Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
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
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
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
ARTICLE 75
HealthData@EU
ARTICLE 76
Access to cross-border registries or databases of electronic health data 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
ARTICLE 81
Right to lodge a complaint with a health data access body