V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies
Jessie P. Bakker, Roland Barge, Jacob Centra, Brian Cobb, Chas Cota, Christine Cong Guo, Bert Hartog, N. Horowicz-Mehler, Elena S. Izmailova, Nikolay V. Manyakov, Samantha J. McClenahan, Stéphane Motola, Smit Patel, Oana Paun, Marian Schoone-Harmsen, Emre Sezgın, Thomas Switzer, Animesh A Tandon, Willem Johan van den Brink, Srinivasan Vairavan · npj Digital Medicine · 2025
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.