FDA Names First Acting Director of Medical Device Cybersecurity – Finally

February 23, 2021

 – Episode #


Windows XP went end of life on April 8th, 2014, but it’s probably running on more than one BioMed device at your health system.

Can you think of an area more needing for Cybersecurity focus than BioMed devices?  Well, the FDA has finally moved to address this gap.

The Food and Drug Administration recently named Kevin Fu as the agency’s first Acting Director of Medical Device Cybersecurity in its Center for Devices and Radiological Health.

The newly created position is designed as a 12-month post, which began on January 1, 2021. Fu will lead the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, including pacemakers, insulin pumps, hospital imaging machines, and other electronic devices.

If you want to know where he is going.

“You can’t simply sprinkle magic security pixie dust after designing a device,” Fu explained to the University of Michigan. “Whether for manufacturers of the Internet of Things or medical devices, we’re not providing the necessary level of security engineering training that companies need.”

Dust off your bio med device security playbooks.  I would be shocked if they have much dust on them, but get them out and turn to page …

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