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Digital Health Technology (DHT) Clinical Validation Research

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Contract Overview

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The contract seeks to conduct clinical investigations aimed at validating digital health technologies including actigraphy, contactless sensors, and photography for use in drug development trials. The goal is to assess the reliability and validity of these technologies as objective data sources to support regulatory decision-making and improve the efficiency of clinical research. The work will involve designing and executing studies that generate high-quality, reproducible data demonstrating how these tools can accurately capture physiological and behavioral biomarkers in real-world or controlled clinical settings. This is a subcontract under the Food and Drug Administration, part of the Department of Health and Human Services, governed by NAICS code 541715 for research and development in the physical, engineering, and life sciences. The opportunity was posted on July 20, 2026, with a response deadline of August 20, 2026. While no specific location or point of contact is provided, the performance location and administrative details will be defined in the subcontract agreement. The project requires expertise in clinical trial methodology, digital sensor validation, and regulatory science to meet the FDA’s standards for integrating novel digital health technologies into pharmaceutical development pipelines.

General Info

Validate digital health technologies for FDA-regulated drug trials using actigraphy, sensors, and photography.

Agency

Department Of Health And Human Services → Food And Drug Administration

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

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Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Food And Drug Administration
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Food And Drug Administration
Office AddressN/A
ContactsNo contact information available

Full Description

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Conduct clinical investigations to evaluate the reliability and validity of digital health technologies such as actigraphy, contactless sensors, and photography in support of drug development trials.

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