Juin 2024

European Health Data Space

France

Published on July 16, 2024

In autumn, a new Regulation on access to health data, the European Health Data Space (EHDS), will enter into force. What does this mean for startups? France Digitale has unpacked the text for you.

The 3 key takeaways:

  • If you’re developing software to manage electronic health records (prescriptions, dispensations, medical imaging reports, examination/lab/diagnostic results…) you’ll need to ensure interoperability with the European data exchange format, obtain a CE marking and allow patients to exercise rights, including an opt-out; 

 

  • If you are developing a wellbeing app that collects data that could be used for medical purposes by a third party, you need to add a label to certify that the data is compatible with European standards;

 

  • If you are used to requesting access to data from hospitals, medical institutions, universities, etc. to develop your technology/product, will be able to do so via a new procedure and fee system managed by the Data Access Body (similar to the Health Data Hub); if you are used to making your health databases available to third parties under a compensation/partnership system, you will have to declare your databases and collaborate with the Body in the event of data access requests from researchers, for example.

To find out more about the deadlines and provisions of the EHDS, please consult our analysis below or contact us at [email protected].