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
EHR SYSTEMS AND WELLNESS APPLICATIONS
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
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
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
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
ARTICLE 47
Labelling of wellness applications
ARTICLE 48
Interoperability of wellness applications with EHR systems
ARTICLE 49
EU database for registration of EHR systems and wellness applications