EHDS Series - 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices

EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices

Lexology April 24, 2024
Covington & Burling LLP

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.

1: Wellness Applications and Medical Devices in Relation to Electronic Health Records

a) Wellness applications

The EHDS contains specific provisions on “wellness applications” that claim...