IEEE Standard for Health Informatics--Device Interoperability Part 10406: Personal Health Device Communication--Device Specialization--Basic Electrocardiography (ECG) (1‐ to 3‐lead ECG) - Redline

Abstract

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set-top boxes) in a manner that enables plug-and-play interoperability is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to including support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analyzing the detected electrical activity to determine known cardiac phenomena. This standard is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g., ECG and respiration rate).