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<p>We propose the addition of <i>usability validation</i> 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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年1月24日

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  • 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

摘要

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.