HHS · no agency ID · record R0835

AI and Vaccine Labeling

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

Overview

Development stage: In development or acquisitionSource: a) Pre-deployment – The use case is in a development or acquisition status.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: Not reported
Withheld from public reporting: NoSource: a) No

Mission

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

Problem the AI is intended to solve

The app is designed to streamline vaccine label review processes, offering several key features to simplify and improve efficiency. It includes MedDRA integration for term searches, comprehensive search across all vaccine documents, and vaccine-specific information retrieval. Additionally, the app provides lookup functionality for approval timelines and active ingredients, as well as tools for detecting duplicates and comparing section content using AI-enhanced technology.

Expected benefits

Enhance the vaccine label review process, making it more efficient and effective.

System outputs

The AI system's output is a list of similarities and differences between vaccine label sections, as well as highlighted changes or updates to vaccine labels. Additionally, it may identify duplicate or similar vaccines and provide recommendations for label revisions or updates. The system generates summarized information about vaccine ingredients, approval timelines, and other relevant details. These outputs would be presented in a user-friendly format, such as tables, charts, or highlighted text, to facilitate easy review and analysis by the user.

Technology

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

Sourcing

How it was built: Not reported
Vendor (as reported): Not reported
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: Not reported
Privacy Impact Assessment: Not reported
Authorization to Operate: Not reported
Demographic features: Not reported
Training and evaluation data: Not reported
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