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 48. Interoperability of wellness applications with EHR systems
- 1.Manufacturers of wellness applications may claim interoperability with an EHR system, provided that the relevant common specifications and essential requirements referred to in Article 36 and Annex II, respectively, are met. In the event of such claim, those manufacturers shall duly inform users of the interoperability of such wellness applications and the effects of such interoperability.
- 2.The interoperability of wellness applications with EHR systems shall not entail the automatic sharing of all or part of the health data from the wellness application with, or automatic transmission of all or part of such data to, the EHR system. The sharing or transmission of such data shall only be possible if it is in accordance with Article 5 and after consent is given by the natural person concerned and interoperability shall be limited exclusively to those purposes. The manufacturers of wellness applications claiming interoperability with an EHR system shall ensure that the natural person concerned is able to choose which categories of health data from the wellness application are to be inserted in the EHR system and the circumstances for the sharing or transmission of those categories of data.
Relevant Recitals for this Article
Users of wellness applications, including applications for mobile devices, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions in cases where data produced by wellness applications are useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should also be informed about the compliance of such wellness applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A mandatory labelling scheme for wellness applications for which interoperability with EHR systems is claimed should therefore be established as an appropriate mechanism for providing transparency for the users of wellness applications regarding compliance with requirements under this Regulation, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. The Commission should set out by means of implementing acts the details regarding the format and content of such label.
Member States should remain free to regulate other aspects of the use of wellness applications, provided that the corresponding rules are in compliance with Union law.