Health IT Analytics February 7, 2018
The FDA draft guidance on clinical decision support tools does not adequately account for the rapid growth of machine learning, AMIA says.
The FDA’s recent guidance on classifying and regulating clinical decision support (CDS) systems is currently too ambiguous for developers to effectively follow, contends the the American Medical Informatics Association (AMIA) in a response to the draft framework.
The FDA guidance, published in accordance with provisions in the 21st Century Cures Act, is intended to help developers and vendors understand which CDS products may require more extensive review by the regulatory agency.
But the guidance is not as clear as it could be when it comes to the fastest-growing category of clinical decision support tools: those that are powered...
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