HHS · no agency ID · record R0825

Renamed: Information Visualization Platform (InfoViP) to Support Analysis of FAERS safety reports Previously: Information Visualization Platform (InfoViP) to Support Analysis of adverse event reports

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: 2025-08 (month precision)Source: Aug-25
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Document processing and extraction Derived by keyword rules; see methodology

Problem the AI is intended to solve

The AI is intended to support the analysis of FAERS Individual Case Study Reports in post-market safety surveillance by automating duplicate detection, creating temporal visualizations, and classifying reports by information quality.

Expected benefits

Information Visualization Platform (InfoVIP) supports post-market surveillance using AI to assist with review and analysis of adverse event reports with advanced visualizations including temporal data and algorithms for detection of duplicate FAERS adverse event reports and classification of reports by level information quality.

System outputs

Performs Natural Language Processing (NLP) and applying Machine Learning (ML) algorithm to extract data from unstructured case narratives and combine with structured data to support analysis and review of adverse event reports.

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): FAERS
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: Adverse Event data in FAERS
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