EHDS
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
- Recitals
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
ANNEXES
EHDS
EHDS Article 35. Identification of economic operators
- Economic operators shall, on request, identify the following to the market surveillance authorities, for 10 years from the date when the last EHR system covered by the EU declaration of conformity has been placed on the market:
- (a)any economic operator that has supplied them with an EHR system; and
- (b)any economic operator to which they have supplied an EHR system.
Relevant Recitals for this Article
It is necessary to provide for a clear and proportionate distribution of obligations corresponding to the role of each economic operator in the supply and distribution process of EHR systems. Economic operators should be responsible for compliance in relation to their respective roles in such process and should ensure that they make available on the market only EHR systems which comply with relevant requirements.