How Do You Construct a Safe, Effective Algorithm?

It’s not an easy question to answer, but with a well thought out roadmap, it’s doable.

By John Halamka, M.D., President, Mayo Clinic Platform and Paul Cerrato, MA, senior research analyst and communications specialist, Mayo Clinic Platform, and Sonya Makhni, MD, MS, MBA, Medical Director, Mayo Clinic Platform.

By July 30, 2023, the US Food and Drug Administration had cleared almost 700 AI-enabled medical algorithms. Within a year, that number had grown to 950, and that does not include the many algorithms that do not require FDA clearance or approval. Unfortunately, the evidence strongly suggests that many of these digital tools, both approved and not, have a credibility problem because they lack transparency, measures of reliability, and demonstrated consistency.

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