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New FDA medtech cybersecurity chief: Guidance to debut in 2021

The FDA’s first medical device cybersecurity chief says he will work across private and public lines to lower the threat of cyberattacks against medical devices and the healthcare systems and patients who use them.

Medical device manufacturers can expect a new FDA cybersecurity draft guidance for new medical devices sometime this year, according to the agency’s first acting director of medical device cybersecurity.

University of Michigan computer science researcher Kevin Fu has a big assignment to tackle during his one-year tenure — to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital security threats.

An associate professor of electrical engineering and computer science, Fu is the founder of the Archimedes Center for Medical Device Security at the university and considers updating legacy medical device software a “huge challenge.” Medtech executives need to better understand that challenge, not only to safeguard their older devices but so they can appreciate the value of cybersecurity early in the design of medical devices, Fu has said.

source:New FDA medtech cybersecurity chief: Guidance to debut in 2021

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