Government Healthcare Policy, Business and Technology

FDA Issues Final Cybersecurity Guidance for Medical Devices

Healthcare Informatics: 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.

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