Agentlag

EHDS

Én agent per artikkel. Et operativt tre er skrevet for hånd ut fra artikkelens vilkår. Et strukturelt tre følger artikkelens punkter ordrett, på originalspråket.

CELEX 32025R0327 · Lest 2026-08-31 · Rettsakten

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EHDS har 105 artikkelagenter, hvorav 0 med håndskrevet operativt tre. Hver agent har egen adresse, egen kildelinje og egen hash.

Kontrollert mot utgiveren · 2026-08-31

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

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