Navigating the EU Regulatory Maze to Conduct International Medical Research Developing AI

  • Workshop
  • Arts & Craft
  • Friday 22.05 — 14:15 - 15:30

Organising Institution

I3LUNG Project

International

While the GDPR aims to facilitate research by providing some related exceptions (cf. Art. 89), experiences since its adoption raise questions as to whether it really achieves that goal. Several challenges have been identified so far including the fragmentation of research-related rules in the national laws, uncertainty about international data transfer frameworks (e.g. the adequacy decisions for the US), etc. The recent case law (i.e. SRB case) re-opens the debate on what is to be understood as personal data. Although the AI Act was adopted not-so-long-ago, the Digital Omnibus Proposal has several points related to personal data, research, innovation, AI training. However, the implications of all these are unclear regarding international medical research developing AI, which require vast amount of health data. Through small group discussions, this workshop will be a platform for lawyers and researchers to exchange and, collaboratively, propose best practices for research, considering the evolving regulatory environment.

Host

Halid Kayhan

Centre for IT & IP Law (CiTiP), KU Leuven - Belgium

Halid Kayhan is a researcher in law at KU Leuven Centre for IT & IP Law (CiTiP) and has been involved in numerous Horizon2020 and HorizonEurope projects: CyberSANE, CoRoSect, PRAETORIAN, PharmaLedger, I3LUNG, and Digi4Live. His reseach focuses on legal and ethical aspects of medical AI, livestock data sharing, and dual use risks of innovative research collaborations. He previously worked on protection of critical infrastructures, robotics, automation of work (with a focus on insect farming), blockchain, pharmaceutical supply chains and clinical trials, among others.

Host

Eylem Karakaya

Centre for IT & IP Law (CiTiP), KU Leuven - Belgium

Eylem Karakaya (°1999) is a doctoral researcher. She obtained a Master of Laws (2022) from the KU Leuven, followed by a Master in Taxation (2023) from the same institution. She then pursued an LLM in IT/IP Law at the KU Leuven, which she recently finalized. Throughout her studies, she was part of the law review Jura Falconis for four years and pursued several internships. On October 7th of 2024, she joined CiTiP as doctoral researcher, where she will be involved in the FLIPR project and conduct a PhD on AI-based medical devices and its safety risks for underrepresented patients.

Host

Francesco Trovò

Politecnico di Milano (PoliMi) - Italy

Francesco Trovò is an associate professor with the Dipartimento di Elettronica, Informazione e Bioingegneria at the Politecnico di Milano. He received his Ph.D. in Information Technology from the Politecnico di Milano in 2015. He is currently the lecturer for the courses of Online Learning and Monitoring (Ph.D.), and Machine Learning (M.S.). His main research interest is in online machine learning, specifically in microeconomic environments with opponents and non-stationarities. He is currently working on applying machine learning techniques in oncology.