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The HL7 aECG standard was created in response to the Food and Drug Administration’s digital electrocardiogram initiative which was introduced November, 2001. The FDA initiative required ECG waveforms and annotations submitted to the FDA to have a standard format for the data. At the time, no current ECG waveform standards met all the FDA's needs. As a result, the FDA, sponsors, core laboratories, and device manufactures worked together within HL7 to create a standard to meet the FDA requirements.
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