The V3+ Framework is an extension of DiMe’s existing Verification, Analytical Validation, and Clinical Validation (V3) Framework to include a fourth component – usability validation. Usability must be accounted for the successful large-scale implementation of sensor-based digital health technologies (sDHTs). Verification, analytical validation, clinical validation, and usability validation are the critical components of equal importance for determining whether an sDHT is fit-for-purpose.

This extended framework must be used in conjunction with the original V3 framework to build high-quality products, transform the way we care for people, and conduct clinical trials.