European Commission publishes draft rules for the operation of the EHDS BoardEuropean Commission publishes draft rules for the operation of the EHDS Board and outlines the benefits of secondary use of health dataEuropean Commission publishes draft rules for the operation of the EHDS Board
- Post by: Alper Idrisoglu
- 9 December, 2025
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The European Health Data Space (EHDS) is a major EU initiative aimed at making health data more accessible, secure, and usable across all Member States. It introduces a common framework for accessing, sharing, and reusing health data in a responsible manner. As part of this process, the European Commission is publishing a series of implementing acts that explain how various aspects of the regulation will function in practice.
The Commission has now released the first draft implementing act, which outlines how the European Health Data Space Board (EHDS Board) will be established and its operational framework. The proposal outlines the Board’s mandate, the representation of Member States, the process for making decisions, the creation of two-year work plans, and the mechanisms for ensuring transparency, confidentiality, and cooperation with other EU bodies. The draft is now open for public consultation on the Commission website.
Link to the consultation:
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14992-European-Health-Data-Space-Board-operations_en
The EHDS Board will play a central coordinating role as the EHDS is implemented across the EU. It will offer guidance, identify common challenges, support national authorities, and encourage the exchange of best practices. Its work will be essential for creating a harmonised and trusted environment for health data across borders.
The broader purpose of the EHDS becomes even clearer when looking at the Commission’s explanation of the secondary use of health data. Secondary use refers to situations where health data is reused for research, innovation, public health, policy-making, and personalized medicine. According to the Commission, the secondary use of data can improve healthcare outcomes, drive scientific discoveries, strengthen public health policy, and support the development of new AI-based solutions.
Background on secondary use of data:
https://health.ec.europa.eu/ehealth-digital-health-and-care/reuse-health-data_en
The EHDS framework introduces strict rules to ensure that the secondary use of data is lawful, secure, and transparent. These include authorisation by Health Data Access Bodies, data minimisation, anonymisation and pseudonymisation, secure processing environments, and an opt-out option for individuals who do not want their data to be reused. Prohibited uses include any form of decision-making that negatively affects individuals or groups based on their health data.
The benefits described by the Commission are significant. Researchers gain faster and easier access to well-documented datasets. Innovators and industry gain access to high-quality anonymised data for developing new medical technologies. Policymakers gain stronger evidence for decision-making. Patients benefit from better treatments and increased transparency about how their data is used.
These developments align closely with the research priorities of the Health and Technology Research Lab at BTH. Our work focuses on applied health technology, including digital biomarkers, AI-assisted diagnosis, ageing, and chronic disease monitoring. The EHDS can support this work by improving data availability, promoting interoperability, and enabling responsible cross-border research using large and diverse European datasets. It also strengthens our efforts in trustworthy and explainable AI, secure data infrastructures, and patient-centred innovation.
With the release of this draft implementing act, the European Commission invites all stakeholders, including researchers, health organisations, companies, and citizens, to give feedback and help shape the next steps of the EHDS.