The telemonitoring application CardioCare@Home by Byteflies has reached the highest validation level (level 3+) for DiGA in Belgium and can be permanently reimbursed with immediate effect. It is therefore the second digital application at this level.
CardioCare@Home is used for the remote monitoring of people with chronic heart failure. The data is collected by a wearable device (CardioCare Patch) and transmitted to a healthcare provider so that they can make an informed decision. Since January 1, 2025, the app has been available in all hospitals that have joined the new agreement with INAMI/RIZIV (the Belgian national health and disability insurance institute).
The mHealthBelgium platform (launched in 2018) is the Belgian counterpart to the German DiGA approval procedure and is based on a “validation pyramid” with 3 levels (see graphic):
- Level 1: CE certification of the app as a medical device
- Level 2: additional ICT criteria & application for reimbursement to INAMI/RIZIV
- Level 3- (“minus”): temporary reimbursement, still collecting data
- Level 3+ (“plus”): permanent reimbursement, socio-economic benefits demonstrated
Further information on the approval of digital health applications in Belgium is available in our updated blog post: DiGA in Belgium – Approval of Digital Health Applications