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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Autores principales:	Kushal Kadakia, Bakul Patel, Anand Shah
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/e6cd3676b6b641c1a1a0670ff13db78c
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spelling	oai:doaj.org-article:e6cd3676b6b641c1a1a0670ff13db78c2021-12-02T11:02:39ZAdvancing digital health: FDA innovation during COVID-1910.1038/s41746-020-00371-72398-6352https://doaj.org/article/e6cd3676b6b641c1a1a0670ff13db78c2020-12-01T00:00:00Zhttps://doi.org/10.1038/s41746-020-00371-7https://doaj.org/toc/2398-6352Digital 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.Kushal KadakiaBakul PatelAnand ShahNature PortfolioarticleComputer applications to medicine. Medical informaticsR858-859.7ENnpj Digital Medicine, Vol 3, Iss 1, Pp 1-3 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Computer applications to medicine. Medical informatics R858-859.7
spellingShingle	Computer applications to medicine. Medical informatics R858-859.7 Kushal Kadakia Bakul Patel Anand Shah Advancing digital health: FDA innovation during COVID-19
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.
format	article
author	Kushal Kadakia Bakul Patel Anand Shah
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 Portfolio
publishDate	2020
url	https://doaj.org/article/e6cd3676b6b641c1a1a0670ff13db78c
work_keys_str_mv	AT kushalkadakia advancingdigitalhealthfdainnovationduringcovid19 AT bakulpatel advancingdigitalhealthfdainnovationduringcovid19 AT anandshah advancingdigitalhealthfdainnovationduringcovid19
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Advancing digital health: FDA innovation during COVID-19

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