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FDA Taking Actions to Address Cybersecurity in Medical Devices

Nov 13, 2018

Healthcare Analytics News reports the FDA “made two moves to address the cybersecurity of medical devices.” First, it “announced increased coordination with the Department of Homeland Security on the matter, and today it released new guidelines for premarket submissions of medical devices.”

ExecutiveGov reports the FDA and the Department of Homeland Security are teaming up to “resolve cybersecurity issues in medical systems to maintain patient safety.” The article explains, “The FDA said Tuesday its Center for Devices and Radiological Health and the DHS’ Office of Cybersecurity and Communications will coordinate with each other and initiate discussions with medical device manufacturers and researchers about cyber vulnerabilities and threats to healthcare technologies.” FDA Commissioner Scott Gottlieb announced, “As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients.”

Healthcare IT News reports FDA Commissioner Scott Gottlieb explained the partnership with DHS saying, “The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns. But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone.”

FierceHealthIT reports the FDA updated guidance Wednesday that includes “several new cybersecurity recommendations for medical devices.” Commissioner Gottlieb said, “This is part of the total product lifecycle approach to device safety, in which manufacturers must adequately address device cybersecurity from the design phase through the device’s time on the market to help ensure patients are protected from cybersecurity threats.”

From the news release of the American Association for Justice.

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