EU regulatory register · EHDS
Article 65Relationship with supervisory authorities under Regulation (EU) 2016/679
CELEX 32025R0327 · Read on 2026-08-31
Short answer
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.
Verbatim from the article. Source: NovaCopilot · https://legal.exploreworldai.com/eu/rattsakter/helsodata-2025-327/artikel-65 · Short answer as data · Official text
Official text
Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.
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.
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.
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