HHS · no agency ID · record R0838

Creating a development network

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: 2022-12 (month precision)Source: Dec-22
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

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.

Expected benefits

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.

System outputs

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

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): Sentinel
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): Contractor teams
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: Electronic Health Record (EHR)
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