Half Of 24 FDA-Approved Clinical AI Or Machine Learning Devices For Use With People With Dementia Lacked Information About The Training Or Validation Data Sets

Of 24 artificial intelligence (AI) or machine learning (ML) devices authorized for clinical use with people with Alzheimer’s disease and related dementias (ADRD), 12 lacked information about the training or validation data sets, according to a recent study. This includes the demographic data supporting the U.S. Food and Drug Administration’s (FDA) authorization of the devices. The 24 devices are for use by clinical professionals and can be used to support earlier diagnosis or provide symptom monitoring for people with ADRD. The lack of transparency about the demographic representativeness of training and validation datasets raises questions about algorithmic . . .