CEN 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.
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:
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.
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.).
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.
The International Organization for Standardization is an international standard-setting body composed of representatives from various national standards organizations.
An open standard is a standard that is publicly available and has various rights to use associated with it, and may also have various properties of how it was designed. There is no single definition and interpretations vary with usage.
Interoperability is a characteristic of a product or system, whose interfaces are completely understood, to work with other products or systems, at present or in the future, in either implementation or access, without any restrictions.
|11073-00101||Health informatics – PoC medical device communication – Part 00101: Guide – Guidelines for the use of RF wireless technology|
|11073-10101:2004(E)||Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature|
|11073-10101a:2015(E)||Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature Amendment 1: Additional Definitions|
|11073-10102:2014(E)||Health informatics – Point-of-care medical device communication – Part 10102: Nomenclature – Annotated ECG|
|11073-10103:2012(E)||Health informatics – Point-of-care medical device communication – Part 10103: Nomenclature – Implantable device, cardiac|
|11073-10201:2004(E)||Health informatics – Point-of-care medical device communication – Part 10201: Domain information model|
|11073-10207:2017||Health informatics – Point-of-care medical device communication – Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication|
|11073-20101:2004(E)||Health informatics – Point-of-care medical device communication – Part 20101: Application profile – Base standard|
|11073-20701:2018||Health informatics – Point-of-care medical device communication – Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding|
|11073-20702:2016||Health informatics – Point-of-care medical device communication – Part 20702: Medical Devices Communication Profile for Web Services|
|11073-30200a: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 wireless|
|11073-30400:2012(E)||Health informatics – Point-of-care medical device communication – Part 30400: Transport profile – Cabled Ethernet|
|11073-90101:2008(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
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
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 and a simpler communications model.
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 */
This section needs additional citations for verification . (February 2014) (Learn how and when to remove this template message)
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.
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.
The Open Systems Interconnection model is a conceptual model that characterizes and standardizes the communication functions of a telecommunication or computing system without regard to its underlying internal structure and technology. Its goal is the interoperability of diverse communication systems with standard communication protocols. The model partitions a communication system into abstraction layers. The original version of the model had seven layers.
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.
This module is the interface between a proprietary (eventually native) protocol and the ISO/IEEE (VITAL) object world. It is not defined within the standard and as a result it can be implemented free.
MMOs (Managed Medical Objects) are stored hierarchically within a tree structure in a form named Domain Information Model (DIM). This MMOs and their arrangement in the DIM are defined within this standard. The implementation of the MDIB (Medical Device Information Base) and their functionality is out of the scope of the standard.
This module is subject to the standards ISO/IEC 15953 and ISO/IEC 15954. It has services available, that controlling the association assembly and disassembly. A possible association and their condition is negotiated here, no MMOs are transmitted over this module.
Services for the data exchange of MMOs (Managed Medical Objects) between Agent-Manager systems, are defined in this module. This data exchange is highly dynamic. Objects are created, changed or deleted by services named CREATE, UPDATE, DELETE. Through reports, which can be defined detailed down to the single object attribute, it is possible to trigger complex operations in Agent or Manager, through this services.
This layer contains the encoding of object data. Objects, groups of objects attributes or single attributes are encoded by ASN.1 representations, respectively the spezialization MDER (Medical Device encoding Rules).
That layer controls connection at the session level.
The central core of the standard is the so-called Domain Information Model. Objects containing vital-sign data representations and their relationships are defined in this model. Objects for additional services around vital signs data objects, are defined also here.
For content sensitive classification of the objects, they are divided into packages.
The package that defines objects, to map medical vital signs data. There are different objects to store vital signs data in different ways. As an example the RealTimeSampleArray object for the management of e.g. ECG data be mentioned.
This small package is related within the medical package. It is used for setting and administrating alert parameters to objects from the medical package.
A representation of a medical device can be achieved with objects of this package. It contains concrete derivations of the abstract MDS (MedicalDevice System) object. One of these concrete derivations are ever the root object of a DIM tree. The Battery object and the Clock object are further objects in this package. The last one can be used for time synchronization of medical device data.
Inside the control package, objects for the remote control of a medical device are defined. There are objects used for influenceing the modality of measuring (for example the SetRangeOperation object) and objects for direct remote control of medical devices (for example the ActivateOperation object).
Other than the name supposes, in this package essential and ever used objects are defined. This package is built on so-called scanner objects in different derivations. Scanning data in other objects and generation of event reports, who can be sendend, is the sense of this objects. The scanner objects have a wide range of different attributes (e.g. scan interval, scan lists, scan period etc.), for a wide range of applications of the DIM. As an example, the FastPeriCfgScanner object (Fast Periodic Configurable Scanner) is specially constructed for the requirements of real-time data exchange in conjunction with the RealTimeSampleArray object to transmit live data from egc devices.
The objects in these package contain information, which are responsible for basic communication profiles. These packages are developed very open, so that different communication profiles and interfaces to proprietary device interfaces can be built. Annotation by the author: From a historic view, the standard was developed for the first time in the early 90s, this package has to be reconstructed.
Storing Patient related data in online or offline archives is the idea for objects in the archival package. For Example, the Patient Archive object can store vital signs data, demographic data and treatment data in one object.
The patient package contains only one object, the Patient Demographics object. This object contains patient related data and can be set in relationship to an MDS object or one of the objects from the archive package, to give anonymous data the reference to patient data.
The complete communication sequence can be very complex. This article should provide basic information, that can be described in more detail at a later time in a separate article.
The finite state machine regulates the synchronization of an Agent Manager system over different conditions. A complete session roundtrip starts up with the disconnected state, is transferred by multiple stages to the initialized state, in what the actual data transfer shall be done, and ends with the disconnected state.
During the association phase, the configuring state will be reached. In this condition Agent and Manager are to exchange object data for the first time. In the process a MDSCreateEvent in the form of a report would be triggered. This report creates a copy of the MDS root object from the Agent MDIB in the Manager MDIB. Afterward a Contextscanner object is created in the Agent MDIB. This scanner object scans the complete MDIB and generates a report containing the complete Agent MDIB representation, except the MDS root object. The Manager evaluates this report and creates the objects defined here in his own MDIB copy. At this point the manager has an exact copy of the Agent MDIB. Both are now at configured state.
The Common Medical Device Information Service Element (CMDISE) provides a GET service, to deliver data requested by the Manager. The Agent GET service retrieves a list of attribute ids. These ids identify explicit values within Agents MDIB. Now the Agent creates a report, containing the requested values. This report is sent back to the Manager.
In an MDIB, additional objects shall be created through the CREATE service of CMDISE. The Manager requests the Agent through this service to create a scanner object itself, and to fix the scanner object on one or more values. Optional for example the scan interval for the data delivery can be set. The Agent creates the scanner object in his own MDIB and sends the Manager a response message. Now the Manager creates a copy of the scanner object in his MDIB. The data updates from Agent to Manager now occur automatically through the scanner object. Through CMDISE's DELETE service, the scanner object can be deleted, like all other MDIB objects.
Digital Imaging and Communications in Medicine (DICOM) is the standard for the communication and management of medical imaging information and related data. DICOM is most commonly used for storing and transmitting medical images enabling the integration of medical imaging devices such as scanners, servers, workstations, printers, network hardware, and picture archiving and communication systems (PACS) from multiple manufacturers. It has been widely adopted by hospitals, and is making inroads into smaller applications like dentists' and doctors' offices.
The Common Management Information Protocol (CMIP) is the OSI specified network management protocol.
A management information base (MIB) is a database used for managing the entities in a communication network. Most often associated with the Simple Network Management Protocol (SNMP), the term is also used more generically in contexts such as in OSI/ISO Network management model. While intended to refer to the complete collection of management information available on an entity, it is often used to refer to a particular subset, more correctly referred to as MIB-module.
An electronic health record (EHR) is the systematized collection of patient and population electronically-stored health information in a digital format. These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.
A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
IEC 61850 is an international standard defining communication protocols for intelligent electronic devices at electrical substations. It is a part of the International Electrotechnical Commission's (IEC) Technical Committee 57 reference architecture for electric power systems. The abstract data models defined in IEC 61850 can be mapped to a number of protocols. Current mappings in the standard are to MMS, GOOSE, SMV, and soon to Web Services. These protocols can run over TCP/IP networks or substation LANs using high speed switched Ethernet to obtain the necessary response times below four milliseconds for protective relaying.
openEHR is an open standard specification in health informatics that describes the management and storage, retrieval and exchange of health data in electronic health records (EHRs). In openEHR, all health data for a person is stored in a "one lifetime", vendor-independent, person-centred EHR. The openEHR specifications include an EHR Extract specification but are otherwise not primarily concerned with the exchange of data between EHR-systems as this is the focus of other standards such as EN 13606 and HL7.
Continua Health Alliance is an international non-profit, open industry group of nearly 240 healthcare providers, communications, medical, and fitness device companies. Continua Health Alliance members aim to develop a system to deliver personal and individual healthcare. Continua was a founding member of Personal Connected Health Alliance which was launched in February 2014 with other founding members mHealth SUMMIT and HIMSS.
The European Committee for Standardization (CEN) Standard Architecture for Healthcare Information Systems, Health Informatics Service Architecture or HISA is a standard that provides guidance on the development of modular open information technology (IT) systems in the healthcare sector. Broadly, architecture standards outline frameworks which can be used in the development of consistent, coherent applications, databases and workstations. This is done through the definition of hardware and software construction requirements and outlining of protocols for communications. The HISA standard provides a formal standard for a service-oriented architecture (SOA), specific for the requirements of health services, based on the principles of Open Distributed Processing. The HISA standard evolved from previous work on healthcare information systems architecture commenced by Reseau d’Information et de Communication Hospitalier Europeen (RICHE) in 1989, and subsequently built upon by a number of organizations across Europe.
The ISO/TC 215 is the International Organization for Standardization's (ISO) Technical Committee (TC) on health informatics. TC 215 works on the standardization of Health Information and Communications Technology (ICT), to allow for compatibility and interoperability between independent systems.
Healthcare Technology Management is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare technology. These healthcare technology managers are, much like other healthcare professionals referred to by various specialty or organizational hierarchy names.
The system of concepts to support continuity of care, often referred to as ContSys, is an ISO and CEN standard . Continuity of care is an organisational principle that represents an important aspect of quality and safety in health care. Semantic interoperability is a basic requirement for continuity of care. Concepts that are needed for these purposes must represent both the content and context of the health care services.
In medicine, monitoring is the observation of a disease, condition or one or several medical parameters over time.
Barcode technology in healthcare is the use of optical machine-readable representation of data in a hospital or healthcare setting.
A body area network (BAN), also referred to as a wireless body area network (WBAN) or a body sensor network (BSN) or a medical body area network (MBAN), is a wireless network of wearable computing devices. BAN devices may be embedded inside the body, implants, may be surface-mounted on the body in a fixed position Wearable technology or may be accompanied devices which humans can carry in different positions, in clothes pockets, by hand or in various bags. Whilst there is a trend towards the miniaturization of devices, in particular, networks consisting of several miniaturized body sensor units (BSUs) together with a single body central unit (BCU). Larger decimeter sized smart devices, accompanied devices, still play an important role in terms of acting as a data hub, data gateway and providing a user interface to view and manage BAN applications, in-situ. The development of WBAN technology started around 1995 around the idea of using wireless personal area network (WPAN) technologies to implement communications on, near, and around the human body. About six years later, the term "BAN" came to refer to systems where communication is entirely within, on, and in the immediate proximity of a human body. A WBAN system can use WPAN wireless technologies as gateways to reach longer ranges. Through gateway devices, it is possible to connect the wearable devices on the human body to the internet. This way, medical professionals can access patient data online using the internet independent of the patient location.
Medical device connectivity is the establishment and maintenance of a connection through which data is transferred between a medical device, such as a patient monitor, and an information system. The term is used interchangeably with biomedical device connectivity or biomedical device integration. By eliminating the need for manual data entry, potential benefits include faster and more frequent data updates, diminished human error, and improved workflow efficiency.
Dipak Kalra is President of the European Institute for Health Records and of the European Institute for Innovation through Health Data. He undertakes international research and standards development, and advises on adoption strategies, relating to Electronic Health Records.
The IEEE 11073 service-oriented device connectivity (SDC) family of standards defines a communication protocol for point-of-care (PoC) medical devices. The main purpose is to enable manufacturer-independent medical device-to-device interoperability.. Furthermore, interconnection between medical devices and medical information systems is enabled. However, IEEE 11073 SDC does not compete with established and emerging standards like HL7 v2 or HL7 FHIR. IEEE 11073 SDC is part of the established ISO/IEEE 11073 family of standards.
Android 4.0 implements support for IEEE 11073 via the BluetoothHealth class
NIST Standard Conformance Tools
11073 Web site
ZigBee provides support for IEEE 1073 via the ZigBee Health Care Profile (ZHCP)