It was announced last week by Belgium’s National Institute for Health and Disability Insurance (Rijksinstituut voor Ziekte- en Invaliditeitsverzekering [RIZIV] / Institut National d’Assurance Maladie-Invalidité [INAMI]) and the Belgian Federation of the medical technology industry (beMedTech) that medical apps can now be reimbursed in Belgium. Companies can now submit data showing that their medical apps provide clinical and socio-economic value to end-users. This development means that medical apps can now get M3 classification, which is the third and highest level of the validation pyramid on the mHealthBelgium platform. The M1 level was launched in 2019 and medical apps that have this basic classification are approved as CE marked medical devices, comply with General Data Protection Regulation (GDPR), and are entered into the Federal Agency for Medicines and Health Products (FAMHP) database. The M2 level was launched in May 2020 and apps can achieve this classification if they meet certain M1 criteria as well as others in user identification and authentication, interoperability, and data protection. Apps can only be submitted for M3 or reimbursement once M1 and M2 have been met, and if they demonstrate clinical and socio-economic value (Figure 1).
The mHealthBelgium platform was created in 2018 and contains information about CE-marked apps intended for patients, healthcare professionals (HCPs), or healthcare institutions, such as data protection, security, data interoperability, and how they are financed. mHealthBelgium is managed by beMedTech and the Belgian Federation of Technology Companies (Agoria), in collaboration with three public entities: FAMHP, the competent authority for the safety, quality, effectiveness, and efficiency of drugs and medical devices, is responsible for level M1; the eHealth platform is a federal public institution devoted to the secure exchange of health data and is responsible for level M2; INAMI, which is responsible for the financing of drugs, medical devices, and benefits of health insurance in Belgium, is responsible level M3 (Figure 1).
Figure 1: mHealthBelgium Validation Pyramid for Health Applications.
Source: GlobalData; adapted from mHealthBelgium, 2021.
Currently, 25 medical apps have received M1 classification, of which seven are also classed as level M2 apps, of which seven are also classed as level M2 apps (Table 1).
The apps span a range of uses and can be used by patients, HCPs, and caregivers, and can be used in prevention and diagnosis, treatment, and follow-up, as well as online medical education. Specific uses include screening for heart conditions, tracking chronic diseases such as diabetes, remote patient monitoring and telemedicine, collection of PRO data, and improving communication between patients and their HCPs.
The ongoing revolution in digital health seen in many countries has no doubt been accelerated by the Covid-19 pandemic. Rapid adoption, innovation, and unprecedented demand have been witnessed since early 2020, particularly in telehealth and virtual care. In Europe, several countries introduced temporary changes to reimbursement policies for telemedicine. In Belgium, for example, INAMI approved this in March 2020 where doctors are reimbursed when they triage and support people who may be infected with Covid-19 and also when they provide continuity of care for other patients, particularly those with chronic conditions who are unable to see their doctor.
This new reimbursement framework is a significant milestone in the Belgian government’s 2015–2018 eHealth plan to integrate medical apps into the country’s healthcare system and increase access to these tools for patients and HCPs alike. It will also help drive the ongoing digital transformation of healthcare and enable Belgium to join other pioneering countries in Europe for digital health, such as Germany.