Article 38Information sheet accompanying the EHR system

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 professional users.

2. 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.

3. 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.