As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement
FDA Law Blog
JANUARY 5, 2023
To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware. FDA has shown a willingness to intervene in this space.
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