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DiMe Unveils the sDHT Adoption Navigator to Transform Clinical Trials

The integration of technology into health care is crucial for enhancing patient outcomes and streamlining clinical processes. A significant step has been made with the launch of the sDHT Adoption Navigator by the Digital Medicine Society (DiMe). This innovative resource, which receives funding from the U.S. Food and Drug Administration (FDA), aims to support teams in the effective deployment of sensor-based digital health technologies (sDHTs) within clinical trials.

Overview of the sDHT Adoption Navigator

Released on February 4, 2026, the Navigator is designed to simplify the complexities associated with the adoption of sDHTs in medical product development. It amalgamates a wealth of regulatory guidance, scientific standards, and best practices, providing users with a centralized and easily navigable platform. The key feature of this resource is its ability to significantly reduce the time and effort required for teams to decipher the regulatory landscape surrounding digital health technologies.

Sarah Averill Lott, the Program Lead at DiMe, emphasized the need for such a resource, stating, "The science, technology, and regulatory foundations for sDHTs have advanced substantially, but progress still slows when teams struggle to translate that material into action." This quote encapsulates the challenges faced by organizations in aligning their projects with regulatory requirements while ensuring effective collaboration.

Key Features of the Navigator

The Navigator is composed of two main components:

• - sDHT Adoption Roadmap: This interactive guide provides a structured approach for teams. It addresses critical areas such as patient-centered endpoint selection, best practices for implementing sDHTs, validation planning, and crucial regulatory considerations. This roadmap is tailored to reflect the real-world workflows of developers.
• - sDHT Adoption Library featuring NaVi: NaVi is an AI-powered research assistant that shortcuts the search process by accessing a curated library of over 300 vetted documents. This repository includes important FDA guidelines and industry best practices, allowing users swift access to necessary information.

The development of the sDHT Adoption Navigator was a comprehensive endeavor. It involved extensive research into peer-reviewed literature, regulatory guidance, and gray literature. Furthermore, extensive interviews were conducted with stakeholders such as regulators, technology developers, and clinical trial teams to ensure the resource meets the needs of all participants in the digital health ecosystem.

The Importance of the sDHT Adoption Navigator

This resource comes at a pivotal moment as the digital transformation of health care continues to gather momentum. As sDHTs increasingly play a role in supporting medical product development, capturing critical data points from patients—ones historically challenging to gather—has never been more vital. These technologies are not only enhancing the precision of data collection but are also shifting the focus toward more meaningful outcomes for patients.

The Navigator facilitates an easier integration process for sDHTs by consolidating information about evidence requirements and validation pathways. This effort aligns with the FDA's commitment to modernizing the medical product development landscape and streamlining the deployment of effective digital tools.

Access and Future Contributions

Currently, the sDHT Adoption Navigator is available free of charge, serving as an open-access resource for all interested parties. It supplements existing resources provided by DiMe, including libraries dedicated to digital measurement products and endpoints. Organizations keen on contributing to the ongoing expansion of these valuable resources are encouraged to reach out to the DiMe team.

About DiMe and DATAcc

The Digital Medicine Society, known as DiMe, is a global nonprofit organization committed to ensuring that digital technologies are used safely and effectively in healthcare. Through its collaborative initiatives, DiMe aims to redefine healthcare delivery for improved patient outcomes. Notably, the Digital Health Measurement Collaborative Community (DATAcc) operates under its umbrella, fostering collaboration among stakeholders to elevate the standards of digital health measures in research.

For further information on the sDHT Adoption Navigator, visit DiMe's website.