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Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices
2021
Journal of Medical Internet Research
One of the greatest strengths of artificial intelligence (AI) and machine learning (ML) approaches in health care is that their performance can be continually improved based on updates from automated learning from data. However, health care ML models are currently essentially regulated under provisions that were developed for an earlier age of slowly updated medical devices—requiring major documentation reshape and revalidation with every major update of the model generated by the ML algorithm.
doi:10.2196/30545
pmid:34697010
pmcid:PMC8579211
fatcat:tnypt3u6pzcq7ajkjpmvnzxhfi