The Annotated ECG (aECG) HL7 standard was created in response to the FDA’s digital ECG initiative introduced November, 2001. 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. The aECG standard was created by HL7’s Regulated Clinical Research Information Management (RCRIM) in response to the FDA’s need. It passed final balloting in January, 2004, and was accepted by ANSI May, 2004. This implementation guide (IG) offers supplemental material for the January, 2004 aECG standard. It does not by itself provide all the information required to fully implement the standard.
Realized by Fabio Badilini, A.M.P.S. LLC and Barry D. Brown, Mortara Instruments, Inc.