The European Health Data Space Regulation, or the EHDS, was published in March of 2025 as a part of a broader strategy of the European Commission to harmonize the rules on data access. It regulates how data can be accessed and shared for different purposes, including healthcare as well as other purposes, such as the research and development of health policies. Furthermore, it aims to secure third-party access rights, as well as encourage more open data-sharing.
The goal of the Regulation is for patients to be given more control over their data. In addition, it regulates how the data collected from patients can be used and shared for the purpose of treating the patients.
The newly adopted Regulation governs the primary and secondary use of data:
- Primary use of data covers the use of data for treating a patient or monitoring their status;
- Secondary use of data includes the use of data for other purposes, i.e., the research of new pharmaceuticals as well as the development of new medical devices
It is of particular significance that under the new Regulation, data holders can make the collected data available for secondary use.
The data that can be shared includes, but is not limited to:
- Data on pathogens that are harmful to humans;
- Data from completed clinical trials and studies
- Human genetic data
It should be noted that the Member States keep the right to add additional categories of data that can be shared.
Prepared by,
Daniel Vujacic, LL.M. (UW)