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

This standard provides a means to systematically evaluate ECG waveforms and measurement locations. It responds to the United States Food and Drug Association’s need for more systematic evaluation of noncardiac drugs for negative cardiac effects. Before this initiative, sponsors were submitting ECG findings tabulations with their applications. However, the FDA could not systematically evaluate the ECG waveforms nor the measurement locations the findings came from. Most, if not all, ECGs were collected with paper and not electronically retained.