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AAMI CR515:2025
Cybersecurity considerations unique to machine learning – enabled medical devices
This consensus report specifically addresses the unique cybersecurity threats associated with developing and deploying machine learning–enabled medical device software, as distinct from the broader cybersecurity risks applicable to all medical device life cycle phases. This includes potential cybersecurity threats that can arise from or during data collection, product design, product deployment, product use, and maintenance.
Association for the Advancement of Medical Instrumentation [aami]