TEHDAS’ proposals for clarifying EHDS governance
Governing health data in Europe should be based on clearly defined roles for organisations that will process health data. TEHDAS has set out options and considerations to help clarify the health data governance structure in the European health data space.
A new report by the joint action Towards the European Health Data Space (TEHDAS) argues that for the European health data space (EHDS) to be successful, those involved in governing health data will need to have clearly defined roles.
The report suggests ways to clarify the governance structure as described in the European Commission’s EHDS proposal, with the aim of boosting people’s trust in data sharing. This will facilitate the use of data for secondary purposes such as research, policymaking and innovation.
The report expresses the need to clarify the composition and tasks of the European health data space board that will determine the implementation of the EHDS. Under the Commission’s proposal, each member state will nominate one or more organisations to the EHDS board chaired by the Commission. The proposal also mentions the possibility of having experts and observers on the board.
TEHDAS suggests that the EHDS regulation should specify the board’s composition and tasks. Additionally, the board’s rules of procedure should be jointly formulated by the Commission and the member states. The TEHDAS report also hopes the board will liaise with external stakeholders in a dedicated forum to ensure the board benefits from their expertise.
EHDS governance in line with EU interoperability framework
TEHDAS recommends that for the EHDS governance to function well, the different levels of the European interoperability framework need to be addressed by the EHDS board and subgroups. The framework includes legal, organisational, semantic and technical aspects and gives specific guidance on how to set up interoperable digital public services. The report describes issues and solutions per interoperability layer.
Health data access bodies
The report also identifies other matters concerning the tasks and responsibilities of the health data access bodies. Under the Commission’s proposal, each member state will create one or more health data access bodies to enable access to health data for secondary purposes.
TEHDAS also highlights the need for investments in technology and human resources to ensure that the bodies can carry out the many tasks allocated to them. The Commission and the member states will have to find ways to share the financial burden for the initial startup of these bodies. TEHDAS will deliver a sustainability plan for the EHDS in spring 2023.
TEHDAS hopes that the report on the options and considerations will facilitate the best possible outcome for the EHDS negotiations.
The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.