CTA 2108

Current Revision
Validation of Health Technology under Unconstrained Test Conditions

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CTA 2108
There are few studies that evaluate Digital Health Technology-derived health, wellness, and performance metrics via naturalistic or unconstrained protocols. Expanding validation efforts to include such protocols is becoming more critical as Digital Health Technology devices are increasingly utilized for longitudinal monitoring, evaluation, and reporting purposes (e.g., fatigue risk monitoring in industry and the military; surrogate end-point patient outcome monitoring within the clinical setting). An assessment and validation of existing Digital Health Technology devices under naturalistic and unconstrained test conditions present opportunities and challenges that must be considered in study design and testing and reporting approaches. This document provides a framework for designing and implementing Digital Health Technology-derived device characterization and validation studies for specific use cases. The intent is for this framework to be utilized for the creation of more targeted standards development and application across a broad set of use cases with direct real-world application relevance. 2 BACKGROUND/PUR
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