The European Health Data Space: Unlocking the power of health data

Abstract

In today's healthcare landscape, data are no longer just a by-product of treatment but a vital asset. Health data can transform research, improve outcomes, and guide policy, but only if they are accessible, high-quality, secure, and used ethically. The European Health Data Space (EHDS) stands at the center of this transformation. It focuses on making health data available for primary as well as secondary use, allowing data that were originally collected for care to also benefit research, innovation, and policy-making. European Union (EU) member states must create national data catalogues where researchers can explore a comprehensive overview of available data sets from hospitals, insurers, public institutions, and citizen science projects. These catalogues help researchers find and request data more easily, even discovering data sets they had not initially considered. This boosts ongoing projects, inspires new ideas, and fosters collaboration across disciplines.

By supporting open data policies and the FAIR principles (Findable, Accessible, Interoperable, and Reusable),¹ the EHDS encourages ethical and efficient reuse of data. Reducing redundant data collection saves time and resources. Linking data sets from different sources allows researchers to conduct richer, more nuanced analyses, revealing insights that would remain hidden in isolated data sets, such as environmental data. Specific efforts are made to obtain structured data from free text documents such as reports and protocols (e.g. with artificial intelligence [AI] tools).

Yet data access is not only a technical issue; it is also legal and political. Existing legislation can unintentionally block access to data that could be crucial for public health research. In Belgium, the Health Data Agency (HDA) was established to support and safeguard responsible data use in line with EHDS goals. Belgium's HDA promotes legal reforms that remove such barriers while protecting privacy and ethical standards.² Member states should recognize health research as a public good and align with EU statistical standards, encouraging public bodies to release valuable data sets for research use.

Efficient data access must also be well-managed. The EHDS requires efficient handling of data access applications and data requests (anonymized data to the level of statistical usage only). Member states should prioritize applications that address urgent national and EU health challenges, such as chronic disorders, health inequalities, or digital transformation. This requires transparent and inclusive collaboration among stakeholders to ensure that data usage is rooted in public interest and patient needs.

Building a robust health data system also demands coordinated efforts across national and European levels. The EHDS requires each member state to create at least one health data access body responsible for granting permits, ensuring data security, and maintaining quality standards (https://health.ec.europa.eu/ehealth-digital-health-and-care/ehds-action/projects-supporting-ehds/health-data-access-bodies-community-practice_en). Belgium's model, combining national oversight through the HDA with hospital-led initiatives, is emerging as a strong example of how to coordinate across levels of governance.

AI is a major area where health data can drive innovation.^{3, 4} AI tools can detect illness earlier, personalize treatment, and improve resource use. But for this to work, consistent coding and interoperability standards are essential so researchers can access usable, compatible data. In Belgium, the HDA Academy provides training and tools to support these developments and build needed skills.

None of this works without trust. People must trust that their data are handled securely and with transparency. The EHDS emphasizes data quality, validation, and openness to ensure that researchers use reliable data and that citizens understand how and why their data is used. Trust also means participation. The concept of ‘data solidarity’ recognizes that just as people contribute to healthcare through taxes, they also contribute through their data. These data should serve the public interest, not be monopolized by private actors.

We are at a critical juncture in health policy. Data can reshape how we prevent, diagnose, and treat disease,⁵ but only if we invest in systems that ensure responsible access and use. The EHDS with the Belgian HDA is doing just that, coordinating across governments, empowering researchers, protecting patients, and driving innovation.