For better Healthcare, 
Research & Policy Making    

Health Data Agency

By making health data more easily, securely and transparently available to agencies, institutions and companies to design sustainable health policies based on scientific research.

Our vision

The Belgian Health Data Agency (HDA) strives for a high-quality, data-driven healthcare system in which health (care) data and data related to health (care) are available for secondary use in a uniform, transparent and secure manner. To achieve this, the HDA focuses on the following objectives: 

  1. Facilitate the availability of health (care) data and health (care) related data; 
  2. Develop secure and reliable methods for the exchange of personal health data, with an emphasis on cybersecurity; 
  3. Develop and implement a policy strategy on health (care) data and health (care) related data; 
  4. Stimulate innovation, scientific research and policy support research that can contribute to better, affordable, preventive and targeted healthcare. 
  5. Ensuring the trust of citizens and patients by emphasising transparency and security around the re-use of health data, while respecting the rights and obligations of the parties involved

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Our mission

The Belgian Health Data Agency (HDA), in collaboration with regional and federal data holders and users, will facilitate access to quality health (care) data and data related to health (care) in a simplified and more uniform, reliable, transparent and secure manner, through the development of a framework in which the re-use (secondary use) of quality health (care) data and data related to health (care) is optimally facilitated. Within the framework of the tasks described in the law, the HDA supports the re-use of health and health-related data for population management, health prevention and healthcare policy, through research and innovation based on health needs and the active role of citizens, thereby contributing to better health and quality of life. 

History

The establishment of the Health Data Agency (HDA) is a significant step toward realizing the European Commission’s 2019-2024 political priority 'A Europe for the Digital Age' within the health space in Belgium. The EU's Digital Strategy provides for the creation of a European health data space (EHDS) to promote targeted research, diagnosis and treatment.

The healthcare system needs to be transformed. Demographic and technological developments have an impact on the healthcare system. Improving the quality and accessibility of healthcare and adapting healthcare to the new needs of patients are therefore key objectives.

Numerous data on health are collected: health care utilization, mortality, causes of death, social security information, clinical data and health insurance reimbursement data are routinely collected for the management and operation of health and social security services. Information on the health status and health care of the population is fragmented across organizations and systems. There is not yet an integrated federal initiative that facilitates the use and reuse of these data for health policy and health research.

The coalition agreement and the Public Health Policy Paper of 28 October 2021 set the creation of the Health (Care) Data Agency as an objective:

  • The HDA should support the transition of the Belgian health (care) system to data-driven care;
  • Central to this is making data available for policy support, innovation, research and product development;
  • The easy, uniform, transparent and secure availability of health data in all its facets should lead to higher quality, affordable, preventive and targeted care for every citizen.

Together with the five founding organizations (FAMHP, FPS, KCE, NIHDI and Sciensano), the HDA was set up. The HDA was established by law the 14th of March 2023 as an ASAA (administrative service with accounting autonomy) with enterprise number 0800309782.

As mentioned in the law, the governing bodies of the Health Data Agency are the Governance Board and the User Board. The Governance Board is a strategic body competent to carry out the acts necessary to accomplish the missions of the Health Data Agency. The User Board assists it in this task. To this end, the User Board is responsible for formulating proposals or advice to the Governance Board, on its own initiative or on request. These bodies comply with a public code of deontology.

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European projects

"Europe for the digital age" strategy. 

The European Commission has launched the European Data Spaces initiative as part of its ‘Europe for the Digital Age’ strategy. This initiative aims to improve the exchange of data in various fields.

European Health Data Space (EHDS)

The European Health Data Space (EHDS) is an initiative under this strategy. Common rules have been defined between European countries to make better use of health data, while protecting citizens' privacy. This regulation seeks to overcome the challenges associated with accessing and sharing electronic health data.

Objectives of the European data strategy

The strategy aims to :

- Establish a single data market.

- Strengthen Europe's international competitiveness.

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    Adoption of Regulation (EU) 2025/327

    On 26 March 2025, Regulation (EU) 2025/327 on the European Health Data Space (EHDS) was adopted. This regulation marks a major change in the use of health data within the European Union. However, it will not be applied immediately. A transitional phase began on 26 March 2025, during which the European and national institutions will have to adopt implementing acts to make the regulation fully operational. From March 2027, the European Commission will have to adopt a series of implementing acts, providing detailed rules for the application of the EHDS Regulation. These acts will concern different categories of data, with different deadlines depending on the categories and obligations.

    General purpose

    The general purpose is to establish a common framework for the use and exchange of electronic health data across the EU for the benefit of patients, healthcare professionals and regulators.

     

    In this evolving digital landscape, the Health Data Agency can play an important role for Belgium. The HDA's operational framework is purposefully designed to align with the EHDS and future initiatives, ensuring ongoing compliance with European legal requirements. Operating from an inter-federal standpoint, the HDA collaborates with the Belgian health(care) ecosystem to foster cross-region and cross-border collaboration.  

    European projects in Belgium

    A number of European projects have been launched to prepare for the establishment of this health data space in Belgium, including :

    Health Data registry policy

    In Belgium, registries are electronic databases in which structured information related to healthcare is collected. These data are provided by healthcare professionals and healthcare institutions (hospitals, general practitioners, etc.), generally through forms or templates that must be completed.

    Once collected, the data are anonymized and/or pseudonymized (Pseudonymization is a personal data processing technique that replaces identifying information (such as names and addresses) with aliases (such as codes or numbers), making direct identification impossible without additional securely stored information), analyzed, and made available to stakeholders such as the National Institute for Health and Disability Insurance (NIHDI/RIZIV-INAMI), the Federal Public Service (FPS) Public Health, scientific institutions, researchers, and hospitals.

    Healthcare providers, such as hospitals and general practitioners, remain responsible for collecting and submitting the data.

    The Health Data Agency is now responsible for the management, storage, and secure provision of registry data that were previously managed by Healthdata.be.

    A new vision for registry policy

    The registry policy is evolving to respond to a rapidly changing environment:

    • The adoption of the European Health Data Space (EHDS) Regulation.
    • Technological developments enabling more flexible data collection, storage, and use.
    • Investments in “data capabilities” projects.
    • Initiatives developed by the federated entities.

    Key principles of this new vision

    This evolution is based on:

    • A federated model: data remain stored with the stakeholders who produce or manage them, without prior centralization.
    • The “only once” principle: data are recorded only once and then securely reused, avoiding duplicate data entry.
    • Standardization at source: data are structured and harmonized from the moment they are created, particularly within the Electronic Patient Record (EPR).
    • Automated and standardized exchanges: data flow smoothly, automatically, and consistently between systems.
    • Reuse of existing components: existing solutions are reused whenever possible and aligned with the EHDS.
    • Application of FAIR principles: data and metadata are made Findable, Accessible, Interoperable, and Reusable.
    • Secure use of data: data exchanges and uses comply with security, confidentiality, and legal requirements.

    Integration of Healthdata.be

    The Healthdata.be platform, historically used for the collection and secure dissemination of health data, became part of our Agency on 1 April 2026.

    This integration enables:

    • Greater consistency in healthcare data management.
    • Stronger governance.
    • More effective implementation of the new registry policy.

    An information session held on 7 January 2026 provided a detailed presentation of the roles, responsibilities, and practical arrangements of this integration. The presentation and recording are available.

    What are the next steps?

    We are continuing to operationalize this vision through several workstreams:

    • Developing the conceptual architecture.
    • Building the technical systems and defining their requirements.
    • Establishing governance and funding mechanisms.
    • Assessing the prerequisites for implementation.

    The objective is to ensure maximum alignment with the European Health Data Space while closely involving all stakeholders.

    Further information

    Annual Report

    The HDA Annual Report 2025 describes the Belgian and European context for its creation. The report also describes the strategic and operational objectives, as well as the actions and staffing, and provides an overview of the achievements in 2025. The report is available in Dutch for the moment.

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