Agent · helsodata-2025-327-53

EHDS artikel 53: Purposes for which electronic health data can be processed for secondary use

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

CELEX 32025R0327 · 2026-08-31 · Weight 70 · 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. Health data access bodies shall only grant access to electronic health data referred to in Article 51 for secondary use to a health data user where the processing of the data by that health data user is necessary for one of the following purposes:

   Paragraph 1

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

   Paragraph 2 applies

   (a)

   Paragraph 2

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

   Paragraph 3 applies

   the public interest in the areas of public or occupational health, such as activities to protect against serious cross-border threats to health, public health surveillance or activities ensuring high levels of quality and safety of healthcare, including patient safety, and of medicinal products or medical devices;

   Paragraph 3

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

   Paragraph 4 applies

   (b)

   Paragraph 4

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

   Paragraph 5 applies

   policymaking and regulatory activities to support public sector bodies or Union institutions, bodies, offices or agencies, including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

   Paragraph 5

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

   Paragraph 6 applies

   (c)

   Paragraph 6

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

   Paragraph 7 applies

   statistics as defined in Article 3, point (1), of Regulation (EC) No 223/2009, such as national, multi-national and Union-level official statistics, related to health or care sectors;

   Paragraph 7

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

   Paragraph 8 applies

   (d)

   Paragraph 8

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

   Paragraph 9 applies

   education or teaching activities in health or care sectors at vocational or higher education level;

   Paragraph 9

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

    Paragraph 10 applies

    (e)

    Paragraph 10

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

    Paragraph 11 applies

    scientific research related to health or care sectors that contributes to public health or health technology assessments, or ensures high levels of quality and safety of healthcare, of medicinal products or of medical devices, with the aim of benefiting end-users, such as patients, health professionals and health administrators, including:

    Paragraph 11

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

    Paragraph 12 applies

    (i)

    Paragraph 12

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

    Paragraph 13 applies

    development and innovation activities for products or services;

    Paragraph 13

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

    Paragraph 14 applies

    (ii)

    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. Health data access bodies shall only grant access to electronic health data referred to in Article 51 for secondary use to a health data user where the processing of the data by that health data user is necessary for one of the following purposes:
2. 2(a)
3. 3the public interest in the areas of public or occupational health, such as activities to protect against serious cross-border threats to health, public health surveillance or activities ensuring high levels of quality and safety of healthcare, including patient safety, and of medicinal products or medical devices;
4. 4(b)
5. 5policymaking and regulatory activities to support public sector bodies or Union institutions, bodies, offices or agencies, including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;
6. 6(c)
7. 7statistics as defined in Article 3, point (1), of Regulation (EC) No 223/2009, such as national, multi-national and Union-level official statistics, related to health or care sectors;
8. 8(d)
9. 9education or teaching activities in health or care sectors at vocational or higher education level;
10. 10(e)
11. 11scientific research related to health or care sectors that contributes to public health or health technology assessments, or ensures high levels of quality and safety of healthcare, of medicinal products or of medical devices, with the aim of benefiting end-users, such as patients, health professionals and health administrators, including:
12. 12(i)
13. 13development and innovation activities for products or services;
14. 14(ii)

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

Citation: 32025R0327 art. 53, Purposes for which electronic health data can be processed for secondary use. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-53 (hämtad 2026-08-31, bevis sha256:56ed75e7400c63e1, bygge legal-2026-08-25).