Label2Enable provides feedback on the EHDS (European Health Data Space)

Label2Enable reflected specifically on the EHDS provisions concerning health and wellbeing apps. The inclusion of interoperability labelling of wellness apps in the EHDS proposal is welcomed and the Commission is urged to consider the role of the existing CEN-ISO 82304-2 label as the ideal starting point for this voluntary labelling.

EHDS Article 31(3) provides that the Commission may adopt implementing acts to determine the content and format of the voluntary label. Label2Enable will provide excellent materials for the development of such implementing legislation. These include:

1. A CEN-ISO 82304-2 certification scheme aligned with EU legislation such as MDR, GDPR and the AI Act, with which app assessment organisations can be accredited. The scheme will be tested with 24 health app manufacturers and 6 app assessment organizations including 2 notified bodies and maintained beyond the project to ensure that documentation is self-explanatory for all; assessment results allow for cross country recognition and that the process is efficient.

2. Experimental vignette studies to test which display of the label in app stores, app libraries and trusted sources promotes the intended behaviours.

3. Analysis of label legislations such as the EU Energy label Directive for relevance for the CEN-ISO 82304-2 label. And

4. Testing the label with people with limited health literacy in four corners of Europe to co-create communication to adequately introduce the label.

Read the full feedback provided by Label2Enable here: https://bit.ly/L2E_EHDS