HELT TALKS

What are the 'HELT Talks' ?

HELT stands for Health, Law, and Technology – three broad subject areas that intersect each other in discourses around improving quality and access to health care, or advancing medical research beyond the state-of-the-art. Following on the success of the HELT Symposium, our annual flagship event which brings together representatives from the academia, industry, research organisations, healthcare professionals and policymakers, the HELT Talks was conceived as a year-round (monthly) event, providing a dynamic platform for thought-provoking discussions and stimulating debates on the future of digital health and care, through the prism of regulatory responses and relevant policy initiatives.

What is the typical format of a session at HELT Talks?

HELT Talks sessions are typically divided into two parts. In the first part, each speaker gives a presentation on a specific topic, touching upon particular challenges and open issues around the integration of technology in the realm of health care that require delving into legal and regulatory frameworks. The second part of the session aims at encouraging a deeper level of reflection on the topic under discussion, through organic conversations between the speakers and the audience.

What kind of topics are covered at HELT Talks?

HELT Talks cover a breadth of topics on law, health and technology, ranging from legal challenges for the use of health data and regulatory issues concerning advanced medical technology, to the use of artificial intelligence in medicine, data governance and data extraterritoriality in health care.

TALK of the Month

30 January 2025 | 13.00 - 15.00

AI in healthcare in the era of the AI Act: New opportunities and new challenges

This month’s talk delves into the transformative role of artificial intelligence (AI) in healthcare under the regulatory framework established by the AI Act. Adopted in 2024, this legislation introduces a comprehensive set of requirements to address AI-specific challenges, including opacity, self-learning capabilities, and autonomy. When combined with the Medical Devices Regulation (MDR), the AI Act aims to enhance the safety, transparency, and quality of AI-driven healthcare solutions, particularly in diagnostics and treatment.

However, these advances bring significant challenges that require immediate attention during the implementation phase. Critical issues include establishing a standardization framework to define compliance procedures and aligning the AI Act with the MDR’s conformity assessment processes. This session will feature insights from two distinguished speakers: Yiannos S. Tolias, Legal Lead for AI and AI liability in healthcare & European Health Data Space (EHDS) at the DG for Health and Food Safety of the European Commission, and Sofia Palmieri, FWO postdoctoral fellow within Metamedica research group at Ghent University and AI Policy and Compliance Officer at the European Institute for Innovation through Health Data (i~HD). Whether you are a healthcare provider, technologist, or policymaker, this discussion will equip you with the tools to navigate the evolving regulatory landscape and fully harness the potential of AI in healthcare.

Speakers

Dr. Yiannos S. Tolias

European Commission, DG for Health and Food Safety

Yiannos is the legal lead on AI and AI liability in Healthcare in the DG for Health and Food Safety at the European Commission. He is also part of the team that developed the European Health Data Space (EHDS) legislative initiative and a member of the EC teams that contributed to the development of the AI Act and Product Liability Directive. He was a Senior Emile Noel Fellow at NYU Law School carrying out research on AI in medicine and law. Prior to joining the European Commission, he was an Assistant Professor of EU law at the Universities of Edinburgh and Dundee. He holds a Ph.D. in EU Constitutional law from the University of Edinburgh and he was later a Post-doctoral Research Fellow.

Dr. Sofia Palmieri

Ghent University, Metamedica research group; the European Institute for Innovation through Health Data (i~HD)

Dr. Sofia Palmieri is a FWO postdoctoral fellow within Metamedica research group at Ghent University. Her research is positioned at a crossroads between law, ethics, AI, and healthcare. She investigates the perimeter of regulation for the safe, patient-centered, and evidence-based use of Artificial Intelligence in the medical field. She also joined AI4Health – a subsection of AI4Belgium - as a core team member. She co-chairs the Young Scholar Interest Group of the European Association of Health Law and co-lead the Ethics and Law group within HINT.gent. Recently, she joined The European Institute for Innovation through Health Data (i~HD) as Healthcare AI Policy and Compliance Officer.