aecg-hl7协议(英文)。有需要的下,
The Annotated ECG (aECG) HL7 standard was created 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
for the digital waveforms and measurement locations (annotations) be made available with the
application.
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