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BioWorld - Friday, June 12, 2026
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Home » DoJ creates program to ramp up False Claims Act litigation for cybersecurity lapses
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DoJ creates program to ramp up False Claims Act litigation for cybersecurity lapses

Oct. 27, 2021
By Mark McCarty
The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.
Medical technology Regulatory Cybersecurity U.S. Courts

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