DIN EN ISO 11073-10421:2013-03

The ISO/IEEE 11073 family of standards enables the data transfer between medical devices and computer systems. It allows for automated, detailed recording of personal vital data and functional parameters by using monitoring and therapy devices - for example, in an intensive care unit or in the operating theatre, but also in the domestic or private environment. The primary objectives are: - provision of "plug-and-play" functionality and interoperability with medical devices for real-time applications which are associated with patients or which are person-related. - simplification of the efficient exchange of measured vital data, relevant contextual information, and operational data of the medical devices used. "Real-time" means that data from several different medical devices, if appropriate, are recorded exactly on time and can be plotted or processed in fractions of seconds. "Plug-and-play" means that users only have to establish the communication link to a device. Its recognition, configuration of communication parameters and application, if applicable, and finally, the beginning of the data transfer are automatically achieved by the system, that means, without human intervention. Within the context of the ISO/IEEE 11073 family of standards for health-related device communication, this standard establishes a normative definition of the communication between personal telehealth peak flow monitoring devices (agents) and compute engines (for example, cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, in particular ISO/IEEE 11073 standards on terminology, information profiles, application profiles and data transport. This standard specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines common core functions for communication of peak flow meters for telehealth applications. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (for example, for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic. This standard provides the data modeling and its transport shim layer according to standard ISO/IEEE 11073-20601 and does not specify the measurement method. This standard addresses the need for an openly defined, independent standard for controlling information exchange to and from personal health devices (agents) and compute engines (for example, cell phones, personal computers, personal health appliances, set top boxes). Interoperability is the key to growing the potential market for these devices and enabling people to be better informed participants in the management of their health. The committee responsible for this standard is NA 063-07-02 AA "Interoperabilität" ("Interoperability") at DIN.