EU AI Act for Healthcare: What Articles 6, 12, and Annex III Require of Hospital AI Deployments
EU AI Act high-risk classification applies to several healthcare AI use cases including AI as a safety component of medical devices under Article 6(1) and the Annex III categories covering access to essential services, biometric categorization, and emergency triage. From August 2, 2026, hospitals deploying these AI systems take on deployer obligations under Article 26 and have to support providers in meeting Articles 8 through 17. The Medical Device Regulation and the EU AI Act layer for software-as-a-medical-device. The architecture that satisfies the high-risk regime is per-decision audit records that capture identity, data class, policy state, and decision outcome on the hospital side.