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V3 | Verification, analytical validation, and clinical validation (V3)

V3 was DiMe’s first project. We launched the sprint effort in the fall of 2019 and published our manuscript in 2020 demonstrating our ability to deliver clinical quality work on a tech timeline. 

The three-component V3 framework is novel and intentionally combines well established practices from both software and clinical development to establish the shared foundation for evaluating whether digital clinical measures are fit-for-purpose.

The V3 framework is a modular approach that allows digital sensing products, algorithms, and clinical use cases to be evaluated separately by parsing out evidence and documentation required at each level of the digital clinical measures stack. 

Meet the experts who developed V3

A group of 17 experts with different disciplinary expertise collaborated to develop the V3 framework. This sprint team represented experts from a variety of different work settings and multiple regulatory regions. Meet the team:

Jennifer C. Goldsack, Andrea Coravos, Jessie P. Bakker, Brinnae Bent, Ariel V. Dowling, Cheryl Fitzer-Attas, Alan Godfrey, Job G. Godino, Ninad Gujar, Elena Izmailova, Christine Manta, Barry Peterson, Benjamin Vandendriessche, William A. Wood, Ke Will Wang & Jessilyn Dunn

V3 is emerging as the gold standard for evaluating fit-for-purpose digital measures

V3 has been adopted by:

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DiMe’s projects are seeded by our member community, where experts share the greatest barriers to advancing the field of digital medicine. When the most complex and significant roadblocks can be addressed with a cross-ecosystem, pre-competitive approach, that’s where we come in: DiMe convenes multi-stakeholder teams to quickly dive deep into issues and rapidly produce high-quality resources that meaningfully enable progress.
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