The Netherlands is working on a digital highway for healthcare data: citizens will have more control

The EHDS, which came into force on March 26, 2025, requires member states to be fully prepared for digital data exchange by 2031 at the latest . For citizens, this means a significant shift: where explicit consent is often still required for data sharing, 'data availability' will soon become the norm, unless citizens themselves impose restrictions.

New rights for patients

The regulation gives citizens a set of digital rights to strengthen control over their own healthcare data :

• Direct access: Citizens will have the right to access their electronic health records immediately and free of charge via online portals or apps.
• Control over data: Patients can add information to their files themselves, rectify data, or have it transferred digitally to another healthcare provider.
• Opt-out right: The Netherlands makes use of the European option to offer citizens an 'opt-out'. This allows them to prevent their data from being made available to other healthcare providers (primary use) or for research purposes (secondary use) via the central infrastructure.

The ministry is currently investigating how existing services, such as Personal Health Environments (PHEs) and My Health Overview (MGO), can serve as the official 'access service' for these rights .

Establishment of new healthcare authority

In order to manage the enormous flow of data, the government intends to establish a new independent administrative body (zbo). This organization will fulfill two important functions:

1. Digital Health Authority (ADG): Responsible for the availability and exchange of healthcare data between healthcare providers and citizens.
2. Health Data Access Body (HDAB): This body will grant licenses for the reuse of healthcare data for research and innovation.

Consequences for healthcare IT

The arrival of the EHDS also has major consequences for the Dutch Electronic Data Exchange in Healthcare Act (Wegiz). One notable change is the way in which ICT systems in healthcare are assessed . Whereas the Wegiz was based on mandatory testing by external parties, the EHDS prescribes a system of 'self-assessment' by suppliers, similar to the CE marking . The Netherlands will amend its national legislation in this regard to avoid double regulation for software suppliers.

Timeline

The introduction will take place in stages. In the first half of 2026, the first tranche of the implementation legislation will be subject to internet consultation. The final law, including the rules for opting out, must be in force by March 26, 2029, at the latest . After the summer of 2026, the minister will further inform the House about the precise details of civil rights and the technical feasibility for the healthcare sector .

Read Minister Bruijn's letter to parliament here