With the Regulation on the European Health Data Space (EHDS) now published in the Official Journal on March 5, 2025, a significant transformation in the access and use of health data across Europe is on the horizon. The EHDS is set to be implemented in stages over several years, with the secondary use section becoming applicable from March 26, 2029. This ambitious project promises to harmonize the way health data is accessed and utilized, fostering innovation and improving healthcare outcomes throughout the EU.
The Role of the European Commission
Central to the successful implementation of the EHDS is the European Commission’s responsibility for preparing numerous implementing acts. These acts include detailed descriptions of data sets, templates for data access requests, and secure processing platforms. The aim is to create a robust framework that ensures the security and privacy of health data while making it easily accessible for legitimate uses. The EU-funded project Tehdas has taken a leading role in this preparation. In January 2025, Tehdas launched consultations to provide detailed guidance on data descriptions and application practices.
The Commission has also provided an extensive FAQ to assist stakeholders in understanding the EHDS framework. This resource addresses various aspects of the EHDS, offering clarity on the procedural and technical elements involved. Updated blog posts further provide valuable insights into the secondary use of health data, perspectives from data holders and users, and the implications for wellness applications and medical devices. These efforts are geared towards ensuring that all parties involved are well-prepared for the transition to the new data access and usage paradigms.
Understanding the Transition and Timelines
The Regulation on the European Health Data Space (EHDS) was officially published in the Official Journal on March 5, 2025, marking the beginning of a significant shift in how health data can be accessed and used throughout Europe. This regulation is set to be rolled out in phases over the next several years. One of the major milestones is the application of the secondary use section, which will become effective from March 26, 2029. The introduction of the EHDS is expected to standardize the methods for accessing and leveraging health data across the EU. This harmonization aims to drive both innovation and enhanced healthcare outcomes. By creating a more unified data approach, the EHDS seeks to foster an integrated healthcare environment, ultimately providing benefits to patients, medical professionals, and researchers alike. This ambitious initiative underlines the EU’s commitment to advancing healthcare through improved data utilization and will likely serve as a model for other regions.
