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 27. Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
- 1.Manufacturers of medical devices or in vitro diagnostic medical devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745 and Article 2, point (2), of Regulation (EU) 2017/746, respectively, that claim interoperability of those medical devices or in vitro diagnostic medical devices with the harmonised software components of EHR systems shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those medical devices and in vitro diagnostic medical devices.
- 2.Providers of AI systems considered to be high-risk in accordance with Article 6 of Regulation (EU) 2024/1689 (the ‘high-risk AI system’) and which do not fall within the scope of Regulation (EU) 2017/745 or (EU) 2017/746, that claim interoperability of those high-risk AI systems with the harmonised software components of EHR systems, shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, as laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those high-risk AI systems.
Relevant Recitals for this Article
Certain software components of EHR systems could be considered medical devices under Regulation (EU) 2017/745 or diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council . Software or modules of software which fall within the definition of a medical device, diagnostic medical devices or an artificial intelligence (AI) system considered to be high-risk (the ‘high-risk AI system’) should be certified in accordance with Regulations (EU) 2017/745, (EU) 2017/746 and (EU) 2024/1689, as applicable. While such products are required to fulfil the requirements under the respective Regulation governing those products, Member States should take appropriate measures to ensure that the respective conformity assessment is carried out as a joint or coordinated procedure in order to limit the administrative burden on manufacturers and other economic operators. The essential requirements on interoperability of this Regulation should only apply to the extent that the manufacturer of a medical device, an diagnostic medical device, or a high-risk AI system, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with such EHR system. In such case, the provisions on common specifications for EHR systems should be applicable to those medical devices, diagnostic medical devices and high-risk AI systems.