Report calls out weak FDA stance on medical device cybersecurity, favors stronger regulation

From: Healthcare IT News

Institute for Critical Infrastructure Technology says the feds should do more than just suggest safeguards.

By Mike Miliard

A report this week from the Institute for Critical Infrastructure Technology, a bipartisan collaborative meant to bridge the gap between federal agencies and private-sector leaders in the interest of protecting critical infrastructure, claims recent guidance from U.S. Food and Drug Administration for device makers falls way short.

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Specifically, the study, “Assessing the FDA’s Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle ‘Suggestions’ May Not Be Enough,” knocks the agency for failing to implement enforceable regulations for manufacturers.

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