Agent layer

EHDS

One agent per article. An operative tree is written by hand from the article's conditions. A structural tree follows the article's paragraphs verbatim.

CELEX 32025R0327 · Read 2026-08-31 · The act

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EHDS carries 105 article agents, 0 of them with a hand written operative tree. Every agent has its own address, source line and hash.

Checked against the publisher · 2026-08-31

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Showing 105 of 105 agents · Last read against source: 2026-08-31

Article	Heading	Tree	Weight
10	Right of natural persons to opt out in primary use	structuralOpen	70
11	Access by health professionals to personal electronic health data	structuralOpen	70
12	Health professional access services	structuralOpen	70
13	Registration of personal electronic health data	structuralOpen	70
14	Priority categories of personal electronic health data for primary use	structuralOpen	70
15	European electronic health record exchange format	structuralOpen	70
16	Identification management	structuralOpen	70
17	Requirements for technical implementation	structuralOpen	70
18	Compensation for making personal electronic health data available	structuralOpen	70
19	Digital health authorities	structuralOpen	70
20	Reporting by digital health authorities	structuralOpen	70
21	Right to lodge a complaint with a digital health authority	structuralOpen	70
22	Relationship with supervisory authorities under Regulation (EU) 2016/679	structuralOpen	70
23	MyHealth@EU	structuralOpen	70
24	Supplementary cross-border digital health services and infrastructures	structuralOpen	70
25	Harmonised software components of EHR systems	structuralOpen	70
26	Placing on the market and putting into service	structuralOpen	70
27	Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems	structuralOpen	70
28	Claims	structuralOpen	70
29	Procurement, reimbursement and financing	structuralOpen	70
30	Obligations of manufacturers of EHR systems	structuralOpen	70
31	Authorised representatives	structuralOpen	70
32	Obligations of importers	structuralOpen	70
33	Obligations of distributors	structuralOpen	70
34	Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals	structuralOpen	70
35	Identification of economic operators	structuralOpen	70
36	Common specifications	structuralOpen	70
37	Technical documentation	structuralOpen	70
38	Information sheet accompanying the EHR system	structuralOpen	70
39	EU declaration of conformity	structuralOpen	70
40	European digital testing environment	structuralOpen	70
41	CE marking of conformity	structuralOpen	70
42	National requirements and reporting to the Commission	structuralOpen	70
43	Market surveillance authorities	structuralOpen	70
44	Handling of risks posed by EHR systems and of serious incidents	structuralOpen	70
45	Handling of non-compliance	structuralOpen	70
46	Union safeguard procedure	structuralOpen	70
47	Labelling of wellness applications	structuralOpen	70
48	Interoperability of wellness applications with EHR systems	structuralOpen	70
49	EU database for registration of EHR systems and wellness applications	structuralOpen	70
5	Right of natural persons to insert information in their own EHR	structuralOpen	70
50	Applicability to health data holders	structuralOpen	70
51	Minimum categories of electronic health data for secondary use	structuralOpen	70
52	Intellectual property rights and trade secrets	structuralOpen	70
53	Purposes for which electronic health data can be processed for secondary use	structuralOpen	70
54	Prohibited secondary use	structuralOpen	70
55	Health data access bodies	structuralOpen	70
56	Union health data access service	structuralOpen	70
57	Tasks of health data access bodies	structuralOpen	70
58	Obligations of health data access bodies towards natural persons	structuralOpen	70
59	Reporting by health data access bodies	structuralOpen	70
6	Right of natural persons to rectification	structuralOpen	70
60	Duties of health data holders	structuralOpen	70
7	Right to data portability for natural persons	structuralOpen	70
8	Right to restrict access	structuralOpen	70
9	Right to obtain information on accessing data	structuralOpen	70
1	Subject matter and scope	structuralOpen	66
2	Definitions	structuralOpen	66
3	Right of natural persons to access their personal electronic health data	structuralOpen	66
4	Electronic health data access services for natural persons and their representatives	structuralOpen	66
100	Right to receive compensation	structuralOpen	62
101	Representation of a natural person	structuralOpen	62
102	Evaluation, review and progress report	structuralOpen	62
103	Amendment to Directive 2011/24/EU	structuralOpen	62
104	Amendment to Regulation (EU) 2024/2847	structuralOpen	62
105	Entry into force and application	structuralOpen	62
61	Duties of health data users	structuralOpen	62
62	Fees	structuralOpen	62
63	Enforcement by health data access bodies	structuralOpen	62
64	General conditions for the imposition of administrative fines by health data access bodies	structuralOpen	62
65	Relationship with supervisory authorities under Regulation (EU) 2016/679	structuralOpen	62
66	Data minimisation and purpose limitation	structuralOpen	62
67	Health data access applications	structuralOpen	62
68	Data permit	structuralOpen	62
69	Health data request	structuralOpen	62
70	Templates to support access to electronic health data for secondary use	structuralOpen	62
71	Right to opt out from the processing of personal electronic health data for secondary use	structuralOpen	62
72	Simplified procedure for access to electronic health data from a trusted health data holder	structuralOpen	62
73	Secure processing environment	structuralOpen	62
74	Controllership	structuralOpen	62
75	HealthData@EU	structuralOpen	62
76	Access to cross-border registries or databases of electronic health data for secondary use	structuralOpen	62
77	Dataset description and dataset catalogue	structuralOpen	62
78	Data quality and utility label	structuralOpen	62
79	EU dataset catalogue	structuralOpen	62
80	Minimum specifications for datasets of high impact	structuralOpen	62
81	Right to lodge a complaint with a health data access body	structuralOpen	62
82	Capacity building	structuralOpen	62
83	Training programmes and information for health professionals	structuralOpen	62
84	Digital health literacy and digital health access	structuralOpen	62
85	Additional requirements for public procurement and Union funding	structuralOpen	62
86	Storage of personal electronic health data for primary use	structuralOpen	62
87	Storage of personal electronic health data by health data access bodies and secure processing environments	structuralOpen	62
88	Third-country transfer of non-personal electronic data	structuralOpen	62
89	International governmental access to non-personal electronic health data	structuralOpen	62
90	Additional conditions for transfer of personal electronic health data to a third country or an international organisation	structuralOpen	62
91	Health data access applications and health data requests from third countries	structuralOpen	62
92	European Health Data Space Board	structuralOpen	62
93	Stakeholder forum	structuralOpen	62
94	Tasks of the EHDS Board	structuralOpen	62
95	Steering groups for MyHealth@EU and HealthData@EU	structuralOpen	62
96	Roles and responsibilities of the Commission regarding the functioning of the EHDS	structuralOpen	62
97	Exercise of the delegation	structuralOpen	62
98	Committee procedure	structuralOpen	62
99	Penalties	structuralOpen	62