+Article 38 2

Article 38 2

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.

1. Übersicht

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Bezeichnung Regulierung

1.1 Referenzen

1.2 Identifizierte Anforderungen

1.3 Zugehörige Standards

2. Identifizierte Anforderungen

Anforderungen
Quelle Anforderung

3. Zugehörige Standards

Standards
Quelle Anforderung