Led by Bert Cappelle (Ghent University Hospital), the second session of the Legal Framework training sessions, provided participants with a practical overview of the legal and organisational framework required before researchers can access health data. 

Rather than focusing on legislation alone, the training demonstrated how legal, ethical and technical safeguards work together to enable secure and responsible data sharing across Europe.

Participants were guided through the complete data access process, covering the role of the Consortium Agreement, the Study Protocol, local ethical approval, the Data Sharing Agreement and the Secure Processing Environment (SPE). Together, these elements ensure that data access is always linked to a clearly defined research purpose, with responsibilities, conditions and governance agreed before any study begins.

As Bert Cappelle highlights the importance of this subject: “Federated research succeeds when strong technology meets strong governance.” Clear governance, transparent agreements and collaboration between all partners are essential to protect sensitive health data while enabling high-quality research across the INDICATE consortium.

The upcoming third training of the Legal Framework training sessions take place on September 10, from 14.00 – 16.00.