HHS · no agency ID · record R0849

Support tools that can be used in conjunction with Electronic Health Record (EHR) data, such as machine learning and natural language processing (NLP), and the use of Artificial Intelligence (AI) chart review tools

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: No function tag matched Derived by keyword rules; see methodology

Problem the AI is intended to solve

This AI project is designed to solve the problem of rapidly responding to urgent or emerging drug safety signals that require immediate attention and coordinated action. It aims to leverage key expertise and resources at the Sentinel Operations Center to quickly address time-sensitive safety concerns that may pose risks to public health.

Expected benefits

Supports using AI tools to help with medical chart review for emerging safety needs, enabling faster response to urgent drug safety concerns that require immediate attention to protect public health.

System outputs

Electronic Health Record (EHR) data

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