Regulation (EU) 2025/327 — European Health Data Space

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