Mayo Clinic June 13, 2022
John Halamka

Software as a medical device continues to evolve with advances in machine learning. So do the federal regulations governing these digital tools.

By John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform

The term software as a medical device (SaMD) may sound cryptic to anyone not familiar with health care IT. To explain the term, the U.S. Food & Drug Administration (FDA) quotes the International Medical Device Regulatory Forum’s definition: “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” This kind of standalone software is having a major impact on the delivery of medical care worldwide,...

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