Torous, JohnStern, ArielBourgeois, Florence T.2023-04-192022-08-19Torous, John, Ariel Dora Stern, and Florence T. Bourgeois. "Regulatory Considerations to Keep Pace with Innovation in Digital Health Products." npj Digital Medicine 5, no. 121 (August 2022).2398-6352https://nrs.harvard.edu/URN-3:HUL.INSTREPOS:37374849Rapid 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.en-USHealth Information ManagementHealth InformaticsComputer Science ApplicationsMedicine (miscellaneous)Journal Article2023-04-1910.1038/s41746-022-00668-9