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 47. Labelling of wellness applications
- 1.Where a manufacturer of a wellness application claims interoperability with an EHR system in relation to the harmonised software components of EHR systems and therefore compliance with the common specifications referred to in Article 36 and essential requirements laid down in Annex II, such wellness application shall be accompanied by a label, clearly indicating its compliance with those specifications and requirements. That label shall be issued by the manufacturer of the wellness application.
- 2.The label referred to in paragraph 1 shall indicate the following information:
- (a)the categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;
- (b)a reference to common specifications to demonstrate compliance;
- (c)the validity period of the label.
- 3.The Commission shall, by means of implementing acts, determine the format and content of the label referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 4.The label shall be drawn-up in one or more official languages of the Union or in an easily understandable language determined by the Member State in which the wellness application is placed on the market or put into service.
- 5.The validity of the label shall not exceed three years.
- 6.If the wellness application is an integral part of a device or is embedded in a device after it has been put into service, the accompanying label shall be shown in the application itself or placed on that device. Where the wellness application consists only of software, the label shall have a digital format and shall be shown in the application itself. Two-dimensional (2D) barcodes may also be used to display the label.
- 7.The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.
- 8.Each supplier of a wellness application for which a label has been issued shall ensure that the wellness application that is placed on the market or put into service is accompanied by the label for each individual unit, free of charge.
- 9.Each distributor of a wellness application for which a label has been issued shall make the label available to customers at the point of sale in electronic form.
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.