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.