Agent · helsodata-2025-327-105

EHDS artikel 105: Entry into force and application

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

   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

   Paragraph 1

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

   Paragraph 2 applies

   This Regulation shall apply from 26 March 2027.

   Paragraph 2

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

   Paragraph 3 applies

   However, Articles 3 to 15, Article 23(2) to (6), Articles 25, 26, 27, 47, 48 and 49 shall apply as follows:

   Paragraph 3

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

   Paragraph 4 applies

   (a)

   Paragraph 4

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

   Paragraph 5 applies

   from 26 March 2029 to priority categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data;

   Paragraph 5

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

   Paragraph 6 applies

   (b)

   Paragraph 6

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

   Paragraph 7 applies

   from 26 March 2031 to priority categories of personal electronic health data referred to in Article 14(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;

   Paragraph 7

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

   Paragraph 8 applies

   (c)

   Paragraph 8

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

   Paragraph 9 applies

   from one year from the date established in a delegated act to be adopted pursuant to Article 14(2) for each amendment of the main characteristics of personal electronic health data set out in Annex I, provided that that date is subsequent to the date of application referred to in points (a) and (b) of this subparagraph for the categories of personal electronic health data concerned.

   Paragraph 9

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

    Paragraph 10 applies

    Chapter III shall apply to EHR systems put into service in the Union referred to in Article 26(2) from 26 March 2031.

    Paragraph 10

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

    Paragraph 11 applies

    Chapter IV shall apply from 26 March 2029. However, Article 55(6), Article 70, Article 73(5), Article 75(1) and (12), Article 77(4) and Article 78(6) shall apply from 26 March 2027; Article 51(1), points (b), (f), (g), (m) and (p), shall apply from 26 March 2031; and Article 75(5) shall apply from 26 March 2035.

    Paragraph 11

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

    Paragraph 12 applies

    The implementing acts referred to in Article 13(4), Article 15(1), Article 23(4) and Article 36(1) shall apply from the dates referred to in the third paragraph of this Article depending on the categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c), or Article 14(1), points (d), (e) and (f), respectively.

    Paragraph 12

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

    Paragraph 13 applies

    The implementing acts referred to in Article 70, Article 73(5), Article 75(12), Article 77(4) and Article 78(6) shall apply from 26 March 2029.

    Paragraph 13

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

    Paragraph 14 applies

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    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. 1This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. 2This Regulation shall apply from 26 March 2027.
3. 3However, Articles 3 to 15, Article 23(2) to (6), Articles 25, 26, 27, 47, 48 and 49 shall apply as follows:
4. 4(a)
5. 5from 26 March 2029 to priority categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data;
6. 6(b)
7. 7from 26 March 2031 to priority categories of personal electronic health data referred to in Article 14(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;
8. 8(c)
9. 9from one year from the date established in a delegated act to be adopted pursuant to Article 14(2) for each amendment of the main characteristics of personal electronic health data set out in Annex I, provided that that date is subsequent to the date of application referred to in points (a) and (b) of this subparagraph for the categories of personal electronic health data concerned.
10. 10Chapter III shall apply to EHR systems put into service in the Union referred to in Article 26(2) from 26 March 2031.
11. 11Chapter IV shall apply from 26 March 2029. However, Article 55(6), Article 70, Article 73(5), Article 75(1) and (12), Article 77(4) and Article 78(6) shall apply from 26 March 2027; Article 51(1), points (b), (f), (g), (m) and (p), shall apply from 26 March 2031; and Article 75(5) shall apply from 26 March 2035.
12. 12The implementing acts referred to in Article 13(4), Article 15(1), Article 23(4) and Article 36(1) shall apply from the dates referred to in the third paragraph of this Article depending on the categories of personal electronic health data referred to in Article 14(1), points (a), (b) and (c), or Article 14(1), points (d), (e) and (f), respectively.
13. 13The implementing acts referred to in Article 70, Article 73(5), Article 75(12), Article 77(4) and Article 78(6) shall apply from 26 March 2029.
14. 14This Regulation shall be binding in its entirety and directly applicable in all Member States.

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

Citation: 32025R0327 art. 105, Entry into force and application. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-105 (hämtad 2026-08-31, bevis sha256:c34224b21bb9d250, bygge legal-2026-08-25).