Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-25-170

Response due Jun 22, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting research applications under the UG3/UH3 cooperative agreement mechanism to develop and validate digital health technology (DHT) derived biomarkers and outcome assessments for remote monitoring and clinical trial endpoint development. The program supports a two-phase milestone-driven approach: an exploratory/planning phase (UG3) followed by a full implementation phase (UH3). Clinical trials are optional under this funding opportunity. The goal is to advance the use of wearables, sensors, and other digital health tools to generate objective, remotely-collected biomarker and endpoint data suitable for regulatory and clinical research use.

What they want

Applicants must propose research to develop, validate, and/or qualify digital health technology (DHT)-derived biomarkers and outcome assessments intended for use in remote patient monitoring and as clinical trial endpoints. The work is structured as a two-phase cooperative agreement: Phase 1 (UG3) is an exploratory/planning phase with defined milestones; Phase 2 (UH3) is a full research implementation phase contingent on milestone achievement. Clinical trials are optional but permitted. Research should address the technical and analytical validation of DHT-derived measures, their fit-for-purpose qualification, and their readiness for regulatory submission or clinical deployment.

Deliverables

Validated DHT-derived biomarkers suitable for remote monitoring
Validated outcome assessments for use as clinical trial endpoints
UG3 phase milestone report demonstrating readiness for UH3
Final research findings and regulatory-ready documentation

Technical requirements

Research must address DHT-derived biomarker and outcome assessment development
Two-phase milestone-driven cooperative agreement structure (UG3 exploratory phase + UH3 implementation phase)
UH3 phase contingent on successful UG3 milestone completion
Clinical trials are optional but permissible
Analytical and technical validation of DHT-derived measures required
Fit-for-purpose qualification methodology must be addressed
Research must support regulatory or clinical deployment readiness

How they evaluate

Scientific and technical merit (peer review)
Milestone feasibility and clarity for UG3/UH3 transition
Relevance to NIH programmatic priorities in digital health
Regulatory readiness and fit-for-purpose qualification plan

Submission: Electronic submission via Grants.gov federal grants portal

Risks & flags

Extremely long open window (November 2024 – June 2026) may indicate rolling/multiple submission cycles rather than a single competitive award — applicants should verify specific submission dates in the full FOA
UG3/UH3 phased mechanism with milestone gates introduces funder discretion over whether Phase 2 is funded, reducing awardee certainty
Full text of the FOA was not provided; key eligibility restrictions, budget caps, and scoring criteria could not be verified from the synopsis alone

Market context

inferred from NAICS

Professional, Scientific & Technical Services

NAICS 541711

US market size: $2.0T
Typical award: $25K – $50M

Typical buyers

All federal civilianDoDStates

Commonly required

8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Digital Health Technology Derived Biomarke…

Due Jun 22

Onboard ↗