Machine learning AI in medical devices: adapting regulatory frameworks and standards to ensure safety and performance

Abstract

The BSI/AAMI Initiative on Artificial Intelligence (AI) in medical technology is an effort to explore the ways that AI, and in particular machine learning, pose unique challenges to the current body of standards and regulations governing medical technologies. Its aim is to determine what additional guidance or standards might be needed to promote the safety and effectiveness of medical AI technologies.

This second paper builds on the initial work set out in the first white paper (“The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation”). It examines how AI is different from conventional medical device software, explores the implications of these differences, and discusses the controls that may be necessary to ensure AI in healthcare is safe and effective. The paper also provides some recommendations for evolving standards and guidance for medical AI technologies in the future.

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