HHS · no agency ID · record R0830

Real World Data/Evidence

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

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: 2024-10 (month precision)Source: Oct-24
Withheld from public reporting: NoSource: a) No

Mission

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

Problem the AI is intended to solve

FDA receives numerous submissions containing real-world data and evidence, but identifying and cataloging these studies across various submission types is time-intensive and critical for regulatory reporting requirements under PDUFA (Prescription Drug User Fee Act).

Expected benefits

Assist in identifying industry unstructured submissions containing Real World Data/Evidence (RWD/E) by analyzing parsed content for likely indicators to support congressional reporting and regulatory decision-making.

System outputs

Supports extracting text from unstructured documents and tagging for documents containing Real World Evidence and Real World Data

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): CDEROne Analytics: FISMA-high environment
Custom-developed code: Yes
Public source code: Not reported

Sourcing

How it was built: Contract and in-houseSource: c) Developed with both contracting and in-house resources
Vendor (as reported): Deloitte
Vendors (standardized): Deloitte

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: applicant submissions
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