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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 28 CELEX: 32025R0327 Claims
In the information sheet, instructions for use or other information accompanying EHR systems, and in the advertising of EHR systems, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the professional user as defined in Article 3, point (8), of Regulation (EU) 2018/1807 of the European Parliament and of the Council with regard to their intended purpose, interoperability and security by: (a) ascribing functions and properties to the EHR system which it does not have; (b) failing to inform the professional user of likely limitations related to interoperability or security features of the EHR system in relation to its intended purpose; (c) suggesting uses for the EHR system other than those stated to form part of the intended purpose in the technical documentation. |