Article 31, Voluntary labelling of wellness applications, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. Where a manufacturer of a wellness application claims interoperability with an EHR system and therefore compliance with the essential requirements laid down in Annex II and common specifications in Article 23, such wellness application may be accompanied by a label, clearly indicating its compliance with those requirements. The label shall be issued by the manufacturer of the wellness application.
2. The label shall indicate the following information:
(a) categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;
(b) reference to common specifications to demonstrate compliance;
(c) validity period of the label.
3. The Commission may, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.
5. The validity of the label shall not exceed 5 years.
6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device. 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 with 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 or, upon request, in physical form.
10.The requirements of this Article shall not apply to wellness applications which are high-risk AI systems as defined under Regulation […] [AI Act COM/2021/206 final].