AI in Digital Health: Innovation vs. Regulation — The European Reality

In this meeting, we will examine what health AI innovators, healthcare systems, and decision-makers need to understand as artificial intelligence becomes increasingly embedded in digital health across Europe. The discussion will highlight the evolving regulatory landscape, key risks for AI-enabled solutions, and practical considerations for bringing innovations to the European market while maintaining compliance without slowing innovation.

Nika Mendelev will lead the session. With more than 20 years of experience in medical device R&D and regulatory affairs—including auditing for a Notified Body—she supports health technology companies in translating innovation into compliant products for the European market. She is also an active board member of the DIN “AI in Healthcare” Committee and will share a clear, practitioner’s perspective on what to expect and how to prepare.