CEN ISO/IEEE 11073 Health informatics - Medical / health device communication standards enable communication between medical, health care and wellness devices and external computer systems. They provide automatic and detailed electronic data capture of client-related and vital signs information, and of device operational data.
Background
Goals Real-time plug-and-play interoperability for citizen-related medical, healthcare and wellness devices; 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 both point-of-care devices (ventilators, infusion pumps, ECG, etc.) and 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 specialisations; 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).
Problems In the absence of standards for these devices, (a) data is captured either manually or at considerable expense (using specialized equipment), or (b) it is not captured at all, which is most often the case. Manually captured data is labour-intensive, recorded infrequently (e.g., written down hourly by a nurse clinician), and prone to human error. Use of expensive custom connectivity equipment (a) drives up the cost of care delivery; (b) is only used for patients with the highest acuity; and (c) tends to lock care providers into single companies or partnerships that provide "complete" information system solutions, making it difficult to choose best-of-breed technologies to meet client needs, or the most cost effective systems. Development and deployment of advanced care delivery systems are hindered. For example, systems that collect real-time data from multiple devices and use the information to detect safety problems (e.g., adverse drug events), or to quickly determine a client's condition and automatically, or with minimal carer involvement, optimally adjust a device's operation (e.g., for insulin delivery based on glucose level information) cannot operate without these standards. With no standardisation in this area, even when similar devices do provide communications, there is no consistency in the information and services that are provided, thus inhibiting the development of advanced care delivery systems or even consistent health records. In short: appropriate use of 11073 device communication standards can help deliver better health, fitness and care, more quickly, safely, and at a lower cost.
Motivation These are the only standards addressing this area of connectivity. They provide a complete solution for medical device connectivity, starting at the physical cable or wireless connection up through the abstract representation of information and the services used for its management and exchange. They can enable full disclosure of device-mediated information. So measurement modalities be declared in detail and the associated metrics & alerts communicated, together with any user-made changes to settings. In addition, the device can communicate its manufacturer, model, serial number, configuration, operating status and network location – all in real time if required. The IEEE 11073 standards have been developed with a high level of international participation. They have been, and continue to be, adopted as International Organization for Standardization (ISO) standards through ISO TC215 Health Informatics and as European standards through the European Committee for Standardization (CEN) TC251 Health Informatics, specifically as the CEN ISO/IEEE 11073 series. The end result is a single set of internationally harmonized standards that have been developed and adopted by ISO and CEN member countries. These CEN ISO/IEEE 11073 standards have been developed in close coordination with other standards development organisations, including IEEE 802, IHTSDO, IrDA, HL7, DICOM, and CLSI. Memoranda of Understanding with IHE, IHTSDO, and HL7; and (through ISO) close liaison with Continua Health Alliance assist still wider integration. The CEN ISO/IEEE 11073 nomenclature is now being used to populate, and to establish equivalence, within SNOMED CT - the most widely used clinical terminology. A liaison between the IEEE 11073 standards group and the USA Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) in the USA helps ensure that patient safety and efficacy concerns are fully addressed in the standards. The Continua Health Alliance and the English NHS National Programme for Information Technology (NPfIT) both specify use of the standards for device communication. The standards have been included in the USA National Committee on Vital and Health Statistics recommendations to the Department of Health and Human Services related to patient medical record information message formats supporting Health Insurance Portability and Accountability Act (HIPAA) compliant implementations. The cost of integrating innovative technologies into established product lines is reduced — and a barrier to new companies is lowered.
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