npj Digital Medicine (Jan 2025)
V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies
- Jessie P. Bakker,
- Roland Barge,
- Jacob Centra,
- Bryan Cobb,
- Chas Cota,
- Christine C. Guo,
- Bert Hartog,
- Nathalie Horowicz-Mehler,
- Elena S. Izmailova,
- Nikolay V. Manyakov,
- Samantha McClenahan,
- Stéphane Motola,
- Smit Patel,
- Oana Paun,
- Marian Schoone,
- Emre Sezgin,
- Thomas Switzer,
- Animesh Tandon,
- Willem van den Brink,
- Srinivasan Vairavan,
- Benjamin Vandendriessche,
- Bernard Vrijens,
- Jennifer C. Goldsack
Affiliations
- Jessie P. Bakker
- Digital Medicine Society
- Roland Barge
- Regeneron Pharmaceuticals Inc
- Jacob Centra
- Digital Medicine Society
- Bryan Cobb
- Genentech
- Chas Cota
- Stel Life Inc
- Christine C. Guo
- ActiGraph LLC
- Bert Hartog
- Johnson & Johnson Innovative Medicine
- Nathalie Horowicz-Mehler
- Exponent Inc
- Elena S. Izmailova
- Koneksa Health
- Nikolay V. Manyakov
- Johnson & Johnson Innovative Medicine
- Samantha McClenahan
- Digital Medicine Society
- Stéphane Motola
- Sysnav Healthcare
- Smit Patel
- Digital Medicine Society
- Oana Paun
- AARDEX Group
- Marian Schoone
- Netherlands Organisation for Applied Scientific Research (TNO)
- Emre Sezgin
- Nationwide Children’s Hospital
- Thomas Switzer
- Genentech
- Animesh Tandon
- Department of Heart, Vascular, and Thoracic, Division of Cardiology and Cardiovascular Medicine, Children’s Institute, Cleveland Clinic Children’s
- Willem van den Brink
- Netherlands Organisation for Applied Scientific Research (TNO)
- Srinivasan Vairavan
- Johnson & Johnson Innovative Medicine
- Benjamin Vandendriessche
- Digital Medicine Society
- Bernard Vrijens
- AARDEX Group
- Jennifer C. Goldsack
- Digital Medicine Society
- DOI
- https://doi.org/10.1038/s41746-024-01322-2
- Journal volume & issue
-
Vol. 8,
no. 1
pp. 1 – 13
Abstract
Abstract 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.
