Description
Open health data is one of the most valuable assets of our society. Well managed and shared responsibly, they can save lives, drive medical discoveries, or even optimize hospital resources. However, for decades, this data has remained fragmented in institutional silos, with incompatible formats and technical and legal barriers that made it difficult to reuse. Now, the European Union is radically changing the landscape with an ambitious strategy that combines two complementary approaches:
- Facilitate open access to statistics and non-sensitive aggregated data.
- Create secure infrastructures to share personal health data under strict privacy guarantees.
In Spain, this transformation is already underway through the National Health Data Space or research groups that are at the forefront of the innovative use of health data. Initiatives such as IMPACT-Data, which integrates medical data to drive precision medicine, demonstrate the potential of working with health data in a structured and secure way. And to make it easier for all this data to be easy to find and reuse, standards such as HealthDCAT-AP are implemented.
All this is perfectly aligned with the European strategy of the European Health Data Space Regulation (EHDS), officially published in March 2025, which is also integrated with the Open Data Directive (ODD), in force since 2019. Although the two regulatory frameworks have different scopes, their interaction offers extraordinary opportunities for innovation, research and the improvement of healthcare across Europe.
A recent report prepared by Capgemini Invent for data.europa.eu analyzes these synergies. In this post, we explore the main conclusions of this work and reflect on its relevance for the Spanish open data ecosystem.
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Two complementary frameworks for a common goal
On the one hand, the European Health Data Space focuses specifically on health data and pursues three fundamental objectives:
- Facilitate international access to health data for patient care (primary use).
- Promote the reuse of this data for research, public policy, and innovation (secondary use).
- Technically standardize electronic health record (EHR) systems to improve cross-border interoperability.
For its part, the Open Data Directive has a broader scope: it encourages the public sector to make government data available to any user for free reuse. This includes High-Value Datasets that must be published for free, in machine-readable formats, and via APIs in six categories that did not originally include "health." However, in the proposal to expand the new categories published by the EU, the health category does appear.
The complementarity between the two regulatory frameworks is evident: while the ODD facilitates open access to aggregated and non-sensitive health statistics, the EHDS regulates controlled access to individual health data under strict conditions of security, consent and governance. Together, they form a tiered data sharing system that maximizes its social value without compromising privacy, in full compliance with the General Data Protection Regulation (GDPR).
Main benefits computer by user groups
The report looks at four main user groups and examines both the potential benefits and challenges they face in combining EHDS data with open data.
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Patients: Informed Empowerment with Practical Barriers
European patients will gain faster and more secure access to their own electronic health records, especially in cross-border contexts thanks to infrastructures such as MyHealth@EU. This project is particularly useful for European citizens who are displaced in another European country. .
Another interesting project that informs the public is PatientsLikeMe, which brings together more than 850,000 patients with rare or chronic diseases in an online community that shares information of interest about treatments and other issues.
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Potential health professionals subordinate to integration
On the other hand, healthcare professionals will be able to access clinical patient data earlier and more easily, even across borders, improving continuity of care and the quality of diagnosis and treatment.
The combination with open data could amplify these benefits if tools are developed that integrate both sources of information directly into electronic health record systems.
3. Policymakers: data for better decisions
Public officials are natural beneficiaries of the convergence between EHDS and open data. The possibility of combining detailed health data (upon request and authorisation through the Health Data Access Bodies that each Member State must establish) with open statistical and contextual information would allow for much more robust evidence-based policies to be developed.
The report mentions use cases such as combining health data with environmental information to assess health impacts. A real example is the French Green Data for Health project, which crosses open data on noise pollution with information on prescriptions for sleep medications from more than 10 million inhabitants, investigating correlations between environmental noise and sleep disorders.
4. Researchers and reusers: the main immediate beneficiaries
Researchers, academics and innovators are the group that will most directly benefit from the EHDS-ODD synergy as they have the skills and tools to locate, access, combine and analyse data from multiple sources. In addition, their work already routinely involves the integration of various data sets.
A recent study published in PLOS Digital Health on the case of Andalusia demonstrates how open data in health can democratize research in health AI and improve equity in treatment.
The development of EHDS is being supported by European programmes such as EU4Health, Horizon Europe and specific projects such as TEHDAS2, which help to define technical standards and pilot real applications.
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Recommendations to maximize impact
The report concludes with four key recommendations that are particularly relevant to the Spanish open data ecosystem:
- Stimulate research at the EHDS-open data intersection through dedicated funding. It is essential to encourage researchers who combine these sources to translate their findings into practical applications: improved clinical protocols, decision tools, updated quality standards.
- Evaluate and facilitate direct use by professionals and patients. Promoting data literacy and developing intuitive applications integrated into existing systems (such as electronic health records) could change this.
- Strengthen governance through education and clear regulatory frameworks. As EHDS technical entities become operationalized, clear regulation defining common regulatory frameworks will be essential.
- Monitor, evaluate and adapt. The period 2025-2031 will see the gradual entry into force of the various EHDS requirements. Regular evaluations are recommended to assess how EHDS is actually being used, which combinations with open data are generating the most value, and what adjustments are needed.
Moreover, for all this to work, the report suggests that portals such as data.europa.eu (and by extension, datos.gob.es) should highlight practical examples that demonstrate how open data complements protected data from sectoral spaces, thus inspiring new applications.
Overall, the role of open data portals will be fundamental in this emerging ecosystem: not only as providers of quality datasets, but also as facilitators of knowledge, meeting spaces between communities and catalysts for innovation. The future of European healthcare is now being written, and open data plays a leading role in that story.
