Above and Beyond Compliance: Leveraging the AI Act to Enhance Quality Assurance in Clinical Decision-Making (XtraTrack Season 2026)

24-06-2026 16:00

The European Artificial Intelligence Act (AI Act) serves primarily as a framework for product regulation, establishing essential requirements for AI systems to be placed on the European market. It adopts a risk-based approach, which is (partly) aligned with the New Legislative Framework —the European-level legal architecture that already governs specific product categories, such as medical devices. This ensures that AI tools in healthcare are subject to rigorous safety and performance standards before they reach the clinical environment. However, the narrative of quality in healthcare does not end with a successful conformity assessment. While the AI Act introduces significant regulatory demands, this presentation questions whether a product-centric approach is sufficient to address the transformative shifts in clinical practice. Does the Act truly capture the nuanced measures required to manage the evolving relationship between clinician, patient, and machine? By exploring the boundaries of the current legal framework, the presentation seeks a balanced perspective on the role of regulation in the pursuit of progressive, high-quality healthcare. We argue that while the AI Act provides a necessary foundation, achieving the highest standards of care requires looking above and beyond statutory compliance toward a more comprehensive integration of legal, ethical, and clinical safeguards.

Prof. Dr. Griet Verhenneman - Institute for International Research on Criminal Policy, METAMEDICA Ghent University, Faculty of Law and Criminology

Prof. Dr. Griet Verhenneman (Doctor of Law) is a legal expert in data protection, privacy, artificial intelligence and the law at Ghent University. She is a member of the Department of Criminology, Criminal Law, and Social Law, and more specifically, the Institute for International Research on Criminal Policy (IRCP). Prof. Verhenneman’s research centres on the legal dimensions of eHealth. Data law forms the common thread throughout her work, which spans a broad spectrum of topics—from EHDS and genomics to AI and medical devices. Drawing on her background as a former Data Protection Officer, she actively promotes an interdisciplinary approach to scientific research, bridging the gap between theory and practice. Within the University of Ghent, Prof. Verhenneman is a member of the board of MetaMedica and i4S. MetaMedica facilitates interdisciplinary research and education in health law, health privacy law, and medical ethics, while i4S (Smart Solutions for Secure Societies) is a multidisciplinary economic valorisation platform focused on crime, security, technology, digitisation, and privacy. She teaches, i.e. Artificial Intelligence, Law and Ethics, Data Protection Law and Information- and source criticism. Additionally, Prof. Verhenneman continues to be involved in teaching, training, and policy-making in hospitals. She is actively involved in the Data Access Committee of Ghent University Hospital, contributing to discussions on the use of real-world data for healthcare, quality improvement, and scientific research. As a Special Visiting Lecturer at the Department of Public Health and Primary Care, KU Leuven, she teaches data protection to medical specialists in training.

Organized by GMDS AG MoCoMed / Impressum / Privacy