Foundational V3 Framework Extended to Incorporate Usability Validation of Sensor-Based Digital Health Technologies

Digital Medicine Academy® supports the extension launch with new V3+ Crash Course

BOSTON, Feb. 27, 2024 /PRNewswire/ -- To support the rapid evolution of digital clinical measures, today, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) released an extension of its foundational Verification, Analytical Validation, and Clinical Validation (V3). The V3+ extension adds a fourth component of "Usability Validation," incorporating the evaluation of user experience at scale. Additional resources, a supporting manuscript, and new educational material are now available to make it easy for developers to implement it as they build sensor-based digital health technologies (sDHTs).

V3 was DiMe's first project in 2020 and has since become the industry standard for assessing the quality of the sensors, performance of the algorithms, and clinical relevance of the digital clinical measures generated by sDHTs. The original three-component V3 Framework has been accessed over 30,000 times, cited more than 250 times in peer-reviewed journals, and leveraged by over 140 teams, including NIH, FDA, and EMA. The three components of the original V3 framework remain unchanged; the V3+ framework is now extended to evaluate the ease of use, efficiency, and user satisfaction of sDHTs.

"We're seeing the development and use of sDHTs grow at unprecedented rates," said DiMe CEO Jennifer Goldsack. "We're at the point where sDHTs are increasingly positioned to improve lives at scale and to ensure usability and trust, a fourth component of V3, now 'V3+' is needed. A focus on usability validation will now ensure that data sDHTs produce in clinical trials, healthcare delivery, and public health can be relied upon for clinical, regulatory, and payer decision-making."

"DiMe's V3 Framework has been instrumental in helping us align on the concepts of verification and validation consistently both internally and with outside stakeholders as we leverage technology in clinical trials to support drug development," said Thomas Switzer, Principal Digital Health Scientist, Early Clinical Development Informatics, Genentech. "I was proud to join DATAcc in the development of V3+ to include usability as a requirement in this framework. This will help further advance the field of digital measures and the impact these instruments have on developing medicines for patients."

Participating in the development of V3+ and supporting resources were project partners: AARDEX Group, ActiGraph, ATCOR Medical, Exponent, Genentech, Global Kinetics, Janssen Pharmaceutical Companies of Johnson & Johnson, Regeneron, Sage Therapeutics, Stel Life Inc, SYSNAV, and TNO.

To jumpstart your understanding of V3+, and to learn how to maximize the potential market of digital measurement products, enroll in DiMe's new course, "Building Fit-for-Purpose Sensor-based Digital Health Technologies: A Crash Course" today! Additionally, DiMe continues to drive the industry on digital endpoints and will launch a new project focused on building the business case for digital endpoints. To learn more about this upcoming project, click here.

About the Digital Medicine Society: DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.

About DATAcc by DiMe: The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is a collaborative community with the FDA's Center for Devices and Radiological Health. We provide a forum for collaboration where partners and experts from across the digital health field work to advance the use of digital health measures in research to improve lives.

Media Contact:
Carla English
[email protected]

SOURCE Digital Medicine Society (DiMe)