(Springer Science and Business Media LLC, 2022-08-19) Torous, John; Stern, Ariel; Bourgeois, Florence T.
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 evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.
