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European Health Data Space (EHDS)

The European Health Data Space (EHDS), strengthens patient rights and promotes scientific research, innovation, and policy. The EHDS includes regulations to facilitate the sharing of health data, for example, with other healthcare providers, other European countries, researchers, and policymakers.


 

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About the EHDS

The European Health Data Space (EHDS) gives citizens more control over their electronic health data. The European legislation in the EHDS aligns with the National vision and strategy on the health information system and the vision and strategy for the secondary use of health data of the Dutch government. 

 

The EHDS consists of three parts:

Chapter II: Primary Data Use, Chapter III: Electronic Health Records (EHRs), Chapter IV: Secondary Data Use. You can consult the EHDS regulation here. You can consult the EHDS regulation here.

The Role of Health-RI

Health-RI is closely involved in the implementation of the EHDS, particularly in the area of secondary use. Additionally, Health-RI is one of the partners in the HDAB-NL project. In this project, Health-RI collaborates with the Ministry of Health, Welfare and Sport with project management from ICTU, RIVM, and CBS.

The EHDS states that each European member state must establish a Health Data Access Body (HDAB) to enable the secondary use of health data. The HDAB-NL  project is developing the necessary infrastructure for this and advising on the governance structure of an HDAB. The Dutch HDAB will connect with HDABs from other countries via the European HealthData@EU infrastructure. This will make it easier for researchers to request health data from other countries.

If you want to know more about the EHDS or the HDAB-NL program, please contact our experts Merlijn van Rijswijk and Susanne Rebers.

Read more on the programme HDAB-NL  (Dutch)

On the HDAB-NL community (Dutch), you can engage in discussions about the HDAB and participate in the various work packages. You can create your own topics or respond to other community members' posts.

 Become a member of the HDAB-NL Community (Dutch)

The EHDS and Secondary Data Use: What Does It Mean for You?

The EHDS ensures that health data is more easily shared and reused. This means that data is shared by default, both for primary and secondary use. This principle is similar to the organ donor register, where it is assumed that you do not object to organ donation unless you explicitly state otherwise. Sharing by default, unless you object, is known as opt-out.

Within the EHDS, holders of health data (data holders) are required to make health data available and deliver it to the HDAB. This facilitates the work of researchers and policymakers because they now have access to more data from more countries, following a transparent review of the request.

Below is more information about the different roles in the EHDS:

  • Citizen/Patient
  • Data Holders
  • Data Users
  • HDAB

Citizens and Patients

As a citizen, the EHDS gives you more control over the electronic health data stored about you. Additionally, healthcare providers will have more time for patient care. All of this contributes to a healthier society. The secondary use of health data is therefore important to promote good, accessible, and affordable care and to support prevention.

A citizen/patient:

  • Has access to information about the secondary use of health data.
  • Has an opt-out right for secondary use, meaning they can indicate that (certain) health data should not be used.
  • Can view a general overview of the permits granted and the fines/sanctions imposed

Data Holder

If you process health data, it is likely that you have obligations to provide certain types of data to the HDAB, provided that more than 10 people work at your organization.

A data holder:

  • Must update and submit metadata to the HDAB at least annually.
  • Must check at least once a year to ensure the description is accurate.
  • Is required to provide data if a data request is approved (obligation).
  • May charge a fee equivalent to the marginal costs.

Would you like more information on the roles of data users or the HDAB within the EHDS?

Data User

Researchers/data users can more easily access more usable datasets with anonymous or pseudonymous health data. This facilitates research into, for example, new treatments. They also gain quicker insight into which data is available, where it is located, and its quality.

A data user:

  • May submit a request or application if there is a valid reason to use health data for secondary use.
  • Must pay a fee for the use of health data. A portion of this fee goes to the data holder.
  • Must comply with permit conditions and may choose to discontinue.
  • Gains access to data with a permit: anonymized or, if not possible, pseudonymized. Access to data occurs in a secure processing environment.
  • Must publish results and outputs, which are made findable via the HDAB website.

Health Data Access Body (HDAB)

The Health Data Access Body (HDAB) is the central point for the secondary use of health data. Data users search for health data using the HDAB catalog and submit a request. The HDAB reviews the request, and if it is approved, the HDAB asks the data holder to make the health data available in a secure processing environment. The national HDAB connects with other European HDABs, allowing researchers to request health data from other countries.

The HDAB:

  • Makes health data discoverable for requests and applications.
  • Grants permits or provides responses to requests.
  • Provides a secure processing environment where health data is accessible to data users.
  • Informs citizens about data processing and facilitates the right to object if the member state assigns this task to the HDAB.
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