HL7 Version 3 Standard: Regulated Studies; Annotated ECG (aECG), Release 1

DESCRIPTION

The purpose of the HL7 Version 3 Annotated Electrocardiogram (aECG) standard is to provide a means to systematically evaluate the ECG waveforms and measurement locations.  The US Food and Drug Association (FDA) continues to be concerned about evaluating noncardiac drugs for negative cardiac effects, such as prolonged ECG QT interval. Before this initiative, sponsors were submitting ECG findings tabulations (e.g. QT interval measurements) with their applications. However, the FDA could not systematically evaluate the ECG waveforms and the measurement locations the findings came from. Most, if not all, ECGs were collected with paper and not electronically retained. The Annotated ECG (aECG) standard responds to the FDA’s need for more systematic evaluation.

ALTERNATIVE NAMES

HL7 Version 3 Standard: Regulated Studies; Annotated ECG (aECG), Release 1 may also go by the following names or acronyms:

TARGETS

• US FDA
• Pharmaceutical Companies
• Clinical Research Organizations
• Device Manufacturers

BENEFITS

• Provides a common means of electronically storing both the ECG wave form and associated annotations
• Allows for comparative analysis in the assessment of pharmaceutical products for negative cardiac effects

IMPLEMENTATIONS/CASE STUDIES

• HL7 Annotated ECG is now the most widely adopted ECG standard in the world
• The pharmaceutical industry and all device manufacturers and software companies working in any capacity with ECGs support this format

DEVELOPMENT BACKGROUND

The Annotated ECG (aECG) standard was created by HL7’s Regulated Clinical Research Information Management (RCRIM) in response to the FDA’s digital ECG initiative introduced November, 2001. The FDA continues to be concerned about evaluating noncardiac drugs for negative cardiac effects, like prolonged QT. Before this initiative, sponsors were already submitting ECG findings tabulations (e.g. QT interval measurements) with their applications. However, the FDA could not systematically evaluate the ECG waveforms and measurement locations those findings came from. Most (if not all) ECGs in current trials were collected with paper and not electronically retained. The next logical step for the FDA was to ask that the digital waveforms and measurement locations (annotations) be made available with the application.

 

A necessary step for submitting the ECG waveforms and annotations to the FDA was to have a standard format for the data. An evaluation of current ECG waveform standards found no existing standards that met all the FDA’s needs. Therefore the FDA, sponsors, core laboratories, and device manufactures worked together within HL7 to create a standard to meet the needs.

RELATED DOCUMENTS

	HL7 Version 3 Standard: Regulated Studies; Annotated ECG (aECG), Release 1		(Download) (18.23 MB)
	HL7 Version 3 Implementation Guide: Annotated ECG (aECG) R1, Release 2 - US Realm	(View Brief)	(Download) (1.54 MB)

TOPIC

• Regulated Studies

BALLOT TYPE

• Normative

STATUS DATE

2019-08-09

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• ANSI-approved

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• Universal