{"id":4431,"date":"2017-07-20T11:59:37","date_gmt":"2017-07-20T09:59:37","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=4431\/"},"modified":"2023-01-24T15:05:35","modified_gmt":"2023-01-24T14:05:35","slug":"ee-uu-guia-seguridad-cibernetica-2","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2017\/07\/20\/ee-uu-guia-seguridad-cibernetica-2\/","title":{"rendered":"EE.UU. : gu\u00eda para la seguridad cibern\u00e9tica"},"content":{"rendered":"<p>La FDA sigue trabajando para implementar la seguridad cibern\u00e9tica de dispositivos m\u00e9dicos.<\/p>\n<p>Pues, se ha pubblicado la primera versi\u00f3n de la gu\u00eda \u201cContenido de las Presentaciones Postventa para la administraci\u00f3n de Seguridad Cibern\u00e9tica en dispositivos m\u00e9dicos\u201d. Esa completa la gu\u00eda final emitida en 2014 y titulada \u201cContenido de las Presentaciones antes del mercado para la administraci\u00f3n de Seguridad Cibern\u00e9tica en dispositivos m\u00e9dicos\u201d.<\/p>\n<p>Con Seguridad Cibern\u00e9tica, la FDA entiende la prevenci\u00f3n de todos aquellos accesos no autorizados, los cambios o la distribuci\u00f3n incontrolada de datos que podr\u00edan afectar la eficacia del dispositivo m\u00e9dico, los servidores o tambi\u00e9n las redes que puedan da\u00f1ar gravemente a los pacientes.<\/p>\n<p>Desdehace unos a\u00f1os la FDA sigue trabajando para mitigar esos riesgos tr\u00e1s la publicaci\u00f3n de unas gu\u00edas: en primer lugar con la gu\u00eda titulada \u201cContenido de las Presentaciones antes del mercado para la administraci\u00f3n de Seguridad Cibern\u00e9tica en dispositivos m\u00e9dicos\u201d con la que recomienda que los fabricantes presenten la documentaci\u00f3n antes del mercado (durante el proceso 510(k) o PMA, por ejemplo); y en seguida con la primera versi\u00f3n de la gu\u00eda \u201cContenido de las Presentaciones Postventa para la administraci\u00f3n de Seguridad Cibern\u00e9tica en dispositivos m\u00e9dicos\u201d en la que hay un listado de todos los requisitos postventa, por lo m\u00e1s en relaci\u00f3n con la vuelta de informaciones desde el comercio.<\/p>\n<p>&nbsp;<\/p>\n<p>Para m\u00e1s informaciones:<br \/>\n<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DigitalHealth\/ucm373213.htm\">http:\/\/www.fda.gov\/MedicalDevices\/DigitalHealth\/ucm373213.htm<\/a><br \/>\n<a href=\"http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm482022.pdf\">http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm482022.pdf<\/a><br \/>\n<a href=\"http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm356190.pdf\">http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm356190.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La FDA sigue trabajando para implementar la seguridad cibern\u00e9tica de dispositivos m\u00e9dicos. Pues, se ha pubblicado la primera versi\u00f3n de la  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[680,3],"tags":[],"class_list":["post-4431","post","type-post","status-publish","format-standard","hentry","category-blog-es","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>EE.UU. : gu\u00eda para la seguridad cibern\u00e9tica - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"description\" content=\"La FDA sigue trabajando para implementar la seguridad cibern\u00e9tica de dispositivos m\u00e9dicos. 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