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Creating a Safety Net for Medical Devices

A life-cycle approach for monitoring cybersecurity vulnerabilities

Suzanne Schwartz
Tue, 11/22/2016 - 00:00
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During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of their medical devices.

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Many medical devices are “life critical systems,” meaning they play a crucial role in monitoring and protecting human life. As more of these systems use technology to interconnect, we must be dedicated to securing them from hackers and cyber attacks.

Here at the U.S. Food and Drug Administration (FDA), we work with hospitals, healthcare professionals, and patients to provide medical device manufacturers with guidance for monitoring, identifying, and addressing cybersecurity vulnerabilities in their devices before and after they have entered the market. To further counter threats, the FDA has been making a deliberate effort to work with outside groups—including those we have previously not engaged with—such as security researchers.

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