Unlike a drug—with apologies for stating the obvious—digital medicine tools have software, hardware, algorithms—it’s possible that different companies contributed to the tool’s components.1 So relying on existing regulatory frameworks will not work with these tools, the measurers say. Verifying performance against established criteria; validating the algorithm’s performance to accurately capture the metrics; and clinically validating the tool’s output are the three necessary components to reach standardization, proponents say.1
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