Relationship with supervisory authorities under Regulation (EU) 2016/679

The supervisory authority or supervisory authorities responsible for monitoring and enforcing the application of Regulation (EU) 2016/679 shall also be competent for monitoring and enforcing the application of Articles 3 and 5 to 10 of this Regulation. The relevant provisions of Regulation (EU) 2016/679 shall apply mutatis mutandis. Supervisory authorities shall be empowered to impose administrative fines up to the amount referred to in Article 83(5) of Regulation (EU) 2016/679.

The supervisory authorities referred to in the first paragraph of this Article and digital health authorities referred to in Article 19 shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences.

SECTION 3 Cross-border infrastructure for primary use of personal electronic health data