This site is about the European Health Data Space EHDS and similar projects in member states.
The European Health Data Space (EHDS) is an EU regulation that was published in the Official Journal of the European Union on March 5, 2025 and entered into force on March 26, 2025. It is intended to make all existing national electronic patient records (EPRs) and all other data available in the healthcare system(!) usable throughout the EU, both for medical treatments (primary use) and as a data source for non-profit and commercial research (secondary use).
The EHDS text can be found here, but has yet to be transposed into national law. The EU member states do not have to implement most of the requirements of the regulation until March 26, 2027.
It is envisaged that every EU citizen will automatically receive an ePA, but the member states may allow exceptions. The existing opt-out rules in some EU countries (only available in German) such as in Germany are such exceptions, which we hope will remain in place after the implementation of the EHDS.
Objection to “secondary use” is permissible in any case. “Secondary use” means access to “research data”, which can then be used by people and institutions from all over the EU. In addition, the holdings of health insurance funds and hospitals can also be requested directly for “secondary use”.
This website was created at the beginning of 2023, the subpages currently reflect this information status. We are currently checking whether and how we reflect current developments.
There is a menu on the upper right hand side, with our page’s structure. You can explore other pages. On these pages you’ll find a lot of links to documents.
The commission’s proposal of a regulation is here. It is currently discussed in EU’s parliament and council. A joint opinion on it by EU’s data protection authorities has been given.
The parliament’s time schedule for processing this file with names of reporters and fraction’s shadow reporters is here. The parliament’s comittees involved are Civil Liberties, Justice and Home Affairs (LIBE) and Environment, Public Health and Food Safety (ENVI). Current status is that the first version of a comittee report has been drafted.
EU documents on EHDS (and the regulation process)
Related EU regulations and initiatives