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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
Regulatory considerations to keep pace with innovation in digital health products
John Torous1, Ariel D Stern2,3,4, Florence T Bourgeois4,5,6
1Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. jtorous@bidmc.harvard.edu.
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 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.
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