-compliant.