EHDS implementation: EPF raises concerns and proposes solutions
The European Patients' Forum (EPF) has published a new paper on the implementation of the European Health Data Space (EHDS), focusing on the role of Health Data Access Bodies (HDABs) in issuing data permits for the secondary use of health data. Drawing on experiences and perspectives from patient organisations across Europe, the paper highlights concerns related to the interpretation of "public interest", patient involvement in governance, and ethical oversight, while proposing practical solutions to support a consistent, trustworthy and patient-centred implementation of the EHDS.
Health Data Access Bodies will play an important role in the EHDS by assessing requests for access to health data for secondary use. As Member States establish these new governance structures, ensuring consistent and trustworthy decision-making will be essential to the success of the European Health Data Space.
In its paper, EPF highlights concerns regarding the interpretation of the concept of "public interest", which is central to decisions on data access but remains insufficiently defined within the EHDS framework. Without greater clarity and common guidance, differing interpretations across Member States could result in fragmented implementation and create uncertainty for both patients and stakeholders.
The paper also underlines the importance of embedding patient perspectives within the governance of Health Data Access Bodies. Experiences shared by patient organisations across Europe demonstrate that patient involvement remains uneven, ranging from formal participation in advisory and ethics bodies to more limited consultation mechanisms. EPF argues that meaningful and structured patient engagement should be built into governance frameworks from the outset to ensure legitimacy, accountability and public confidence.
To support a successful and patient-centred implementation of the EHDS, EPF calls for greater clarity on how public interest should be assessed when evaluating data access requests, stronger and more structured patient involvement in governance, and the preservation of robust ethical and scientific oversight throughout the data permit process. Together, these measures can help ensure that health data are used responsibly, transparently and in ways that ultimately improve healthcare, research and public health outcomes across Europe.