lexiara

art_38__para_2

2. The information sheet referred to in paragraph 1 shall specify: the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative; the name and version of the EHR system and date of its release; the intended purpose of the EHR system; the categories of electronic health data that the EHR system has been designed to process; the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.