{"id":8252,"date":"2018-11-14T13:59:50","date_gmt":"2018-11-14T12:59:50","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8252"},"modified":"2023-01-26T14:18:01","modified_gmt":"2023-01-26T13:18:01","slug":"ee-uu-actualizada-la-directriz-fda-sobre-ciberseguridad-de-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/11\/14\/ee-uu-actualizada-la-directriz-fda-sobre-ciberseguridad-de-dispositivos-medicos\/","title":{"rendered":"EE.UU.: actualizada la Directriz FDA sobre ciberseguridad de dispositivos m\u00e9dicos"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-8324 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/11\/USA-cybersecurity-300x173.jpg\" alt=\"\" width=\"300\" height=\"173\" \/><\/p>\n<p>Para permitir un proceso de revisi\u00f3n previo a la comercializaci\u00f3n m\u00e1s eficiente para la protecci\u00f3n efectiva de los dispositivos m\u00e9dicos comercializados contra las vulnerabilidades de seguridad de TI, la FDA emiti\u00f3 el 18 de octubre pasado el borrador de la nueva edici\u00f3n de la Directriz <a href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM623529.pdf\"><em>\u201cContent of Premarket Submissions for Management of Cybersecurity in Medical Devices. Draft Guidance for Industry and Food and Drug Administration Staff\u201d<\/em><\/a>.<\/p>\n<p><span style=\"font-size: 1rem;\">La edici\u00f3n 2018 introduje las siguientes integraciones:<\/span><\/p>\n<ul>\n<li>definiciones nuevas y\/o actualizadas de t\u00e9rminos clave;<\/li>\n<li>un enfoque de dos niveles para la evaluaci\u00f3n del riesgo de TI en los dispositivos m\u00e9dicos:\n<ol>\n<li>Nivel 1 (mayor riesgo) en el que se incluyen los dispositivos que pueden conectarse a otro producto m\u00e9dico o no m\u00e9dico, a una red o a Internet y\/o que podr\u00edan causar da\u00f1os directos al paciente;<\/li>\n<li>Nivel 2 (riesgo est\u00e1ndar) para los dispositivos restantes;<\/li>\n<\/ol>\n<\/li>\n<li>el concepto de \u00abdispositivo confiable\u00bb (<i>trustworthy device<\/i>), es decir un dispositivo m\u00e9dico que contenga hardware, software y\/o l\u00f3gica programables razonablemente efectivas y seguras en t\u00e9rminos de ciberseguridad;<\/li>\n<li>recomendaciones para el etiquetado de dispositivos m\u00e9dicos sujetos a riesgos de seguridad inform\u00e1tica.<\/li>\n<\/ul>\n<p>La nueva versi\u00f3n de la Directriz pretende <strong>subrayar los controles durante el dise\u00f1o y desarrollo de dispositivos m\u00e9dicos\u00a0<\/strong>en riesgo de ciberseguridad, antes de ser colocados en el mercado. Una vez finalizada, reemplazar\u00e1 la <a href=\"https:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm356190.pdf\">versi\u00f3n anterior<\/a>\u00a0publicada en octubre de 2014.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Para permitir un proceso de revisi\u00f3n previo a la comercializaci\u00f3n m\u00e1s eficiente para la protecci\u00f3n efectiva de los dispositivos m\u00e9dicos comercializados  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23504,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-8252","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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