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.
Availability 11073 standards are available freely to those actively involved in their development, others may purchase them. For published and draft standards search for '11073' at: IEEE, ISO or CEN. Standards may be purchased from the national standards organisation or bookstore (e.g. AFNOR, BSI, DIN, JIS, UNI, etc.).
Overview
The ISO/IEEE 11073 Medical / Health Device Communication Standards are a family of ISO, IEEE, and CEN joint standards addressing the interoperability of medical devices. The ISO/IEEE 11073 standard family defines parts of a system, with which it is possible, to exchange and evaluate vital signs data between different medical devices, as well as remote control these devices.
Point-of-care medical device 11073-00101Health informatics – PoC medical device communication – Part 00101: Guide – Guidelines for the use of RF wireless technology11073-10101:2004(E)Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature11073-10101a:2015(E)Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature Amendment 1: Additional Definitions11073-10102:2014(E)Health informatics – Point-of-care medical device communication – Part 10102: Nomenclature – Annotated ECG11073-10103:2012(E)Health informatics – Point-of-care medical device communication – Part 10103: Nomenclature – Implantable device, cardiac11073-10201:2004(E)Health informatics – Point-of-care medical device communication – Part 10201: Domain information model11073-10207:2017Health informatics – Point-of-care medical device communication – Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication11073-20101:2004(E)Health informatics – Point-of-care medical device communication – Part 20101: Application profile – Base standard11073-20701:2018Health informatics – Point-of-care medical device communication – Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding11073-20702:2016Health informatics – Point-of-care medical device communication – Part 20702: Medical Devices Communication Profile for Web Services11073-30200a:2011(E)Health informatics – Point-of-care medical device communication – Part 30200: Transport profile – Cable connected (amended)11073-30300:2004(E)Health informatics – Point-of-care medical device communication – Part 30300: Transport profile – Infrared wireless11073-30400:2012(E)Health informatics – Point-of-care medical device communication – Part 30400: Transport profile – Cabled Ethernet11073-90101:2008(E)Health informatics – Point-of-care medical device communication – Part 90101: Analytical instruments – Point-of-care test
The 'core' standards are: 11073-10101, 11073-10201, 11073-20101 and 11073-30200
Personal health device ISO/IEEE 11073 personal health device (PHD) standards are a group of standards addressing the interoperability of personal health devices (PHDs) such as weighing scales, blood pressure monitors, blood glucose monitors and the like. The standards draw upon earlier IEEE11073 standards work, but differ from this earlier work due to an emphasis on devices for personal use (rather than hospital use) and a simpler communications model.
These are described in more detail at ISO/IEEE 11073 Personal Health Data (PHD) Standards
Core standard
Nomenclature Within this standard nomenclature codes are defined, these give the possibility to clearly identify objects and attributes in relation to the so-called OID-Code ( ). The nomenclature is divided in partitions, to demarcate codes with regards to content and functions. Programmatically these codes are defined as constants, those can be used by a pseudonym. example in C:
#define MDC_PART_OBJ 1 /* Definition for the Partition Object Infrastructure */ #define MDC_MOC_VMS_MDS_SIMP 37 /* Define the Object Simple Medical Device System */
Domain information model
This standard is the "heart" of VITAL. Within this, objects and their arrangement in a Domain Information Model for vital signs data transmission are defined. Beyond this the standard defines a service model for the standardized communication.
Base standard The common background for assembly and transmission of objects and their attributes are defined in this standard. It's subdivided in a communication model and an information model. The communication model describes the layers 5 to 7 of the OSI 7-layer model. The information model defines the modeling, formatting and the syntax for transmission coding of the objects.
Agent/manager principle
All defined parts of this standard family are designed to allow communication according to this principle. The arrangement of two or more medical devices as a system, so that the components are possible to understand and to interact, are the basic idea of this principle.
The agent is the part of the principle that is connected to the medical devices. It provides the data. The manager keeps a copy of the agent data, reacts on update events from them, and triggers events on the agent. In most use cases the manager is only used to remotely monitor and display agent data, but in some cases it may also remotely control the agents. Agents and manager are built in the same structure. This enables an agent to act as a manager and reverse. Besides the plain agent-manager application, hybrid systems over multiple stages are possible.
Agent application process(es) This module is the interface between a proprietary (eventually native) protocol and the ISO/IEEE (VITAL) object world.