ESIP key messages on the proposal for Regulation on the European Health Data Space

The European Social Insurance Platform (ESIP) welcomes the establishment of the European Health Data Space (EHDS) and puts forward a set of key messages in light of the ongoing institutional negotiations

We endorse the clear distinction between primary and secondary use of health data and accordingly the establishment of two separate infrastructures and a twofold governance mechanism where access is granted by national competent authorities, connected through an EU infrastructure.

According to the current, broad definition, social security institutions are to be considered data holders of medical administrative data. It is important to highlight that social security institutions are also key data users of health data to support decision-making around the provision of healthcare   


In this context, we recommend to:

  • Ensure compatibility with national governance frameworks and infrastructures on health data access, with a view to the protection of prior investment;
  • Introduce stricter criteria and conditions for secondary use of health data, enhancing transparency of data access applications and promoting return on investment;
  • Preserve the highest level of data safety and quality, by restricting the scope to certified health applications only as opposed to voluntary labelled wellness applications;
  • Entrust Member States with a stronger role with view to the establishment of the EHDS.


Find here our key messages towards the establishment of the EHDS