Regulation on the European Health Data Space (EHDS)
Wellness applications and registration – Regulation on the European Health Data Space (EHDS)

Regulation on the European Health Data Space (EHDS) 47: Label wellness apps that claim EHR interoperability and never share data automatically

Articles 47 and 48: a wellness application claiming interoperability with EHR harmonised components carries a manufacturer-issued label (data categories confirmed, common specifications referenced, validity of at most three years) in the application or on the device, supplied free with each unit and made available by distributors at the point of sale; manufacturers inform users of the interoperability and its effects; interoperability never means automatic sharing: data flows to the EHR only under Article 5 and with the person's consent, who chooses the categories and circumstances. Market surveillance authorities check compliance.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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