Agent · helsodata-2025-327-68

EHDS artikel 68: Data permit

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. For the purposes of granting access to electronic health data, the health data access bodies shall assess whether all the following criteria are fulfilled:

   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

   the purposes described in the health data access application correspond to one or more of the purposes listed in Article 53(1);

   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

   the requested data are necessary, adequate and proportionate for the purposes described in the health data access application, taking into account data minimisation and purpose limitation requirements provided for in Article 66;

   Punkt 5

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

   Paragraph 6 applies

   (c)

   Punkt 6

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

   Paragraph 7 applies

   the processing complies with Article 6(1) of Regulation (EU) 2016/679 and, in the case of pseudonymised data, there is sufficient justification that the purpose cannot be achieved with anonymised data;

   Punkt 7

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

   Paragraph 8 applies

   (d)

   Punkt 8

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

   Paragraph 9 applies

   the health data applicant is qualified in relation to the intended purposes of data use and has appropriate expertise, including professional qualifications in the areas of healthcare, care, public health or research, consistent with ethical practice and applicable laws and regulations;

   Punkt 9

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

    Paragraph 10 applies

    (e)

    Punkt 10

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

    Paragraph 11 applies

    the health data applicant demonstrates sufficient technical and organisational measures to prevent the misuse of the electronic health data and to protect the rights and interests of the health data holder and of the natural persons concerned;

    Punkt 11

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

    Paragraph 12 applies

    (f)

    Punkt 12

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

    Paragraph 13 applies

    the information on the assessment of ethical aspects of the processing, referred to in Article 67(2), point (j), where applicable, complies with national law;

    Punkt 13

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

    Paragraph 14 applies

    (g)

    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. For the purposes of granting access to electronic health data, the health data access bodies shall assess whether all the following criteria are fulfilled:
2. 2(a)
3. 3the purposes described in the health data access application correspond to one or more of the purposes listed in Article 53(1);
4. 4(b)
5. 5the requested data are necessary, adequate and proportionate for the purposes described in the health data access application, taking into account data minimisation and purpose limitation requirements provided for in Article 66;
6. 6(c)
7. 7the processing complies with Article 6(1) of Regulation (EU) 2016/679 and, in the case of pseudonymised data, there is sufficient justification that the purpose cannot be achieved with anonymised data;
8. 8(d)
9. 9the health data applicant is qualified in relation to the intended purposes of data use and has appropriate expertise, including professional qualifications in the areas of healthcare, care, public health or research, consistent with ethical practice and applicable laws and regulations;
10. 10(e)
11. 11the health data applicant demonstrates sufficient technical and organisational measures to prevent the misuse of the electronic health data and to protect the rights and interests of the health data holder and of the natural persons concerned;
12. 12(f)
13. 13the information on the assessment of ethical aspects of the processing, referred to in Article 67(2), point (j), where applicable, complies with national law;
14. 14(g)

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

Sitering: 32025R0327 art. 68, Data permit. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-68 (hämtad 2026-08-31, bevis sha256:172d61695c965c2f, bygge legal-2026-08-25).