• Content Type

Research and analysis item

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


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.

“The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation” is the first white paper published in this series.

Key Information

Name of organisation: British Standards Institution
Type of organisation: SDO

Date published: 5 Jan 2020


Type: Report

Type of organisation:

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