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 38. Information sheet accompanying the EHR system
- 1.EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users.
- 2.The information sheet referred to in paragraph 1 shall specify:
- (a)the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;
- (b)the name and version of the EHR system and date of its release;
- (c)the intended purpose of the EHR system;
- (d)the categories of electronic health data that the EHR system has been designed to process;
- (e)the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
- 3.As an alternative to supplying the information sheet referred to in paragraph 1 of this Article with the EHR system, manufacturers may enter the information referred to in paragraph 2 of this Article into the EU database for registration of EHR systems and wellness applications referred to in Article 49.
Relevant Recitals for this Article
EHR systems should be accompanied by an information sheet that includes information for its professional users and by clear and complete instructions for use, including in accessible formats for persons with disabilities. If an EHR system is not accompanied by such information, the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators should be required to add to the EHR system that information sheet and those instructions for use.