# Presentation: 731193

## Standards ECG Waveform Interchange

**Suave Lobodzinski, Ph.D**
**Professor of Electrical and Biomedical Engineering**
**California State University**
**Chief Scientist, iWay Corporation**
**slobo@iwy.com**

- November, 2001
- Long Beach, California

## Scope of Standards Applicable to ECG Waveform

- S. Lobodzinski (c) 2001

## Present Day Standardization Initiatives for ECG Waveform

**1. DICOM Supplement 30 - Waveform Interchange **
**2. CEN TC251 PT5-007 - ENV1064 Standard Communications Protocol for Computer - Assisted Electrocardiography (SCP-ECG) - European Standard.**
**3. HL7, level 3.0**
**Proposed Standards (Drafts):**
**1. IEC NWIP/Ed.1 (IEC 62D/443/NP) -- Standard communications protocol for computer assisted electrocardiography - US version of the SCP-ECG.**
**2. IEEE P1073.1.6 Standard for Medical Device Communications - Medical Device Data Language (MDDL) - Virtual Medical Device, Specialized - ECG Component **
**3. CEN TC251 PT5-021 - Draft Vital Signs Information Representation Standard (VITAL) - European Standard.**

- S. Lobodzinski (c) 2001

## Digital Imaging and Communications in Medicine (DICOM v3.0) 

**What is DICOM?**
**The DICOM Standard is a set of rules that allow medical images, waveform data and associated information to be exchanged between imaging equipment, ECG equipment, computers, and hospitals. **
**The DICOM Standard evolved through collaboration between medical equipment companies (represented through the National Electrical Manufacturers Association, NEMA) and representatives from major medical societies including the American College of Cardiology, American College of Radiology, European Society of Cardiology, and American Society of Nuclear Cardiology.**
**Supplement 30 specifically addresses waveform data interchange.**

- S. Lobodzinski (c) 2001

## Brief History of DICOM 

** ****and National Electrical Manufacturer’s Association (NEMA)**
**DICOM 2.0 (1988) Revised Standard for Point-to-Point**
** ****connections.**
**DICOM 3.0 (1993)**** The DICOM standard was voted and**
**passed by members of NEMA. This version included TCP/IP**
**networking protocol. **
**Supplement 30 (2000) The waveform interchange.**

- Brief History of DICOM

- S. Lobodzinski (c) 2001

## ECG Data Interchange Model using DICOM

**ECG Client**

**ECG Client**

**DICOM ECG**
** ****Server**

**DATABASE**

**XML**
**Structured**
**Document**
**(ECG)**

**CD ROM**
**DVD**

***Scope of DICOM Waveform Standard***

- S. Lobodzinski (c) 2001

## Networked Electronic ECG Acquisition and Processing 

- An example of all electronic ECG trial using an enterprise wide iTRIALTM system

- S. Lobodzinski (c) 2001

## Features of DICOM Waveform Interchange Standard

**Support for 12-lead and time series data (Holter)**
**Time Synchronization Frame of Reference**
**Annotation**
**Waveforms in Image Objects**

- S. Lobodzinski (c) 2001

## Summary and Conclusions

**DICOM standard offers measurable benefits to digital ECG interchange**
**DICOM supports structured reporting and waveform annotation **
**A combination of DICOM Waveform interchange and structured XML reporting forms a robust infrastructure for digital ECG clinical trials **

- S. Lobodzinski (c) 2001