On 3 February 2025, Luca Pani, FACILITATE coordinator, delivered a comprehensive keynote presentation at the two-day Clinical Research Data Sharing Alliance-CRDSA’s 2025 Summit, exploring the challenges and opportunities of the European Health Data Space (EHDS).
His talk provided a deep dive into the EU institutions involved, their key legislations and initiatives, and the crossinstitutional tensions shaping the data sharing landscape.
With a global perspective, he compared the divergent approaches of the EU and the US, highlighting key differences between FDA’s remit and EU data governance. The discussion also featured real-world examples, including the work of FACILITATE in shaping the future of patient-centered data sharing.
Outlining the mission of FACILITATE, Pani dwelt on the ethical and patient-centric aspect of the project, recalling its objectives:
- build a trusted, patient-centric ecosystem for ethical and legal reuse of clinical trials data
- enhance study participants’ access to their health data during and after the trial
- develop flexible, actionable solutions for the restitution of individual participant data to encourage adoption.
“Central to the project” he pointed, emphasizing the importance of the ethical ecosystem on which FACILITATE is founded “is the creation of a prototype process for data return that defines who, when and how individual clinical trial data can be returned to participants, based on their informed choice”.
Finally, he highlighted the difficulties and challenges facing the project: legal uncertainties due to the varying GDPR implementations and overlapping regulations, complex interoperability caused by different standards among EU members, the complexity of cross-border collaboration and challenges related to data quality and security.
Pani concluded his lecture by outlining the results of FACILITATE, the main challenges and the roadmap for 2025, which essentially consists of:
- iterate pilot programs and gather participants’ feedback
- advocate the return of individual participant data by design
- consolidate learnings, scale processes, and prepare for EU adoption
- finalize guidance documents facilitating uptake
- extend the FACILITATE ethical framework to data sharing.
