HHS · no agency ID · record R0844

Use case package 1: Empirical application of the Sentinel EHR and claims Data Partner network to address ARIA insufficient inferential requests (UC1)

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: 2023-09 (month precision)Source: Sep-23
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: No function tag matched Derived by keyword rules; see methodology

Problem the AI is intended to solve

This AI project is designed to solve the problem of determining whether available data sources and analytical methods are suitable for specific pharmacoepidemiologic research questions. It aims to systematically evaluate data fitness-for-purpose and identify viable use cases where protocol-based studies can reliably assess drug safety and effectiveness in real-world populations.

Expected benefits

Improved capture of unstructured Electronic Health Record (EHR) data for drug safety studies, enabling FDA to better assess medication safety and effectiveness using real-world healthcare information.

System outputs

Natural Language Processing (NLP) for Electronic Health Record (EHR) unstructured data extraction

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): In-house (CDER staff) and 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-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