As of January 2021, the Belgian national institute for health and disability insurance (RIZIV/INAMI) has decided that eHealth apps can receive reimbursement. As a result of this, there has been a lack of clarity about the new possibilities in Belgium. A possibility has indeed opened up where medical device apps can be reimbursed. In order to get reimbursed, eHealth apps need to be CE-certified, have an integrated safe information flow with other Belgian healthcare organizations, and have a proven effectiveness—both socially and economically.
There has been some unclarity with regards to eHealth reimbursement in Belgium. eHealth startups can only apply to get reimbursed within the framework of the National Institute for Health and Disability Insurance (RIZIV). This possibility was introduced in January 2021.
Reimbursement for medical devices in Belgium
eHealth can help healthcare professionals deliver care remotely and in a personalized way. Sometimes, treatments may even be fully digitized, resulting in a reduction of the overall costs of care. Covid-19 has demonstrated and reinforced the value of eHealth for the healthcare industry. However, reimbursement for eHealth solutions can in practice be rather complex and difficult to obtain. According to Marleen Louagie, head of medical directorate at RIZIV: “The financing [of medical apps] is important to give the right care in the right way to the patient”. In many countries, structural reimbursement routes for eHealth solutions have yet to be integrated in the reimbursement system. In January, the National Institute for Health and Disability Insurance (RIZIV) in Belgium decided that medical apps can now be submitted for reimbursement. In doing so, entering the Belgian healthcare market has become an attractive strategy for eHealth startups.
‘It’s great to see how Belgium is progressing to ensure sustainable financing for eHealth applications. We hope that many eHealth startups will be able to gather the required evidence to use this route to be able to help as many people as possible.’ Managing Director Medscaler, Nino Bellengé.
What should an eHealth startup do in order to get reimbursed?
In order to get reimbursed, medical apps have to get to the highest level of the mHealthBelgium validation pyramid (figure 1). mHealthBelgium is an online platform which categorizes medical apps, so that healthcare professionals and patients can view the current status of apps regarding safety and efficacy. Their validation pyramid categorizes eHealth apps in three levels, each with different requirements:
• M1, the first level, is controlled by the Federal Agency for Medicine and Health Products (FAMHP). They oversee the safety, effectiveness and quality of medicines and medical devices. Apps will be submitted to this level if they are CE-certified, registered at the FAMHP and if they work in line with the General Data Protection Regulation (GDPR). Once admitted to M1, apps can apply for M2.
• M2 is controlled by the Belgium eHealth platform called eGezondheid, a Belgian federal government agency. They ensure an organized and safe information exchange between different care actors. Apps in M2 should prove that they have an integrated information flow with other Belgian organizations, while ensuring the safety of the data.
• M3, the highest level, is controlled by the RIZIV. If a medical app is admitted to level 3, they are reimbursed. The RIZIV is responsible for the reimbursement of medicines and medical devices. To get into M3, apps have to meet all criteria of M1 and M2 and have a proven effectiveness, both socially and economically.
Figure 1: The validation pyramid of mHealthBelgium. Each level is controlled by a different organization (to the left) and has different requirements (to the right). Adapted from mHealthBelgium.be[i]
Up until recently, level M3 was not in place. However, with the decision on implementing the reimbursement framework from the Committee Health Insurance of the RIZIV, applications can now apply to be reimbursed. Currently, 18 apps have been admitted in level M1, and 8 apps in M2. With the M3 level going live, these 8 apps can apply to be reimbursed by demonstrating their social and economic effectiveness.
Would you like to know what the implications of this new opportunity are for your solution? Are you considering entering the Belgium market, or do you want to know how these processes are structured in other countries? Feel free to each out to us with your questions. At MedScaler we offer a standardized approach for market introductions of medical devices and eHealth solutions.
 De specialist, Medische apps vanaf nu terugbetaalbaar, validatiepiratmide mHealthBelgium klaar. 21 Januari 2021. https://www.despecialist.eu/nl/nieuws/e-health/medische-apps-vanaf-nu-terugbetaalbaar-validatiepiramide-mhealthbelgium-klaar.html
 mHealthBelgium, The validation Pyramid.