sDHT Adoption Navigator at a glance
- Purpose: Centralized educational platform to support adoption of sensor-based digital health technologies in clinical trials
- Developer: Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe)
- FDA role: Resource developed with funding support and incorporates FDA regulatory guidance
- Core feature: Interactive roadmap covering endpoint selection, validation planning, and regulatory considerations
- AI component: Built-in research assistant, NaVi, helps users navigate more than 300 curated regulatory and scientific documents
- Industry impact: Designed to reduce implementation barriers, improve alignment, and accelerate generation of high-quality digital endpoint data
The Digital Medicine Society (DiMe), through its Digital Health Measurement Collaborative Community (DATAcc), has launched a new educational resource designed to help sponsors and technology developers integrate sensor-based digital health technologies (sDHTs) into clinical trials.1
Developed with funding from the FDA, the sDHT Adoption Navigator consolidates regulatory guidance, scientific standards, and industry best practices into a centralized platform. The goal is to streamline adoption of digital measurement tools and reduce operational friction for clinical development teams.
Sensor-based DHTs—including wearable sensors, smartphone-based monitoring tools, and connected devices—are increasingly being used to capture patient-centered endpoints and real-world physiological data. However, fragmented regulatory guidance and evolving validation requirements have created challenges for sponsors seeking to incorporate these tools into clinical research.
“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, in a press release.
Centralizing regulatory guidance and industry standards
The Navigator aggregates more than 300 vetted documents, including FDA guidance, peer-reviewed research, and industry best practices, organizing them around key decision points in clinical development.
By structuring these materials into an accessible platform, the resource allows teams to identify relevant validation pathways, regulatory expectations, and implementation strategies more efficiently. This approach is intended to reduce the need for sponsors and developers to independently navigate hundreds of disparate sources.
The platform was developed through a multi-stage research process, including literature reviews, stakeholder interviews, and expert validation. Regulators, clinical trial teams, and technology developers contributed insights to ensure the resource aligns with current regulatory and operational realities.
Interactive roadmap and AI-enabled research tools
The Navigator includes two primary components designed to support adoption across the clinical trial lifecycle.
The sDHT Adoption Roadmap provides an interactive framework covering endpoint selection, validation planning, implementation best practices, and early regulatory considerations. Embedded tools and direct links to supporting materials allow users to align development decisions with regulatory expectations.
The resource also includes the sDHT Adoption Library featuring NaVi, an artificial intelligence (AI)-enabled research assistant that helps users locate relevant regulatory guidance and scientific standards from a curated database.
Operating within a controlled environment, the AI tool is designed to streamline access to validated materials while supporting efficient decision-making.
Supporting broader adoption of digital measurement in clinical trials
The Navigator arrives as sDHTs play an expanding role in clinical trials, particularly in decentralized and hybrid study models.
These technologies enable continuous, objective data collection outside traditional clinical settings, allowing researchers to capture outcomes that may otherwise be difficult to measure. This capability can improve endpoint precision while reducing participant burden.
Regulators, including the FDA, have increasingly supported the use of digital health technologies where appropriately validated, recognizing their potential to enhance evidence generation and improve clinical trial efficiency.
The Navigator is intended to support this shift by helping sponsors and developers align with regulatory expectations earlier in the development process.
Regulatory initiatives reinforce digital and AI integration
The release of the Navigator builds on broader regulatory efforts to establish clearer frameworks for emerging digital and AI-driven technologies in drug development.
Earlier this year, the FDA and EMA identified ten guiding principles for good AI practice across the medicines lifecycle. The principles provide high-level recommendations for the use of AI in evidence generation, clinical trials, manufacturing, and post-market monitoring.2
Regulators emphasized a risk-based, human-centric approach to AI adoption, with requirements for transparency, data governance, and lifecycle performance monitoring.
The agencies also noted a significant increase in regulatory submissions incorporating AI and digital technologies, reflecting their expanding role across clinical development.
Industry commentary on the use of new technology
In 2025, Applied Clinical Trials spoke with Jon Walsh, founder and chief scientific officer of Unlearn.AI to explore what the future holds for clinical trials as new, emerging technology becomes more embedded into the industry.
“Another major shift is the ability to run more innovative trial designs. This could include adaptive designs or open-label studies earlier in the development process, supported by digital twins,” Walsh said in a video interview. “These approaches can help drugs reach the market faster, give more patients access to treatments sooner, and still allow for high-quality decision-making. Overall, we hope to see continued adoption of these methods across the industry.”
Reducing barriers to digital health adoption in clinical development
Together, regulatory initiatives and industry-led resources such as the sDHT Adoption Navigator reflect a broader shift toward enabling responsible integration of digital tools in clinical research.
By consolidating regulatory science and best practices into a structured platform, the Navigator is designed to help clinical development teams navigate the complexity of digital measurement adoption.
As digital health technologies continue to evolve, tools that clarify regulatory expectations and support operational implementation are expected to play an increasingly important role in advancing more efficient, patient-centered clinical trials.
References
1. DiMe launches FDA-funded sDHT Adoption Navigator to support teams developing and deploying sensor-based digital health technologies in clinical trials. News release. DiMe. February 4, 2026. Accessed February 16, 2026. https://aijourn.com/dime-launches-fda-funded-sdht-adoption-navigator-to-support-teams-developing-and-deploying-sensor-based-digital-health-technologies-in-clinical-trials/
2. FDA and EMA Align on Ten Principles to Guide Artificial Intelligence Use in Drug Development. Applied Clinical Trials. January 29, 2026. Accessed February 16, 2026. https://www.appliedclinicaltrialsonline.com/view/fda-ema-align-ten-principles-artificial-intelligence-use-drug-development
