Managing authorisation for cross-border exchange of personal electronic health data
Article 7
1. The Commission shall, on behalf of the steering group, be responsible for managing the procedures for authorising the exchange of personal electronic health data. They shall be the following: (a) authorising a national contact point for digital health to start the exchange of personal electronic health data; (b) authorising a national contact point for digital health or an authorised participant to continue the exchange of personal electronic health data after an upgrade to the latest major release; (c) authorising a national contact point for digital health or an authorised participant to continue the exchange of personal electronic health data after an operational compliance check referred to in Article 9, point b; (d) addressing significant incidents in the exchange of personal electronic health data. 2. The Commission, in collaboration with the steering group, shall propose the methodology for the procedures on authorisations referred to in paragraph 1, for approval by the steering group. 3. The steering group shall decide whether or not to grant an authorisation referred to in paragraph 1, points (a), (b) or (c) on the basis of the requirements laid down in Articles 10 to 12. 4. Where the steering group decides not to grant an authorisation provided for in paragraph 1, the national contact point for digital health may request the steering group to review its decision.