mhealth

The reimbursement pathway for digital mobile health applications in Belgium

Digital health is an umbrella term for the use of digital technologies to improve health. Digital health refers to concepts of eHealth, mobile health (mHealth) and developments in big data and new technology. Digital health tools range from mobile medical apps and software that support the clinical decisions to artificial intelligence and machine learning in healthcare.

Belgium is considered as one of Europe’s frontrunners in mHealth. Together with Germany and France, it was one of the first countries in Europe developing an official framework for the reimbursement of mobile health apps. mHealthBelgium, also known as mobile health Belgium, is the Belgian platform for mobile apps that are CE-marked as a medical device. mHealthBelgium is a public-private platform which is led by the sector federations beMedTech and Agoria and the health administrations RIZIV, the FAMHP and the eHealth platform.

Within the mHealthBelgium framework, an mHealth application is defined as software application with a medical purpose that (1) has a CE-marking as medical device and (2) allows a patient to share from his/her own environment health related information (with or without sensors) with a healthcare professional.

The health app regulatory framework for financing of medical apps was announced in January 2021. This framework consists of a so-called ‘validation pyramid’ with 3 levels. Apps at level 3 are eligible for government funding.

  • Level 1 (M1) determines the basic criteria for an app: CE-marking, compliance with the European data protection regulations (GDPR), and product notification in the database of the Federal Agency for Medicines and Health Products of Belgium.
  • Level 2 (M2) is based on the interoperability and connectivity to the basic services of the eHealth platform. Manufacturers must demonstrate all the requirements of level 1 and the app must have been submitted to a risk assessment. They must proof to meet all imposed criteria regarding authentication, security and the use of local e-health services by means of standardised tests (if applicable).
  • Level 3 (M3) is the highest level of the pyramid that regulates reimbursement of mHealth apps. Manufacturers must demonstrate all the requirements of level 2. In addition, the app must allow a healthcare professional to diagnose, to apply a therapy or to monitor a patient, all  from a distance via a medical device made for use by the patient in his/her own environment

The 3rd level is divided in two categories

  • Level M3 (M3 light): medical apps that are in the process of collecting data about their health-economic added value can already qualify for provisional financing.
  • Level M3+: once an app from M3 has proven its added value, it can end up in category M3+and be reimbursed on a structural basis. The government does not finance an application per se, but will reimburse its use within a certain care process.

MoveUP is the first mobile health application to be reimbursed in Belgium. On July 4th 2022, we counted one app in level 3, twelve in level 2 and twenty-three in level 1 (https://mhealthbelgium.be/apps). In comparison, Germany counts almost 32 DiGAs (digitale Gesundheitsanwendung) approved for reimbursement, either provisionally or permanently (https://diga.bfarm.de/de/verzeichnis).

 

Do you need a situation analysis or strategic advice about market access approaches for your digital health tool? Our market access consultants and health economic experts can support your for market access in Belgium, the Netherlands, Spain, Italy, the Nordics and other EU countries.

Contact us (b.dhaene@hm3a.eu) for more information.