Understanding the EHDS
The European Health Data Space
Advancing Health Research and Innovation Across Europe
The European Health Data Space (EHDS) is an important European Union initiative designed to support the exchange, access and responsible use of electronic health data.
It establishes a common framework for both the primary use of health data in healthcare and the secondary use of health data for purposes including scientific research, innovation, policymaking, public health and regulatory activities.
The EHDS creates opportunities to strengthen European collaboration, support research and generate new insights from health data while maintaining appropriate safeguards.
Secondary Use of Health Data
Enabling New Opportunities for Research
Secondary use refers to the use of existing health data for permitted purposes beyond those for which the data was originally collected.
Under the EHDS, eligible researchers and other authorised users will be able to request access to relevant electronic health data through structured procedures, subject to defined legal requirements and safeguards.
The framework will also establish responsibilities for health data holders concerning relevant datasets and their availability for permitted secondary use.
This approach supports the responsible reuse of valuable health information and offers opportunities for research across institutions, organisations and European borders.
Implementation Timeline
Preparing for the Transition
The phased implementation provides an opportunity for organisations to review their responsibilities, prepare governance and operational arrangements, and contribute to the development of effective secondary-use practices.
How EHDS Secondary Use Will Work
A Connected European Framework
The EHDS establishes a structured approach to secondary use that combines European connectivity with national implementation.
Health Data Access Bodies
Health Data Access Bodies (HDABs) will exercise defined statutory responsibilities, including the assessment of access applications, issuing data permits and overseeing relevant secondary-use arrangements.
HealthData@EU
HealthData@EU will provide the European cross-border infrastructure connecting participating authorities and supporting secondary-use activities across Member States.
Health Data Holders
Organisations falling within the EHDS definition of health data holders will have responsibilities concerning relevant electronic health data, including dataset descriptions and making data available in accordance with applicable requirements.
Health Data Users
Eligible researchers and other authorised applicants will be able to request access to relevant datasets for permitted purposes, subject to the applicable access procedures and safeguards.
Together, these arrangements establish a framework for responsible secondary use across Europe.
The Opportunity for International Data Holders
Supporting Research Across Borders
International pharmaceutical and biotechnology companies, academic institutions and research collaborations play an important role in generating and managing valuable health and clinical research data.
The EHDS provides an opportunity to support greater reuse of these resources for research and innovation through a common European framework.
As organisations prepare for implementation, effective governance, operational coordination and trusted access arrangements will be important in supporting secondary-use activities across multiple jurisdictions.
Vivli Europe is working with stakeholders to explore practical approaches that support these needs and contribute to successful implementation.
Vivli Europe’s Contribution
Supporting the Practical Implementation of the EHDS
Vivli Europe is developing operational approaches that complement the EHDS regulatory framework and European infrastructure.
Our work brings established clinical data-sharing expertise together with European stakeholder engagement to support readiness, coordinated workflows and trusted secondary-use arrangements.
We aim to contribute scalable solutions that help international data holders and researchers participate effectively in the emerging European health data ecosystem.