Regulatory considerations to keep pace with innovation in digital health products

Abstract Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the...

Full description

Bibliographic Details
Main Authors: John Torous, Ariel D. Stern, Florence T. Bourgeois
Format: Article
Language:English
Published: Nature Portfolio 2022-08-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-022-00668-9