As cyberattacks on healthcare persist, can the FDA’s new device regs hold up?

MedTech Dive April 3, 2024
Ricky Zipp

Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.

Medical device cybersecurity was an afterthought for the industry and regulators for years, even as hackers continually targeted the healthcare sector.

That changed last year when Congress codified stricter medical device cybersecurity requirements and the Food and Drug Administration finalized souped-up guidance for manufacturers. The new actions prioritized security at a time when cyberattacks and incidents were not just compromising data but crippling hospitals’ operations and threatening patient safety.

“I view last year as the beginning of time … a new world. Because the community has spent, I would say, a good 15 years thoughtfully working...

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