本资源包包含了HL7 AECG(医疗信息交换标准)的相关文档和资料,旨在促进电子临床文档在不同系统间的互操作性。
The Annotated ECG (aECG) HL7 standard was developed in response to the FDAs digital ECG initiative introduced in November 2001. The FDA remains concerned about evaluating non-cardiac drugs for potential negative cardiac effects, such as prolonged QT intervals. Prior to this initiative, sponsors were already submitting tabulations of ECG findings (such as measurements of the QT interval) with their applications. However, the FDA was unable to systematically evaluate the actual ECG waveforms and measurement locations from which these findings originated. Most (if not all) ECGs collected in current trials were recorded on paper rather than electronically stored. Therefore, the next logical step for the FDA was to request that digital waveforms and measurement annotations be included with applications.