Great news from Belgium: seven telemonitoring applications reached the highest level of the mHealthBelgium validation pyramid (level 3+) in February 2025.
This means the apps can be reimbursed on a regular basis by the Belgian health insurance system (INAMI/RIZIV) as part of a specific care pathway for chronic heart failure.
The following apps have been newly added:
The mHealthBelgium validation pyramid is the Belgian counterpart to the German DiGA approval procedure and is based on 3 levels.
Level 1 – CE certification as a medical device
Level 2 – meeting additional IT criteria + application for reimbursement submitted
Level 3 – app is reimbursed as part of a specific care pathway:
Level 3- (“light”) = provisional reimbursement for apps still collecting data
Level 3+ (“plus”) = permanent reimbursement for apps with proven benefit
Further information on the approval of digital health applications in Belgium is available in our expert article: DiGA in Belgium – Approval of Digital Health Applications