Inside Digital Health August 12, 2019
Software as a medical device (SaMD) and U.S. Food and Drug Administration (FDA) 510(k) clearance might not be the most familiar terms to all health system leaders, physicians and nurses who use computers, but if they hope to take advantage of the latest artificial intelligence (AI)-enabled programs, they will need to keep up. The most recent FDA proposed regulatory framework on SaMD is likely to transform patient care in the next few years. Understanding how the guidelines fit into the picture will enable clinicians and their organizations to take full advantage of the machine learning-based diagnostic and treatment algorithms now being introduced.
Deciphering the Terminology
To make sense of SaMD, it helps to understand the FDA’s expanded definition of...
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