{"id":9219,"date":"2013-12-20T08:14:50","date_gmt":"2013-12-20T07:14:50","guid":{"rendered":"http:\/\/catai.net\/blog\/?p=9219"},"modified":"2013-12-20T08:14:50","modified_gmt":"2013-12-20T07:14:50","slug":"2013-fda-mhealth-2a-ed-y-normas-eu","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2013\/12\/2013-fda-mhealth-2a-ed-y-normas-eu\/","title":{"rendered":"2013: FDA-mHealth (2\u00aa Ed) y normas EU."},"content":{"rendered":"<p>Les adjunto el libro en segunda edici\u00f3n del 2013 sobre las <a href=\"https:\/\/catai.net\/blog\/wp-content\/uploads\/2013\/12\/FDA_Regulation_of_Mobile_Health_2013.pdf\">FDA_Regulation_of_Mobile_Health_2013<\/a>.<\/p>\n<p>Es un recopilatorio muy completo que explica con ejemplos que una aplicaci\u00f3n m\u00f3vil regulada es aquella que el vendedor la vende para controlar aspectos necesarios o esenciales en una enfermedad y as\u00ed lo hace constar en su folleto de venta. Esto significa que la misma aplicaci\u00f3n puede y no puede ser considerada un Aparato Medico o Medical Device (MD) sin cambiar nada en ella si se usa o no para captar, controlar, gestionar o ayudar aspectos ligados con la enfermedad o la prevenci\u00f3n de la misma.<\/p>\n<p>El libro dedica el ultimo <strong>capitulo a las regulaciones de la UE<\/strong>. <span style=\"text-decoration: underline;\">Es esencial<\/span>, ya que simplifica los conceptos que las autoridades de la UE tienen sobre lo que es un MD de una forma notable. Un elemento esencial a tener en cuenta es que si el software inicialmente considerado MD-type I (autoregulado) interacciona con un aparato medico de tipo superior cambiando su estado pasa inmediatamente a considerarse del mismo nivel que el aparato medico al que modifica.<\/p>\n<p>Uno de los <span style=\"text-decoration: underline;\">problemas en la regulacion de la UE<\/span> es que NO CONSIDERA LA HISTORIA CL\u00cdNICA un MD, y la historia cl\u00ednica interacciona con elementos de medida y evaluaci\u00f3n del pacientes (an\u00e1lisis cl\u00ednicos), con el control de aparatos m\u00e9dicos y visualizaci\u00f3n de cambios de par\u00e1metros en el tiempo y lo esencial REALIZA PRESCRIPCIONES ELECTR\u00d3NICAS para los pacientes, ademas de ciertas funciones de inteligencia artificial si usa sistemas de soporte de decisiones (DSS).<\/p>\n<p>Otro problema en ambas regulaciones es que no considera un <a href=\"http:\/\/www.youtube.com\/watch?v=F21cPb7jp5U&amp;feature=share&amp;list=PL5BE7CEBF8E6E52D9&amp;index=11\">HEALTHCLOUD un MD<\/a>. Bajo nuestro criterio es otro elemento esencial a regular.<\/p>\n<ol>\n<li>No solo <strong>identificar y\u00a0controlar el acceso<\/strong> en cualquier punto del mundo (con o sin el BYOD) y sobre todo si el acceso es &#8220;<a href=\"https:\/\/catai.net\/blog\/2013\/12\/always-on-poc-especifico-para-sanidad-byod\/\">Always on<\/a>&#8221; como vimos en los anteriores posts , sino tambien<\/li>\n<li><strong>Controlar los SLA<\/strong> (Service Levels of Agreedments) o lo que es lo mismo los contratos de las distintas modalidades de servicio en la nube (SaaS, PaaS,IaaS) cumplan los requerimientos sobre la seguridad y accesibilidad de los datos para cada una de las partes as\u00ed como sus obligaciones y deberes. Que incluso deberia incluir donde se almacenan los datos que provienen de la UE.<\/li>\n<li>Establecer cuanto antes los\u00a0<strong>est\u00e1ndares\u00a0de conectividad e interoperabilidad<\/strong> para la Healthcloud.<\/li>\n<li>Establecer los est\u00e1ndares de computaci\u00f3n (cloud computing), connectividad (switch fabric) y seguridad que eviten fugas y riesgos en entornos no estandarizados.<\/li>\n<li>Establecer los requerimiento de tiempos de latencia y accesibilidad a los datos sanitarios y a los aparatos m\u00e9dicos conectados en la nube (de acuerdo con la IEEE 11073).<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Les adjunto el libro en segunda edici\u00f3n del 2013 sobre las FDA_Regulation_of_Mobile_Health_2013. Es un recopilatorio muy completo que explica con ejemplos que una aplicaci\u00f3n m\u00f3vil regulada es aquella que el vendedor la vende para controlar aspectos necesarios o esenciales en una enfermedad y as\u00ed lo hace constar en su folleto de venta. Esto significa que [&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":[21,1,22,3,38,26,28,29,32],"tags":[],"class_list":["post-9219","post","type-post","status-publish","format-standard","hentry","category-educacion","category-general","category-inclusion","category-informes","category-contratacion-externa","category-publicaciones","category-sanidad","category-seguridad","category-sociedad_red"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>2013: FDA-mHealth (2\u00aa Ed) y normas EU. | 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\/12\/2013-fda-mhealth-2a-ed-y-normas-eu\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2013: FDA-mHealth (2\u00aa Ed) y normas EU. | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"Les adjunto el libro en segunda edici\u00f3n del 2013 sobre las FDA_Regulation_of_Mobile_Health_2013. 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