Articles of the European Health Data Space (EHDS), Article 36, Health data access bodies

Article 36, Health data access bodies, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Member States shall designate one or more health data access bodies responsible for granting access to electronic health data for secondary use. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this Article. Where a Member State designates several health data access bodies, it shall designate one health data access body to act as coordinator, with responsibility for coordinating requests with the other health data access bodies.

2. Member States shall ensure that each health data access body is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers.

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

4. Member States shall communicate to the Commission the identity of the health data access bodies designated pursuant to paragraph 1 by the date of application of this Regulation. They shall also communicate to the Commission any subsequent modification of the identity of those bodies. The Commission and the Member States shall make this information publicly available.