US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

A Rhode Island patient advocacy group for chronic pain sufferers has petitioned the US Food and Drug Administration to classify and regulate a proprietary risk-scoring algorithm from Boston-based Bamboo Health as a software as a medical device, or SaMD.

SaMD, according to the FDA, is software that is separate from the hardware of a medical device, that collects, analyzes, or displays medical information to diagnose,...