Who should be accountable when an AI system causes harm to a patient? European rules now exist, but the answer is still contested.

The second webinar in the EUPHA Digital Health and AI Section series “From hype to hope” looks at how AI regulation is taking shape in Europe, and what it means once it reaches health systems and clinical practice. Three short talks move from fundamental rights and patient protection, to institutional accountability and public governance, to the daily reality of healthcare professionals and organisations. Each is followed by immediate questions from the audience, before a moderated discussion with all three speakers.

Moderators

Robbe Saesen

Hashaam Akhtar

Speakers

Shirley Kempeneer

Shirley Kempeneer is Assistant Professor of Public Governance at Tilburg University. Her research focuses on digital transformation and the regulation and governance of artificial intelligence in the public sector. Her work examines the broader institutional questions raised by AI, including how responsibility and accountability are organised and what effective AI governance in the public interest requires beyond regulation alone.

Sara Roda

Sara Roda is a Senior Policy Adviser at CPME (Standing Committee of European Doctors) responsible for the digital health file, working on the European Health Data Space, AI, data protection, cybersecurity, among others. She is a Portuguese lawyer and an external PhD student at the VUB – Vrije Universiteit Brussel. Her research interests are on health data sharing and access, medical confidentiality, privacy and data protection, innovation/experimentation in law and ethics. She holds a DES – Diplome d’études specialisés” in public and administrative law from the Université Libre de Bruxelles law school (2006) and an LLM in International and European Law from VUB/IES – Institute of European Studies in Brussels (2018).

Janos Meszaros

Janos Meszaros is a Postdoctoral Researcher at KU Leuven, positioned across the Faculty of Pharmaceutical Sciences and the Centre for IT & IP Law (CiTiP). His research sits at the critical intersection of data protection, AI, and medical law. Janos brings international expertise to the European context, having spent five years at the National Academy of Science in Taiwan investigating the regulatory challenges of AI and big data in healthcare. His professional background also includes legal practice in IT law, providing him with a pragmatic perspective on complex regulatory analysis in the life sciences.