Chilmark Research January 30, 2020
Roughly two years after we reviewed the first FDA guidance on Clinical Decision Support (CDS), FDA issued new draft guidance. The FDA was criticized for not basing their first draft regulation criteria on use-case risk. Since then the International Medical Device Regulators Forum (IMDRF), which the FDA chaired, created a framework for organizing Software as a Medical Device (SaMD) by risk categories. While CDS is a very broad category that encompasses many functions, this guidance could have an outsize impact on the need to provide transparency in AI/ML platforms and algorithms for healthcare.
Guidance and regulation are sorely needed. The criminal settlement for Practice Fusion includes the admission that their CDS alerts were intentionally biased to increase prescriptions of ‘sponsoring’...
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