Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 Febr... (32025R0327)
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)
- 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)
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- CHAPTER II
- PRIMARY USE
- SECTION 1
- Rights of natural persons in relation to the primary use of their personal electronic health data, and related provisions
- Article 3
- Right of natural persons to access their personal electronic health data
- 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
- Article 6
- Right of natural persons to rectification
- Article 7
- Right to data portability for natural persons
- Article 8
- Right to restrict access
- Article 9
- Right to obtain information on accessing data
- Article 10
- Right of natural persons to opt out in primary use
- Article 11
- Access by health professionals to personal electronic health data
- Article 12
- Health professional access services
- Article 13
- Registration of personal electronic health data
- Article 14
- Priority categories of personal electronic health data for primary use
- Article 15
- European electronic health record exchange format
- Article 16
- Identification management
- Article 17
- Requirements for technical implementation
- Article 18
- Compensation for making personal electronic health data available
- SECTION 2
- Governance for primary use
- Article 19
- Digital health authorities
- Article 20
- Reporting by digital health authorities
- Article 21
- Right to lodge a complaint with a digital health authority
- Article 22
- Relationship with supervisory authorities under Regulation (EU) 2016/679
- SECTION 3
- Cross-border infrastructure for primary use of personal electronic health data
- Article 23
- MyHealth@EU
- Article 24
- Supplementary cross-border digital health services and infrastructures
- CHAPTER III
- EHR SYSTEMS AND WELLNESS APPLICATIONS
- SECTION 1
- Scope and general provisions for EHR systems
- Article 25
- Harmonised software components of EHR systems
- Article 26
- Placing on the market and putting into service
- Article 27
- Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
- Article 28
- Claims
- Article 29
- Procurement, reimbursement and financing
- SECTION 2
- Obligations of economic operators with regard to EHR systems
- 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
- SECTION 3
- Conformity of the harmonised software components of EHR systems
- Article 36
- Common specifications
- Article 37
- Technical documentation
- Article 38
- Information sheet accompanying the EHR system
- Article 39
- EU declaration of conformity
- Article 40
- European digital testing environment
- Article 41
- CE marking of conformity
- Article 42
- National requirements and reporting to the Commission
- SECTION 4
- Market surveillance of EHR systems
- Article 43
- Market surveillance authorities
- Article 44
- Handling of risks posed by EHR systems and of serious incidents
- Article 45
- Handling of non-compliance
- Article 46
- Union safeguard procedure
- SECTION 5
- Other provisions on interoperability
- Article 47
- Labelling of wellness applications
- Article 48
- Interoperability of wellness applications with EHR systems
- SECTION 6
- Registration of EHR systems and wellness applications
- Article 49
- EU database for registration of EHR systems and wellness applications
- CHAPTER IV
- SECONDARY USE
- SECTION 1
- General conditions with regard to secondary use
- 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
- Article 53
- Purposes for which electronic health data can be processed for secondary use
- Article 54
- Prohibited secondary use
- SECTION 2
- Governance and mechanisms for secondary use
- Article 55
- Health data access bodies
- Article 56
- Union health data access service
- 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
- Article 61
- Duties of health data users
- Article 62
- Fees
- Article 63
- Enforcement by health data access bodies
- 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
- SECTION 3
- Access to electronic health data for secondary use
- Article 66
- Data minimisation and purpose limitation
- 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
- 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
- SECTION 4
- Cross-border infrastructure for secondary use
- Article 75
- HealthData@EU
- Article 76
- Access to cross-border registries or databases of electronic health data for secondary use
- SECTION 5
- Health data quality and utility for secondary use
- Article 77
- Dataset description and dataset catalogue
- Article 78
- Data quality and utility label
- Article 79
- EU dataset catalogue
- Article 80
- Minimum specifications for datasets of high impact
- SECTION 6
- Complaints
- Article 81
- Right to lodge a complaint with a health data access body
- CHAPTER V
- ADDITIONAL ACTIONS
- Article 82
- Capacity building
- Article 83
- Training programmes and information for health professionals
- Article 84
- Digital health literacy and digital health access
- Article 85
- Additional requirements for public procurement and Union funding
- Article 86
- Storage of personal electronic health data for primary use
- Article 87
- Storage of personal electronic health data by health data access bodies and secure processing environments
- Article 88
- Third-country transfer of non-personal electronic data
- 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
- Article 91
- Health data access applications and health data requests from third countries
- CHAPTER VI
- EUROPEAN GOVERNANCE AND COORDINATION
- Article 92
- European Health Data Space Board
- Article 93
- Stakeholder forum
- Article 94
- Tasks of the EHDS Board
- Article 95
- Steering groups for MyHealth@EU and HealthData@EU
- Article 96
- Roles and responsibilities of the Commission regarding the functioning of the EHDS
- CHAPTER VII
- DELEGATION OF POWERS AND COMMITTEE PROCEDURE
- Article 97
- Exercise of the delegation
- Article 98
- Committee procedure
- CHAPTER VIII
- MISCELLANEOUS
- Article 99
- Penalties
- Article 100
- Right to receive compensation
- Article 101
- Representation of a natural person
- Article 102
- Evaluation, review and progress report
- Article 103
- Amendment to Directive 2011/24/EU
- Article 104
- Amendment to Regulation (EU) 2024/2847
- CHAPTER IX
- DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONS
- Article 105
- Entry into force and application
- ANNEX I
- Main characteristics of priority categories of personal electronic health data for primary use
- ANNEX II
- Essential requirements for the harmonised software components of EHR systems and for products for which interoperability with EHR systems has been claimed
- 1. General requirements
- 2. Requirements for interoperability
- 3. Requirements for security and logging.
- ANNEX III
- Technical documentation
- ANNEX IV
- EU declaration of conformity
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