Secondary Use of Health Data under the EHDS and the GDPR

From March 2029, access to health data for research, statistics, policy and the development of AI changes fundamentally across the European Union. Whoever wants to use data no longer asks a favour of the hospital, the registry or the ministry, but applies for a permit from an independent public body. And whoever holds data must deliver. That is the core of Chapter IV of the European Health Data Space. This book explains how the system works, where the Regulation is silent or contested, and what the Member States still have to decide.

It is written for lawyers and for those who have to work with lawyers: researchers and data scientists, data protection officers, legal counsel in healthcare, policy makers at registries, hospitals, insurers and governments, and the people who will staff the new health data access bodies. Two introductory chapters give readers without legal training the concepts the rest of the book relies on. Where the law uses open norms, the book sets out the competing readings, with the arguments on both sides, before taking a position.

What the book covers:

• The permit system of the EHDS in full: the data permit, the health data request, the secure processing environment, the health data access body, the data holders, the permitted purposes and the prohibited uses, and the opt-out.
• The institutions and infrastructure: trusted holders, data hubs, HealthData@EU, the EHDS Board, the dataset catalogues and the deadlines and remedies that apply to an application.
• The contested questions: whether the permit is the only route to secondary use, whether an application may be confined to catalogued datasets, what counts as scientific research, what a holder may charge, which intellectual property rights can exist in health data, and where personal data ends and anonymous data begins.
• The GDPR alongside the EHDS: the assessment that has to be made for health research with or without the EHDS, how the Regulation allocates the roles of controller and processor by law rather than by fact, which legal grounds remain open to a data user, and what survives of the rights of data subjects.
• The policy choices left to national implementing legislation, from the position and independence of the access body to the micro-exception, the determinants of health, ethical review and archive law.
• A closing chapter with the findings and a full list of recommendations, sorted by addressee: the Union legislature, the Commission and the EHDS Board, national legislators, access bodies, data holders, researchers and supervisory authorities.

The analysis is doctrinal at its core and enriched with comparison, discourse analysis and a longitudinal reading of the successive drafts of the Regulation. Well over a thousand footnotes to the Regulation, its recitals, the case law and the literature make every claim traceable.

Also available in Dutch

A shorter and more practical Dutch edition of this book, Hergebruik van gezondheidsgegevens: de EHDS & de AVG, is published by Wolters Kluwer. It is written for practitioners in the Netherlands, leaves out most of the comparative and historical material, and is the only edition that deals with the Dutch implementing act. Read more about the Dutch edition here.

About the author

Antoinette Vlieger holds a doctorate in law and works as an independent legal counsel on the EHDS and European health data law. She advises healthcare institutions, registries, research organisations and public bodies on the secondary use of health data and speaks regularly at conferences on the EHDS.

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