{"id":12390,"date":"2021-02-08T09:17:46","date_gmt":"2021-02-08T15:17:46","guid":{"rendered":"https:\/\/saluddigital.com\/?p=12390"},"modified":"2025-10-21T13:04:39","modified_gmt":"2025-10-21T19:04:39","slug":"el-plan-de-accion-en-salud-digital-de-la-fda-se-centra-en-la-inteligencia-artificial","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/plataformas-digitales\/el-plan-de-accion-en-salud-digital-de-la-fda-se-centra-en-la-inteligencia-artificial\/","title":{"rendered":"FDA's Digital Health Action Plan focuses on Artificial Intelligence."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"12390\" class=\"elementor elementor-12390\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-771c8633 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"771c8633\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b444805\" data-id=\"b444805\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-73d59af2 elementor-widget elementor-widget-heading\" data-id=\"73d59af2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The FDA, that recently released its Digital Health action plan, and will take a multi-pronged approach to the development of safe software based on Artificial Intelligence and machine learning.<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3af54b44 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"3af54b44\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6c2054fa\" data-id=\"6c2054fa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-76a9540b elementor-widget elementor-widget-text-editor\" data-id=\"76a9540b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The document published on January 12 on the official FDA (Food and Drug Administration) website, takes into account five central axes of action for software as a medical device (SaMD) to continue their development and be applied. This essentially contemplates those based on Artificial Intelligence (AI) and machine learning:<\/p><ul><li>Continue the development of the proposed regulatory framework, including by issuing draft guidance on a pre-determined change control plan (for software learning over time);\u00a0<\/li><li>Support the development of machine learning best practices to evaluate and improve machine learning algorithms;<\/li><li>Encourage a patient-centered approach, including device transparency to users;<\/li><li>Develop methods to evaluate and improve machine learning algorithms; and\u00a0<\/li><li>Continue pilot testing of real-world performance monitoring.\u00a0<\/li><\/ul>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4a9dcbc8 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"4a9dcbc8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4fa25787\" data-id=\"4fa25787\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-322eff9b elementor-widget elementor-widget-image\" data-id=\"322eff9b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"630\" src=\"https:\/\/saluddigital.com\/wp-content\/uploads\/2021\/02\/El-Plan-de-acci\u00f3n-en-Salud-Digital-de-la-FDA-se-centra-en-la-Inteligencia-Artificial.jpg\" class=\"attachment-full size-full wp-image-12391\" alt=\"\" srcset=\"https:\/\/saluddigital.com\/wp-content\/uploads\/2021\/02\/El-Plan-de-acci\u00f3n-en-Salud-Digital-de-la-FDA-se-centra-en-la-Inteligencia-Artificial.jpg 1200w, https:\/\/saluddigital.com\/wp-content\/uploads\/2021\/02\/El-Plan-de-acci\u00f3n-en-Salud-Digital-de-la-FDA-se-centra-en-la-Inteligencia-Artificial-660x347.jpg 660w, https:\/\/saluddigital.com\/wp-content\/uploads\/2021\/02\/El-Plan-de-acci\u00f3n-en-Salud-Digital-de-la-FDA-se-centra-en-la-Inteligencia-Artificial-768x403.jpg 768w, https:\/\/saluddigital.com\/wp-content\/uploads\/2021\/02\/El-Plan-de-acci\u00f3n-en-Salud-Digital-de-la-FDA-se-centra-en-la-Inteligencia-Artificial-840x441.jpg 840w, https:\/\/saluddigital.com\/wp-content\/uploads\/2021\/02\/El-Plan-de-acci\u00f3n-en-Salud-Digital-de-la-FDA-se-centra-en-la-Inteligencia-Artificial-16x8.jpg 16w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-2711a931\" data-id=\"2711a931\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3deb96bc elementor-widget elementor-widget-text-editor\" data-id=\"3deb96bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>On the first point, the FDA, plans to publish guidance later this year that addresses more elements of safety and efficacy of SaMDs. And also, to promote regulations with greater personalization in the face of new technologies.<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1561a422 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"1561a422\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1dee05e7\" data-id=\"1dee05e7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6cbaf02d elementor-widget elementor-widget-text-editor\" data-id=\"6cbaf02d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Also, the FDA in its efforts to seek as much transparency as possible regarding SaMDs, seeks the implementation of a public workshop on how labeling on devices improves trust in devices, especially those based on AI and machine learning. \u201cPromoting transparency is a key aspect of a patient-centered approach, and we believe this is especially important for AI\/ML-based medical devices, which may learn and change over time, and which may incorporate algorithms exhibiting a degree of opacity,\u201d the FDA explained.<\/p><p>Similarly, the agency seeks to reduce opacity in the performance of AI and machine learning algorithms through a new methodology for their evaluation. In this sense, enters the last of the five points, which points to the real world, \u201cGathering performance data on the real-world use of the SaMD may allow manufacturers to understand how their products are being used, identify opportunities for improvements, and respond proactively to safety or usability concerns. Real-world data collection and monitoring is an important mechanism that manufacturers can leverage to mitigate the risk involved with AI\/ML-based SaMD modifications, in support of the benefit-risk profile in the assessment of a particular marketing submission,\u201d explained 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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2d17624c elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no\" data-id=\"2d17624c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5c727094\" data-id=\"5c727094\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1b49cb36 elementor-widget elementor-widget-toggle\" data-id=\"1b49cb36\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-4571\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-4571\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/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\t<a class=\"elementor-toggle-title\" tabindex=\"0\"> BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-4571\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-4571\"><p><strong>HEALTH CARE IT NEWS<\/strong><\/p><p><a href=\"https:\/\/www.healthcareitnews.com\/news\/fda-action-plan-puts-focus-ai-enabled-software-medical-device\">https:\/\/www.healthcareitnews.com\/news\/fda-action-plan-puts-focus-ai-enabled-software-medical-device<\/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":"<p>La FDA, que recientemente public\u00f3 su plan de acci\u00f3n en Salud Digital, adoptar\u00e1 un enfoque m\u00faltiple para el desarrollo de software seguros basados en Inteligencia Artificial y aprendizaje autom\u00e1tico. El documento publicado el 12 de enero en el sitio oficial de la FDA (Administraci\u00f3n de Medicamentos y Alimentos), toma en cuenta cinco ejes centrales de acci\u00f3n para que los software como dispositivo m\u00e9dico (SaMD, por sus siglas en ingl\u00e9s) contin\u00faen su desarrollo y sean aplicados. Esto contempla en esencia aquellos basados en Inteligencia Artificial (IA) y aprendizaje autom\u00e1tico: Continuar el desarrollo del marco regulatorio propuesto, incluso mediante la publicaci\u00f3n de un borrador de orientaci\u00f3n sobre un plan de control de cambios predeterminado (para el aprendizaje del software a lo largo del tiempo);&nbsp; Apoyar el desarrollo de buenas pr\u00e1cticas de aprendizaje autom\u00e1tico para evaluar y mejorar los algoritmos de aprendizaje autom\u00e1tico; Fomentar un enfoque centrado en el paciente, incluida la transparencia del dispositivo para los usuarios; Desarrollar m\u00e9todos para evaluar y mejorar los algoritmos de aprendizaje autom\u00e1tico;&nbsp;y&nbsp; Continuar las pruebas piloto de monitoreo de desempe\u00f1o en el mundo real.&nbsp; Sobre el primer punto, la FDA, tiene planeada la publicaci\u00f3n de una gu\u00eda a lo largo de este a\u00f1o, que contemple m\u00e1s elementos de seguridad y eficacia de los SaMD. Y tambi\u00e9n para promover regulaciones con mayor personalizaci\u00f3n ante las nuevas tecnolog\u00edas. Asimismo, la FDA en sus esfuerzos por buscar la mayor transparencia posible en relaci\u00f3n a los SaMD, busca la implementaci\u00f3n de un taller p\u00fablico sobre c\u00f3mo los etiquetados en los dispositivos mejoran la confianza en los dispositivos, especialmente aquellos basados en IA y aprendizaje autom\u00e1tico. \u201cPromover la transparencia es un aspecto clave de un enfoque centrado en el paciente, y creemos que esto es especialmente importante para los dispositivos m\u00e9dicos basados \u200b\u200ben IA \/ ML, que pueden aprender y cambiar con el tiempo, y que pueden incorporar algoritmos que muestran un grado de opacidad\u201d, explica la agencia. De igual forma la agencia busca reducir la opacidad en el funcionamiento de los algoritmos de IA y aprendizaje autom\u00e1tico, a trav\u00e9s de una nueva metodolog\u00eda para su evaluaci\u00f3n. En este sentido, entra el \u00faltimo de los cinco puntos, que apunta haca el mundo real, &#8220;recopilar datos de rendimiento sobre el uso del SaMD en el mundo real puede permitir a los fabricantes comprender c\u00f3mo se utilizan sus productos, identificar oportunidades de mejora y responder de manera proactiva a preocupaciones de seguridad o usabilidad. La recopilaci\u00f3n y el monitoreo de datos del mundo real es un mecanismo importante que los fabricantes pueden aprovechar para mitigar el riesgo involucrado con las modificaciones de SaMD basadas en AI \/ ML, en apoyo del perfil de riesgo-beneficio en la evaluaci\u00f3n de una presentaci\u00f3n de marketing en particular&#8221;, explica la FDA. BIBLIOGRAF\u00cdA HEALTH CARE IT NEWS https:\/\/www.healthcareitnews.com\/news\/fda-action-plan-puts-focus-ai-enabled-software-medical-device<\/p>","protected":false},"author":1,"featured_media":12391,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[154,153],"tags":[145],"class_list":["post-12390","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunidades-conectadas","category-plataformas-digitales","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/12390","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=12390"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/12390\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/12391"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=12390"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=12390"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=12390"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}