HL7 AECG
HL7 aECG (the HL7 Annotated Electrocardiogram) is a standard medical record data format for storing and retrieving electrocardiogram data for a patient. Like other HL7 formats, it is XML based. The HL7 aECG standard was created in response to the Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...’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. The aECG standard was created by HL7's Re ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts v ...
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