Artificial Intelligence-based Deduplication Algorithm for Classification of Duplicate Reports in the FDA Adverse Event Reports (FAERS)

Section 1: Use Case Identifiers

Use Case ID: HHS-FDA-00013
Agency: HHS
Op Div/Staff Div: FDA
Use Case Topic Area: Mission-Enabling (internal agency support)
Is the AI use case found in the below list of general commercial AI products and services?
None of the above.
What is the intended purpose and expected benefits of the AI?
The deduplication algorithm is applied to all historical and incoming case report submissions to the FDA Adverse Event Reporting System (FAERS) to identify duplicate individual case safety reports (ICSRs). Unstructured data that is in free text FAERS narratives is processed through a natural language processing system to extract relevant clinical features. Both structured and unstructured data are then used in a probabilistic record linkage approach to identify duplicates. Application of the deduplication algorithm is optimized for processing entire FAERS database to support the data mining analytics process.

Enhance the efficiency of removing duplicate FAERS reports to support data mining.
Describe the AI system's outputs.
Uses Natural Language Processing (NLP) to extract out clinical features from free text narratives in a case safety report and uses them in the identification of duplicative case safety reports in the FAERS database.
Stage of Development: Implementation and Assessment
Is the AI use case rights-impacting, safety-impacting, both, or neither?
Neither

Section 2: Use Case Summary

Date Initiated: 12/2023
Date when Acquisition and/or Development began: 09/2024
Date Implemented: N/A
Date Retired: N/A
Was the AI system involved in this use case developed (or is it to be developed) under contract(s) or in-house?
Developed with contracting resources.
Provide the Procurement Instrument Identifier(s) (PIID) of the contract(s) used.
BAAFY23C2AWP1
Is this AI use case supporting a High-Impact Service Provider (HISP) public-facing service?
N/A
Does this AI use case disseminate information to the public?
No
How is the agency ensuring compliance with Information Quality Act guidelines, if applicable?
N/A
Does this AI use case involve personally identifiable information (PII) that is maintained by the agency?
Yes
Has the Senior Agency Official for Privacy (SAOP) assessed the privacy risks associated with this AI use case?
ongoing

Section 3: Data and Code

Do you have access to an enterprise data catalog or agency-wide data repository that enables you to identify whether or not the necessary datasets exist and are ready to develop your use case?
Yes
Describe any agency-owned data used to train, fine-tune, and/or evaluate performance of the model(s) used in this use case.
Adverse Event data in FAERS
Is there available documentation for the model training and evaluation data that demonstrates the degree to which it is appropriate to be used in analysis or for making predictions?
Documentation is complete
Which, if any, demographic variables does the AI use case explicitly use as model features?
Sex/Gender
Does this project include custom-developed code?
Yes
If the code is open-source, provide the link for the publicly available source code.
N/A

Section 4: AI Enablement and Infrastructure

Does this AI use case have an associated Authority to Operate (ATO) for an AI system?
No
System Name: N/A
How long have you waited for the necessary developer tools to implement the AI use case?
6-12 months
For this AI use case, is the required IT infrastructure provisioned via a centralized intake form or process inside the agency?
Yes
Do you have a process in place to request access to computing resources for model training and development of the AI involved in this use case?
Yes
Has communication regarding the provisioning of your requested resources been timely?
Yes
How are existing data science tools, libraries, data products, and internally-developed AI infrastructure being re-used for the current AI use case?
Re-use production level code from a different use-case
Has information regarding the AI use case, including performance metrics and intended use of the model, been made available for review and feedback within the agency?
Limited documentation for review