Legal text
Regulation (EU) 2025/327 on the European Health Data Space
The full final text of the EHDS Regulation. Each article links to its recitals, its earlier draft versions and the Dutch translation.
Every statutory definition explained: the glossary→Which obligation applies when? The timeline 2025–2035→
Chapter I
GENERAL PROVISIONS
Chapter II
PRIMARY USE
- Art. 3Right of natural persons to access their personal electronic health data
- Art. 4Electronic health data access services for natural persons and their representatives
- Art. 5Right of natural persons to insert information in their own EHR
- Art. 6Right of natural persons to rectification
- Art. 7Right to data portability for natural persons
- Art. 8Right to restrict access
- Art. 9Right to obtain information on accessing data
- Art. 10Right of natural persons to opt out in primary use
- Art. 11Access by health professionals to personal electronic health data
- Art. 12Health professional access services
- Art. 13Registration of personal electronic health data
- Art. 14Priority categories of personal electronic health data for primary use
- Art. 15European electronic health record exchange format
- Art. 16Identification management
- Art. 17Requirements for technical implementation
- Art. 18Compensation for making personal electronic health data available
- Art. 19Digital health authorities
- Art. 20Reporting by digital health authorities
- Art. 21Right to lodge a complaint with a digital health authority
- Art. 22Relationship with supervisory authorities under Regulation (EU) 2016/679
- Art. 23MyHealth@EU
- Art. 24Supplementary cross-border digital health services and infrastructures
Chapter III
EHR SYSTEMS AND WELLNESS APPLICATIONS
- Art. 25Harmonised software components of EHR systems
- Art. 26Placing on the market and putting into service
- Art. 27Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
- Art. 28Claims
- Art. 29Procurement, reimbursement and financing
- Art. 30Obligations of manufacturers of EHR systems
- Art. 31Authorised representatives
- Art. 32Obligations of importers
- Art. 33Obligations of distributors
- Art. 34Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
- Art. 35Identification of economic operators
- Art. 36Common specifications
- Art. 37Technical documentation
- Art. 38Information sheet accompanying the EHR system
- Art. 39EU declaration of conformity
- Art. 40European digital testing environment
- Art. 41CE marking of conformity
- Art. 42National requirements and reporting to the Commission
- Art. 43Market surveillance authorities
- Art. 44Handling of risks posed by EHR systems and of serious incidents
- Art. 45Handling of non-compliance
- Art. 46Union safeguard procedure
- Art. 47Labelling of wellness applications
- Art. 48Interoperability of wellness applications with EHR systems
- Art. 49EU database for registration of EHR systems and wellness applications
Chapter IV
SECONDARY USE
- Art. 50Applicability to health data holders
- Art. 51Minimum categories of electronic health data for secondary use
- Art. 52Intellectual property rights and trade secrets
- Art. 53Purposes for which electronic health data can be processed for secondary use
- Art. 54Prohibited secondary use
- Art. 55Health data access bodies
- Art. 56Union health data access service
- Art. 57Tasks of health data access bodies
- Art. 58Obligations of health data access bodies towards natural persons
- Art. 59Reporting by health data access bodies
- Art. 60Duties of health data holders
- Art. 61Duties of health data users
- Art. 62Fees
- Art. 63Enforcement by health data access bodies
- Art. 64General conditions for the imposition of administrative fines by health data access bodies
- Art. 65Relationship with supervisory authorities under Regulation (EU) 2016/679
- Art. 66Data minimisation and purpose limitation
- Art. 67Health data access applications
- Art. 68Data permit
- Art. 69Health data request
- Art. 70Templates to support access to electronic health data for secondary use
- Art. 71Right to opt out from the processing of personal electronic health data for secondary use
- Art. 72Simplified procedure for access to electronic health data from a trusted health data holder
- Art. 73Secure processing environment
- Art. 74Controllership
- Art. 75HealthData@EU
- Art. 76Access to cross-border registries or databases of electronic health data for secondary use
- Art. 77Dataset description and dataset catalogue
- Art. 78Data quality and utility label
- Art. 79EU dataset catalogue
- Art. 80Minimum specifications for datasets of high impact
- Art. 81Right to lodge a complaint with a health data access body
Chapter V
ADDITIONAL ACTIONS
- Art. 82Capacity building
- Art. 83Training programmes and information for health professionals
- Art. 84Digital health literacy and digital health access
- Art. 85Additional requirements for public procurement and Union funding
- Art. 86Storage of personal electronic health data for primary use
- Art. 87Storage of personal electronic health data by health data access bodies and secure processing environments
- Art. 88Third-country transfer of non-personal electronic data
- Art. 89International governmental access to non-personal electronic health data
- Art. 90Additional conditions for transfer of personal electronic health data to a third country or an international organisation
- Art. 91Health data access applications and health data requests from third countries
Chapter VI
EUROPEAN GOVERNANCE AND COORDINATION
Chapter VII
DELEGATION OF POWERS AND COMMITTEE PROCEDURE
Chapter VIII
MISCELLANEOUS
Chapter IX