{"id":8873,"date":"2013-09-30T11:09:07","date_gmt":"2013-09-30T10:09:07","guid":{"rendered":"http:\/\/catai.net\/blog\/?p=8873"},"modified":"2013-09-30T11:28:13","modified_gmt":"2013-09-30T10:28:13","slug":"norma-fda-para-apps-medicas-moviles","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2013\/09\/norma-fda-para-apps-medicas-moviles\/","title":{"rendered":"Norma FDA para apps medicas moviles"},"content":{"rendered":"<p>Con fecha 25 de Septiembre se ha publicado la <a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM263366.pdf\">guia de la FDA<\/a> para las aplicaciones m\u00f3viles en Salud.<\/p>\n<p>Esperemos que en Espa\u00f1a <strong>se dejen de crear organismos regionales a costa del consumidor<\/strong>, que analizan las aplicaciones m\u00f3viles en Salud para certificarlas y actuemos como la FDA que considera<\/p>\n<p>1.- La mayoria de las aplicaciones m\u00f3viles no se encuentran en el concepto de APARATOS MEDICOS (MD=Medical Devices) definidos por la FDA (o <strong>la marca CE de Aparato Medico para nosotros<\/strong>).<\/p>\n<p>2.- Algunas de las aplicaciones moviles cumple los criterios de MD, pero como no implican riesgo o el riesgo es minimo para el usuario la FDA no les exige las normas reguladoras de un MD<\/p>\n<p>3.- La FDA define como APLICACIONES MEDICAS MOVILES aquellas que \u00a0debido a su funcionalidad y no a su plataforma implican riesgos para el paciente si no funcionan como en principio especifican.<\/p>\n<p>ANTECEDENTES<\/p>\n<p>El 15 de Febrero 2011, la FDA regulo la clasificacion de las computadoras o los aparatos medicos basados en software que se usan para la transferencia electronica de datos, su almacenamiento, su vision o conversion en datos medicos como MEDICAL DEVICES DATA SYSTEMS (MDDS) pertenecientes desde la Clase III (alto riesgo) a la clase I (bajo riesgo) de MD.<\/p>\n<p>Con anterioridad habia ya especificado que el software por si mismo utilizado para analizar datos medicos es en si mismo un accesorio de un MD o lo que es lo mismo un MD de tipo software.<\/p>\n<p><a href=\"https:\/\/catai.net\/blog\/wp-content\/uploads\/2013\/09\/FDA-Regulation.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-8880\" title=\"FDA-Regulation\" src=\"https:\/\/catai.net\/blog\/wp-content\/uploads\/2013\/09\/FDA-Regulation-297x300.jpg\" alt=\"\" width=\"297\" height=\"300\" srcset=\"https:\/\/catai.net\/blog\/wp-content\/uploads\/2013\/09\/FDA-Regulation-297x300.jpg 297w, https:\/\/catai.net\/blog\/wp-content\/uploads\/2013\/09\/FDA-Regulation-100x100.jpg 100w, https:\/\/catai.net\/blog\/wp-content\/uploads\/2013\/09\/FDA-Regulation.jpg 300w\" sizes=\"auto, (max-width: 297px) 100vw, 297px\" \/><\/a>DEFINICIONES<\/p>\n<p><strong>Plataforma m\u00f3vil<\/strong>: Commercial off-the-shelf (COTS) plataforma computacional con o sin conectividad inhalambrica que es un &#8220;handheld device&#8221; es decir de peque\u00f1o tama\u00f1o que quepa en la mano, incluyendo los port\u00e1tiles.<br \/>\nAplicacion m\u00f3vil: Es una aplicacion de software que corre en una plataforma movil o aquella dise\u00f1ada para una plataforma movil que se ejecuta en un servidor.<\/p>\n<p><strong>Aplicacion Medical Movil<\/strong> : \u00a0La que comple la definicion de MD segun la FDA -section 201(h) \u00a0(FD&amp;C Act)4 o bien que intenta ser un accesorio de un MD o que transforma una plataforma movil en un MD.<\/p>\n<p>Y mucho cuidado con los proveedores de servicios IT, porque habitualmente no se les considera promotores, due\u00f1os o &#8220;manufacturers&#8221; excepto que: Creen una aplicaci\u00f3n o un sistema de software que permita <span style=\"text-decoration: underline;\">acceso a funciones propias de un MD<\/span> a trav\u00e9s de una <strong>subscripci\u00f3n web<\/strong>, de <strong>un SaaS<\/strong> (software as a service) o de accesos similares.<\/p>\n<p>Queda sin aclarar el papel de promotor o &#8220;manufacturer&#8221; de las administraciones o los medicos. Para ellos si una aplicaci\u00f3n se encuentra en un grupo practico (red de telemedicina) y es usado por otros usuarios de la red no es un promotor, sin embargo si lo publicita para uso general si es un promotor. Bajo mi punto de vista, las administraciones vuelven a salir indemnes de la multitud de aplicaciones &#8220;in house&#8221; de software que generan a su libre albedr\u00edo sin que nadie las controle.<\/p>\n<p>En cualquier caso\u00a0las APLICACIONES MEDICA MOVILES se clasifican como cualquier MD en clase I (sujetas a controles generales), clase II (Sujetas a controles generales y especiales), y clase III (sujetas a aprobacion antes de la comercializaci\u00f3n)<\/p>\n<p>Nos queda todavia pendientes el <a href=\"https:\/\/catai.net\/blog\/2011\/06\/tm-proveedores-certificados\/\">control de los proveedores de servicios<\/a>.<\/p>\n<p>Y controlar los <a href=\"https:\/\/catai.net\/blog\/2013\/05\/aspectos-legales-de-la-tm\/\">aspectos legales de la TELEMEDICINA <\/a>que se hace con estos aparatos medicos.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Con fecha 25 de Septiembre se ha publicado la guia de la FDA para las aplicaciones m\u00f3viles en Salud. Esperemos que en Espa\u00f1a se dejen de crear organismos regionales a costa del consumidor, que analizan las aplicaciones m\u00f3viles en Salud para certificarlas y actuemos como la FDA que considera 1.- La mayoria de las aplicaciones [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[3,40,38,13,28,29,32,9],"tags":[],"class_list":["post-8873","post","type-post","status-publish","format-standard","hentry","category-informes","category-innovacion","category-contratacion-externa","category-phealth","category-sanidad","category-seguridad","category-sociedad_red","category-unesco"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Norma FDA para apps medicas moviles | Telemedicina<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/catai.net\/blog\/2013\/09\/norma-fda-para-apps-medicas-moviles\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Norma FDA para apps medicas moviles | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"Con fecha 25 de Septiembre se ha publicado la guia de la FDA para las aplicaciones m\u00f3viles en Salud. 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