Digital Therapeutics Should Be Regulated With Gold-Standard Evidence

"There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive proliferation of mental and behavioral health apps and associated marketing claims. We are particularly concerned about one component of this sector, namely “software as a medical device”, which the Food and Drug Administration (FDA) defines as “software intended to be used for one or more medical purposes,….without being part of a hardware medical device,” and where the purpose is “treatment or alleviation of disease.” This new approach to treatment, increasingly referred to as digital therapeutics (DTx), has the potential to transform mental health care. The global DTx market was valued at more than $3.5 billion in 2020 and is projected to reach $23.5 billion by 2030. According to industry reporting, the largest number of DTx programs today are related to mental health, and most FDA submissions for DTx use cognitive behavioral therapy to promote behavior change in conditions ranging from insomnia to substance use disorder. The opportunity for innovation is clear. However, there are challenges that must be addressed.

A Problem, But One With A Known Solution

A central problem is that there continues to be significant confusion, amongst both clinicians and payers, about what constitutes a digital therapeutic versus a wellness app. Consequently, there is pressing need to firmly establish standards of evidence generation that differentiate DTx as treatments from products that may support mental well-being but lack the potential of DTx to transform the mental health treatment landscape..." Lire la suite