EHDS Regulation

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docs/ehds-article-numbering.md on GitHub

EHDS article numbering: proposal vs adopted

Most EHDS article references in this repository are the numbers from the 2022 proposal, COM(2022) 197 final. The Regulation was renumbered before adoption, and the adopted numbers in Regulation (EU) 2025/327 are different, in places by more than twenty.

This matters in one specific room. A regulator who knows the Regulation reads "secure processing environment, Art. 50" and sees Art. 50 of the adopted text, which is Applicability to health data holders. The claim looks wrong even though the substance is right.

New material uses the adopted numbers. Existing material has not been rewritten: roughly 48 files carry proposal numbers, and a mass renumber before a demo is the kind of change that quietly breaks something. Use this table when reading them, and correct a file whenever you are editing it anyway.

1. Chapter IV, secondary use

Proposal Title in the proposal Adopted Title as adopted
33 Minimum categories of electronic data 51 Minimum categories of electronic health data
34 Purposes for secondary use 53 Purposes for which data can be processed
35 Prohibited secondary use 54 Prohibited secondary use
36 Health data access bodies 55 Health data access bodies
37 Tasks of health data access bodies 57 Tasks of health data access bodies
38 Obligations towards natural persons 58 Obligations towards natural persons
39 Reporting by health data access bodies 59 Reporting by health data access bodies
41 Duties of data holders 60 Duties of health data holders
42 Fees 62 Fees
43 Penalties by health data access bodies 63 Enforcement by health data access bodies
44 Data minimisation and purpose limitation 66 Data minimisation and purpose limitation
45 Data access applications 67 Health data access applications
46 Data permit 68 Data permit
47 Data request 69 Health data request
49 Access from a single data holder 72 Simplified procedure, trusted health data holder
50 Secure processing environment 73 Secure processing environment
51 Joint controllers 74 Controllership
52 Cross-border infrastructure (HealthData@EU) 75 HealthData@EU
53 Access to cross-border sources 76 Access to cross-border registries or databases
55 Dataset description 77 Dataset description and dataset catalogue
56 Data quality and utility label 78 Data quality and utility label
57 EU Datasets Catalogue 79 EU dataset catalogue
58 Minimum dataset specifications 80 Minimum specifications for datasets of high impact

No successor: proposal Art. 40 (data altruism in health) and Art. 54 (mutual recognition) were absorbed elsewhere. New in the adopted text with no proposal counterpart: Art. 56 (Union health data access service), Art. 61 (duties of health data users), Art. 70 (templates), Art. 71 (opt-out from secondary use), Art. 81 (right to complain).

2. Elsewhere

Proposal Subject Adopted
3 Rights of natural persons, primary use 3 to 10 (split into seven articles)
5 Priority categories, primary use 14
6 European EHR exchange format 15
9 Identification management 16
10 Digital health authority 19
12 MyHealth@EU 23
29 Risks and serious incidents 44
59 Capacity building 82
64 EHDS Board 92
65 Tasks of the EHDS Board 94
66 Joint controllership groups 95 (now steering groups)
72 Entry into force and application 105

There is no constant offset. Art. 36 shifts by 19, Art. 37 by 20, Art. 46 by 22, Art. 50 by 23. Look it up rather than adding a number.

3. Dates, from Art. 105

Date What applies
26 March 2027 The Regulation generally. Access bodies and national contact points designated and notified (Art. 55(6), 75(1)).
26 March 2029 Chapter IV in full. Chapter II for the first priority categories of data.
26 March 2031 The further data categories in Art. 51(1)(b), (f), (g), (m), (p), and Chapter III for EHR systems already in service.
26 March 2035 Third-country participation in HealthData@EU, Art. 75(5).

4. The retention claim, resolved

docs/audit-retention-policy.md used to cite "EHDS Art. 50(3)" for a ten-year retention duty on access events. Nothing sourced the ten years. The adopted Art. 73(1)(e) requires access logs for at least one year, and the policy now keeps twelve months as that floor (#694).