Agent · helsodata-2025-327-1

EHDS artikel 1: Subject matter and scope

Structural tree: the article's own paragraphs, verbatim.

CELEX 32025R0327 · 2026-08-31 · Weight 66 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOfficial source

Inputs

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14)

Rule tree

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

   Paragraph 1 applies

   1. This Regulation establishes the European Health Data Space (EHDS) by providing for common rules, standards and infrastructures and a governance framework, with a view to facilitating access to electronic health data for the purposes of primary use of electronic health data and secondary use of those data.

   Paragraph 1

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

   Paragraph 2 applies

   2. This Regulation:

   Paragraph 2

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

   Paragraph 3 applies

   (a)

   Paragraph 3

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

   Paragraph 4 applies

   specifies and complements the rights laid down in Regulation (EU) 2016/679 of natural persons in relation to the primary use and secondary use of their personal electronic health data;

   Paragraph 4

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

   Paragraph 5 applies

   (b)

   Paragraph 5

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

   Paragraph 6 applies

   lays down common rules for electronic health record systems (‘EHR systems’) in relation to two mandatory harmonised software components, namely the European interoperability software component for EHR systems and the European logging software component for EHR systems, as defined in Article 2(2), points (n) and (o), respectively, and for wellness applications which are claimed to be interoperable with EHR systems in…

   Paragraph 6

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

   Paragraph 7 applies

   (c)

   Paragraph 7

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

   Paragraph 8 applies

   lays down common rules and mechanisms for primary use of electronic health data and secondary use of electronic health data;

   Paragraph 8

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

   Paragraph 9 applies

   (d)

   Paragraph 9

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

    Paragraph 10 applies

    establishes a cross-border infrastructure enabling the primary use of personal electronic health data across the Union;

    Paragraph 10

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

    Paragraph 11 applies

    (e)

    Paragraph 11

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

    Paragraph 12 applies

    establishes a cross-border infrastructure for secondary use of electronic health data;

    Paragraph 12

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

    Paragraph 13 applies

    (f)

    Paragraph 13

14. If: alla(in_scope = true, punkt = 14)

    Paragraph 14 applies

    establishes governance and coordination mechanisms at Union and national level for both primary use of electronic health data and secondary use of electronic health data.

    Paragraph 14

If no rule matches: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.

The article text as read

1. 11. This Regulation establishes the European Health Data Space (EHDS) by providing for common rules, standards and infrastructures and a governance framework, with a view to facilitating access to electronic health data for the purposes of primary use of electronic health data and secondary use of those data.
2. 22. This Regulation:
3. 3(a)
4. 4specifies and complements the rights laid down in Regulation (EU) 2016/679 of natural persons in relation to the primary use and secondary use of their personal electronic health data;
5. 5(b)
6. 6lays down common rules for electronic health record systems (‘EHR systems’) in relation to two mandatory harmonised software components, namely the European interoperability software component for EHR systems and the European logging software component for EHR systems, as defined in Article 2(2), points (n) and (o), respectively, and for wellness applications which are claimed to be interoperable with EHR systems in relation to those two harmonised software components, as regards primary use of electronic health data;
7. 7(c)
8. 8lays down common rules and mechanisms for primary use of electronic health data and secondary use of electronic health data;
9. 9(d)
10. 10establishes a cross-border infrastructure enabling the primary use of personal electronic health data across the Union;
11. 11(e)
12. 12establishes a cross-border infrastructure for secondary use of electronic health data;
13. 13(f)
14. 14establishes governance and coordination mechanisms at Union and national level for both primary use of electronic health data and secondary use of electronic health data.

No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.

Citation: 32025R0327 art. 1, Subject matter and scope. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-1 (hämtad 2026-08-31, bevis sha256:8b436edc9eb312c1, bygge legal-2026-08-25).