Articles of the European Health Data Space (EHDS), Article 16, Claims

Article 16, Claims, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

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 user with regard to its 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 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 in the technical documentation to form part of the intended purpose.