Article 12, MyHealth@EU, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States.
2. Each Member State shall designate one national contact point for digital health to ensure the connection to all other national contact points for digital health and to the central platform for digital health. Where a designated national contact point is an entity consisting of multiple organisations responsible for implementing different services, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The national contact point for digital health shall be considered an authorised participant in the infrastructure. Each Member State shall communicate the identity of its national contact point to the Commission by [the date of application of this Regulation]. Such contact point may be established within the digital health authority established by Article 10 of this Regulation. Member States shall communicate to the Commission any subsequent modification of the identity of those contact points. The Commission and the Member States shall make this information publicly available.
3. Each national contact point for digital health shall enable the exchange of the personal electronic health data referred to in Article 5 with all other national contact points. The exchange shall be based on the European electronic health record exchange format.
4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
5. Member States shall ensure connection of all healthcare providers to their national contact points for digital health and shall ensure that those connected are enabled to perform two-way exchange of electronic health data with the national contact point for digital health.
6. Member States shall ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.
7. The national contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘MyHealth@EU’ for the processing operations in which they are involved. The Commission shall act as processor.
8. The Commission shall, by means of implementing acts, allocate responsibilities among controllers and as regards the processor referred to in paragraph 7 of this Article, in accordance with Chapter IV of Regulation (EU) 2016/679. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
9. The approval for individual authorised participants to join MyHealth@EU for different services, or to disconnect a participant shall be issued by the Joint Controllership group, based on the results of the compliance checks.