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. 

Government authorities and platforms

Monitor national digital health stratgies, ensure efficient operation and cooperation within the healthcare system

National Institute for Health and Disability Insurance: manages health insurance funds Federal Agency for Medicines and Health Products (FAMHP) The Social Security Crossroads Bank: it allows the decentralised recording and the well-organised and secure exchange of data between social security institutions beMedTech: the Belgian federation of the medical technology industry with almost 200 companies Sciensano: a federal research institute mHealthBelgium : a private initiative by Agoria and beMedTech, serves as a public platform to promote mHealth applications to the broader public and informs about reimbursements. ehealth platform: federal public institution that enables electronic information exchange between all health care actors MaSanté: the patient interface of the Belgian health system Healthdata.be: the Belgian platform gathering individual health data collected by national and regional administrations

The associations

Federate companies and facilitate their market access

Hospitals.be (Belgian Hospital Association): contributes to the Belgian hospital science’s progress and development. Association des Hôpitaux Privés de Belgique (Belgian Association of Private Hospitals): promotes, defends and represents private healthcare establishments in Belgium. Ligue des Usagers des Services de Santé (LUSS): strives for the access to quality healthcare for everyone and enhances participation in health policies in french-speaking Belgium. Vlaams Patiënten Platform (VPP): the flemish equivalent of La LUSS Agoria: The Belgian federation of technology companies.

Hubs and innovation clusters

 Federate and facilitate the incubation of new digital health technologies 

Lifetech.brussels : hub of the Brussels Capital Region MedTech Wallonia : hub of the Walloon Region MedVia: hub of the Flemish Region Brussels Life Science Incubator (BLSI)

Training courses

Universities and their groups that offer training and support for digital health innovations 

Research Institute for Health Sciences and Technology from Mons University : interdisciplinary research group focused on improving the health system Medical Device Technology Ghent : an entrepreneur, investor, industrial network for medical innovations linked to the University of Ghent.