Friday, September 18, 2020

Digital Health Applications: Debates Similar to the "LDT" Debate in Labs; Nature Digital Medicine Journal

Part of my work is in digital health, and that community of companies has debates about FDA regulation of digital health, similar to the diagnostics debates about FDA-authorized IVDs versus LDTs.

See a window into that digital regualatory debate in a recent conference summary from "Digital Therapeutics East" - article here.

A current Senate proposal, S. 3532, would allow Medicare coverage of "prescription digital therapeutics" in some circumstances (here).

Meanwhile, I note there is a new NATURE journal, NATURE DIGITAL MEDICINE, now being published.  Home page here.