The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) has introduced the sDHT Adoption Navigator, an educational resource aimed at supporting the integration of sensor-based digital health technologies in trials for medical product development.
The tool has been developed with funding from the US Food and Drug Administration (FDA) and combines industry best practices, regulatory guidance, and scientific standards into a single accessible platform.
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Over the past decade, academia, regulatory authorities, and industry have generated a substantial body of work in sensor-based digital health technologies (sDHTs).
The sDHT Adoption Navigator distils this knowledge for quick access, reducing the need for teams to independently source information from multiple locations.
It collates public materials from authorities such as the FDA alongside industry resources and best practices. More than 300 vetted documents have been reviewed, categorised, and connected to aspects of the development and adoption of sDHT.
By promoting early alignment around guidance and key decision points, the Navigator aims to facilitate substantive discussions among adopters and developers throughout development, validation, and deployment stages.
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By GlobalDataTwo main components of the Navigator are the interactive sDHT Adoption Roadmap that guides teams through endpoint selection, implementation practices, validation planning, and regulatory considerations; and an sDHT Adoption Library featuring NaVi AI research assistant leveraging a curated library of more than 300 documents.
The resource was developed through scoping reviews, expert interviews, and panel validation.
With increasing adoption of sDHTs in measuring patient-centred outcomes in trials, the platform aims to support efficient integration while aligning with FDA efforts to modernise product development. The open-access tool complements other DATAcc resources.
DiMe programme lead Sarah Averill Lott said: “The science, technology, and regulatory foundations for sDHTs have advanced substantially, but progress still slows when teams struggle to translate that material into action.
“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 programme. Our goal is to reduce friction, shorten learning curves, and enable more effective collaboration across the ecosystem.”
In April 2025, ProofPilot partnered with DiMe to advance the development of digital tools for clinical research.
