The European Health Data Space (EHDS): A New Era for Research and Innovation – What Businesses Need to Know
The Regulation on the European Health Data Space (EHDS) marks a major shift in the European landscape for health data.
By enabling the regulated and secure secondary use of health data, the Regulation— which entered into force at the end of March 2025, represents a turning point for innovation and competitiveness among private actors. It unlocks unprecedented opportunities to boost research, accelerate innovation and transform the quality of healthcare.
A New Framework to Unlock the Potential of Health Data
Against the backdrop of increasing digitalisation and enhanced interoperability across the European Union, the EHDS Regulation establishes a unified legal framework allowing the use of anonymised or pseudonymised health data for purposes such as research, health product development, public policymaking, education and statistical analysis.
This second pillar of the EHDS, alongside the primary use of health data by citizens and healthcare professionals, aims to improve access for companies and institutions to a wide range of datasets, while ensuring the protection of fundamental rights and economic interests.
Health data holders, such as hospitals and public bodies, are thus required to make available categories of data including determinants of health (living conditions, environmental factors or behaviours), access to healthcare services and healthcare expenditure, as well as data on pathogens and administrative healthcare information (such as reimbursements or prescriptions).
A Structured and Secure Legal Framework
Building on existing EU legislation, such as the GDPR, the Data Governance Act, the Data Act and the NIS2 Directive, the EHDS Regulation sets out, in its Chapter IV, the conditions governing the secondary use of health data.
It introduces a formalised procedure for access to such data and provides for the designation, in each Member State, of a national health data access body. At this stage, this body has not yet been designated in Belgium.
Access to health data is subject to strict legal safeguards, including:
- fees must be reasonable and transparent;
- trade secrets and intellectual property rights must be protected;
- data use is limited to specific and authorised purposes.
Our advice:
Access to health data for secondary use represents a strategic opportunity, but it is subject to a robust legal framework and strict procedural requirements.
For companies seeking to use health data for research or innovation purposes, it is essential to anticipate the regulatory requirements and to secure every stage of the project.
If you would like to discuss this with one of our experts, our firm is at your disposal to support you.