Agent · helsodata-2025-327-64

EHDS artikel 64: General conditions for the imposition of administrative fines by health data access bodies

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

CELEX 32025R0327 · 2026-08-31 · Weight 62 · 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. Each health data access body shall ensure that the imposition of administrative fines pursuant to this Article in respect of infringements referred to in paragraphs 4 and 5 is effective, proportionate and dissuasive in each individual case.

   Paragraph 1

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

   Paragraph 2 applies

   2. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or instead of, enforcement measures referred to in Article 63(3) and (4). Health data access bodies shall decide whether to impose an administrative fine and the amount of the administrative fine in each individual case by giving due regard to the following circumstances:

   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

   the nature, gravity and duration of the infringement;

   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

   whether any penalties or administrative fines have already been imposed by other competent authorities for the same infringement;

   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

   the intentional or negligent character of the infringement;

   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

    any action taken by the health data holder or health data user to mitigate the damage caused;

    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

    the degree of responsibility of the health data user, taking into account technical and organisational measures implemented by that health data user pursuant to Article 67(2), point (g), and Article 67(4);

    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

    any relevant previous infringements by the health data holder or health data user;

    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. Each health data access body shall ensure that the imposition of administrative fines pursuant to this Article in respect of infringements referred to in paragraphs 4 and 5 is effective, proportionate and dissuasive in each individual case.
2. 22. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or instead of, enforcement measures referred to in Article 63(3) and (4). Health data access bodies shall decide whether to impose an administrative fine and the amount of the administrative fine in each individual case by giving due regard to the following circumstances:
3. 3(a)
4. 4the nature, gravity and duration of the infringement;
5. 5(b)
6. 6whether any penalties or administrative fines have already been imposed by other competent authorities for the same infringement;
7. 7(c)
8. 8the intentional or negligent character of the infringement;
9. 9(d)
10. 10any action taken by the health data holder or health data user to mitigate the damage caused;
11. 11(e)
12. 12the degree of responsibility of the health data user, taking into account technical and organisational measures implemented by that health data user pursuant to Article 67(2), point (g), and Article 67(4);
13. 13(f)
14. 14any relevant previous infringements by the health data holder or health data user;

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

Citation: 32025R0327 art. 64, General conditions for the imposition of administrative fines by health data access bodies. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-64 (hämtad 2026-08-31, bevis sha256:8e218c358931ba7a, bygge legal-2026-08-25).