Healthcare IT News October 17, 2019
The U.S. Food and Drug Administration unveiled a new set of draft recommendations on clinical decision support software recently, and in its guidance, the agency said it’s taking a risk-based approach to categorization of these various CDS tools, many of them powered by artificial intelligence, that it hopes will be an “appropriate regulatory framework that takes into account the realities of how technology advances play a crucial role in the efficient development of digital health technologies.”
Given the vast proliferation of AI and machine learning software across healthcare, and the speed at which it’s evolving, that certainly won’t be the last word from the FDA, or other regulatory agencies, on the subject.
A truly global framework
Indeed, said Robert Havasy,...
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