Abstract
Issue/problem
The European Health Data Space (EHDS) creates new opportunities for secondary use of health data. Simultaneously, it raises concerns about secure, transparent, fair and responsible data use. The EHDS regulation leaves responsibility for ethics expertise largely to Member States (MS), creating ambiguities and risks of inconsistent interpretation.
Description of the problem
Using a multi‑method approach, the study examined whether existing ethical governance structures are equipped to address upcoming ethical challenges under the EHDS. Based on the European Network of Research Ethics Committees an in-depth mapping and comparison of ethical expertise and secondary use processes was carried out, complemented by a workshop on the role of ethics in the EHDS conducted within the TEHDAS2 Joint Action and supported by six semi-structured qualitative expert interviews across four European countries. The analysis explored which new expertise data ethics requires, how benefits and risks of secondary use can be assessed, and the consequences of fragmented ethics requirements across MS.
Results
Results suggest that existing ethical structures, such as clinical trials regulation and bioethical committees, are insufficient for the ethical challenges posed by secondary use of health data. Relevant expertise appears fragmented and weakly institutionalized, particularly beyond national contexts, underscoring the need for harmonized approaches to ensure accountability and equity.
Lessons
Data ethics should be institutionalized as a core governance element of the EHDS. Embedding interdisciplinary expertise and building ethical capacity is essential to enable sustainable, equitable, and transparent secondary use of health data. Without coordinated ethical frameworks, the EHDS risks ethics dumping, declining public trust, unequal benefits and administrative burdens. This analysis underscores the role of harmonized data ethics as an enabler for innovation.
Key messages
• The EHDS offers new opportunities for secondary use but lacks harmonised ethical governance, thus risking fragmentation, ethics dumping and loss of public trust.
• A data ethics beyond traditional bioethics is needed, to ensure fair, transparent, equitable and efficient data use across Europe.