The role of post-market surveillance in monitoring of artificial intelligence enabled medical devices after deployment - a comprehensive review

Abstract

Transformative advances in diagnostics and treatment can be achieved when Artificial Intelligence (AI) is integrated into medical devices. The unique challenge with the introduction of adaptive nature of AI and ML models are safety and performance especially during longer period. Therefore, pre-market evaluation of the medical devices is not sufficient. This highlights the role of Post-market surveillance, which ensures the safe monitoring of these technologies. The performance of the AI-enabled medical devices may show variation due to changes in clinical practice, progressive disease, and unexpected change in data in real-world population unlike traditional devices. AneffectivePost-marketsurveillanceforAIenableddevicesmustbeproactiveandmustbedatadriven.Toalleviate any risks which may arise, post-market surveillance (PMS) systematically collects and analyzes the data from real world. Essential elements of PMS include setting performance standards, maintaining a watch for model instability, executing user feedbacks and enforcing stringent guidelines for clear incident reporting.