Agent · helsodata-2025-327-67

EHDS artikel 67: Health data access applications

Strukturelt tre: artikkelens egne punkter, ordrett.

CELEX 32025R0327 · 2026-08-31 · Vekt 62 · 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 | 14)

Regeltre

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

   Paragraph 1 applies

   1. A natural or legal person may submit a health data access application for the purposes referred to in Article 53(1) to a health data access body.

   Punkt 1

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

   Paragraph 2 applies

   2. The health data access application shall include:

   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 health data applicant’s identity, a description of that health data applicant’s professional functions and activities, including the identity of the natural persons who would have access to the electronic health data if a data permit were issued; the health data applicant shall notify the health data access body of any update of the list of natural persons;

   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 purposes referred to in Article 53(1) for which access to data is applied for;

   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

   a detailed explanation of the intended use of the electronic health data and expected benefit related to that use and how that benefit would contribute to the purposes referred to in Article 53(1);

   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

    a description of the requested electronic health data, including their scope, time range, format, sources and, where possible, the geographical coverage where such data are requested from health data holders in several Member States or from authorised participants in HealthData@EU referred to in Article 75;

    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

    a description explaining whether the electronic health data need to be made available in a pseudonymised or anonymised format; in the case of a pseudonymised format, a justification as to why the processing cannot be carried out using anonymised data;

    Punkt 12

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

    Paragraph 13 applies

    (f)

    Punkt 13

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

    Paragraph 14 applies

    where the health data applicant intends to bring datasets already held by that health data applicant into the secure processing environment, a description of those datasets;

    Punkt 14

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. A natural or legal person may submit a health data access application for the purposes referred to in Article 53(1) to a health data access body.
2. 22. The health data access application shall include:
3. 3(a)
4. 4the health data applicant’s identity, a description of that health data applicant’s professional functions and activities, including the identity of the natural persons who would have access to the electronic health data if a data permit were issued; the health data applicant shall notify the health data access body of any update of the list of natural persons;
5. 5(b)
6. 6the purposes referred to in Article 53(1) for which access to data is applied for;
7. 7(c)
8. 8a detailed explanation of the intended use of the electronic health data and expected benefit related to that use and how that benefit would contribute to the purposes referred to in Article 53(1);
9. 9(d)
10. 10a description of the requested electronic health data, including their scope, time range, format, sources and, where possible, the geographical coverage where such data are requested from health data holders in several Member States or from authorised participants in HealthData@EU referred to in Article 75;
11. 11(e)
12. 12a description explaining whether the electronic health data need to be made available in a pseudonymised or anonymised format; in the case of a pseudonymised format, a justification as to why the processing cannot be carried out using anonymised data;
13. 13(f)
14. 14where the health data applicant intends to bring datasets already held by that health data applicant into the secure processing environment, a description of those datasets;

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

Sitering: 32025R0327 art. 67, Health data access applications. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-67 (hämtad 2026-08-31, bevis sha256:fff604415fd788f3, bygge legal-2026-08-25).