HHS · no agency ID · record R0820

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

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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: 2023-04 (month precision)Source: Apr-23
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Summarization, Forecasting and prediction Derived by keyword rules; see methodology

Problem the AI is intended to solve

Need to proactively identify emerging issues and clusters within MedWatch reports using advanced analytics.

Expected benefits

Assist with consistent monitoring and identification of product risks from MedWatch reporting patterns and report content to support review staff in detecting potential safety problems that could affect patients.

System outputs

Identify product risk signals from MedWatch reports by using time series analysis to flag products and topic modeling to summarize the comments.

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): CDEROne Analytics: FISMA-high environment
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)
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: MedWatch data from LSMV and IQVIA 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.

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