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 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.
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