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Machine Learning AI in Medical Devices

Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance

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

The first white paper in this series, The emergence of artificial intelligence and machine learning algorithms in healthcare: Recommendations to support governance and regulation, is available here.

This second paper builds on that initial work. It examines how AI is different from traditional medical devices and medical software, explores the implications of those differences, and discusses the controls necessary to ensure AI in healthcare is safe and effective. Because these differences will not be the same for the full range of systems, it is important to identify what aspects of AI are of concern.

To preview this file click here.

April 21, 2020
Available for Immediate Download