European Health Data Space

The European Commission has presented a draft regulation on a European Health Data Space (EHDS). The ambition is to create an IT infrastructure for sharing health data across Europe.

The purpose of the European Health Data Space nationally and cross-border in the EU is to:

  • increase citizens' digital access to and control over their own health data 
  • support the free movement of citizens in the EU
  • promote an EU market for electronic patient record systems, medical devices and high-risk systems with artificial intelligence (primary data use) 
  • create a coherent, secure and efficient structure for the use of health data for research, innovation, policy-making and legislation (secondary data use).

The European Commission presented the draft regulation in 2022. The draft is still under discussion, so the final design is not yet known.

EHDS projects

To support the overall objectives of the regulation, the Danish Health Data Authority participates in two projects related to primary and secondary use of data, respectively: