Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you've built DHT that captures clinical signals, the NIH will fund you to validate it across multiple diseases and move it into regulated trials—but only if you can lock in patient advocacy partnerships.
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What this is
The NIH is seeking proposals to develop and validate biomarkers or clinical outcomes extracted from digital health technologies (wearables, apps, sensors, etc.) that can serve as primary or secondary endpoints in clinical trials with remote monitoring capabilities. Projects must demonstrate feasibility and clinical utility across at least three distinct disease or condition populations and require mandatory partnerships with nonprofit patient advocacy groups. This is a UG3/UH3 mechanism, meaning it supports exploratory/developmental work (UG3 phase) with optional progression to clinical trial execution (UH3 phase), running through June 2026.
Who can apply
For-profit and nonprofit organizations, small businesses, universities, and government entities are all eligible. Applicants must be U.S.-based institutions or organizations; small businesses and startups are explicitly welcome, but you will need a strong partnership with at least one nonprofit patient advocacy organization to meet core requirements.
Eligible applicant types
- Native American tribal governments (Federally recognized)
- Special district governments
- State governments
- Native American tribal organizations (other than Federally recognized tribal governments)
- Public and State controlled institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- Independent school districts
- Small businesses
- For profit organizations other than small businesses
- Public housing authorities/Indian housing authorities
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- City or township governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- County governments
Full description — from the agency
The purpose of this proposed Notice of Funding Announcement (NOFO) is to support development of biomarkers or clinical outcomes derived from digital health technology (DHT) for use in clinical trials for remote monitoring as primary or secondary endpoints. To improve clinical impact, increase statistical feasibility, and promote standardization, applicants will be expected to develop and test the digitally derived assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations will be required.
Topics: digital health biomarkers · remote monitoring endpoints · clinical trial technology · wearable assessment · digital outcome measures
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.