European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
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 Free Flow of Non-Personal Data Regulation 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.
Related Recitals