Use case package 2 (UC2): Empirical application of the Sentinel EHR and claims Data Partner network to enhance ARIA insufficient inferential requests and atypical descriptive requests

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

Translation and transcription Derived by keyword rules; see methodology

Problem the AI is intended to solve

This AI project is designed to solve the problem of translating theoretical innovative methods into practical, real-world applications within the Innovation Center (IC) development network. It aims to create concrete, evidence-based examples that demonstrate how new technologies and approaches can be effectively implemented to address specific pharmacoepidemiologic and drug safety surveillance challenges.

Expected benefits

Developing advanced methods including machine learning to address incomplete information in drug safety studies, validating health outcome algorithms using Natural Language Processing (NLP)-assisted chart review, and applying NLP to analyze cannabis-derived product exposures in electronic health records, ultimately improving FDA's drug safety surveillance capabilities.

System outputs

EHR data elements; EHR-linked to claims 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

EHR data elements; EHR-linked to claims data

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.

Potential impacts and how they were identified

Not reported