28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive proliferation of mental and behavioural health apps and associated marketing claims. 

We are particularly concerned about one component of this sector, namely “software as a medical device”, which the 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.”

Read Health Affairs article