{"id":8989,"date":"2013-10-30T09:09:05","date_gmt":"2013-10-30T08:09:05","guid":{"rendered":"http:\/\/catai.net\/blog\/?p=8989"},"modified":"2013-10-30T11:11:56","modified_gmt":"2013-10-30T10:11:56","slug":"mhealth-software-act-hr-3303","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2013\/10\/mhealth-software-act-hr-3303\/","title":{"rendered":"mHealth SOFTWARE act (HR 3303)"},"content":{"rendered":"<p><a href=\"http:\/\/blackburn.house.gov\/uploadedfiles\/blackb_044_xml.pdf\">The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act<\/a>, clasifica las APPs en 3 tipos\u00a0: CLINICA- SALUD- MEDICA ,<\/p>\n<p>limitando\u00a0<strong>la actuacion de la FDA al campo MEDICO<\/strong>. Es decir son los unicos que deben llevar la marca de Aparatos medicos o MD.<\/p>\n<p><a href=\"http:\/\/www.practicefusion.com\/ehrbloggers\/2013\/10\/what-the-software-act-of-2013-could-mean-for-health-tech.html\">La clasificacion<\/a><a href=\"http:\/\/www.practicefusion.com\/ehrbloggers\/2013\/10\/what-the-software-act-of-2013-could-mean-for-health-tech.html\">\u00a0de cada<\/a><a href=\"http:\/\/www.practicefusion.com\/ehrbloggers\/2013\/10\/what-the-software-act-of-2013-could-mean-for-health-tech.html\"> uno<\/a> debe hacerse en ingles porque la traduccion puede desvirtual el sentido: \u00a0medical software\u00a0&#8220;is marketed to and <strong><span style=\"text-decoration: underline;\">leads to changes in any bodily function<\/span><\/strong> of human beings or other animals&#8221; . &#8220;As proposed, \u2018clinical software\u2019 is intended and marketed for use in the <em>healthcare setting by a healthcare provider<\/em>, while \u2018health software\u2019 is not used in the <em>direct delivery of patient care<\/em>.&#8221;<\/p>\n<p>El software clinico y de salud es el esencial para mejorar\u00a0la seguridad e innovacion\u00a0sanitaria, disminuir los costes e incrementar\u00a0la eficacia de la atencion sanitaria mejorando la salud de los individuos.<\/p>\n<p>La camara de EEUU exhorta al presidente a que establezca igualmente marcos regulatorios para los otros dos campos del software no regulados por la FDA, es decir que REGULE LOS RIESGO y tambien REGULE LAS CARGAS por ley.<\/p>\n<p>Se trata de otra prespectiva ya que como ya hemos contado en Canada todo el software se considera MD y por lo tanto los riesgos y las cargas estan reguladas como MD. En realidad la vision de USA se acerca algo mas a la de la UE aunque EEUU estan mucho mas avanzados que nosotros en estos aspectos.<\/p>\n<p>La ley incentiva la INNOVACION MEDICA pero con suficientes garantias. Para la FDA le deja la tarea de regular el SOFTWARE solo cuando tiene la capacidad de cambiar la fisiologia de usuario final sin que este tenga oportunidad o esta sea limitada para intervenir de forma informada y consentida.<\/p>\n<p>No todos estan de acuerdo en dividir el software artificialmente en 3 compartimentos con regulaciones diferentes. Yo seria partidario de no dividirlo y considerarlo como <a href=\"https:\/\/catai.net\/blog\/2013\/09\/medinfo2013-sumario\/\">en Canad\u00e1 todo el perteneciente al grupo de los MD<\/a> o aparatos medicos.<\/p>\n<p>La informacion basica puede encontrarse en <a href=\"http:\/\/www.mhealthnews.com\/news\/new-bill-would-limit-fdas-mhealth-regulatory-authority?page=0\">este articulo<\/a>.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, clasifica las APPs en 3 tipos\u00a0: CLINICA- SALUD- MEDICA , limitando\u00a0la actuacion de la FDA al campo MEDICO. Es decir son los unicos que deben llevar la marca de Aparatos medicos o MD. La clasificacion\u00a0de cada uno debe hacerse en ingles porque la traduccion [&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":[11,22,3,40,13,28,32,9],"tags":[],"class_list":["post-8989","post","type-post","status-publish","format-standard","hentry","category-diagnostico-no-invasivo","category-inclusion","category-informes","category-innovacion","category-phealth","category-sanidad","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>mHealth SOFTWARE act (HR 3303) | 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\/10\/mhealth-software-act-hr-3303\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"mHealth SOFTWARE act (HR 3303) | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, clasifica las APPs en 3 tipos\u00a0: CLINICA- SALUD- MEDICA , limitando\u00a0la actuacion de la FDA al campo MEDICO. 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