Bridging Semantic Interoperability and Trustworthy AI: Towards a Common Framework for High-Risk AI Medical Devices under the EU AI Act and ISO Standards

A critical topic for future discussion is the convergence between clinical information interoperability standards—such as ISO 13606, ISO 13940, and HL7 FHIR—and emerging standards for artificial intelligence under development within ISO/TC 215 Task Force 5 and ISO/IEC JTC 1/SC 42. This alignment is essential for operationalising the EU Artificial Intelligence Act in synergy with the Medical Device Regulation (MDR), particularly for high-risk AI systems deployed as medical technologies. The harmonisation of health information models with AI-related terminologies, ethical frameworks, and interoperability requirements offers a path towards technically robust and regulation-ready AI systems. By encoding patient context, consent, clinical reasoning, and system constraints using established semantic models, these standards can provide the traceability, accountability, and transparency demanded by European regulatory frameworks. Beyond compliance, such convergence would foster greater trust and adoption of AI in clinical settings, reinforcing the safe and meaningful integration of AI into the fabric of health systems.