Agent · helsodata-2025-327-72

EHDS artikel 72: Simplified procedure for access to electronic health data from a trusted health data holder

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. Where a health data access body receives a health data access application pursuant to Article 67 or a health data request pursuant to Article 69 that only covers electronic health data held by a trusted health data holder designated in accordance with paragraph 2 of this Article, the procedure set out in paragraphs 4 to 6 of this Article shall apply.

   Punkt 1

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

   Paragraph 2 applies

   2. Member States may establish a procedure whereby health data holders can apply to be designated as trusted health data holders, provided the health data holders meet the following conditions:

   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

   they are able to provide access to health data through a secure processing environment that complies with Article 73;

   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

   they have the necessary expertise to assess health data access applications and health data requests;

   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

   they provide the necessary guarantees to ensure compliance with this Regulation.

   Punkt 8

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

   Paragraph 9 applies

   Member States shall designate trusted health data holders following an assessment of the fulfilment of those conditions by the relevant health data access body.

   Punkt 9

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

    Paragraph 10 applies

    Member States shall establish a procedure to regularly review whether the trusted health data holder continues to fulfil those conditions.

    Punkt 10

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

    Paragraph 11 applies

    Health data access bodies shall indicate the trusted health data holders in the dataset catalogue referred to in Article 77.

    Punkt 11

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

    Paragraph 12 applies

    3. Health data access applications and health data requests referred to in paragraph 1 shall be submitted to the health data access body, which may forward them to the relevant trusted health data holder.

    Punkt 12

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

    Paragraph 13 applies

    4. Following receipt of a health data access application or health data request pursuant to paragraph 3 of this Article, the trusted health data holder shall assess the health data access application or health data request against the criteria listed in Article 68(1) and (2) or Article 69(2) and (3), as applicable.

    Punkt 13

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

    Paragraph 14 applies

    5. The trusted health data holder shall submit the assessment it carries out pursuant to paragraph 4, accompanied by a proposal for decision, to the health data access body within two months of receipt of the health data access application or health data request from the health data access body. Within two months of receipt of the assessment, the health data access body shall issue a decision on the health data acces…

    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. Where a health data access body receives a health data access application pursuant to Article 67 or a health data request pursuant to Article 69 that only covers electronic health data held by a trusted health data holder designated in accordance with paragraph 2 of this Article, the procedure set out in paragraphs 4 to 6 of this Article shall apply.
2. 22. Member States may establish a procedure whereby health data holders can apply to be designated as trusted health data holders, provided the health data holders meet the following conditions:
3. 3(a)
4. 4they are able to provide access to health data through a secure processing environment that complies with Article 73;
5. 5(b)
6. 6they have the necessary expertise to assess health data access applications and health data requests;
7. 7(c)
8. 8they provide the necessary guarantees to ensure compliance with this Regulation.
9. 9Member States shall designate trusted health data holders following an assessment of the fulfilment of those conditions by the relevant health data access body.
10. 10Member States shall establish a procedure to regularly review whether the trusted health data holder continues to fulfil those conditions.
11. 11Health data access bodies shall indicate the trusted health data holders in the dataset catalogue referred to in Article 77.
12. 123. Health data access applications and health data requests referred to in paragraph 1 shall be submitted to the health data access body, which may forward them to the relevant trusted health data holder.
13. 134. Following receipt of a health data access application or health data request pursuant to paragraph 3 of this Article, the trusted health data holder shall assess the health data access application or health data request against the criteria listed in Article 68(1) and (2) or Article 69(2) and (3), as applicable.
14. 145. The trusted health data holder shall submit the assessment it carries out pursuant to paragraph 4, accompanied by a proposal for decision, to the health data access body within two months of receipt of the health data access application or health data request from the health data access body. Within two months of receipt of the assessment, the health data access body shall issue a decision on the health data access application or health data request. The health data access body shall not be bound by the proposal submitted by the trusted health data holder.

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

Sitering: 32025R0327 art. 72, Simplified procedure for access to electronic health data from a trusted health data holder. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-72 (hämtad 2026-08-31, bevis sha256:241d4547dacde785, bygge legal-2026-08-25).