Regulation (EU) 2025/327 of the European Parliament and of the Council of 11…

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance)

directive · European Union · 32025R0327

1029 provisions in 1216 nodes · 81 provisions hand work to national law

Defined terms · All instruments · European standard · Internet · access to information · activity report · advertising · artificial intelligence · branch · cartel

Table

REGULATION (EU) 2025/327 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 February 2025

on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847

(Text with EEA relevance)

Article 1 Subject matter and scope

Article 2 Definitions

Article 3 Right of natural persons to access their personal electronic health data

Subparagraph

Article 4 Electronic health data access services for natural persons and their representatives

Article 5 Right of natural persons to insert information in their own EHR

Subparagraph

Article 6 Right of natural persons to rectification

Subparagraph

Article 7 Right to data portability for natural persons

Subparagraph

Article 8 Right to restrict access

Subparagraph

Article 9 Right to obtain information on accessing data

Article 10 Right of natural persons to opt out in primary use

Subparagraph

Article 11 Access by health professionals to personal electronic health data

Subparagraph

Article 12 Health professional access services

Subparagraph

Article 13 Registration of personal electronic health data

Subparagraph

Article 14 Priority categories of personal electronic health data for primary use

Article 15 European electronic health record exchange format

Article 16 Identification management

Subparagraph

Article 17 Requirements for technical implementation

Subparagraph

Article 18 Compensation for making personal electronic health data available

Subparagraph

Article 19 Digital health authorities

Article 20 Reporting by digital health authorities

Article 21 Right to lodge a complaint with a digital health authority

Subparagraph

Article 22 Relationship with supervisory authorities under Regulation (EU) 2016/679

Subparagraph

Article 23 MyHealth@EU

Subparagraph

Article 24 Supplementary cross-border digital health services and infrastructures

Subparagraph

Article 25 Harmonised software components of EHR systems

Subparagraph

Article 26 Placing on the market and putting into service

Subparagraph

Article 27 Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems

Article 29 Procurement, reimbursement and financing

Subparagraph

Article 30 Obligations of manufacturers of EHR systems

Article 31 Authorised representatives

Article 32 Obligations of importers

Article 33 Obligations of distributors

Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals

Article 35 Identification of economic operators

Article 36 Common specifications

Article 37 Technical documentation

Subparagraph

Article 38 Information sheet accompanying the EHR system

Article 39 EU declaration of conformity

Subparagraph

Article 40 European digital testing environment

Subparagraph

Article 41 CE marking of conformity

Subparagraph

Article 42 National requirements and reporting to the Commission

Subparagraph

Article 43 Market surveillance authorities

Subparagraph

Article 44 Handling of risks posed by EHR systems and of serious incidents

Subparagraph

Article 45 Handling of non-compliance

Article 46 Union safeguard procedure

Subparagraph

Article 47 Labelling of wellness applications

Article 48 Interoperability of wellness applications with EHR systems

Subparagraph

Article 49 EU database for registration of EHR systems and wellness applications

Subparagraph

Article 50 Applicability to health data holders

Article 51 Minimum categories of electronic health data for secondary use

Article 52 Intellectual property rights and trade secrets

Subparagraph

Article 53 Purposes for which electronic health data can be processed for secondary use

Article 54 Prohibited secondary use

Article 55 Health data access bodies

Article 56 Union health data access service

Subparagraph

Article 57 Tasks of health data access bodies

Article 58 Obligations of health data access bodies towards natural persons

Article 59 Reporting by health data access bodies

Article 60 Duties of health data holders

Subparagraph

Article 61 Duties of health data users

Subparagraph

Article 62 Fees

Subparagraph

Article 63 Enforcement by health data access bodies

Subparagraph

Article 64 General conditions for the imposition of administrative fines by health data access bodies

Article 65 Relationship with supervisory authorities under Regulation (EU) 2016/679

Subparagraph

Article 66 Data minimisation and purpose limitation

Subparagraph

Article 67 Health data access applications

Article 68 Data permit

Article 69 Health data request

Article 70 Templates to support access to electronic health data for secondary use

Subparagraph

Article 71 Right to opt out from the processing of personal electronic health data for secondary use

Article 72 Simplified procedure for access to electronic health data from a trusted health data holder

Article 73 Secure processing environment

Article 74 Controllership

Subparagraph

Article 75 HealthData@EU

Article 76 Access to cross-border registries or databases of electronic health data for secondary use

Subparagraph

Article 77 Dataset description and dataset catalogue

Subparagraph

Article 78 Data quality and utility label

Article 79 EU dataset catalogue

Subparagraph

Article 80 Minimum specifications for datasets of high impact

Subparagraph

Article 81 Right to lodge a complaint with a health data access body

Subparagraph

Article 82 Capacity building

Subparagraph

Article 83 Training programmes and information for health professionals

Subparagraph

Article 84 Digital health literacy and digital health access

Subparagraph

Article 85 Additional requirements for public procurement and Union funding

Subparagraph

Article 86 Storage of personal electronic health data for primary use

Subparagraph

Article 87 Storage of personal electronic health data by health data access bodies and secure processing environments

Subparagraph

Article 88 Third-country transfer of non-personal electronic data

Subparagraph

Article 89 International governmental access to non-personal electronic health data

Article 90 Additional conditions for transfer of personal electronic health data to a third country or an international organisation

Subparagraph

Article 91 Health data access applications and health data requests from third countries

Article 92 European Health Data Space Board

Subparagraph

Article 93 Stakeholder forum

Subparagraph

Article 94 Tasks of the EHDS Board

Article 95 Steering groups for MyHealth@EU and HealthData@EU

Subparagraph

Article 96 Roles and responsibilities of the Commission regarding the functioning of the EHDS

Article 97 Exercise of the delegation

Subparagraph

Article 98 Committee procedure

Article 100 Right to receive compensation

Subparagraph

Article 101 Representation of a natural person

Subparagraph

Article 102 Evaluation, review and progress report

Article 103 Amendment to Directive 2011/24/EU

Subparagraph

Article 104 Amendment to Regulation (EU) 2024/2847

Article 105 Entry into force and application

Main characteristics of priority categories of personal electronic health data for primary use

Table

ANNEX II

Essential requirements for the harmonised software components of EHR systems and for products for which interoperability with EHR systems has been claimed

Subparagraph

1. General requirements

Table

2. Requirements for interoperability

Table

3. Requirements for security and logging.

Table

ANNEX III

Technical documentation

EU declaration of conformity

Subparagraph