Table 4 Summary of analytical validation.

From: Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

Who?

Engineers, data scientists/analysts/statisticians, physiologists, behavioral scientists, and clinical researchers

What?

Protocol for data capture from a human participant.

Algorithms applied to sample-level data to yield measurements that are indicative of clinical concepts.

When?

First use in human subjects.

Where?

Research or clinical laboratories.

Why?

To evaluate the performance of the algorithm, and its ability to measure, detect, or predict physiological or behavioral metrics.

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