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FDA Issues Final Cybersecurity Guidance for Medical Devices

December 29, 2016
by Heather Landi
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The U.S. Food and Drug Administration on Tuesday issued its finalized guidance for addressing cyber vulnerabilities in medical devices and offered recommendations to medical device manufacturers to maintain the security of internet-connected devices, such has pacemakers and insulin pumps.

First issued in draft form last January, the 30-page FDA guidance on the postmarket management of cybersecurity in medical devices recommends that manufacturers and stakeholders develop a way to monitor and detect cybersecurity vulnerabilities in their devices and then assess and detect the level of risk a vulnerability poses to patient safety. The guidance also recommends manufacturers work with cybersecurity researchers to receive information about potential vulnerabilities, or a coordinated vulnerability disclosure policy. Additionally, the guidance also recommends that manufacturers deploy mitigations, such as software patches, to address cybersecurity issues early, before they can be exploited and cause harm.

The guidance does not include any plans for enforcement action if the guidelines are not followed.

“Today’s postmarket guidance recognizes today’s reality – cybersecurity threats are real, ever-present, and continuously changing. In fact, hospital networks experience constant attempts of intrusion and attack, which can pose a threat to patient safety. And as hackers become more sophisticated, these cybersecurity risks will evolve,” Suzanne Schwartz, M.D., FDA’s director for science and strategic partnerships at the Center for Devices and Radiological Health, wrote in a blog post that accompanied the release of the guidance.

Schwartz also wrote that medical devices that are connected to a hospital’s network or even a patient’s own Internet service at home, offer significant technological advances in patient care and, at the same time, an increase in the risk of cybersecurity breaches that could affect a device’s performance and functionality.

“The best way to combat these threats is for manufacturers to consider cybersecurity throughout the total product lifecycle of a device. In other words, manufacturers should build in cybersecurity controls when they design and develop the device to assure proper device performance in the face of cyber threats, and then they should continuously monitor and address cybersecurity concerns once the device is on the market and being used by patients,” Schwartz wrote.

“Central to these recommendations is FDA’s belief that medical device manufacturers should implement a structured and comprehensive program to manage cybersecurity risks,” Schwartz wrote.

The FDA also recommends that manufacturers and stakeholder consider applying the National Institute of Standards and Technology’s (NIST) core principles for improving critical infrastructure cybersecurity.

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