The Digital Health Measurement Collaborative Community, known as DATAcc, part of the Digital Medicine Society, has introduced the sDHT Adoption Navigator, a new educational platform created to assist life sciences companies and technology developers in integrating sensor-based digital health technologies, or sDHTs, into clinical trials for medical product development. Funded by the U.S. Food and Drug Administration, the resource consolidates regulatory guidance, scientific standards, and industry best practices into a single, easy-to-use platform. This centralization saves teams time and effort that would otherwise be spent navigating hundreds of separate sources to locate relevant guidance and evidence.
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Sarah Averill Lott, Program Lead at DiMe, explained that while the scientific, technological, and regulatory frameworks for sDHTs have progressed considerably, many teams struggle to translate this information into practical steps. She said the sDHT Adoption Navigator is intended to accelerate the adoption process by helping teams align early, select or develop fit-for-purpose technologies, and quickly identify the guidance and evidence most relevant to their specific programs. The goal is to reduce friction, shorten learning curves, and encourage more effective collaboration across the digital health ecosystem.
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The Navigator organizes publicly available materials from regulatory authorities, including the FDA, alongside curated industry resources and best practices. More than 300 vetted documents have been categorized and linked to specific aspects of sDHT development and adoption. By helping teams establish a common understanding of guidance and evidence needs, the platform encourages more productive discussions across development, validation, and deployment stages.
The tool includes two main components. The sDHT Adoption Roadmap is an interactive guide that helps teams navigate patient-centered endpoint selection, implementation best practices, validation planning, and early regulatory considerations. Embedded tools and direct links to relevant resources are integrated into workflows that mirror real-world development processes. The second component, the sDHT Adoption Library featuring NaVi, is an AI-powered research assistant that uses the curated library of over 300 documents to quickly locate relevant information, streamlining access to regulatory and industry guidance.
Developed through a multi-stage research process that included literature reviews, in-depth interviews with regulators, developers, and clinical teams, and validation by an expert panel, the Navigator reflects a decade of collective knowledge on sDHT adoption. The platform arrives at a critical moment as sDHTs are increasingly used to capture patient-centered outcomes and other measures that are challenging to record through traditional methods. The resource aligns with FDA efforts to modernize medical product development and accelerate the use of sDHTs while ensuring high-quality data and reducing participant burden in clinical trials.
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