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

The supervisory authority or authorities responsible for monitoring and enforcing the application of Regulation (EU) 2016/679 shall also be competent for monitoring and enforcing the application of the right to opt out from the processing of personal electronic health data for secondary use pursuant to Article 71. Those supervisory authorities shall be empowered to impose administrative fines up to the amount referred to in Article 83 of Regulation (EU) 2016/679.

68/96 ELI: http://data.europa.eu/eli/reg/2025/327/oj

The supervisory authorities referred to in the first paragraph of this Article and the health data access bodies referred to in Article 55 of this Regulation shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences. The relevant provisions of Regulation (EU) 2016/679 shall apply mutatis mutandis.

SECTION 3 Access to electronic health data for secondary use