Digital healthcare in Belgium

Key figures

11,5 M

inhabitants

11.6% of GDP

of healthcare expenditure in 2020

6

federated entities (composed of 3 regions and 3 communities)

A federal state made up of communities and regions

The healthcare 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 organizational rules, regulation of healthcare products and activities, healthcare professionals and patients' rights.

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

Meeting the ambassadors

The digital healthcare sector is developing around two data exchange platforms

There are many players in the healthcare sector in Belgium. Each of them applies its own working methods for collecting and recording healthcare data.
The digital health sector is developing from two free data exchange platforms made available by the state. The Banque Carrefour de la sécurité sociale is the skeleton enabling information exchanges from one social sector to another, and the platform ehealth, specialized in healthcare, offers services facilitating exchanges between players in the healthcare ecosystem.
All Belgian residents have an electronic identity with which they can access their digital health space. This interface gives them control over their data.

How do you access the Belgian market?

1. Take into account the functional and modular criteria of the ehealth core platform

The BCSS and ehealth platforms form the core services of digital healthcare. Any innovation, to ensure its usability, must take into account reference operability criteria. 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 listing the digital healthcare 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 on Belgian territory from conception to use.
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 provides three-step access to the Belgian market for healthcare mobile apps.

  1. The FAMHP may or may not recognize the solution as a medical device (MD)
  2. The ehealth platform recognizes the interoperability and technical compliance of the DM with the Belgian healthcare system
  3. INAMI may allow temporary or definitive reimbursement of the DM

More information here

Government authorities and platforms

They are the guarantors of smooth operation and cooperation in 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: the Belgian platform for CE marked mobile applications as medical devices 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

They bring companies together and facilitate their incubation

.
Hospitals.be (Belgian Association for Hospitals) : contributes to the Belgian hospital science’s progress and development. Verbond van de Private Ziekenhuizen van België (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.

Support and innovation initiatives

They bring together and facilitate the incubation of new technologies

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

Training

Universities and their groups that train and support digital healthcare 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.