Frequently Asked Questions

• Individual citizens are experiencing difficulties accessing and controlling their own health data.
• Healthcare professionals are having trouble accessing and sharing health data.
• Researchers, policy makers and regulators are having trouble accessing health data.

When safe access is granted to these stakeholders, it will be possible to use data for research, innovation, personal control and enhancing healthcare quality. Also, citizens will have greater control over their electronic health data because they will be able to add and change information, rectify errors, restrict access and know what health professional accessed the data. This will enhance diagnostics, prevention, treatment, continuity of care and efficiency.

View the factsheet

The EHDS differentiates between primary and secondary uses of data. Primary use means the use of personal health data by citizens and healthcare professionals. Secondary use concerns the (re)use of aggregated health data by researchers, policy makers, innovators and companies.

When the proposal is accepted, a national ‘digital health authority’ will be installed to supervise the regulations on primary use of data. In addition, ‘health data access bodies’ will be established which (amongst other things) will be responsible for processing data requests, providing data permits and ensuring electronic health data will be made available. 

The EHDS builds on regulations like the General Data Protection Regulation, proposed data governance regulations, the proposed data regulation and the NIS guidelines in order to ensure that private data will be protected and secondary data cannot be traced back to individuals.

In principle, the Dutch parliament is positive about reinforcing citizens' rights to access and control their own health data, anywhere in the EU. Also, regulating the market for electronic medical file systems for safety and interoperability and enhancing the availability of health data for research, innovation and policy making, are seen as positive developments, provided they comply with the highest standards of privacy and data protection.

The parliament has some reservations about the impact of the regulation on Dutch society. Therefore, an impact assessment will be conducted to obtain a clearer view on legal, financial, technical, organizational, social and ethical consequences.

For more information on the Dutch government’s position, see here.

Health-RI strongly supports the development of an EHDS. Read our position here. There is much conceptual synergy between the EHDS, the Wegiz and the Obstacle Removal Program started by the ministries of VWS, EZK and OCW, conjointly with Health-RI and many stakeholders. In general, we stand by the EHDS and its goals regarding reuse of health data for research, innovation and policy making.

Besides continuing the Obstacle Removal Program, Health-RI and its stakeholders intend to concentrate on writing a proposition on the EHDS.

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The EHDS is a proposal. The substantive points are currently being discussed with the European Council and the European Parliament. This process may take up to 3 years. In the meantime, the government and stakeholders are anticipating on the new regulation, conducting the impact assessment and comparing the EHDS to the new Dutch Egiz regulation.

If you have any questions regarding the EHDS, Health-RI's position or if you would like to contribute to our work, please contact us!

• Legal Impact Analysis for VWS by Radboud University (link in Dutch)
• Technical and Societal Impact Analysis for VWS by TNO (link in Dutch)
• Financial Impact Analysis for VWS by KPMG (link in Dutch)
• Statement and Amendments from European Patients Forum
• Study on an infrastructure and data ecosystem supporting the impact assessment of the European health data space