Summary
Consensus report addressing cybersecurity threats unique to machine-learning-enabled medical device software, distinct from general medical-device cybersecurity risks. The report covers threats that may arise during data collection, product design, deployment, use, and maintenance, and FDA recognizes the complete standard in its medical-device consensus standards database.
Healthcare Implications
Provides AI/ML medical-device manufacturers with a recognized reference for cybersecurity risk analysis and documentation, including model- and data-related threats. Providers and health systems can use the standard in vendor due diligence for AI/ML-enabled devices, while developers should still account for FDA cybersecurity guidance and statutory cybersecurity requirements beyond this consensus report.