{"id":9496,"date":"2014-03-10T08:53:01","date_gmt":"2014-03-10T07:53:01","guid":{"rendered":"http:\/\/catai.net\/blog\/?p=9496"},"modified":"2014-03-10T08:53:01","modified_gmt":"2014-03-10T07:53:01","slug":"soup-software-in-healthcare","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2014\/03\/soup-software-in-healthcare\/","title":{"rendered":"SOUP software in healthcare."},"content":{"rendered":"<p><strong>SOUP<\/strong> stands for\u00a0<a title=\"Soup (Software of Unknown Pedigree)\" href=\"http:\/\/en.wikipedia.org\/wiki\/Soup_(Software_of_Unknown_Pedigree)\">software of unknown pedigree or provenance<\/a>\u00a0and in Healthcare it is extremly common in most of the autonomous regions in Spain. It represents \u00a0&#8220;in house&#8221;\u00a0home-made\u00a0software for the health care control and EHR of the various autonomous communities. One of the common characteristics is that <strong>has never pass any official<\/strong> national based or EU based <strong>quality control<\/strong> system or the requirements for type I Medical Devices.<\/p>\n<p>For that software it is essential to control risks and fails to assure a minimum quality control following <strong><a href=\"http:\/\/medicaldevices.bsigroup.com\/en-GB\/our-services\/iec-62304\/\">IEC-62304<\/a><\/strong> software control cicle 3rd Edition and <strong>ISO 14971<\/strong> Risk management for Medical Devices together with\u00a0<strong>ISO 13485 <\/strong>of Quality management that <strong>should be certified<\/strong>\u00a0as a first step to get the CE-mark in the EU. And finally we do not have to forget <a href=\"https:\/\/catai.net\/blog\/2013\/04\/une-1790032013-riesgos-en-la-seguridad-del-paciente\/\">patient security norms<\/a>,<\/p>\n<p>How many of our &#8220;in house&#8221; software for patient control and EHR do fulfill those norms?<\/p>\n<p style=\"text-align: center;\">Who is at a National level responsible for it?<\/p>\n<p>Now with the Apps controling or selfcontroling healthcare regulation requirements have increase. <a href=\"https:\/\/catai.net\/blog\/2013\/10\/mhealth-software-act-hr-3303\/\">FDA have controlled<\/a> in the States.<\/p>\n<p style=\"text-align: center;\">Who is going to control it in Spain?<\/p>\n","protected":false},"excerpt":{"rendered":"<p>SOUP stands for\u00a0software of unknown pedigree or provenance\u00a0and in Healthcare it is extremly common in most of the autonomous regions in Spain. It represents \u00a0&#8220;in house&#8221;\u00a0home-made\u00a0software for the health care control and EHR of the various autonomous communities. One of the common characteristics is that has never pass any official national based or EU based [&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":[3,28,29,32,9],"tags":[],"class_list":["post-9496","post","type-post","status-publish","format-standard","hentry","category-informes","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>SOUP software in healthcare. | 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\/2014\/03\/soup-software-in-healthcare\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SOUP software in healthcare. | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"SOUP stands for\u00a0software of unknown pedigree or provenance\u00a0and in Healthcare it is extremly common in most of the autonomous regions in Spain. 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