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Post-market Management of Cybersecurity in Medical Devices Guidance

In January 2016, the FDA released the Post-market Management of Cybersecurity in Medical Devices Guidance. This new draft guidance outlines the steps manufactures should take to continually address cyber security risks with their devices in order to better protect public health. The draft guidance outlines the FDA's expectations for monitoring, identifying, and addressing cyber security vulnerabilities in medical devices once they have entered the market.

 

This guideline offers a framework that organizations can build upon to ensure that their cyber security polices, procedures, and strategies proactively address cyber security risks in medical devices before the organization, patients, or the public at large, face financial harm or bodily injury from an unaddressed vulnerability by an unknown threat.