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V3+: An extension to the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies

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.

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Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

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