OMB Individually Reported

Creating a development network

Low riskExact public inventory row

Description

The AI is intended to solve the problem of inconsistent data formats and inefficient access to unstructured clinical data across multiple healthcare sites. It aims to standardize EHR and claims data conversion into the Sentinel Common Data Model and develop processes for storing and extracting metadata from free text notes to enable timely execution of future Sentinel surveillance tasks.

Detailed example

Creates a network of organizations that can support development of algorithms and use of AI tools such as Natural Language Processing (NLP).

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

Methods project applying Natural Language Processing (NLP) to extract data from clinical notes to use in pharmacoepidemiology studies, improving FDA's ability to monitor drug safety using real-world healthcare data.

Controls / human review

ATO: Yes; PIA: Not published

Data needed

Electronic Health Record (EHR)