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.