The digital evolution in healthcare is making significant progress. Digital tools intended to deliver therapy via digital means are rapidly evolving. These Digital Therapeutics (DTx) applications deliver evidence-based therapeutic interventions to patients to prevent, manage or treat a medical disorder or disease, with a wide variety of purposes. The nature of Digital Therapeutics is hence characterized by its software-driven therapy, differentiating them from other digital health applications that rather support or monitor the patient without delivering therapy. Digital therapeutics are designed and manufactured according to the latest standards for medical devices and comply with the European Union’s Medical Device Regulation (EU MDR), hence being CE-certified as medical device. This means that they have proven their effectivity (being in line with medical device requirements based on strict clinical validations) as well as their safety and performance. In the Belgian medical device landscape, there is a lot of innovation going on in DTx and several concrete examples are given in the paper. DTx strengthen the patient engagement for their therapeutic pathway under guidance of a healthcare professional. Rethinking the financing of such pathway is crucial to accelerate adoption and incentivize the possible use of DTx, rewarding the value they bring, ranging from improved quality of care and of life, to more personalized therapeutic approaches and healthcare savings. Therefore, government initiatives should be taken to stimulate the adoption of DTx in the healthcare system as surrounding countries are doing nowadays. The Belgian healthcare authorities created the mHealthBelgium validation pyramid for mobile health applications, consisting of 3 levels and being the unique path towards national reimbursement for the use of such digital tools within a care path. Why not applying the mHealthBelgium pyramid framework for more than pure mhealth applications, but embrace all DTx applications used by patients?
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