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 Article 42. National requirements and reporting to the Commission
- 1.Member States may adopt national requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems.
- 2.The national requirements or provisions referred to in paragraph 1 shall not adversely affect the harmonised software components of EHR systems.
- 3.When Member States adopt requirements or provisions in accordance with paragraph 1, they shall inform the Commission thereof.
Relevant Recitals for this Article
Member States should remain competent to define requirements relating to any other software components of EHR systems and the terms and conditions for connection of healthcare providers to their respective national infrastructures, which could be subject to third-party assessment at national level. In order to facilitate the smooth functioning of the internal market for EHR systems, digital health products and associated services, it is necessary to ensure as much as possible transparency as regards national law establishing requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems. Therefore, Member States should inform the Commission of those national requirements so it has the necessary information to ensure that they do not adversely affect the harmonised software components of EHR systems.