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Digital Health Integration and Real-World Evidence (RWE) Analytics

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Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The contract focuses on the development and validation of digital health tools along with the integration of real-world data into regulatory frameworks. This involves utilizing predictive modeling and data science techniques to enhance the analysis and application of real-world evidence in healthcare settings. The work aims to support regulatory decision-making by leveraging advanced analytics to better interpret and utilize data collected outside traditional clinical trials. Awarded by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, the subcontract is classified under the NAICS code 541715, which pertains to research and development in physical, engineering, and life sciences. The place of performance is located in Silver Spring, and the contract was posted in January 2026. This initiative underscores the agency’s commitment to harnessing innovative digital technologies and data-driven methodologies to improve public health outcomes through more effective regulatory science.

General Info

Development and validation of digital health tools integrating real-world data for FDA regulatory decision-making.

Agency

Department Of Health And Human Services → FDA Office Of Acquisitions And Grants ServicesView Agency

NAICS

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

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of FDABAA-25-00123_Award.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

AI Contract Breakdown

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Timeline

PostedJan 13

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

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Office AddressN/A

ContactsNo contact information available

Full Description

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Develop and validate digital health tools and integrate real-world data into regulatory frameworks using predictive modeling and data science techniques.

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