{"id":18622,"date":"2021-07-23T10:26:04","date_gmt":"2021-07-23T08:26:04","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18622"},"modified":"2023-01-24T14:58:57","modified_gmt":"2023-01-24T13:58:57","slug":"usa-fda-document-to-improve-cybersecurity-in-maintenance-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/07\/23\/usa-fda-document-to-improve-cybersecurity-in-maintenance-medical-devices\/","title":{"rendered":"USA: public FDA discussion document to improve cybersecurity in the maintenance of Medical Devices"},"content":{"rendered":"\n<p>The Center for Devices and Radiological Health\n(CDRH) of the Food and Drug Administration (FDA) has published \u201cStrengthening\nCybersecurity Practices Associated with Servicing of Medical Devices:\nChallenges and Opportunities\u201d on<strong>\ncybersecurity <\/strong>problems and solutions associated with the <strong>maintenance of medical devices<\/strong>.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/07\/usa-fda-cybersecurity-manutenzione-dispositivi-medici-1024x536.jpg\" alt=\"Public FDA discussion document to improve Cybersecurity in the maintenance of Medical Devices USA\" class=\"wp-image-18611\"\/><figcaption>Public FDA discussion document to improve cybersecurity in the maintenance <br>of Medical Devices<\/figcaption><\/figure>\n\n\n\n<p>The document intends to\ngather feedback on the issue from groups and individuals outside the FDA.\nStakeholders have until 17 August 2021 to communicate their input, which will\nlead to a shared document, the result of the commitment and responsibility of\nall stakeholders.<\/p>\n\n\n\n<p>This document follows on from the 2018 FDA Medical Device Maintenance\nReport, which was created with the goal of strengthening cybersecurity in the\nmaintenance of Medical Devices.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Four problems, four solutions to improve cybersecurity in the maintenance of medical devices<\/strong><\/h2>\n\n\n\n<p>In the document the FDA identifies the following\n<strong>four areas where it is important to take action<\/strong> to improve cybersecurity\nin the maintenance of medical devices.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1.<\/strong> <strong>Privileged access<\/strong><\/h3>\n\n\n\n<p>Access to a device for maintenance purposes is restricted to specific privileged users (usually designated by the Original Equipment Manufacturer of the device &#8211; <em>Original Equipment Manufacturer<\/em> <em>OEM<\/em>). Extending access to other users or entities to perform service, maintenance or repair functions introduces cybersecurity risks. For this reason, the FDA recommends that companies define privileged access to the device\u2019s operating systems and applications, as well as implement the use of user authentication and related controls to mitigate these risks.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2.<\/strong> <strong>Identify cybersecurity vulnerabilities and incidents<\/strong><\/h3>\n\n\n\n<p>The FDA notes that service providers are able to help identify cybersecurity vulnerabilities and incidents in their early stages, in some cases before the OEMs become aware of these issues. Sharing this information and post-marketing data with appropriate stakeholders (including OEMs and regulatory agencies) could lead to faster identification of cybersecurity threats and incidents. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3.<\/strong> <strong>Prevention and mitigation of cybersecurity vulnerabilities<\/strong><\/h3>\n\n\n\n<p>Generally, prevention and mitigation are achieved through software updates. The FDA recommends that device OEMs engage service providers more in maintaining device security by efficiently implementing software updates and fixes to address cybersecurity risks and incidents.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4.<\/strong> <strong>Challenges and opportunities of the product life cycle<\/strong><\/h3>\n\n\n\n<p>These areas relate to legacy devices used in healthcare environments beyond their intended life cycle. The legacy devices in question are those that cannot be protected against current cybersecurity threats. For more information, see <a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-200318-pp-mdc-n60.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">\u201cPrinciples and Practices for Medical Device Cybersecurity&#8221; (IMDRF)<\/a>. The FDA and other international cybersecurity stakeholders have called for more communication from OEMs when they are no longer able to support software updates and the changes needed to address the cybersecurity risks of devices. Although end-of-life issues of devices can be very difficult to communicate in complex healthcare environments, the FDA recommends the use of liability agreements between OEMs and healthcare facilities for devices that meet acceptable performance criteria when well maintained, but which may cause increasing cybersecurity risks if they are used for an extended period of time.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Would you like to know more about Cybersecurity?<\/strong><\/h2>\n\n\n\n<p>Thema experts are at your disposal for <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">strategic regulatory consulting<\/a>.<\/strong><\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-med.com\">Contact us<\/a><\/strong> and find out what we can do for you.<\/p>\n\n\n\n<p><em>Sources<\/em>:<strong><\/strong><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/www.fda.gov\/medical-devices\/quality-and-compliance-medical-devices\/discussion-paper-strengthening-cybersecurity-practices-associated-servicing-medical-devices?utm_medium=email&amp;utm_source=govdelivery\" target=\"_blank\">Discussion Paper: Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities, FDA, june 17 2021<\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/www.fda.gov\/media\/113431\/download\" target=\"_blank\">FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices, FDA, may 2018<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has published \u201cStrengthening Cybersecurity Practices Associated  [&#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":[2],"tags":[],"class_list":["post-18622","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: public FDA document to improve cybersecurity in maintenance of MD<\/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\/en\/2021\/07\/23\/usa-fda-document-to-improve-cybersecurity-in-maintenance-medical-devices\/\" 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