Agent · helsodata-2025-327-38

EHDS artikel 38: Information sheet accompanying the EHR system

Strukturelt tre: artikkelens egne punkter, ordrett.

CELEX 32025R0327 · 2026-08-31 · Vekt 70 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOffisiell kilde

Inndata

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13)

Regeltre

1. Hvis: alla(in_scope = true, punkt = 1)

   Paragraph 1 applies

   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.

   Punkt 1

2. Hvis: alla(in_scope = true, punkt = 2)

   Paragraph 2 applies

   2. The information sheet referred to in paragraph 1 shall specify:

   Punkt 2

3. Hvis: alla(in_scope = true, punkt = 3)

   Paragraph 3 applies

   (a)

   Punkt 3

4. Hvis: alla(in_scope = true, punkt = 4)

   Paragraph 4 applies

   the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;

   Punkt 4

5. Hvis: alla(in_scope = true, punkt = 5)

   Paragraph 5 applies

   (b)

   Punkt 5

6. Hvis: alla(in_scope = true, punkt = 6)

   Paragraph 6 applies

   the name and version of the EHR system and date of its release;

   Punkt 6

7. Hvis: alla(in_scope = true, punkt = 7)

   Paragraph 7 applies

   (c)

   Punkt 7

8. Hvis: alla(in_scope = true, punkt = 8)

   Paragraph 8 applies

   the intended purpose of the EHR system;

   Punkt 8

9. Hvis: alla(in_scope = true, punkt = 9)

   Paragraph 9 applies

   (d)

   Punkt 9

10. Hvis: alla(in_scope = true, punkt = 10)

    Paragraph 10 applies

    the categories of electronic health data that the EHR system has been designed to process;

    Punkt 10

11. Hvis: alla(in_scope = true, punkt = 11)

    Paragraph 11 applies

    (e)

    Punkt 11

12. Hvis: alla(in_scope = true, punkt = 12)

    Paragraph 12 applies

    the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.

    Punkt 12

13. Hvis: alla(in_scope = true, punkt = 13)

    Paragraph 13 applies

    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.

    Punkt 13

Hvis ingen regel treffer: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.

Artikkelteksten som ble lest

1. 11. 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. 22. The information sheet referred to in paragraph 1 shall specify:
3. 3(a)
4. 4the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;
5. 5(b)
6. 6the name and version of the EHR system and date of its release;
7. 7(c)
8. 8the intended purpose of the EHR system;
9. 9(d)
10. 10the categories of electronic health data that the EHR system has been designed to process;
11. 11(e)
12. 12the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
13. 133. 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.

Ingen rådgivning. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.

Sitering: 32025R0327 art. 38, Information sheet accompanying the EHR system. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-38 (hämtad 2026-08-31, bevis sha256:9bca72420f28c973, bygge legal-2026-08-25).