Recital 64

The establishment of one or more health data access bodies, supporting access to electronic health data in Member States, is essential to promoting the secondary use of health-related data. Member States should therefore establish one or more health data access bodies to reflect, inter alia, their constitutional, organisational and administrative structure. However, one of those health data access bodies should be designated as a coordinator in the event there is more than one health data access body. Where a Member State establishes several health data access bodies, it should lay down rules at national level to ensure the coordinated participation of those bodies in the European Health Data Space Board (the ‘EHDS Board’). That Member State should, in particular, designate one health data access body to function as a single contact point for the effective participation of those bodies, and ensure swift and smooth cooperation with other health data access bodies, the EHDS Board and the Commission. Health data access bodies could vary in terms of organisation and size, spanning from a dedicated fully fledged organisation to a unit or department in an existing organisation. Health data access bodies should not be influenced in their decisions on access to electronic data for secondary use and should avoid any conflicts of interest. Therefore, members of the governance and decision-making bodies of each health data access body and its staff should refrain from any action that is incompatible with their duties and should not engage in any incompatible occupation. However, the independence of the health data access bodies should not mean that they cannot be subject to control or monitoring mechanisms regarding their financial expenditure or to judicial review. Each health data access body should be provided with the financial, technical and human resources, premises and infrastructure necessary for the effective performance of its tasks, including those related to cooperation with other health data access bodies throughout the Union. The members of the governance and decision-making bodies of health data access bodies and their staff should have the necessary qualifications, experience and skills. Each health data access body should have a separate public annual budget, which could be part of the overall state or national budget. In order to enable better access to health data and complementing Article 7(2) of Regulation (EU) 2022/868, Member States should entrust health data access bodies with powers to take decisions on access to and secondary use of health data. This could consist in allocating new tasks to the competent bodies designated by Member States under Article 7(1) of Regulation (EU) 2022/868 or in designating existing or new sectoral bodies responsible for such tasks in relation to access to health data.