For better Healthcare,
Research & Policy Making
Health Data Agency
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:
- Facilitate the availability of health (care) data and health (care) related data;
- Develop secure and reliable methods for the exchange of personal health data, with an emphasis on cybersecurity;
- Develop and implement a policy strategy on health (care) data and health (care) related data;
- Stimulate innovation, scientific research and policy support research that can contribute to better, affordable, preventive and targeted healthcare.
- 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
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 :
Annual Report
The HDA Annual Report 2024 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 2024. The report is available in French, Dutch and German.