Exponent Partners With DiMe to Improve Digital Health Tool Standards

The Digital Medicine Society seeks to expand adoption of its V3 framework through collaboration with industry

Exponent is proud to announce a new partnership with the Digital Medicine Society (DiMe), supporting the nonprofit's efforts to expand the adoption of its V3 framework for evaluating digital health technology (DHT) reliability.

"We are excited to collaborate with DiMe on their efforts to verify and validate digital health technology products under real-world conditions," said Exponent Group Vice President & Principal Scientist John Doyle, Dr.P.H., M.P.H., who is leading the firm's work with DiMe. "Their V3 framework provides a modular approach that allows us to evaluate DHTs, algorithms, and clinical use cases separately, which is important to understanding their real-world value and impact across the healthcare value chain."  

Exponent brings multidisciplinary expertise to the firm's collaboration with DiMe, including the support of Rachel Kelly, Ph.D., Human Factors; Scott McLean, Ph.D., Biomechanics; and Kunal Chaudhary, Ph.D., M.H.A., Health Sciences.  

DiMe's V3 framework — which stands for verification, analytical validation, and clinical validation — was published in 2020 and has since emerged as the de facto standard for evaluating the technical, scientific, and clinical performance of biometric monitoring technologies (BioMeTs) and sensor-based DHT products. Rooted in established practices in software and clinical development, the V3 framework has been used to assess technologies ranging from wearables to ingestible sensing capsules around the world.

In March, DiMe announced the "Extending the Verification, Analytical Validation, and Clinical Validation (V3+) Framework" project aimed at adding new evidence-based components to its approach, with the goal of ensuring that DHTs meet the needs of all users by applying best practices in usability, human factors, and human-centered design.

This new effort will clarify core terminology and best practices for evaluating DHT reliability and broaden the deployment of DHTs to more diverse populations as organizations continue taking digital clinical measures and products to scale. The goal is to help ensure that DHTs meet the necessary industry and regulatory standards for usability, while promoting diversity, equity, and inclusion among research participants and patients. DiMe also seeks to verify that the data generated by DHTs under real-world conditions in decentralized clinical trials and healthcare delivery are trustworthy for clinical, regulatory, and payer decision-making.

Other DiMe industry partner organizations include the Aardex Group, Actigraph, ATCOR Medical (CardieX), Genentech, Janssen, PKG by Global Kinetics, Sage Therapeutics, Stel Life, Sysnav Healthcare, and TNO.