Workshop on the ethical dimensions of the European Health Data Space
As the European Health Data Space (EHDS) moves from legislative design to implementation, stakeholders across sectors are beginning to face a new ethical landscape for the secondary use of health data. The EHDS Regulation, particularly Article 67(2)(j), introduces a requirement for data access requests to include precise ethics aspects around the secondary use of health data. This signals one the one hand the importance of structured and transparent ethical evaluation processes of health data access requests and on the other hand future cooperation on these procedures which remain a national competence. The topic of ethics raises important questions: How should stakeholders, such as the future Health Data Access Bodies (HDABs), ethics committees, researchers, patients, citizens or professional groups, interpret and apply these requirements? Will existing national procedures be sufficient, or are new tools, roles, and collaborations needed?
To address these topics and questions, a workshop, held online on the 23rd of June 2025, brought together 174 participants to explore how ethical considerations should be addressed in practice once the EHDS becomes operational – what will change, what concerns may arise, and what opportunities exist to strengthen trust, transparency, and accountability. The workshop featured four invited expert speakers, a panel debate and three breakout discussion sessions, with speakers and moderators representing diverse backgrounds, including public health, public policy, patient advocacy, medical ethics, research and health informatics, both from national and EU-level. Together, the speakers addressed a wide spectrum of ethical challenges of health data access emerging in the EHDS context. Speakers and participants discussed how wide principles like public interest, societal benefit, and legitimate interest can be translated into operational practice in ways that are both coherent across Member States and sensitive to national and cultural contexts. Key themes included the mutual recognition between ethics boards of of ethical reviews, the evolving role of HDABs in ethical governance, and the need to ensure that ethics remains a living, participatory process, not a one-off compliance step. The workshop aimed to help stakeholders navigate this transition period and begin shaping a shared understanding of ethical governance under the EHDS.
Link to the workshop report: Workshop on the ethical dimensions of the European Health Data Space
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