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Verification, Analytical Validation, and Clinical Validation (V3) framework

The originial V3 framework has become foundational to how the digital medicine field assesses the technical, scientific, and clinical performance of sensor-based digital health technologies (sDHTs). It lays out a modular framework for assessing the quality of the sensor/s (verification), performance of the algorithm/s (analytical validation), and clinical relevance of the outcome measure/s (clinical validation) generated by these tools.

The original three-component V3 Framework has emerged as the de facto standard across the industry for evaluating whether digital clinical measures are fit for purpose. Since its dissemination in 2020, the framework has been accessed over 30,000 times, cited more than 250 times in peer-reviewed journals, and leveraged by over 140 teams, including NIH, FDA, and EMA.

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Clinical Trials, Digital Measures Best Practices

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