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 26. Placing on the market and putting into service
- 1.EHR systems shall be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.
- 2.EHR systems that are manufactured and used within health institutions established in the Union, as well as EHR systems offered as a service as defined in Article 1(1), point (b), of Directive (EU) 2015/1535 of the European Parliament and of the Council to a natural or legal person established in the Union, shall be considered as having been put into service.
- 3.Member States shall not prohibit or restrict the placing on the market of EHR systems which comply with this Regulation, on account of considerations relating to aspects concerning the harmonised software components of EHR systems regulated by this Regulation.
Relevant Recitals for this Article
This Regulation imposes a mandatory conformity self-assessment scheme for the harmonised software components of EHR systems to ensure that EHR systems placed on the Union market are able to exchange data in the European electronic health record exchange format and that they have the required logging capabilities. That mandatory conformity self-assessment, which would be in the form of an EU declaration of conformity by the manufacturer, should ensure that those requirements are fulfilled in a proportionate way, while avoiding an undue burden on Member States and manufacturers.
In order to guarantee the effective exercise by patients of their rights under this Regulation, healthcare providers developing and using an EHR system ‘in-house’ to carry out internal activities without placing it on the market in return for payment or remuneration should also comply with this Regulation. In that context, such healthcare providers should comply with all requirements applicable to manufacturers as regards such EHR systems that are developed ‘in-house’ and that such healthcare providers put into service. However, given that the healthcare providers may need additional time to prepare for compliance with this Regulation, those requirements should only apply to such systems after an extended transitional period.