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Health Research and secondary uses: Facing European Health Data Space Regulation

 

Between November 2024 and January 2025, the Chair of Privacy and Digital Transformation organised an initiative consisting of five online seminars and a final inperson event, held at the Representation Office of the European Commission in Madrid. This initiative animed to analvse and discuss the challenges and opportunities arising from the new European Health Data Space Regulation (EHDS), a fundamental regulatory framework for the secure acces, use, and reuse of electronic health data within the European Union.

During November and December 2024, five specialised seminars were held, addressing essential aspects of the EHDS.
The first seminar, Innovating European Laws: A new legal and ethical framework for electronic health data secondary uses, addressed the new legal and ethical framework for the secondary use of health data, essential for ensuring a balance between innovation and the protection of fundamental rights.
The second seminar, Pseudonymisation v. Anonymisation: Quality of data and secondary uses, analysed the differences between anonymisation and pseudonymisation, two key techniques for protecting privacy and maintaining the quality of data reused in research and public policy.
In the third seminar, Legal grounds for secondary uses in health data reuse: From consent, data altruism and public interest to opting out rules, the legal foundations enabling data reuse were examined, ranging from consent to public interest and opt-out mechanisms, in line with the GDPR and EHDS.
The fourth seminar, Data Holders Challenges, addressed the challenges faced by health data holders, such as interoperability, security, and access rights management.
Finally, the fifth seminar, Authorised participants: The European infrastructures roles, explored the role of European infrastructures and authorised participants within the EHDS ecosystem, which is crucial for cross-border collaboration and innovation.

These seminars provided a space for reflection and dialogue, allowing national and international experts to share perspectives and anticipate the regulatory and technical changes that the EHDS will bring. The initiative concluded in January 2025 with an in-person event in Madrid, at the Representation Office of the European Commission, bringing together national authorities, researchers, healthcare professionals, patient associations, and prominent legal experts to discuss:

  • The regulatory and public policy challenges associated with the deployment of the EHDS
  • Patients’ needs and expectations regarding access to and control of their data.
  • The creation of secure data processing environments and opportunities for reuse in research, innovation, and entrepreneurship.
  • The impact of the EHDS on European healthcare systems and the digital transformation of health.

Through roundtable discussions and presentations, the event fostered a multidisciplinary dialogue that consolidated the conclusions of the previous seminars and delved into the practical implications of the new regulation, significantly contributing to strenghtening understanding and collaboration among the various actors in the healthcare, digital and legal ecosystem, at a devisive moment for the transformation of health data managment in Europe.