Alongside the rollout of the ePA, there is another milestone in the digitalisation of health data: the Regulation on the European Health Data Space (EHDS) already entered into force on March 25. The transition phase now begins.
However, the EU will not determine how the regulation is to be implemented in concrete terms until March 2027, so effects on patients are not yet to be expected.
- From 2029, it should be possible to exchange patient data and e-prescriptions within the EU.
- From 2031, other data such as X-ray images or laboratory findings should follow.
- Finally, from 2034, the participation of non-EU countries should also become possible.
The regulation is primarily relevant for manufacturers of EHR (electronic health record) systems. But medical devices can also be affected, for example if they have an interface to an EHR system.
So check in good time to what extent the regulation is relevant for you.
The Federal Ministry of Health has published further information at https://www.bundesgesundheitsministerium.de/themen/internationale-gesundheitspolitik/europa/europaeische-gesundheitspolitik/ehds.html