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Spain's National Health Data Space One Health 2026: What Changes for Researchers and Healthcare Sector

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Equipo Editorial CambiosLegales
11 May 2026 6 min 63 views

Key data

RegulationResolution of May 4, 2026, from the Under-Secretariat, publishing the Agreement between the State Secretariat for Digitalization and Artificial Intelligence and the CSIC for technical support and integration of health data sets (One Health) within the framework of the National Health Data Space project
BOE PublicationMay 11, 2026
Entry into forceMay 4, 2026
Signatory bodiesState Secretariat for Digitalization and Artificial Intelligence and State Agency Spanish National Research Council (CSIC)
Integrated data areasHuman health, animal health and environmental health
Affected partiesResearchers, health administrations, health sector and technology sector linked to health data
CategoryEducation / Healthcare Digitalization
European reference frameworkEuropean Health Data Space
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The integration of human health, animal and environmental data in a common infrastructure is already a reality in Spain. The agreement signed on May 4, 2026 between the State Secretariat for Digitalization and Artificial Intelligence and the CSIC formalizes the collaboration to structure and incorporate these data sets into the National Health Data Space, published in the BOE on May 11, 2026 through a Resolution from the Under-Secretariat (reference BOE-A-2026-10195).

For researchers, health administrations and technology companies in the health sector, this agreement is not a bureaucratic formality: it is the starting point for a data infrastructure that will change how health information is accessed, shared and exploited in Spain.

What does this regulation establish?

The agreement formalizes collaboration between two bodies with differentiated roles:

  • State Secretariat for Digitalization and Artificial Intelligence: leads the National Health Data Space project and defines the strategic framework.
  • CSIC (Spanish National Research Council): provides technical and scientific support to structure and incorporate data sets into the common space.

The approach adopted is One Health, which is based on the recognition that the health of people, animals and ecosystems are interconnected. Therefore, the data to be integrated covers three differentiated areas:

AreaType of dataMain utility
Human healthClinical, epidemiological and health surveillance data setsEpidemiological research and public health policies
Animal healthAnimal health and zoonosis dataSurveillance of transmissible diseases between animals and people
Environmental healthData on ecosystems and environmental factors with health impactAnalysis of environmental determinants of health

The expected result is greater availability of interoperable data for researchers and public administrations, advancing epidemiological research, health surveillance and evidence-based policy development. All in line with the standards of the European Health Data Space.

Economic and operational impact

This agreement does not generate direct costs for private companies nor does it establish fees or sanctions. Its impact is mainly operational and strategic, with medium-term consequences for actors in Spain's health data ecosystem.

The specific effects that actors in the sector should anticipate are:

  • Greater interoperability: Health information systems will need to be able to communicate with the National Health Data Space infrastructure. Technology companies that provide solutions to health administrations will need to adapt their platforms to defined standards.
  • New opportunities for data access: Researchers and health analytics companies will be able to access more complete and integrated data sets, opening possibilities for the development of epidemiological surveillance solutions, artificial intelligence applied to health and predictive models.
  • Alignment with the European framework: Spanish infrastructure is built in line with the European Health Data Space, which facilitates the scalability of technological solutions to the European market.
  • Impact on health administrations: Administrations will need to review their data management and transfer processes to adapt to the interoperability standards required by the common space.

Who does it affect?

  • Researchers and research centers: Expanded access to interoperable health data on human, animal and environmental health for epidemiological research and health surveillance projects.
  • Health administrations: Obligation to adapt their information systems and data management processes to the standards of the National Health Data Space.
  • Technology companies in the health sector (healthtech): Need to adapt platforms and solutions to defined interoperability standards, and opportunity to develop new services on the common infrastructure.
  • Data analytics and consulting companies: Opportunity to offer integration, structuring and exploitation services for health data to administrations and researchers.
  • Pharmaceutical and biotechnology sector: Potential access to more complete data for clinical research and drug development.

Practical example

A healthtech company that currently provides an epidemiological surveillance platform to an autonomous community works with human health data in its own format. With the National Health Data Space under the One Health approach becoming operational, that platform will need to be able to:

  1. Integrate not only human health data, but also animal and environmental health data in a format interoperable with the common space.
  2. Adapt its APIs and data models to the standards defined by the project, aligned with the European Health Data Space.
  3. Take advantage of access to more complete data sets to improve the predictive capacity of its epidemiological models.

The result: a more powerful solution, with greater analytical capacity, and with the possibility of scaling to other Spanish and European administrations under the same technical standards.

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What should companies do now?

  1. Identify if your activity generates or uses human, animal or environmental health data: If so, this agreement directly affects your operating model and the technical standards you will need to comply with as the National Health Data Space develops.
  2. Review the technical architecture of your health information systems: Assess whether your platforms are compatible with European interoperability standards (such as those defined in the European Health Data Space framework) and plan necessary adaptations.
  3. Explore opportunities for data access: If you are a researcher, analytics company or pharmaceutical sector, start mapping which data sets from the National Health Data Space could be relevant to your projects.
  4. Follow the project development: The agreement is the starting point. The effective integration of data will occur progressively. Keep track of publications from the State Secretariat for Digitalization and Artificial Intelligence and the CSIC on project progress.
  5. Consult with experts in health data protection: The integration of health data involves specific obligations under the GDPR and applicable regulations.


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