Regulatory considerations to keep pace with innovation in digital health products

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 evolutio...

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Detalles Bibliográficos
Autores principales: Torous, John, Stern, Ariel D., Bourgeois, Florence T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9390099/
https://www.ncbi.nlm.nih.gov/pubmed/35986056
http://dx.doi.org/10.1038/s41746-022-00668-9
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author Torous, John
Stern, Ariel D.
Bourgeois, Florence T.
author_facet Torous, John
Stern, Ariel D.
Bourgeois, Florence T.
author_sort Torous, John
collection PubMed
description 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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spelling pubmed-93900992022-08-21 Regulatory considerations to keep pace with innovation in digital health products Torous, John Stern, Ariel D. Bourgeois, Florence T. NPJ Digit Med Perspective 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. Nature Publishing Group UK 2022-08-19 /pmc/articles/PMC9390099/ /pubmed/35986056 http://dx.doi.org/10.1038/s41746-022-00668-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Perspective
Torous, John
Stern, Ariel D.
Bourgeois, Florence T.
Regulatory considerations to keep pace with innovation in digital health products
title Regulatory considerations to keep pace with innovation in digital health products
title_full Regulatory considerations to keep pace with innovation in digital health products
title_fullStr Regulatory considerations to keep pace with innovation in digital health products
title_full_unstemmed Regulatory considerations to keep pace with innovation in digital health products
title_short Regulatory considerations to keep pace with innovation in digital health products
title_sort regulatory considerations to keep pace with innovation in digital health products
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9390099/
https://www.ncbi.nlm.nih.gov/pubmed/35986056
http://dx.doi.org/10.1038/s41746-022-00668-9
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