EHDS (European Health Data Space)

The European Health Data Space (EHDS) is an important piece of European legislation that will fundamentally change how health data is exchanged and used. Its purpose is to make patient data available across national borders in a safe and standardised way. This applies to both primary use (providing care), and secondary use (the use of pseudonymised data for research purposes).

Exchange in accordance with the EHDS required by 2029

The EHDS came into force in March 2025 and requires Electronic Health Record (EHR) systems to make the first data categories available in the EEHRxF format in accordance with the EHDS Implementation Guides by March 2029, and to comply with the logging requirements. This concerns:

• Patient summaries.
• Electronic prescription notifications.
• Medication dispensing.

From March 2031, the following will also be included:

• Images and reports.
• Medical test results, such as lab results and reports.
• Discharge letters.

Read the answers to frequently asked questions about EHDS here.

• What are the main features of the EHDS?
  The European Health Data Space (EHDS) is a regulation designed to support patient care, scientific research, innovation and policymaking across Europe.

  The regulation consists of three parts:

  1.        Primary use of data.
  Making electronic health data available across national borders and sharing it to support the provision of healthcare.

  2.        Secondary use of data.
  Making anonymised health data available for research, innovation, policymaking and regulatory purposes.

  3.        Regulation of the healthcare ICT market.
  Creating an open European market for EHR systems to promote both primary and secondary use of health data.

• What does the EHDS mean for suppliers that provide systems covered by the EHDS regulation?
  Suppliers must:

  • Comply with interoperability requirements (i.e. EEHRxf, the European Exchange Format, and IHE image transactions) and meet logging requirements for the following six data categories:

  From March 2029
  1. Patient summaries
  2. Electronic prescriptions
  3. Medication dispensing

  From March 2031

  4. Medical images & reports
  5. Medical test results & reports
  6. Discharge letters

  • Demonstrate, through self-assessment, that their systems are compliant.
  • Provide users with clear information and documentation on how their solution works.
  • Report and resolve incidents and defects.

• What is the European Electronic Health Records Exchange Format (EEHRxf)?
  The European Electronic Health Record Exchange Format (EEHRxf) is a standardised, machine-readable format designed to facilitate the secure and interoperable exchange of electronic health data across the EU based on FHIR. It enables the seamless transfer of health data between different software applications, devices and healthcare providers.

• What does the EHDS mean for citizens?
  Among other things, citizens have the right to:

  • Access health data from the six data categories.
    From March 2029
    1. Patient summaries
    2. Electronic prescriptions
    3. Medication dispensing
    From March 2031
    4. Medical images and reports
    5. Medical test results and reports
    6. Discharge letters
  • Download a digital copy of this data.
  • Request that their health data be shared with other healthcare providers (data portability), either within their own Member State or in another EU Member State.
  • Request the rectification of their data.
  • Enter their own data into an EHR system.
  • Control how their health data is shared, including the right to opt out under the EHDS.
  • Be informed of relevant (secondary) findings from research, unless they choose not to receive this information.
    

• What does the EHDS mean for healthcare providers?
  Healthcare providers have the right to:

  • Access health data from the six data categories in a user-friendly way:
    From March 2029
    1. Patient summaries
    2. Electronic prescriptions
    3. Medication dispensing
    From March 2031
    6. Medical images and reports
    7. Medical test results and reports
    8. Discharge letters
  • On request, provide citizens with a downloadable copy of their health data or transfer it to another EHR system
  • Request a patient’s health information from a healthcare provider in another European country via MyHealth@EU.

  Following approval of a data request by the Health Data Access Body (HDAB):

  • Make anonymised (or pseudonymised) data available for secondary use.
  • Request datasets from another European country via HealthData@EU, for example for research purposes.
    

• Where can I find more information about the EHDS?
  More information about the EHDS can be found on the following websites:
  Dutch Ministry of Health, Welfare and Sport (VWS): European Health Data Space (EHDS) | Data voor gezondheid
  European Commission: Verordening betreffende de Europese ruimte voor gezondheidsgegevens (EHDS) – Public Health
  XT-EHR, here you will find specifications, Implementation Guides and requirements that the systems must meet: Home – Xt-EHR