{"id":11695,"date":"2020-12-31T10:35:02","date_gmt":"2020-12-31T16:35:02","guid":{"rendered":"https:\/\/saluddigital.com\/?p=11695"},"modified":"2025-10-21T13:59:45","modified_gmt":"2025-10-21T19:59:45","slug":"los-avances-de-la-fda-en-salud-digital-durante-la-pandemia","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/plataformas-digitales\/los-avances-de-la-fda-en-salud-digital-durante-la-pandemia\/","title":{"rendered":"FDA advances in Digital Health during the pandemic"},"content":{"rendered":"
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The Food and Drug Administration (FDA) has implemented temporary policies for the application of innovations in Digital Health during the pandemic. In an article published in npj Digital of the scientific journal Nature, these actions and their implications for the future were identified.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The tools and services based on Digital Health became more relevant during 2020, in response to the COVID-19 pandemic. Telemedicine applied in the remote monitoring of infected or suspected patients, as well as the collection of information through symptom registration applications, were the main applications of health technologies.<\/p>

In the article: Promotion of digital health: FDA innovation during COVID-19, published in Nature, shows the progress made by this body, such as the temporary policies that promoted the use of Digital Health during the pandemic. The article analyzes the context of each of these policies and actions carried out by the agency.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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In 2017, the FDA created the Digital Health Innovation Action Plan, which paid off in 2020 when the Digital Health Center of Excellence was launched. Previous medical device regulations, created in 1976, only applied to analog medical technologies. Devices using software-based hardware did not have the same regulations. It was not until 2013, when to seek digital transformation in the United States medical services, the FDA issued a policy guide.<\/p>

As part of the Digital Health Innovation Action Plan, the FDA is also exploring the creation of a software precertification program, which is currently under development for software as a medical device as a pilot.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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The advances in Digital Health guided by the FDA for years, had in 2020 an increase not only in its use and adoption but also in its development. \u201cThe FDA has sought to expand access to low-risk, clinically appropriate digital health tools during the COVID-19 pandemic by declaring its intent to waive certain regulatory requirements for some devices,\u201d the article explains.<\/p>

The article mentions that Digital Health will be the cornerstone of this effort, and agency officials hope that emerging evidence will inform regulatory science for several key areas. These key areas were divided into three: (1) experience in the use of Digital Health, (2) research on the adoption of digital health products among the population of different age ranges and (3) the use of digital health tools for clinical research.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tBIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

NATURE<\/strong><\/p>

https:\/\/www.nature.com\/articles\/s41746-020-00371-7<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

La Administraci\u00f3n de Medicamentos y Alimentos (FDA), ha implementado pol\u00edticas temporales para la aplicaci\u00f3n de innovaciones en Salud Digital durante la pandemia. En un art\u00edculo publicado en npj Digital de la revista cient\u00edfica Nature se identificaron estas acciones y sus implicaciones a futuro. Las herramientas y servicios basados en Salud Digital, tomaron mayor relevancia durante 2020, en respuesta a la pandemia por COVID-19. La telemedicina aplicada en el monitoreo a distancia de los pacientes contagiados o sospechosos, as\u00ed como la recopilaci\u00f3n de informaci\u00f3n a trav\u00e9s de aplicaciones de registro de s\u00edntomas, fueron las principales aplicaciones de las tecnolog\u00edas en salud. En el art\u00edculo: Promoci\u00f3n de la salud digital: innovaci\u00f3n de la FDA durante COVID-19, publicado en Nature muestra los avances desarrollados por este organismo, como lo fueron las pol\u00edticas temporales que promovieron el uso de Salud Digital en durante la pandemia. El articulo analiza el contexto de cada una de estas pol\u00edticas y acciones realizadas por la agencia. En 2017 la FDA cre\u00f3 el Plan de Acci\u00f3n de Innovaci\u00f3n en Salud Digital, que rindi\u00f3 frutos en 2020 cuando se inaugur\u00f3 el Centro de Excelencia en Salud Digital. Las regulaciones anteriores sobre dispositivos m\u00e9dicos, creadas en 1976, solo correspond\u00edan a las tecnolog\u00edas m\u00e9dicas an\u00e1logas. Los dispositivos que utilizaban hardware basados en software no contaban con las mismas regulaciones. Fue hasta 2013, cuando para buscar la transformaci\u00f3n digital en los servicios m\u00e9dicos de Estados Unidos, la FDA emiti\u00f3 una gu\u00eda de pol\u00edticas. \u201cComo parte del Plan de acci\u00f3n de innovaci\u00f3n en salud digital, la FDA tambi\u00e9n est\u00e1 explorando la creaci\u00f3n de un programa de precertificaci\u00f3n de software, que actualmente se encuentra en desarrollo para software como dispositivo m\u00e9dico como piloto\u201d, explica en art\u00edculo. Los avances en Salud Digital guiados por la FDA desde a\u00f1os atr\u00e1s, tuvieron en 2020 un aumento no solo en su uso y adopci\u00f3n sino en su desarrollo. \u201cLa FDA ha tratado de ampliar el acceso a herramientas de salud digital cl\u00ednicamente apropiadas y de bajo riesgo durante la pandemia de COVID-19 al declarar su intenci\u00f3n de no hacer cumplir ciertos requisitos reglamentarios para algunos dispositivos\u201d, explica el art\u00edculo. El articulo menciona que la Salud Digital ser\u00e1 la piedra angular de este esfuerzo, y los funcionarios de la agencia esperan que la evidencia emergente informe la ciencia regulatoria para varias \u00e1reas clave. Estas \u00e1reas clave fueron divididas en tres: (1) experiencia en el uso de Salud Digital, (2) investigaci\u00f3n en la adopci\u00f3n de productos de salud digital entre la poblaci\u00f3n de distintos rangos de edad y (3) el uso de herramientas de salud digital para la investigaci\u00f3n cl\u00ednica. BIBLIOGRAF\u00cdA NATURE https:\/\/www.nature.com\/articles\/s41746-020-00371-7<\/p>","protected":false},"author":1,"featured_media":11697,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[154,160,153],"tags":[145],"class_list":["post-11695","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunidades-conectadas","category-noticias","category-plataformas-digitales","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/11695","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=11695"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/11695\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/11697"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=11695"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=11695"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=11695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}