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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) article 42 CELEX: 32025R0327 National requirements and reporting to the Commission
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. |