Use case package 1: Empirical application of the Sentinel EHR and claims Data Partner network to address ARIA insufficient inferential requests (UC1)
Description
This AI project is designed to solve the problem of determining whether available data sources and analytical methods are suitable for specific pharmacoepidemiologic research questions. It aims to systematically evaluate data fitness-for-purpose and identify viable use cases where protocol-based studies can reliably assess drug safety and effectiveness in real-world populations.
Detailed example
Natural Language Processing (NLP) for Electronic Health Record (EHR) unstructured data extraction
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
Improved capture of unstructured Electronic Health Record (EHR) data for drug safety studies, enabling FDA to better assess medication safety and effectiveness using real-world healthcare information.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Claims-Electronic Health Record (EHR)