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

doi:10.1038/s41746-024-01322-2

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

NPJ Digit Med. 2025 Jan 24;8(1):51. doi: 10.1038/s41746-024-01322-2.

Authors

Jessie P Bakker^{1

2

3}, Roland Barge⁴, Jacob Centra⁵, Bryan Cobb⁶, Chas Cota⁷, Christine C Guo⁸, Bert Hartog⁹, Nathalie Horowicz-Mehler¹⁰, Elena S Izmailova¹¹, Nikolay V Manyakov¹², Samantha McClenahan⁵, Stéphane Motola¹³, Smit Patel⁵, Oana Paun¹⁴, Marian Schoone¹⁵, Emre Sezgin¹⁶, Thomas Switzer⁶, Animesh Tandon^{17

18

19

20}, Willem van den Brink¹⁵, Srinivasan Vairavan²¹, Benjamin Vandendriessche^{5

22}, Bernard Vrijens^{14

23}, Jennifer C Goldsack⁵

Affiliations

¹ Digital Medicine Society, Boston, MA, USA. jessie.bakker@dimesociety.org.
² Division of Sleep and Circadian Disorders, Mass General Brigham, Boston, MA, USA. jessie.bakker@dimesociety.org.
³ Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA. jessie.bakker@dimesociety.org.
⁴ Regeneron Pharmaceuticals Inc, New York, NY, USA.
⁵ Digital Medicine Society, Boston, MA, USA.
⁶ Genentech, South San Francisco, CA, USA.
⁷ Stel Life Inc, Philadelphia, PA, USA.
⁸ ActiGraph LLC, Pensacola, FL, USA.
⁹ Johnson & Johnson Innovative Medicine, Breda, The Netherlands.
¹⁰ Exponent Inc, New York, NY, USA.
¹¹ Koneksa Health, New York, NY, USA.
¹² Johnson & Johnson Innovative Medicine, Beerse, Belgium.
¹³ Sysnav Healthcare, Vernon, France.
¹⁴ AARDEX Group, Liège, Belgium.
¹⁵ Netherlands Organisation for Applied Scientific Research (TNO), Leiden, The Netherlands.
¹⁶ Nationwide Children's Hospital, Columbus, OH, USA.
¹⁷ Department of Heart, Vascular, and Thoracic, Division of Cardiology and Cardiovascular Medicine, Children's Institute, Cleveland Clinic Children's, Cleveland, OH, USA.
¹⁸ Cleveland Clinic Children's Center for Artificial Intelligence (C4AI), Department of Heart, Vascular, and Thoracic, Children's Institute, Cleveland Clinic Children's, Cleveland, OH, USA.
¹⁹ Department of Pediatrics, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA.
²⁰ Department of Biomedical Engineering, Cleveland Clinic Lerner Research Institute, Cleveland, OH, USA.
²¹ Johnson & Johnson Innovative Medicine, New Brunswick, NJ, USA.
²² Department of Electrical, Computer, and Systems Engineering, Case Western Reserve University, Cleveland, OH, USA.
²³ Department of Public Health, Liège University, Liège, Belgium.

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.

Publication types

Review