OMB Individually Reported
MedWatch Dashboard
Low riskExact public inventory row
Description
Need to proactively identify emerging issues and clusters within MedWatch reports using advanced analytics.
Detailed example
Identify product risk signals from MedWatch reports by using time series analysis to flag products and topic modeling to summarize the comments.
AI / analytics pattern
Natural Language Processing: AI that processes, interprets, and shares information in human language.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
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.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
MedWatch data from LSMV and IQVIA data