First app in level M3 of validation pyramid

18/04/2022

"Medical apps will be given a full role in our health care mechanism."

BRUSSELS, 19/04/2022 – With moveUP, the Riziv officially reimburses the use of a medical app in healthcare for the first time. The rehabilitation app has been provisionally funded for some time, but will now be the first app at the third and highest validation level of mHealthBelgium. Apps at that level can count on government funding. “This is a new step forward for patient-centered care in our country”, Steven Vandeput, coordinator of mHealthBelgium, is satisfied. Two other apps are in the pipeline for funding, one on sleep therapy and one on oncology.

 

Since January 2021, there is a regulatory framework for the financing of medical apps in Belgium. With moveUP, a first app was already reimbursed, but the app had not yet been admitted to level M3 of the mHealthBelgium validation pyramid (see box). That is now about to change: moveUP will be the very first app in our country to be officially reimbursed by the Riziv. The application is used to support patients who have had a knee or hip prosthesis during their rehabilitation.

Medical apps that are still collecting data about their health-economic added value can already count on provisional funding via level M3. In this way, patients can enjoy the benefits faster, a system that is also used, for example, for innovative medicine

The third level of the validation pyramid is also divided into two categories: M3- and M3+. Medical apps that are still collecting data about their health-economic added value can already qualify for provisional financing via level M3 ("M3 light"). In this way, patients can enjoy the benefits faster, a system that is also used, for example, for innovative medicines. moveUP falls into that category. Once an app from M3 has proven its added value, it can end up in category M3+ and be reimbursed on a structural basis.

pyramid en

Don't just say "reimbursement"

There are also some other apps in the pipeline for level M3 funding. Two of them have since received a positive evaluation from the government, one for sleep therapy and one for oncology. The NIHDI is currently reworking the care pathways for sleep therapy and oncology to make room for the use of the conscious apps. It is crucial that an app should always be seen in a broader care process. The government will never “refund” an application per se, but will reimburse its use within a certain care process. This often requires an adjustment to the financing of the care process in question. In the coming months and years, the government is expected to rethink various health care processes to formalize the use of medical apps and other forms of digital health technology.

Rules clarified

Finally, the definition of m-health has been tightened up. With this, the government wants to provide more clarity to manufacturers and distributors of medical apps in Belgium. Until now, it was not always clear to them which criteria an app should or should not meet. Sector federations beMedTech and Agoria therefore urged clarification from the concerned health administrations. According to the updated definition, a mobile medical application is “a software application with a medical purpose that is CE marked as a medical device and that allows a patient to share health-related information with a healthcare provider from his or her own environment”. Apps to be eligible for funding must meet an additional criterion: they must “allow a healthcare professional to remotely diagnose, administer therapy, or monitor a patient through a medical device designed is for use by the patient in his own environment”.

31 medical apps reimbursed in Germany

With this new step, Belgium confirms its international pioneering role in the field of “m-health”. Our country was one of the first countries in Europe to develop an official framework for the reimbursement of medical apps, together with Germany and France. In Germany, the government already reimburses 31 medical apps as part of a healthcare process.

Validation pyramid: international praise

Belgium assesses medical apps on the basis of a validation pyramid. The pyramid has three levels: M1, M2 and M3. The higher apps want to get in the pyramid, the stricter the conditions they have to meet. Applications that reach the top of the pyramid (level M3) can count on government funding. Our country has already garnered a lot of praise internationally with its validation model for m-health applications.

The pyramid is an initiative of the public-private platform mHealthBelgium, which is led by beMedTech and Agoria as sector federations and the Riziv, the FAMHP and the eHealth platform as health administrations. The platform aims to give reliable medical apps an official place in Belgian healthcare. On the one hand, it wants to guide healthcare providers and patients through the proliferation of apps and, on the other hand, it wants to clearly explain to companies which conditions medical apps must meet on the Belgian market.

More info?

Contact mHealthBelgium via:

  • Steven Vandeput, beMedTech, This email address is being protected from spambots. You need JavaScript enabled to view it., +32 485 00 48 18
  • Alexander Olbrechts, Agoria, This email address is being protected from spambots. You need JavaScript enabled to view it., +32 474 52 17 86

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