DiMe launches FDA-funded sDHT Adoption Navigator to support teams developing and deploying sensor-based digital health technologies in clinical trials

Open-access interactive roadmap with AI-powered navigation that puts all regulatory guidance and industry best practices at life sciences and technology developers’ fingertips to accelerate clinical trial or sDHT adoption

BOSTON, Feb. 4, 2026 /PRNewswire/ — The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) today released the sDHT Adoption Navigator, a comprehensive educational resource designed to help life sciences companies and technology developers navigate the integration of sensor-based digital health technologies (sDHTs) into clinical trials for medical product development.

Developed with funding from the U.S. Food and Drug Administration (FDA), the Navigator organizes the growing body of regulatory guidance, scientific standards, and industry best practices into a single, centralized platform. The resource represents over a decade of innovative work across industry, academia, and regulatory authorities, distilled into an experience that can be accessed in minutes, reducing the need for teams to independently search across hundreds of sources to piece together relevant regulatory science and guidance.

“The science, technology, and regulatory foundations for sDHTs have advanced substantially, but progress still slows when teams struggle to translate that material into action,” said Sarah Averill Lott, Program Lead at DiMe. “The sDHT Adoption Navigator is designed to be an accelerator, helping adopters and developers align earlier, build or use fit-for-purpose technologies, and quickly identify the guidance and evidence that are most relevant to their specific program. Our goal is to reduce friction, shorten learning curves, and enable more effective collaboration across the ecosystem.”

The Navigator aggregates public materials from regulatory authorities, including the FDA, alongside curated industry resources and best practices, organizing them around common decision points teams face when working with sDHTs. More than 300+ vetted documents have been reviewed, categorized, and linked to specific aspects of sDHT development and adoption.

By helping teams align early around relevant guidance and key decision points, the Navigator supports more efficient collaboration across the sDHT ecosystem. Developers and adopters who share a common understanding of expectations and evidence needs can engage in more substantive, program-specific discussions across development, validation, and deployment.

The Navigator features two core components:

sDHT Adoption Roadmap: An interactive guide that empowers teams by providing structure and orientation as they navigate patient-centered endpoint selection, sDHT implementation best practices, validation planning, and early regulatory considerations when using sDHTs in clinical trials. The roadmap includes embedded tools and direct links to relevant resources, organized to match real-world workflows.

The sDHT Adoption Library featuring NaVi: a closed-environment AI research assistant that leverages a carefully curated library of more than 300+ vetted documents, including FDA guidance and industry best practices. NaVi helps users quickly locate relevant materials and concepts, streamlining access to information across multiple sources.

Built through a multi-stage research process that included a comprehensive scoping review of peer-reviewed literature, regulatory guidance, and gray literature, in-depth interviews with regulators, technology developers, and clinical trial teams, and validation through an expert panel reflecting the collective learnings of the digital health field around sDHT adoption.

The Navigator comes at a critical time, as sDHTs are increasingly being used to support medical product development to measure aspects of disease that are meaningful to patients and relevant to scientific decision-making, including outcomes that have historically been difficult or impractical to capture in clinical research.

The Navigator aligns with the FDA’s effort to modernize medical product development and accelerate deployment of sDHTs where appropriate. By consolidating information on evidence requirements and validation pathways, the resource helps teams navigate the complexities of sDHT integration, supporting the development of high-quality data and reducing participant burden in clinical trials.

The sDHT Adoption Navigator is available now as a free, open-access resource. It complements DiMe’s existing DATAcc resources, including the Library of Digital Measurement Products, the Library of Digital Endpoints, and digital measurement implementation resources alongside FDA’s own list of medical devices that incorporate sDHTs.

Organizations interested in contributing to the continued expansion of these resources, or those seeking to strategically integrate these frameworks into their internal development programs, are invited to contact the team at [email protected].

About the Digital Medicine Society (DiMe)
The Digital Medicine Society (DiMe) is a global nonprofit organization dedicated to advancing the safe, effective, equitable, and ethical use of digital technologies to redefine healthcare and improve lives. DiMe delivers open-access resources, multi-stakeholder collaborations, and evidence-based frameworks to accelerate the responsible digitization of healthcare. Learn more at www.dimesociety.org.

About DATAcc by DiMe
The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is a collaborative community where the FDA’s Center for Devices and Radiological Health is a member. DATAcc provides 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:
[email protected]

SOURCE Digital Medicine Society (DiMe)

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