V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.

Bakker, Jessie P; Barge, Roland; Centra, Jacob; Cobb, Bryan; Cota, Chas; Guo, Christine C; Hartog, Bert; Horowicz-Mehler, Nathalie et al. · NPJ Digit Med · 2025

expert_opinion · Level V

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Abstract

We propose the addition of usability validation to the extended V3 framework, now "V3+", and describe a pragmatic approach to ensuring that sensor-based digital health technologies can be used optimally at scale by diverse users. Alongside the original V3 components (verification; analytical validation; clinical validation), usability validation will ensure user-centricity of digital measurement tools, paving the way for more inclusive, reliable, and trustworthy digital measures within clinical research and clinical care.