Develop an empirical algorithm to automate negative control identification in Sentinel System using the “Data-driven Automated Negative Control Estimation (DANCE)” algorithm

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

2024-03 (month precision)Source: Mar-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 optimizing the Data-driven Automated Negative Control Estimation (DANCE) algorithm for real-world implementation in large electronic healthcare database studies. It aims to use plasmode simulation to refine the algorithm's performance and then validate the tailored approach through a multisite test case focused on safety endpoint detection, ensuring the method works effectively across different healthcare data environments.

Expected benefits

Supports the use of plasmode simulation to evaluate and tailor implementation of DANCE in settings relevant to large electronic healthcare database studies and to apply the tailored DANCE algorithm to a test case incorporating a safety endpoint in a multisite implementation, improving FDA's ability to detect drug safety signals.

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.

Potential impacts and how they were identified

Not reported