Zio ECG Utilization Service

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

High-impactSource: a) High-impact

Impact justification

Not reported

Start date

Not reported

Withheld from public reporting

Not reported

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 Zio ECG Utilization Service (ZEUS) System is intended to analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring.

Expected benefits

Support diagnoses. It downloads, stores, analyzes and aggregates the electrocardiogram (ECG) data for a Certified Cardiographic Technician (CCT) to review and generate a report of the findings contained within the data. This enables the provision of a complete ECG processing and analysis service. Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns.

System outputs

After patient monitoring by Zio XT or Zio AT Patch, a final report is generated based on the beat-to-beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

Technology

AI classification

Classical / predictive MLSource: Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relatio…

System name(s)

Not reported

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)

Not reported

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

Not reported

Privacy Impact Assessment

Not reported

Authorization to Operate

Not reported

Demographic features

Not reported

Training and evaluation data

Not reported

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