Advancing digital health: FDA innovation during COVID-19

Advancing digital health: FDA innovation during COVID-19

Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital he...

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Bibliographic Details
Main Authors: Kushal Kadakia, Bakul Patel, Anand Shah
Format: Article
Language:English
Published: Nature Publishing Group 2020-12-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-020-00371-7
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spelling doaj-e6cd3676b6b641c1a1a0670ff13db78c2021-02-23T09:42:39ZengNature Publishing Groupnpj Digital Medicine2398-63522020-12-01311310.1038/s41746-020-00371-7Advancing digital health: FDA innovation during COVID-19Kushal Kadakia0Bakul Patel1Anand Shah2U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationU.S. Food and Drug AdministrationDigital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guidance documents to expand the use of digital therapeutics for psychiatric disorders and medical devices for remote patient monitoring. In this article, we contextualize these policies to the agency’s existing regulatory framework for digital health, outline key considerations for patients and health care providers, and identify implications for the future of digital health innovation.https://doi.org/10.1038/s41746-020-00371-7
collection DOAJ
language English
format Article
sources DOAJ
author Kushal Kadakia
Bakul Patel
Anand Shah
spellingShingle Kushal Kadakia
Bakul Patel
Anand Shah
Advancing digital health: FDA innovation during COVID-19
npj Digital Medicine
author_facet Kushal Kadakia
Bakul Patel
Anand Shah
author_sort Kushal Kadakia
title Advancing digital health: FDA innovation during COVID-19
title_short Advancing digital health: FDA innovation during COVID-19
title_full Advancing digital health: FDA innovation during COVID-19
title_fullStr Advancing digital health: FDA innovation during COVID-19
title_full_unstemmed Advancing digital health: FDA innovation during COVID-19
title_sort advancing digital health: fda innovation during covid-19
publisher Nature Publishing Group
series npj Digital Medicine
issn 2398-6352
publishDate 2020-12-01
description Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guidance documents to expand the use of digital therapeutics for psychiatric disorders and medical devices for remote patient monitoring. In this article, we contextualize these policies to the agency’s existing regulatory framework for digital health, outline key considerations for patients and health care providers, and identify implications for the future of digital health innovation.
url https://doi.org/10.1038/s41746-020-00371-7
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AT bakulpatel advancingdigitalhealthfdainnovationduringcovid19
AT anandshah advancingdigitalhealthfdainnovationduringcovid19
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