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FDA Issues New Guidance For Use Of AI In Health Care

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The U.S. Food and Drug Administration recently partnered with Health Canada and the UK's Medicines and Healthcare products Regulatory Agency to issue guiding principles to align efforts and standards for artificial intelligence and machine learning medical device development in health care. "The FDA believes that artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day," said Jim McKinney, public affairs specialist at the FDA, in an email to The Well News. McKinney said the 10 guiding principles grew out of collaborative discussions with Health Canada and MHRA, and learning from several sectors that applied AI and ML technologies for years and have developed good practices that can be readily applied to the medical device industry. Evidence from published information, expert and other public perspectives and review experience was used to develop the guiding principles that will be used by the agency to lay the foundation for the development of Good Machine Learning Practice, which will unify international efforts for medical device development. Over the past decade the FDA has reviewed and authorized a growing number of devices legally marketed with machine learning and expects this trend to continue.