Digital Health Technology Derived Biomarkers and Outcome Assessments (PAR-25-170)

The National Institutes of Health (NIH) has released a new funding opportunity (PAR-25-170) focused on the rigorous development and validation of biomarkers and Clinical Outcome Assessments (COAs) derived from Digital Health Technologies (DHTs). This mechanism aims to standardize remote monitoring tools for use as endpoints in future clinical trials.

Scope

This opportunity utilizes the UG3/UH3 Exploratory/Developmental Phased Award mechanism. Projects must address the following phases:

UG3 Phase (1-2 years): Focuses on the technical performance and analytical validation of the DHTs, incorporating input from People With Lived Experience (PWLE).

UH3 Phase (3-4 years): Involves a prospective longitudinal clinical study to validate the DHT-derived assessments against established standards.

A key objective is to generate data that supports the regulatory acceptance of these digital biomarkers. To promote standardization and broad applicability, applicants must propose to develop and evaluate these tools across three or more distinct diseases or conditions.

Eligibility

Eligible applicants include Higher Education Institutions, Nonprofits, For-Profit Organizations (including Small Businesses), and Local/State Governments. Note: Non-domestic (foreign) entities are not eligible to apply.

Partnership Requirements

To ensure the technologies are patient-centric and clinically relevant, the NIH mandates:

Mandatory Partnerships: Applicants must partner with non-profit patient advocacy organizations.

Patient Input: Study designs must be informed by People With Lived Experience (PWLE) to improve community uptake and endpoint selection.

Deadlines
The application due date is June 22, 2026. Budgets are not limited but must reflect actual project needs; requests exceeding $500,000 in direct costs for any year require prior approval.