AHA critiques FDA's expanded regulation of clinical decision support software

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The American Hospital Association released a statement expressing concerns about the FDA's draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act.

The FDA's guidance document, published in September, clarified the types of clinical decision support software the agency regulates under the act, with a primary goal of monitoring any software that replaces, rather than augments, the decision-making abilities of healthcare providers.

"While the AHA strongly agrees that any CDS algorithm that takes independent review and action out of the hands of the [provider] should be regulated, we are concerned that the FDA's interpretation of this criterion could apply an arbitrary distinction between 'informing clinical management' and 'driving clinical management' that is not directly supported by the statute and does not accurately reflect how CDS is used in a patient care environment," the AHA stated.

Additionally, according to the AHA, "the FDA's interpretation of certain criteria could result in many existing CDS algorithms being subject to the FDA approval process and ultimately slow the pace of innovation and development of new algorithms to support better patient care and outcomes."

Read the full statement here.

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