HHS · no agency ID · record R0842

Data Extraction from IND Safety Reports using OCR/AI Technologies

Department of Health and Human Services · HHS/FDA/CDER

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Overview

Development stage: DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2025-03 (month precision)Source: Mar-25
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Information Technology
Operational functions: Document processing and extraction Derived by keyword rules; see methodology

Problem the AI is intended to solve

Manual extraction of data from IND safety reports is labor-intensive and time-consuming for regulatory staff.

Expected benefits

Expedited processing of Investigational New Drug (IND) Safety Reports received by the Agency, enabling more rapid regulatory action in response to reported adverse events and better protection of clinical trial participants.

System outputs

Using ThinkTrends, a COTS tool, extracted data is converted into E2B(R2) format for automatic ingestion into FAERS LSMV

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): FAERS
Custom-developed code: No
Public source code: Not reported

Sourcing

How it was built: Purchased from vendorSource: a) Purchased from a vendor
Vendor (as reported): ThinkTrends
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: No
Privacy Impact Assessment: Not reported
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: MedWatch 3500 forms and intake system processing logic
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported