eHealth in Belgium

Key figures

11.5 M


11.6% of the GDP

in health expenditures in 2020


federated entities (composed of 3 regions and 3 communities)

A federal state, composed of communities and regions

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 organisation, regulation of health products and activities, health professionals and patients' rights.  

The regions ensure regional economic development and the communities are responsible for the organisation, coordination and financing of health care. Regular inter-ministerial conferences facilitate cooperation between the communities, regions and the federal state.

A la rencontre des ambassadeurs

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.

How do you access the Belgian market?

1. Have a look at the functional and modular criteria on the national platform for ehealth

The BCSS 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 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.

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 or permanent reimbursement of the MD

More information here