Digital healthcare in Belgium

Key figures

11,9 M

inhabitants (2025)

11% of GDP

in health expenditures in 2024

6

federated entities (composed of 3 regions and 3 communities)

A healthcare system divided between the federal government, regions and communities

The health system in Belgium is financed by a compulsory health insurance system. The federal authorities are responsible for matters of general interest, such as : compulsory national health insurance, setting the hospital budget and general rules of organization, regulation of health products and activities, health professionals and patients' rights.  
 

The regions ensure regional economic development and the communities are responsible for preventive healthcare such as vaccination campaigns, the accreditation and quality control of healthcare institutions and matters such as home care, elderly care and rehabilitation. Regular inter-ministerial conferences facilitate cooperation between the communities, regions and the federal state.

Meeting the ambassadors

The eHealth sector is developing on the basis of two data exchange platforms

The healthcare sector has many players in Belgium. Each of them applies its own working methods for collecting and recording health data.
The eHealth sector is developing on the basis of two free data exchange platforms made available by the national government. The Crossroads Bank for Social Security is the backbone that enables information exchanges from one social sector to another and the ehealth platform, specialising in health care, offers services to facilitate exchanges between the players in the health ecosystem.

All Belgian residents have an electronic identity with which they can access their eHealth space. This interface gives them control over their data.

In this landscape, the Belgian Health Data Agency (HDA) plays a key role in the secondary use of health data. It works on the harmonization of metadata within the European framework and supports concrete initiatives, such as hospital networks in Flanders and Wallonia that are developing data warehouses and research tools. Belgium also actively participates in HealthData@EU, which aims to create a common European space for the secure sharing and use of health data.

The Institut national d'assurance maladie-invalidité (INAMI), the federal body responsible for healthcare reimbursement and relations with healthcare providers, has published an inter-federal action plan for the period 2025-2027. This roadmap has been drawn up jointly with all players in the Belgian e-health ecosystem, within the framework of inter-federal governance. It aims to put into operation the BIHR (Belgian Integrated Health Record), an integrated patient record that can be consulted by professionals and citizens alike. The eHealth platform is also continuing to develop its basic services, in order to be able to develop specific e-health projects in the future.

How do I access the Belgian market?

1. Rely on the basic criteria of eHealth

The BCSS (Banque carrefour de la sécurité sociale) and ehealth platforms form the core services of digital health. Any innovation, in order to ensure its usability, must take into account the standard criteria of operability. The list of these criteria can be found on the ehealth platform website.
90% of Belgian hospitals and healthcare professionals use the ehealth platform to choose their healthcare software. It contains a catalogue of digital health solutions available in Belgium and their compatibility with its core services.

2. Obtain market authorization from the Federal Agency for Medicines and Health Products

The Federal Agency for Medicines and Health Products (FAMHP) is responsible for the quality, safety and efficacy of medicines and health products present in Belgium, from when they are conceived to when they are used.
The first step in accessing the Belgian market is compliance with CE marking and EU regulations.
In the case of health applications, notification with the FAMHP is required for reimbursement - not strictly market access.

More information here.

3. Follow the three steps to market access on the BeMedTech platform

The Belgian federal government has created a platform, operated by BeMedTech, that allows three-step access to the Belgian market for mobile health applications.

  1. The FAMHP either recognises the solution as a medical device (MD) or denies it.
  2. The ehealth platform recognises the interoperability and technical compliance of the MD with the Belgian healthcare system
  3. The RIZIV-INAMI may allow temporary (for innovative devices) or permanent reimbursement of the MD

More information here

4. Request reimbursement to the INAMI

Reimbursement of mobile health applications in Belgium is now managed through a purely public procedure. The process involves three steps :

  1. The application must be notified with the FAMHP, so it is published on their public web portal of medical devices.
  2. The applicant must complete a self-declaration regarding the minimal technical criteria published by the eHealth platform. This form is available on the INAMI website and must be submitted together with the reimbursement request.
  3. A reimbursement request must be submitted to RIZIV-INAMI using the template available on their website. INAMI will coordinate an evaluation by a multidisciplinary working group, which may result in temporary or permanent reimbursement.

INAMI also offers pre-submission meetings for applicants to support them in the preparation of their reimbursement requests.

Consult all forms and additional information for reimbursement on this website

Digital health in Belgium is built on a highly structured governance system that brings together federal authorities, regions, communities, and public organizations to improve access to healthcare and enhance the quality of services. This framework enables the coordination of digital health initiatives at the national level while addressing the needs of patients, healthcare professionals, and healthcare institutions. Patients are at the heart of this transformation, which is driven by the secure exchange of data and the development of increasingly advanced digital tools.

Belgian eHealth has been developed around platforms designed to facilitate the exchange of information among the various stakeholders involved in the care pathway. The eHealth platform forms the cornerstone of this strategy by promoting interoperability between digital services and tools. Through the eHealth platform, healthcare professionals, care providers, and institutions can access reliable data while complying with high security standards.

The secure sharing of health data is also organized through several regional health networks. The Walloon Health Network and the Brussels Health Network play an active role in coordinating healthcare services by enabling healthcare professionals and patients to access and exchange essential medical information.

These platforms facilitate access to electronic medical records and support the deployment of the Belgian Integrated Health Record (IHR). This approach helps strengthen continuity of care, improve the services offered to patients, and optimize healthcare professionals' workflows.

The National Institute for Health and Disability Insurance (NIHDI/RIZIV-INAMI) plays a major role in the development of digital health in Belgium. As a key actor in the health insurance system, NIHDI leads several initiatives related to eHealth and the modernization of the Belgian healthcare system. Its eHealth Action Plan is part of a coordinated long-term vision developed in collaboration with public authorities.

Belgium continues to pursue several key priorities: improving data exchange, strengthening platform interoperability, simplifying services for healthcare professionals and patients, and encouraging the adoption of new digital tools.

Belgium also actively participates in European initiatives aimed at strengthening the secure use of health data. The development of the European Health Data Space (EHDS) is part of the broader European regulatory framework governing the sharing of health information. This momentum supports innovation, research, and the creation of new high-value digital services. It also enhances the attractiveness of the Belgian healthcare ecosystem within Europe and fosters the emergence of digital solutions capable of delivering long-term improvements in healthcare.

G_NIUS supports innovators seeking to understand Belgium’s digital health landscape and accelerate the development of their solutions. G_NIUS helps identify opportunities related to the eHealth platform, NIHDI, health data exchange platforms, and the eHealth Action Plan. This support enables project leaders to better understand the expectations of healthcare professionals, integrate their digital innovations into the Belgian eHealth environment, and create services tailored to the real needs of patients and the healthcare sector as a whole.

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