+Article 28 Claims
---+Article 28 (a)
---+Article 28 (b)
---+Article 28 (c)
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Article 28 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 (34) with regard to their intended purpose, interoperability and security by:
1. Overview
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Regulation |
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Article 28 (a)
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ascribing functions and properties to the EHR system which it does not have;
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Article 28 (b)
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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;
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Article 28 (c)
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suggesting uses for the EHR system other than those stated to form part of the intended purpose in the technical documentation.
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1.1 References
1.2 Identified Requirements
1.3 Related Standards
2. Identified Requirements
Requirements
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Requirement |
3. Related Standards
Standards
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Requirement |
- Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
- EULAW -
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