FDA adapting regulations for digital tech

FDA Commissioner Scott Gottlieb Thursday announced initiatives that are intended to facilitate the integration of digital technology into healthcare, including the testing, use and postmarket safety monitoring of drugs.

Speaking at the Health Datapalooza conference, Gottlieb acknowledged that FDA’s "traditional approach to medical product regulation is not always well suited to emerging technologies like digital health, or the rapid pace of change in this area." He outlined strategies the agency is adopting in response to the ubiquity of smartphones, and discussed the challenges and opportunities posed by technologies such as artificial intelligence and clinical decision support software...