Health AI Governance, Medical Devices Health Data

This AGRIR-Lab component develops an interdisciplinary research programme on the governance, regulation, clinical safety, cybersecurity and ethical deployment of artificial intelligence in healthcare. It examines the EU Artificial Intelligence Act, the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation, the European Health Data Space, GDPR, NIS2, Medical Device Software, clinical and performance evaluation, health-data governance, anonymisation, predictive analytics, human oversight and the Greek legal and institutional implementation framework. The component will produce verified source registers, legal and regulatory maps, risk and control matrices, policy briefs, working papers, implementation frameworks and collaboration materials. Every external source URL is verified before inclusion and clearly classified according to its legal, institutional and publication status. The component uses public or lawfully accessible research material only. It does not host identifiable patient data and does not provide medical or clinical advice.