art_64__para_4

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

4. In accordance with paragraph 2 of this Article, infringements of the duties of the health data holder or health data user pursuant to Article 60 and Article 61(1), (5) and (6) shall be subject to administrative fines of a maximum of EUR 10 000 000 or, in the case of an undertaking, of a maximum of 2 % of its total worldwide annual turnover in the preceding financial year, whichever is higher.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.