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Review
. 2022 Aug 19;5(1):121.
doi: 10.1038/s41746-022-00668-9.

Regulatory considerations to keep pace with innovation in digital health products

John Torous  1 , Ariel D Stern  2   3   4 , Florence T Bourgeois  4   5   6
Affiliations
Review

Regulatory considerations to keep pace with innovation in digital health products

John Torous et al. NPJ Digit Med. .

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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Conflict of interest statement

The authors declare no competing interests. A.D.S. is a member of the Scientific Advisory Board of the German Society for Digital Medicine and a member of the Strategic Advisory Board of HumanFirst. She declares consulting income from the U.S. Department of Health and Human Services unrelated to the topic of this article. F.T.B. is a Co-Director of the Harvard-MIT Center for Regulatory Science and receives support from the Center unrelated to the current work. J.T. is a co-founder of Precision Mental Wellness, unrelated to this work. J.T. is an Associate Editor of npj Digital Medicine.

References

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