When Software Becomes Medicine: Ignoring It May Soon Be Malpractice.

Abstract

The convergence of mobile software, artificial intelligence, and biomedical science is ushering in a new era of precision medicine, defined not only by personalization but by real-time adaptability. This shift is exemplified by the evolution of Prescription Digital Therapeutics (PDTs): smartphone-based applications that treat a disease or condition and are regulated in the US by the FDA. Early PDTs (PDT 1.0) such as reSET for substance use disorder, reSET-O for opioid use disorder, and Somryst f