Brussels, 24 April 2025 – A thought-provoking panel titled “From Data Return by Design to Ethical Secondary Use: A Scalable Approach to the Governance of Clinical Trial Data, at the 3rd Health, Law and Technology (HELT) Symposium brought together academic, regulatory, patient advocacy, and industry to discuss the two important aspects of the governance of clinical trial data: the return of individual participant data to patients and its secondary use.
Panelists included Prof. Dr. Johanna Blom (UNIMORE), David Murphy (Irish Data Protection Commission), Veronica Popa (EURORDIS), Swapna Pothula (GSK), and moderator Wenkai Li (VUB). The discussion centered on the importance of involving patients, the ethical and regulatory complexities, the FACILITATE models, and also the potential alignment with the new European Health Data Space (EHDS). The FACILITATE framework—developed through stakeholder dialogue—was seen as a pioneering step toward empowering trial participants and ensuring trustworthy, legally compliant data return and reuse reuse. As health data continues to drive innovation, the session underscored the need for incremental, collaborative approaches to balance legal requirements, ethics, patient interests and scientific advancement.
