ISO/IEE 11073

ISO/IEE 11073

Subject: 
Healthcare
Sub-subject: 
E-health
Reference: 
ISO/IEE 11073
Title: 
Health informatics
Kind of resource: 
Standard
Description: 
ISO/IEEE 11073 Health informatics - Medical / health device communication standards enable communication between medical, health care and wellness devices and with external computer systems. They provide automatic and detailed electronic data capture of client-related and vital signs information, and of device operational data. ISO/IEEE 11073 terminology (i.e. ISO/IEEE 11073-10101) is mandated for the description of medical device data in the U.S. “meaningful use” regulations. 1. Provides real-time plug-and-play interoperability for citizen-related medical, healthcare and wellness devices; 2. Facilitates efficient exchange of care device data, acquired at the point-of-care, in all care environments. ◾ “Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or processed in fractions of a second. ◾ “Plug-and-play” means that all a user has to do is make the connection – the systems automatically detect, configure, and communicate without any other human interaction. ◾ “Efficient exchange of care device data” means that information that is captured at the point-of-care (e.g., personal vital signs data) can be archived, retrieved, and processed by many different types of applications without extensive software and equipment support, and without needless loss of information. The standards are targeted at personal health and fitness devices (such as glucose monitors, pulse oximeters, weighing scales, medication dispensers and activity monitors) and at continuing and acute care devices (such as pulse oximeters, ventilators and infusion pumps). They comprise a family of standards that can be layered together to provide connectivity optimized for the specific devices being interfaced. There are four main partitions to the standards: ◾ Device data, including a nomenclature, or terminology, optimized for vital signs information representation based on an object-oriented data model, and device ◾ General application services (e.g., polled vs. “event driven” services); ◾ Internetworking and gateway standards (e.g., an observation reporting interface from CEN ISO/IEEE 11073-based messaging and data representation to HL7 or DICOM); ◾ Transports (e.g., cable connected or wireless). [Source: Wikipedia] ISO 11073-10101:2004 covers nomenclature architecture for point-of-care (POC) medical device communication (MDC). It defines the overall architecture of the organization and relationships among nomenclature components and provides specifications of semantics and syntaxes. ISO 11073-10101:2004 is intended for use within the context of IEEE Std 1073,1 which sets out the relationship between this and other documents in the POC MDC series. ISO 11073-10201:2004 addresses the definition and structuring of information that is communicated or referred to in communication between application entities. ISO 11073-10201:2004 provides a common representation of all application entities present in the application processes within the various devices independent of the syntax. The definition of association control and lower layer communication is outside the scope of this International Standard. ISO/IEEE 11073-10404:2010 establishes a normative definition of communication between personal telehealth pulse oximeter devices and computer engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards and transport standards. It specifies the use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. ISO/IEEE 11073-10404:2010 defines a common core of communication functionality for personal telehealth pulse oximeters and addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines. 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 ISO/IEEE11073-10406:2012. 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 behaviours in telehealth environments restricting optionality in base frameworks in favour 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 support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena. ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate). ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer engines (e.g., 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 including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors. ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines. ISO/IEEE 11073-10408:2010 establishes a normative definition of communication between personal telehealth thermometer devices and computer engines (e.g., 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, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth thermometers. ISO/IEEE 11073-10408:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines. ISO/IEEE 11073-10415:2010 establishes a normative definition of communication between personal telehealth weighing scale devices and computer engines (e.g., 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, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth weighing scales. ISO/IEEE 11073-10415:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines. ISO/IEEE 11073-10417:2014 establishes a normative definition of communication between personal telehealth glucose meter devices and computer engines (e.g. cell phones, personal computers, personal health appliances and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability are specified. A common core of communication functionality for personal telehealth glucose meters is defined in ISO/IEEE 11073-10417:2014. Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing devices and managers (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10420:2012 defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance. Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in ISO/IEEE 11073-10421:2012 between personal telehealth peak expiratory flow monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth peak expiratory flow monitor devices. ISO/IEEE 11073-10471:2010 establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances and set top boxes) in a manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favour of interoperability. ISO/IEEE 11073-10471:2010 defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined (for example) to determine when a person's activities/behaviour have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting). ISO/IEEE 11073-10471:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and managers Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10472:2012 establishes a normative definition of communication between personal telehealth medication monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10472:2012 defines a common core of communication functionality for personal telehealth medication monitor devices. ISO/IEEE 11073-20101:2004 provides the upper layer [i.e., the International Organization for Standardization's (ISO's) open systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC). ISO/IEEE 11073-20101:2004 is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the Committee for European Normalization (CEN) and ISO. ISO/IEEE 11703-20601:2010 defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible. ISO/IEEE 11703-20601:2010 addresses a need for an openly defined, independent standard for converting the information profile into an interoperable transmission format so the information can be exchanged to and from personal telehealth devices and computer engines (e.g., cell phones, personal computers, personal health appliances and set top boxes). ISO/IEEE 11073-30200:2004 describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices and is suitable for new device designs, but is particularly targeted to modifications of legacy devices. The term legacy devices refers to equipment that is ◾ already in use in clinical facilities; ◾ in active production at the facilities of medical device manufacturers; ◾ beyond the initial stages of engineering development. This standard has been reviewed and then confirmed in 2013 ISO/IEEE 11073-30300:2004 defines an IrDA-based transport profile for medical device communication that uses short-range infrared, as a companion standard to ISO/IEEE 11073-30200, which specifies a cable-connected physical layer. ISO/IEEE 11073-30300:2004 also supports use cases consistent with industry practice for handheld personal digital assistants (PDAs) and network APs that support IrDA-infrared communication. The application of the Ethernet family (IEEE Std 802.3-2008) of protocols for use in medical device communication is addressed in ISO/IEEE 11073-30400:2012. The scope is limited to referencing the appropriate Ethernet family specifications and calling out any specific special needs or requirements of the ISO/IEEE 11073 environment, with a particular focus on easing interoperability and controlling costs. ISO 11073-90101:2008 establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. CLSI document POCT1 provides the framework for engineers to design devices, workstations and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data concentrators and laboratory information systems from a variety of vendors. As an interface standard, ISO 11073-90101:2008 specifies the common communication interfaces and protocols between systems and devices. It facilitates the transfer of data to support the creation of point-of-care applications, services and institutional policies. This International Standard does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. It specifies protocol, not policy. The interfaces specified support the communication required for engineers to build such application-level functionality. Specifying, building and providing the applications to support these services are left to customers, device and information system vendors. ISO 11073-91064:2009 specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, …), ECG signal data, ECG measurement and ECG interpretation results. ISO 11073-91064:2009 specifies the content and structure of the information that is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored. ISO/TS 11073-92001:2007 specifies how medical waveforms, such as electrocardiogram, electroencephalogram, spirometry waveform etc., are described for interoperability among healthcare information systems. ISO/TS 11073-92001:2007 may be used with other relevant protocols such as HL7, DICOM, ISO/IEEE 11073, and database management systems for each purpose. This is a general specification, so specifications for particular waveform types and for harmonization with DICOM, SCP-ECG, X73 etc. are not given. ISO/TS 11073-92001:2007 does not include lower layer protocols for message exchange. For example, a critical real-time application like a patient monitoring system is out of scope and this is an implementation issue. [source: iso.org]
Keywords: 
health, informatics, device, medical, data, computer
Organisation: 
ISO
Geographical area: 
International