As part of the AFS Annual Summit 2024, the side-event titled Bridging Gaps in Digital Health brought together experts and innovators to explore the challenges and opportunities in Europe’s rapidly evolving healthtech sector. The session focused on the complex regulatory landscape that startups face, delving into policies shaping the future of digital health and AI in healthcare.

MEP Tomislav Sokol (European People’s Party) opened the discussion by unpacking the intricacies of the European Health Data Space (EHDS) and Medical Device Regulation (MDR), highlighting their role in enabling startups to bring innovative health solutions to market. Yiannos Tolias (DG Sante, European Commission) emphasized the critical need for data access for startups and how the EHDS is designed to level the playing field, offering comparisons with global regulatory frameworks.

Adding an industry perspective, Verena Thaler (MedTech Europe) shed light on the hurdles startups face under frameworks like GDPR, the Data Act, and the AI Act. She also introduced MedTech’s open letter advocating for reforms to the MDR, urging changes to enhance device availability and spur innovation. On the innovation front, Gareth Walkom (withVR) shared his experiences with regulatory compliance while integrating AI into virtual reality health solutions, emphasizing the adaptability required to navigate evolving policies.

This dynamic discussion underscored the importance of collaboration between policymakers, startups, and industry leaders in driving healthtech innovation forward. Thank you to all speakers and attendees for making this side event a thought-provoking highlight of the summit!