Article 53, Access to cross-border sources of electronic health data for secondary use, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. In the case of cross-border registries and databases, the health data access body in which the data holder is registered shall be competent to decide on data access applications to provide access to electronic health data. Where the registry has joint controllers, the health data access body that shall provide access to electronic health data shall be the body in the Member State where one of the joint controllers is established.
2. Where registries or databases from a number of Member States organise themselves into a single network of registries or databases at Union level, the associated registries may designate one of their members as a coordinator to ensure the provision of data from the registries’ network for secondary use. The health data access body of the Member State in which the coordinator of the network is located shall be competent to decide on the data access applications to provide access to electronic health data for the network of registries or databases.
3. The Commission may, by means of implementing acts, adopt the necessary rules for facilitating the handling of data access applications for HealthData@EU, including a common application form, a common data permit template, standard forms for common electronic health data access contractual arrangements, and common procedures for handling cross-border requests, pursuant to Articles 45, 46, 47 and 48. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).