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European Health Data Space Regulation

Table of Contents

Chapter I — General provisions

Art. 1 — Subject matter and scope Art. 2 — Definitions

Chapter II — Primary use

Art. 3 — Right of natural persons to access their personal electronic health data Art. 4 — Electronic health data access services for natural persons and their representatives Art. 5 — Right of natural persons to insert information in their own EHR Art. 6 — Right of natural persons to rectification Art. 7 — Right to data portability for natural persons Art. 8 — Right to restrict access Art. 9 — Right to obtain information on accessing data Art. 10 — Right of natural persons to opt out in primary use Art. 11 — Access by health professionals to personal electronic health data Art. 12 — Health professional access services Art. 13 — Registration of personal electronic health data Art. 14 — Priority categories of personal electronic health data for primary use Art. 15 — European electronic health record exchange format Art. 16 — Identification management Art. 17 — Requirements for technical implementation Art. 18 — Compensation for making personal electronic health data available Art. 19 — Digital health authorities Art. 20 — Reporting by digital health authorities Art. 21 — Right to lodge a complaint with a digital health authority Art. 22 — Relationship with supervisory authorities under Regulation (EU) 2016/679 Art. 23 — MyHealth@EU Art. 24 — Supplementary cross-border digital health services and infrastructures

Chapter III — Ehr systems and wellness applications

Art. 25 — Harmonised software components of EHR systems Art. 26 — Placing on the market and putting into service Art. 27 — Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems Art. 28 — Claims Art. 29 — Procurement, reimbursement and financing Art. 30 — Obligations of manufacturers of EHR systems Art. 31 — Authorised representatives Art. 32 — Obligations of importers Art. 33 — Obligations of distributors Art. 34 — Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals Art. 35 — Identification of economic operators Art. 36 — Common specifications Art. 37 — Technical documentation Art. 38 — Information sheet accompanying the EHR system Art. 39 — EU declaration of conformity Art. 40 — European digital testing environment Art. 41 — CE marking of conformity Art. 42 — National requirements and reporting to the Commission Art. 43 — Market surveillance authorities Art. 44 — Handling of risks posed by EHR systems and of serious incidents Art. 45 — Handling of non-compliance Art. 46 — Union safeguard procedure Art. 47 — Labelling of wellness applications Art. 48 — Interoperability of wellness applications with EHR systems Art. 49 — EU database for registration of EHR systems and wellness applications

Chapter IV — Secondary use

Art. 50 — Applicability to health data holders Art. 51 — Minimum categories of electronic health data for secondary use Art. 52 — Intellectual property rights and trade secrets Art. 53 — Purposes for which electronic health data can be processed for secondary use Art. 54 — Prohibited secondary use Art. 55 — Health data access bodies Art. 56 — Union health data access service Art. 57 — Tasks of health data access bodies Art. 58 — Obligations of health data access bodies towards natural persons Art. 59 — Reporting by health data access bodies Art. 60 — Duties of health data holders Art. 61 — Duties of health data users Art. 62 — Fees Art. 63 — Enforcement by health data access bodies Art. 64 — General conditions for the imposition of administrative fines by health data access bodies Art. 65 — Relationship with supervisory authorities under Regulation (EU) 2016/679 Art. 66 — Data minimisation and purpose limitation Art. 67 — Health data access applications Art. 68 — Data permit Art. 69 — Health data request Art. 70 — Templates to support access to electronic health data for secondary use Art. 71 — Right to opt out from the processing of personal electronic health data for secondary use Art. 72 — Simplified procedure for access to electronic health data from a trusted health data holder Art. 73 — Secure processing environment Art. 74 — Controllership Art. 75 — HealthData@EU Art. 76 — Access to cross-border registries or databases of electronic health data for secondary use Art. 77 — Dataset description and dataset catalogue Art. 78 — Data quality and utility label Art. 79 — EU dataset catalogue Art. 80 — Minimum specifications for datasets of high impact Art. 81 — Right to lodge a complaint with a health data access body

Chapter V — Additional actions

Art. 82 — Capacity building Art. 83 — Training programmes and information for health professionals Art. 84 — Digital health literacy and digital health access Art. 85 — Additional requirements for public procurement and Union funding Art. 86 — Storage of personal electronic health data for primary use Art. 87 — Storage of personal electronic health data by health data access bodies and secure processing environments Art. 88 — Third-country transfer of non-personal electronic data Art. 89 — International governmental access to non-personal electronic health data Art. 90 — Additional conditions for transfer of personal electronic health data to a third country or an international organisation Art. 91 — Health data access applications and health data requests from third countries

Chapter VI — European governance and coordination

Art. 92 — European Health Data Space Board Art. 93 — Stakeholder forum Art. 94 — Tasks of the EHDS Board Art. 95 — Steering groups for MyHealth@EU and HealthData@EU Art. 96 — Roles and responsibilities of the Commission regarding the functioning of the EHDS

Chapter VII — Delegation of powers and committee procedure

Art. 97 — Exercise of the delegation Art. 98 — Committee procedure

Chapter VIII — Miscellaneous

Art. 99 — Penalties Art. 100 — Right to receive compensation Art. 101 — Representation of a natural person Art. 102 — Evaluation, review and progress report Art. 103 — Amendment to Directive 2011/24/EU Art. 104 — Amendment to Regulation (EU) 2024/2847

Chapter IX — Deferred application, transitional and final provisions

Art. 105 — Entry into force and application

Recitals

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115

Annexes

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 Annex III — Technical documentation Annex IV — EU declaration of conformity

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