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


February 27, 2024


Bryan R. Cobb, PhD

PR. Medical Science Director Digital Medical Team, Genentech

Kimberly Kontson, PhD

Biomedical Engineer, Human-Device Interaction Research Program Coordinator Center for Devices and Radiological Health, U.S. Food and Drug Administration

Elizabeth Kunkoski, MS

Health Science Policy Analyst Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Stéphane Motola, PharmD/MSc

Strategic Partnership Project Manager SYSNAV

Oana Paun

QA Manager Aardex Group

Jessie Bakker MS PhD

Director, Digital Measures and Diagnostics Digital Medicine Society (DiMe)


Benjamin Vandendriessche, PhD

VP, Science Digital Medicine Society (DiMe)

Jennifer Goldsack, MChem, MA, MBA, OLY

CEO Digital Medicine Society (DiMe)

Discussion Topic

As clinical research sponsors and healthcare organizations take digital clinical measures to scale, new challenges related to the usability of sDHTs across diverse populations, settings, and implementation approaches have become pressing.  DATAcc by DiMe has built on the foundation of the original V3 framework by adding a fourth evidence-based component addressing sDHT usability validation. Along with the V3+ manuscript, the project team has developed new, free resources to support research and clinical teams implementing the V3+ recommendations for best practices.

Listen now to learn more about implementing V3+ usability validation with our new resources, as well as DiMe’s new “Building Fit-for-Purpose Sensor-based Digital Health Technologies: A Crash Course,” aimed at educating learners on V3+ fundamentals and helping them understand how to use the framework in their work.

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