{"id":8693,"date":"2019-01-18T14:04:02","date_gmt":"2019-01-18T13:04:02","guid":{"rendered":"http:\/\/www.thema-med.com\/canada-emessa-prima-linea-guida-sulla-cybersecurity-dei-dispositivi-medici\/"},"modified":"2023-01-24T15:05:19","modified_gmt":"2023-01-24T14:05:19","slug":"canada-emessa-prima-linea-guida-sulla-cybersecurity-dei-dispositivi-medici-2","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/01\/18\/canada-emessa-prima-linea-guida-sulla-cybersecurity-dei-dispositivi-medici-2\/","title":{"rendered":"CANAD\u00c1: primera gu\u00eda de salud de Canad\u00e1 sobre la ciberseguridad de dispositivos m\u00e9dicos emitida"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter wp-image-8649 size-full\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/01\/cybersecurity-canada.png\" alt=\"\" width=\"1600\" height=\"844\" \/><\/p>\n<p>En l\u00ednea con el enfoque de ciberseguridad\u00a0<a href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM623529.pdf\">propuesto por la FDA<\/a> de EE. UU., Health Canada emiti\u00f3 en diciembre de 2018 <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/public-involvement-consultations\/medical-devices\/consutation-premarket-cybersecurity-profile\/draft-guidance-premarket-cybersecurity.html#a2.2.5.1\">el primer borrador de una gu\u00eda<\/a> titulada <em>\u201cPre-market Requirements for Medical Device Cybersecurity\u201d<\/em> que contiene los requisitos propuestos por <em>Medical Device Application Licences (MDAL)<\/em> \u00a0para las aplicaciones de dispositivos m\u00e9dicos que contengono <em>software.<\/em><\/p>\n<p>Health Canada cree que para demostrar la seguridad y eficacia de los dispositivos m\u00e9dicos que son potencialmente vulnerables a los ataques cibern\u00e9ticos, los fabricantes deben considerar diversos aspectos de la ciberseguridad, desde el dise\u00f1o y durante todo su ciclo de vida.<\/p>\n<p>Los requisitos de ciberseguridad que deben proporcionarse en nelle <em>Medical Device Licence Applications (MDAL)<\/em> \u00a0se refieren al etiquetado (y la trazabilidad de todos los componentes), el historial de cualquier retirada del dispositivo, la evaluaci\u00f3n del riesgo relacionado con el uso del dispositivo, as\u00ed como los <strong>requisitos seguridad y eficacia<\/strong>: est\u00e1ndares aplicados, pruebas de ciberseguridad realizadas en el dispositivo, la matriz de trazabilidad para las entradas y salidas de dise\u00f1o y el plan de acci\u00f3n posterior a la comercializaci\u00f3n realizado por el fabricante para garantizar la seguridad y la eficacia en todo su ciclo de vida.<\/p>\n<p>El borrador de la gu\u00eda mencionada se encuentra actualmente en consulta, por lo que los fabricantes de dispositivos m\u00e9dicos y otras partes interesadas est\u00e1n invitados a enviar sus comentarios antes del 5 de febrero de 2019.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>En l\u00ednea con el enfoque de ciberseguridad\u00a0propuesto por la FDA de EE. UU., Health Canada emiti\u00f3 en diciembre de 2018 el  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","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-8693","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CANAD\u00c1: primera gu\u00eda de salud de Canad\u00e1 sobre la ciberseguridad de dispositivos m\u00e9dicos emitida - Thema - Medical Regulatory Consultancy<\/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:\/\/www.thema-med.com\/es\/2019\/01\/18\/canada-emessa-prima-linea-guida-sulla-cybersecurity-dei-dispositivi-medici-2\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CANAD\u00c1: primera gu\u00eda de salud de Canad\u00e1 sobre la ciberseguridad de dispositivos m\u00e9dicos emitida - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"En l\u00ednea con el enfoque de ciberseguridad\u00a0propuesto por la FDA de EE. 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