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Communications of the ACM

ACM Opinion

The FDA Should Better Regulate Medical Algorithms


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A doctor checks patient info at a computer workstation.

Medical algorithms are used across healthcare to diagnose disease, offer prognosis, monitor patient health, and more, but recent news is filled with stories of these technologies running amok.

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We know algorithms in healthcare can be biased or ineffective, but it is time for America to pay more attention to the regulatory system that lets these algorithms enter the public domain to begin with. Regulation needs to evolve with innovation. Given the threats of unregulated medical algorithms for patients and communities, we believe the U.S. must improve regulations and oversight on these new-age devices.

In healthcare, if your decisions affect patient lives, "do no harm" must apply—even to algorithms.

From Scientific American
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