mHealthBELGIUM is the Belgian platform for mobile applications that are CE-marked as a medical device.

New since 2024:

  • Changed management: beMedTech and Agoria continue without government support
  • Slightly different interpretation of the pyramid with facelift for level 2
  • More info and transparency on reimbursement phase per app

Latest news

19/04/2022

First app in level M3 of validation pyramid

06/10/2021

Welcome to the Nucleus Smart App by Cochlear on M2!

19/08/2021

FreeStyle Libre Flash Glucose Monitoring System to level M2!

Latest news

19/04/2022

First app in level M3 of validation pyramid

06/10/2021

Welcome to the Nucleus Smart App by Cochlear on M2!

19/08/2021

FreeStyle Libre Flash Glucose Monitoring System to level M2!

mHealthBelgium, also known as mobile health Belgium, is the Belgian platform for mobile apps that are CE-marked as a medical device.

This unique platform centralizes all relevant and necessary information about mobile medical applications that meet criteria imposed by the federal government. Its main goal is to guide citizens, healthcare providers and healthcare institutions in the huge amount of apps (applications) that exist within our healthcare, for all kinds of purposes (diagnostics, therapy, monitoring, prognosis, prediction, prevention, ...) and in all kinds of pathology or therapeutic domains.

On this website you will find information on the following questions, among others:

  • How does the funding of mobile medical apps work in Belgium?
  • What exactly are the government criteria?
  • Which apps with medical claims exist in domain x?
  • What does a particular app do or claim? Who is it intended for?
  • Is a particular app funded by the federal government, or is funding under preparation? And to what care path does it apply?
  • If so, how exactly does a particular app meet the criteria imposed by the government?

This information is provided in 3 languages (Dutch, French, English).

3-level validation pyramid

mHealthBelgium is structured as a 3-level validation pyramid. An application always enters at the lowest level M1 and can climb up the hierarchy via level M2 to the top level M3. Details on this can be found here.

 

Level 3 plus

I have fully proven my social-economic value and I am definitely financed by NIHDI

Level 3 light

I am in the process of proving my social-economic value and I am temporarily financed by NIHDI

Level 2

I submitted a reimbursement request to NIHDI, which is eligible.

Level 1

I am a CE certified medical device

Management by beMedTech and Agoria

mHealthBelgium is managed by sector federations beMedTech (sector federation of the medical technologies industry) and Agoria (sector federation of the technology industry).

It started in 2018 as an initiative of the Belgian federal government after then Health Minister Maggie De Block subsidized 24 pilot projects to investigate and validate the added value of mhealth in Belgian healthcare.

3 government agencies were involved and each worked out 1 level of the pyramid:

  • FAMHP: Federal Agency for Medicines and Health Products, the competent authority for everything to do with safety, quality as well as efficacy and effectiveness of medicines and medical devices. Responsible for criteria within level M1.
  • eHealth platform: a federal government institution whose mission is to promote and support a well-organized, mutual electronic service and information exchange between all healthcare actors, with the necessary guarantees in terms of information security, protection of patient and healthcare provider privacy and respect for medical confidentiality. Responsible for defining the ICT criteria that originally determined level M2.
  • NIHDI: National Institute for Health and Disability Insurance responsible for the reimbursement of medicines, medical devices and benefits in kind. Responsible for the procedure and decision around financing and reimbursement, also regarding mhealth applications, and thus for M3.

mHealthBelgium 2.0 as of 2024

At the end of 2023, the collaboration between the NIHDI, beMedTech and Agoria to manage the platform came to an end. Sector federations beMedTech and Agoria are joining forces to continue the platform.

In a nutshell what stays or changes:

  • The 3-level pyramid will remain.
  • Levels 1 and 3 will be completed exactly the same as before
  • Level 2 gets a facelift, adapted to the updated NIHDI procedure.
  • Detail pages per application remain and are even expanded, e.g. with information on use and reimbursement in surrounding countries.
  • Care processes for which the financing was/will be adapted in such a way that the digital tools will also be financed are listed more clearly: 'under construction' vs. 'active' vs. 'inactive'.