BELGIUM Trends and Developments Contributed by: Thibaut D’hulst, Ilham Irgiou and Ossama M’Rini, Van Bael & Bellis
Reimbursement and Funding: Persistent Challenges and Future Directions One of the most significant remaining barriers in Belgium is the reimbursement and funding of digital health solutions. Reimbursement is for many digital health companies key to success and sustainable growth. Although certain inno- vations have seen progress in securing support, many others still struggle to obtain adequate reimbursement, hindering their broader adop- tion and integration into the healthcare system. Scaling the pyramid: reimbursement of mobile health apps in Belgium Belgium is one of the few countries in Europe that provides for reimbursement for mobile health apps. The mHealthBelgium validation pyramid, introduced in 2018, was designed to facilitate their reimbursement. It categorises apps into three levels: M1 (CE marking as a medical device), M2 (meeting interoperability and connectivity criteria), and M3 (demonstrat- ing socio-economic value for reimbursement). Level M3 has remained a high hurdle, with only a few apps able to demonstrate sufficient socio- economic impact. As of April 2025, eight health apps have reached Level 3+, entitling them to regular reimbursement – a significant increase in comparison with last year. While recent progress is encouraging, significant challenges remain. In October 2024, the Belgian House of Representatives introduced a draft resolution aimed at improving the accessibility and affordability of digital health applications. The resolution suggests that a process such as that of the German “ Fast-Track-Verfahren ”, a fast-track procedure which allows digital health applications to be approved for reimbursement within three months, could be a significant improvement on the current approach proposed by the NIHDI, marked by unclear timelines and
non-binding deadlines. This is particularly rel- evant given the challenges in demonstrating the socio-economic value of health applications, which often takes considerable time. The Ger- man model addresses this by allowing immedi- ate approval and reimbursement if patient ben- efit is proven or granting companies up to 12 months post-inclusion in the central register to demonstrate added value. New reimbursement framework for telemonitoring The NIHDI has implemented a new reimburse- ment framework to support the use of telem- onitoring in the follow-up care of patients hos- pitalised for heart failure. Under this initiative, hospitals that have established agreements with the NIHDI are eligible for reimbursement when providing remote monitoring services through dedicated telemonitoring teams. As of April 2025, 30 healthcare institutions had such agree- ments, and eight telemonitoring applications (FibriCheck, Remecare, moveUp, Healthen- tia, Comunicare, and BeWell@Home, CareLink System and Comarch), the majority of which are Belgian-developed, are approved for reimburse- ment under this scheme. This policy is based on the NIHDI’s assessment that integrating telem- onitoring into the care continuum for heart failure patients can significantly improve both the qual- While other areas are moving forward, telecon- sultations have seen a setback. As of 15 Febru- ary 2025, telephone consultations by GPs are no longer reimbursed. Video consultations remain permitted but are strictly regulated under the Royal Decree of 27 March 2025 which sets out the legal basis and guidelines for remote medi- cal care under the compulsory health insurance scheme. This decision, made primarily for budg- ity and efficiency of care delivery. Setback for teleconsultations
19
CHAMBERS.COM
Powered by FlippingBook