Sentinel System Task Order to address an Emerging Safety Need
Description
This AI project is designed to solve the problem of efficiently validating emerging safety signals through chart review when traditional structured data is insufficient. It aims to use NLP-supported tools to extract and analyze information from unstructured clinical notes, enabling faster and more comprehensive chart abstraction and adjudication processes for urgent safety investigations.
Detailed example
Claims and EHR data
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
This allows FDA to apply Natural Language Processing (NLP) capabilities to extract data from Electronic Health Records (EHRs) as needed to address regulatory gaps around emerging safety needs, enabling faster response to potential drug safety concerns.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Claims and Electronic Health Record (EHR)