Label2Enable provides feedback on the proposed EHDS regulation


January 11, 2023

Label2Enable provides in-depth feedback on the Proposal for a Regulation on the European Health Data Space.

Building on our response to the public consultation in July 2022, we suggest three key amendments to the regulation, recommending to:

1. Extend the definition of wellness apps to include all apps marketed as health and wellness apps.

2. Go beyond interoperability and label quality

3. Reference a suitable quality labelling scheme

We also explain more about quality labelling of apps other than Electronic Health Record interoperability.

Access the PDF document below to see our editorial changes to the regulation text and learn more about quality labelling for apps!

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