Regulatory considerations to keep pace with innovation in digital health products

John Torous; Ariel D Stern; Florence T Bourgeois

doi:10.1038/s41746-022-00668-9

Regulatory considerations to keep pace with innovation in digital health products

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

Authors

John Torous¹, Ariel D Stern^{2

3

4}, Florence T Bourgeois^{4

5

6}

Affiliations

¹ Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. jtorous@bidmc.harvard.edu.
² Harvard Business School, Boston, MA, USA.
³ Digital Health Center, Hasso Plattner Institute, Potsdam, Germany.
⁴ Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA.
⁵ Computational Health Informatics Program (CHIP), Boston Children's Hospital, Boston, MA, USA.
⁶ Department of Pediatrics, Harvard Medical School, Boston, MA, USA.

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.

Publication types

Review