Council of the European Union and European Parliament 11 February 2025, 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)

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European Union · · · Cited by 196 · 11-02-2025

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

Official Journal
of the European Union

L series

2025/327

5.3.2025

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to

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