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European Commission launches the Health Data Space

Yesterday [3 May], the European Commission launched the European Health Data Space. This new initiative is twofold:

First, it will give citizens easy access to their health data in electronic form and free of charge. They will be able to share these data with other health professionals in and across Member States. Citizens will be in control of their data; they will be able to add information, rectify wrong data and restrict access to others. A common European format will be adopted for patient summaries, ePrescriptions, images and image reports, laboratory results, discharge reports.

Manufacturers of electronic health record systems will need to certify compliance with interoperability and security standards.

Secondly, the proposal will improve the use of health data for research, innovation and policymaking. The Data Space proposal also creates a legal framework for the use of health data for research, innovation, public health, policymaking and regulatory purposes. This means that, under strict conditions, researchers, innovators and public institutions or industry will have access to large amounts of high-quality health data. Such access will require a permit from a health data access body (to be set up in all Member States). The identity of the individual will not be revealed.

Next steps

The proposal for a Regulation will follow the ordinary legislative procedure, meaning that the European Parliament and the Council will both discuss the file.

 
Proposal for a Regulation – The European Health Data Space

If you have any questions on this topic, please contact Camille Dornier - Policy Manager: camille.dornier@eurosmart.com

 
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