Article 25, Information sheet accompanying the EHR system, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant, accessible and comprehensible to users.
2. The information sheet referred to in paragraph 1 shall specify:
(a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer and, where applicable, of its authorised representative;
(b) the name and version of the EHR system and date of its release;
(c) its intended purpose;
(d) the categories of electronic health data that the EHR system has been designed to process;
(e) the standards, formats and specifications and versions thereof supported by the EHR system.
3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems and wellness applications referred to in Article 32, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.