Lexology December 15, 2025
New and Emerging Cyber Risks for AI-Enabled Medical Devices and What Regulators Will Expect Next
What Makes AI-Enabled Devices Different?
Traditional thinking around medical device security assumed a certain level of predictability and stability. A device was cleared or approved by a regulator and put into clinical use, where it would not experience significant changes in function or behavior.
AI (artificial intelligence) disrupts this status quo. Models may be updated, tuned, or retrained after deployment, sometimes remotely and sometimes continuously. They may change how they operate and process data in subtle but important ways. From a security and operational perspective, this means that it is harder to establish a fixed security baseline or even a single “validated” state.
Regulators are...
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