Article 42

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

1. Member States may adopt national requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems. 2. The national requirements or provisions referred to in paragraph 1 shall not adversely affect the harmonised software components of EHR systems. 3. When Member States adopt requirements or provisions in accordance with paragraph 1, they shall inform the Commission thereof.

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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.