Comment from DEEP Measures

DEEP Measures accelerates the utilization of digital measures of health by helping pharmaceutical and biotech companies, technology developers, and academic institutions collaborate on the creation, validation, and acceptance of sensor-based digital endpoints. Our structured evidentiary framework and content model is designed to support the development of patient-focused, fit-for-purpose digital measures with appropriate definitions and evidence to enable regulatory qualification and utilization in clinical trials. In our work building structured evidence packages with sponsors, we have observed that the difficulty of assembling regulatory-ready DHT documentation often stems from the absence of a shared, modular content model, which creates the need for sponsors to recreate provenance documentation from scratch for each clinical program. To address this, DEEP Measures works with sponsors to enable reuse of structured, modular DHT evidence components—such as device configuration, analytical validation, and usability evidence—across clinical programs and DHT regulatory submissions. By separating algorithm logic, performance evidence, and operational deployment, we enable controlled evolution of digital measures without loss of reproducibility or auditability, allowing sponsors to present consistent, inspectable documentation across clinical programs and reducing uncertainty during review and inspection. We also support DHT regulatory engagement and evidence submissions to the FDA and EMA to provide transparency in the DHT data capture and processing lineage—from sensor to regulatory submissions and supporting clinical evidence. Additionally, to further accelerate the Digital Health ecosystem, DEEP Measures leads an industry consortium of pharmaceutical companies, including Bayer, BMS, J&J, Pfizer, GSK, and UCB, called the Global Advocacy Network (GAN) that works together to advance regulatory science and accelerate the adoption of harmonized digital measure solutions by actively shaping the regulatory and policy landscape for digital health technologies.