Health Affairs February 28, 2022
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...
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