HHS · no agency ID · record R0850

Sentinel System Task Order to address an Emerging Safety Need

Department of Health and Human Services · HHS/FDA/CDER

Overview

Development stage: DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2024-04 (month precision)Source: Apr-24
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

This AI project is designed to solve the problem of efficiently validating emerging safety signals through chart review when traditional structured data is insufficient. It aims to use NLP-supported tools to extract and analyze information from unstructured clinical notes, enabling faster and more comprehensive chart abstraction and adjudication processes for urgent safety investigations.

Expected benefits

This allows FDA to apply Natural Language Processing (NLP) capabilities to extract data from Electronic Health Records (EHRs) as needed to address regulatory gaps around emerging safety needs, enabling faster response to potential drug safety concerns.

System outputs

Claims and EHR data

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): Sentinel
Custom-developed code: Yes
Public source code: Not reported

Sourcing

How it was built: Contract and in-houseSource: c) Developed with both contracting and in-house resources
Vendor (as reported): Contractor teams
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: No
Privacy Impact Assessment: Not reported
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: Claims and Electronic Health Record (EHR)
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported