EU regulatory register · EHDS
Article 28Claims
CELEX 32025R0327 · Read on 2026-08-31
Short answer
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 …
Verbatim from the article. Source: NovaCopilot · https://legal.exploreworldai.com/eu/rattsakter/helsodata-2025-327/artikel-28 · 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.
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 (34) 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.
Follow-up questions
The text is quoted from the official source and is not legal advice. A national court reads the language version that binds in its jurisdiction.
Verifiable trust signals
- Source-linked answers and explicit evidence gaps
- Obligations, controls, risks and consequences
- Stable objects and verifiable checksums
- Rule-based objects, optional source-linked reasoning
- Model card, source status and audit