The EU European Health Data Space Regulation has entered into force, what now?

On 26 March 2025, the EU European Health Data Space (EHDS) entered into force. A transition period of 2 years has started. From 26 March 2027, this regulation will apply throughout the EU. There are some exceptions, some provisions and articles that will need more time for implementation will be postponed for more than 2 years. All in all, the EHDS, including all its chapters and articles, will be fully applicable throughout the EU on 26 March 2035

What is the EHDS

The aim of the EHDS is to create a single “space” within the entire EU for the electronic exchange of health data.

Until now, this topic has been regulated by EU member states at national level. In the Netherlands, for example, we have the Electronic Data Exchange in Healthcare Act ( Wegiz ) and related laws and regulations.

The Dutch legal framework has a national history, which is largely shaped by the rejection by the Senate of the National Electronic Patient File (EPD) in 2011, partly due to concerns about privacy & security. We previously wrote about the national framework for electronic exchange of health data:

https://www.wisemen.nl/nl/artikelen/wat-is-de-juridische-waarde-van-nen-7510-certificering

The European legislator now wants to establish a single harmonised standard for the internal market. In order to enable cross-border movement of patients and data, but also secondary use of health data for research, innovation, policy-making, preparedness for and response to health threats, such as pandemics. The European legislator wants to reduce fragmentation within the EU. The EHDS is a step towards a European Health Union.

Conclusion

In the coming period, a harmonisation process will take place under the influence of the EHDS in the area of currently divergent national legislation and regulations regarding (electronic) health data and their use in healthcare, science and public health.

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