Agent · helsodata-2025-327-91

EHDS artikel 91: Health data access applications and health data requests from third countries

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Søkes også som: forordning (EU) 2025/327 artikkel 91

CELEX 32025R0327 · 2026-08-31 · Vekt 62 · minimal-risk

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EHDSOffisiell kilde

Inndata

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8)

Regeltre

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

   Paragraph 1 applies

   1. Without prejudice to Articles 67, 68 and 69, health data access applications and health data requests submitted by a health data applicant established in a third country shall be considered eligible by health data access bodies and the Union health data access service if the third country concerned:

   Punkt 1

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

   Paragraph 2 applies

   (a)

   Punkt 2

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

   Paragraph 3 applies

   is an authorised participant on the basis of having a national contact point for secondary use covered by an implementing act referred to in Article 75(5); or

   Punkt 3

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

   Paragraph 4 applies

   (b)

   Punkt 4

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

   Paragraph 5 applies

   allows Union health data applicants access to electronic health data in that third country under conditions that are not more restrictive than those provided for in this Regulation, and therefore such access is covered by an implementing act referred to in paragraph 2 of this Article.

   Punkt 5

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

   Paragraph 6 applies

   2. By means of implementing acts, the Commission may determine that a third country meets the requirement set out in paragraph 1, point (b), of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.

   Punkt 6

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

   Paragraph 7 addressed to the Commission, no direct obligation for businesses

   3. The Commission shall monitor developments in third countries and international organisations that could affect the application of the implementing acts adopted pursuant to paragraph 2, and shall provide for a periodic review of the application of this Article.

   Punkt 7

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

   Paragraph 8 applies

   Where the Commission considers that a third country no longer meets the requirement laid down in paragraph 1, point (b), of this Article, it shall adopt an implementing act repealing the implementing act referred to in paragraph 2 of this Article relating to that third country that benefits from access. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).

   Punkt 8

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. Without prejudice to Articles 67, 68 and 69, health data access applications and health data requests submitted by a health data applicant established in a third country shall be considered eligible by health data access bodies and the Union health data access service if the third country concerned:
2. 2(a)
3. 3is an authorised participant on the basis of having a national contact point for secondary use covered by an implementing act referred to in Article 75(5); or
4. 4(b)
5. 5allows Union health data applicants access to electronic health data in that third country under conditions that are not more restrictive than those provided for in this Regulation, and therefore such access is covered by an implementing act referred to in paragraph 2 of this Article.
6. 62. By means of implementing acts, the Commission may determine that a third country meets the requirement set out in paragraph 1, point (b), of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.
7. 73. The Commission shall monitor developments in third countries and international organisations that could affect the application of the implementing acts adopted pursuant to paragraph 2, and shall provide for a periodic review of the application of this Article.
8. 8Where the Commission considers that a third country no longer meets the requirement laid down in paragraph 1, point (b), of this Article, it shall adopt an implementing act repealing the implementing act referred to in paragraph 2 of this Article relating to that third country that benefits from access. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).

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Sitering: 32025R0327 art. 91, Health data access applications and health data requests from third countries. NovaCopilot, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-91 (hämtad 2026-08-31, bevis sha256:63216df7a29c2cfb, bygge legal-2026-11-02).