Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 – Clinical Trial Optional)
Can you apply?
This grant is for researchers and institutions developing digital health technologies to measure health outcomes and biomarkers for remote monitoring. Eligible applicants include academic medical centers, research institutions, hospitals, and research-focused nonprofits with NIH institutional support. The program funds exploration and validation of wearable devices, smartphone apps, and digital platforms that measure clinical endpoints. Geographic scope is nationwide; applicants must have IRB approval capabilities and access to patient populations for testing technologies.
This grant is for researchers and institutions developing digital health technologies to measure health outcomes and biomarkers for remote monitoring. Eligible applicants include academic medical centers, research institutions, hospitals, and research-focused nonprofits with NIH institutional support. The program funds exploration and validation of wearable devices, smartphone apps, and digital platforms that measure clinical endpoints. Geographic scope is nationwide; applicants must have IRB approval capabilities and access to patient populations for testing technologies.
Program description
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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers and institutions developing digital health technologies to measure health outcomes and biomarkers for remote monitoring. Eligible applicants include academic medical centers, research institutions, hospitals, and research-focused nonprofits with NIH institutional support. The program funds exploration and validation of wearable devices, smartphone apps, and digital platforms that measure clinical endpoints. Geographic scope is nationwide; applicants must have IRB approval capabilities and access to patient populations for testing technologies.
How to apply
Application links
Required documents
- NIH SF-424 (R&R) application form
- Project Narrative (specific aims, significance, innovation, approach)
- Detailed Budget and Budget Justification
- Biosketches of key personnel (NIH format)
- Institutional Certification of IRB and human subjects protections
- Letters of Support from clinical partners
- Preliminary data and validation studies
- Data Management and Sharing Plan
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.399 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$22,629,848
-
$20,187,190
-
$19,625,661
-
$19,227,026
-
$18,138,327
-
$17,827,646
-
$17,614,587
-
$16,535,118
-
$16,126,587
-
$14,347,054
Top States by Funding
- NY 7 awards $57.6M
- SC 3 awards $46.6M
- DE 3 awards $43.2M
- IL 3 awards $38.4M
- WI 3 awards $37.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
FAQ
Who can apply for this grant?
Academic institutions, research hospitals, medical centers, and research nonprofits with active NIH grants or institutional infrastructure. Private companies may apply with institutional collaborators.
What are the key deadlines?
The application opens November 13, 2024, with a fixed deadline of June 22, 2026. Check the NIH website for specific submission times.
What activities does this funding support?
Development and validation of digital health biomarkers, remote monitoring tools, and outcome measurement technologies. Clinical trials are optional but can be included.
How competitive is this program?
Moderately competitive. Success requires strong preliminary data, experienced research teams, and clear validation pathways for your technology.
What is the typical funding range?
UG3/UH3 programs typically provide phased funding: $200K-$500K for UG3 (exploratory phase), then $500K-$2M for UH3 (development phase) if successful.
💡 Tips for applicants
- Build partnerships with clinical sites early to secure patient access and validation populations for your digital health technology.
- Show preliminary data validating your biomarker or outcome measure against established clinical standards.
- Address data privacy, security, and FDA regulatory pathways explicitly in your proposal narrative.
- Clearly define the clinical problem your digital technology solves and why existing measures are insufficient.
- Budget for independent validation studies and technology development; reviewers expect rigorous methodology.
⚠️ Common mistakes
Weak preliminary data showing biomarker validity—reviewers want evidence your digital measure correlates with clinical outcomes. Underestimating timeline and costs for technology validation and clinical testing phases. Unclear FDA pathway or regulatory strategy for your digital health technology.
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