Article 38
Information sheet accompanying the EHR system
In short: EHR systems shall be accompanied by an information sheet.
- EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant,
accessible and comprehensible to professional users.
- The information sheet referred to in paragraph 1 shall specify:
- (a) the identity, registered trade name or registered trademark, and 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) the intended purpose of the EHR system;
- (d) the categories of electronic health data that the EHR system has been designed to process;
- (e) the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
- As an alternative to supplying the information sheet referred to in paragraph 1 of this Article with the EHR system,
manufacturers may enter the information referred to in paragraph 2 of this Article into the EU database for registration of
EHR systems and wellness applications referred to in Article 49.
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