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Real-World Data (RWD) Pipeline Gap Analysis and Facilitation

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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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This subcontract for the FDA Negotiated Contracts Branch focuses on providing technical analysis and facilitation for prime contractors regarding point-of-care data collection and EHR interoperability. The selected provider will lead closed roundtables on FHIR configuration, conduct a structured gap analysis on real-world data pipeline completeness thresholds, and develop a project charter for 2027. Expertise in FHIR and EHR standards is required to successfully deliver the final summary whitepaper, gap analysis, and project charter. The project is categorized under NAICS code 541512 and is based in Silver Spring, Maryland. It was posted on September 14, 2026, with a response deadline of September 21, 2026. This effort supports the Department of Health and Human Services in optimizing data pipelines and interoperability standards for FDA projects.

General Info

FDA subcontract for technical analysis on EHR interoperability, FHIR standards, and data pipelines.

Agency

Department Of Health And Human Services → FDA Negotiated Contracts BranchView Agency

NAICS

541512 - Computer Systems Design ServicesView NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of FDASSOC136354.

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

View the prime solicitation

The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its ts congressionally mandated regulatory mission across 16 project areas

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Negotiated Contracts Branch
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Negotiated Contracts Branch
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Office AddressN/A
ContactsNo contact information available

Full Description

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Performs technical analysis and facilitates roundtables for prime contractors on FDA projects regarding point-of-care data collection and EHR interoperability. Facilitates closed roundtables on FHIR configuration, produces a structured gap analysis on RWD pipeline completeness thresholds, and develops a 2027 project charter. Requires expertise in FHIR and EHR standards. Delivers a summary whitepaper, gap analysis, and project charter.

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