+Članak 38.
---+Article 38 1
---+Article 38 2
---+Article 38 3
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Članak 38.
1. Pregled
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Regulativa |
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Article 38 1
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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.
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Article 38 2
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2. The information sheet referred to in paragraph 1 shall specify:
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(a)
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the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;
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(b)
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the name and version of the EHR system and date of its release;
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(c)
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the intended purpose of the EHR system;
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(d)
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the categories of electronic health data that the EHR system has been designed to process;
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(e)
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the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
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Article 38 3
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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.
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1.1 Reference
1.2 Utvrđeni zahtjevi
1.3 Povezani standardi
2. Utvrđeni zahtjevi
3. Povezani standardi
- Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
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