ISO/TC 215/WG 2 - Systems and Device Interoperability

This document reports on the datasets and a data structure for reporting clinical and biological evaluation metrics (CBEMs). The reporting of radiation dose estimates is outside the scope of this document. This document is applicable to CBEMs for external-beam radiation therapy (EBRT) modalities, but not CBEMs for brachytherapy or molecular radiotherapy. Various types of radiotherapy treatment modalities are available for cancer care. Consequently, there is a growing awareness of the need for objective schemes that will contribute to enable the selection of an appropriate radiotherapy treatment modality for individual patients. The use of CBEMs, the metrics associated with a certain radiotherapy treatment plan for a patient, is attracting attention for clinical purposes in the field of EBRT. In anticipation of the clinical use of CBEMs, the importance of research on clinical and scientific aspects of CBEMs is increasing, in concert with the importance of establishing a standardized data format for reporting of specifics of a CBEM.

This document specifies the data output formats for the specular microscope. The data are usually sent from the specular microscope to either an ophthalmic information system (OIS) or a hospital information system (HIS). This document addresses text-based analysis reporting of the specular microscope measured and analysed data such as the central corneal thickness, the density of endothelial cells per 1 mm2, the coefficient variant, and the ratio of endothelial cells with a hexagonal shape.

This document specifies the measurement data output formats for devices used in general ophthalmic examiniations, including the following modalities: — Refractometer (REF) Refraction — Keratometer (KM) Corneal curvature — Tonometer (TM) Intraocular pressure — Lensmeter (LM) Spectacle lens power — Phoroptor (PHOR) Visual acuity This document only addresses text-based device reporting of ophthalmic examination device data (OEDD). Images generated as needed during an ophthalmic examination are outside the scope of this document.

This document reposts a case study on how to establish and maintain standardized cardiac examination export measurement data (CE-EMD), especially for enabling its secondary use for medical research. The document includes information for CE-EMD on: — Building a representative coalition of stakeholders to identify and establish specifications; — Standardizing both the content and format in reports; — Maintaining and extending the specifications over time. Out-of-scope for this document are any requirements for specific CE-EMD content or formatting. Also, this document is limited to cardiac examination reporting, and does not encompass other clinical care areas or reporting that have been standardized.

This document specifies how medical waveforms, such as electrocardiogram, electroencephalogram, spirometry waveform, etc., are described for interoperability among healthcare information systems. This document can be used with other relevant protocols, such as HL7, DICOM®, the ISO/IEEE 11073 series, 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. This document does not include lower layer protocols for message exchange. For example, a critical real-time application such as a patient monitoring system is out of scope and this is an implementation issue.

This document defines the configuration rules required for a hierarchical structure, directory naming rules, and content identifiers for files and documents containing healthcare information. Content can be expressed as ISO/HL7 27931:2009 (also known as HL7 Ver2.5) as the data format to store clinical data such as prescriptions, lab results, and disease classifications, but can also include other types of file-type such as XML, CDA, DOC/DOCX, PDF, XLS/XLSX, JPEG, MP4, etc. This document does not address the security and privacy attributes of the healthcare information being stored; these are considered implementation-specific.

This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains: — management of telehealth quality processes by the healthcare organization; — strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines; — healthcare processes relating to people such as healthcare activities, planning, and responsibilities; — management of financial resources to support telehealth services; — management of information management and security used in telehealth services; — processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services. This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide. This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems. Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.

This document specifies the data element content and exchange format for tokens used in token-based health information sharing. It includes a) the data items that may be contained in a health information token (HI-TOKEN), b) the value representation for each data item, c) the exchange formats allowed for HI-TOKEN sharing (electronic, machine-readable symbol, print), and d) considerations when establishing governance policies specifying how HI-TOKENs can be used within a specific group of healthcare organizations. Provision is made for both physical media and electronic exchange media. This document addresses the overall conceptual architecture and process for token-based health information sharing, as well as the role of patients, referring healthcare facilities, referred healthcare service providers, and health research institutions. Provision is made for pseudonymization of patient data. This document only defines the specification of the HI-TOKEN used in token-based health information sharing. Data exchange / transport architectures, encryption methods, and specific governance policy requirements are outside the scope of this document.

This document specifies a heterogeneous format of neurophysiological waveform signals to support recording in a single persistent record package as well as interoperable exchange. The document focuses on electroencephalography (EEG) waveforms created during EEG examinations. Specific provision is made for sleep polysomnography examinations (PSG), brain death determination, evoked potentials (EP), and electromyography (EMG) studies. This document is intended for neurophysiology.

This document lists examples of and defines categories of use cases for machine learning in medicine for clinical practice. The developments and applications of machine learning technologies for artificial intelligence consist of 1) data collection and curation, 2) pre-processing, 3) model training and validation, and 4) medicine depending on various kinds of specialty including radiology, pathology, emergency medicine, dermatology, ophthalmology, anaesthesia, surgery, etc., and clinical settings including repeated detection and/or diagnosis, real-time monitoring, and treatment prediction. This document covers categories applications of medicine in (4). It also defines the clinical usages and necessities of the artificial intelligence in medicine. (1) to (3) are not the scope of this document This document also excludes — basic research and other scientific areas, — use cases related to artificial intelligence methods other than machine learning (for example, symbolic artificial intelligence, expert systems), and — non-human results such as veterinary medicine.

This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as defined in Clause 4). An RSP lists the principle health information technology (HIT) standards that form the basis of implementing and deploying interoperable applications in the target domain. An RSP includes a description of the domain, a normative list of standards, and an informative framework for mapping the standards to example deployment use cases. The lists do not include standards that are specifically national in scope. The primary target audience for this document is policy makers (governmental or organizational), regulators, project planners and HIT managers. This document will also be of interest to other stakeholders such as equipment and HIT vendors, clinical and health information management (HIM) professionals and standards developers. The intended usage of this document is to inform decisions about selecting the standards that will form the basis of integration projects in geographic regions or healthcare organizations. For example: — What standards to use for capturing/encoding/exchanging certain types of information — What standards to use for interfaces between the devices and information systems that support information capture, management, exchange, processing and use — What standards to use for specific use cases/deployment scenarios The selected standards, and/or corresponding RSP clauses, might be useful when drafting project specifications.

This document defines a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object-oriented information model that is for medical device communication.

This document provides an environmental scan of common data elements that are captured through various modalities such as cell phones, smart phones, mobile applications and remote monitoring devices that are combined with EHRs, patient portals and PHR systems which can ultimately be applicable to a variety of healthcare service environments. The Health-related data can be used to supplement existing clinical data, filling in gaps in information and providing a more comprehensive picture of ongoing patient healthcare.

The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care (POC) medical device communications. The scope is primarily focused on acute care medical devices and the communication of patient vital signs information.

This document defines the application of Medical waveform Format Encoding Rules (MFER) to describe stress test electrocardiography, which is one of the outputs of exercise, pharmacological and cardiopulmonary stress test. MFER performed in physiological laboratories, healthcare clinics, etc. This document covers not only the electrocardiogram waveform but also the description of related stress information and biological signals, e.g. blood pressure, respiration gas, SpO2, etc..

This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) 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 work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, 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. This standard defines a common core functionality of personal telehealth insulin pump devices. In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) 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 work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, 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. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, a communication protocol specification for a distributed system of PoC medical devices and medical IT systems that need to exchange data, or safely control networked PoC medical devices by profiling Web Service specifications, is defined by this standard. Additional Web Service specifications are part of this standard.

This document describes the concept of a person-owned repository (PoR) of health documents. It suggests representative uses for PoRs and surveys some of the existing technologies and projects that can be categorized as PoRs. It is, however, not intended to cover document formats (such as HL7 CDA), exact communication protocols, details of security and privacy protection strategies, or any other normative aspects of PoRs.

ISO/TS 21089:2018 describes trusted end-to-end flow for health information and health data/record management. Health data is originated and retained, typically as discrete record entries within a trusted electronic health record (EHR), personal health record (PHR) or other system/device. Health data can include clinical genomics information. Health record entries have a lifespan (period of time managed by one or more systems) and within that lifespan, various lifecycle events starting with "originate/retain". Subsequent record lifecycle events may include "update", "attest", "disclose", "transmit", "receive", "access/view" and more. A record entry instance is managed ? over its lifespan ? by the source system. If record entry content is exchanged, this instance may also be managed intact by one or more downstream systems. Consistent, trusted management of record entry instances is the objective of this document, continuously and consistently whether the instance is at rest or in motion, before/during/after each lifecycle event, across one or more systems.

ISO/IEEE 11073-10427:2018 establishes a normative defi nition of communication between devices containing a power source (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. Using existing terminology, information profi les, applica-tion profi le standards, and transport standards as defi ned in other ISO/IEEE 11073 standards, this standard de-fi nes a common core of communication functionality of personal health devices (PHDs) containing a battery, including: 1) current device power status (e.g., on mains or on battery); 2) power charge status (e.g., percent of full charge); and 3) estimated time remaining (e.g., minutes).

ISO 12052:2017, within the field of health informatics, addresses the exchange of digital images and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information. ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying: - for network communications, a set of protocols to be followed by devices claiming conformance to this document; - the syntax and semantics of Commands and associated information which can be exchanged using these protocols; - for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media; - information that is to be supplied with an implementation for which conformance to this document is claimed. ISO 12052:2017 does not specify: - the implementation details of any features of the DICOM standard on a device claiming conformance; - the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document; - a testing/validation procedure to assess an implementation's conformance to this document. ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field. ISO 12052:2017 has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments. ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

ISO 14199:2015 defines a set of models collectively referred to as the Biomedical Research Integrated Domain Group (BRIDG) model for use in supporting development of computer software, databases, metadata repositories, and data interchange standards. It supports technology solutions that enable semantic (meaning-based) interoperability within the biomedical/clinical research arena and between research and the healthcare arena. The clinical research semantics are represented as a set of visual diagrams which describe information relationships, definitions, explanations, and examples used in protocol-driven biomedical research. These diagrams are expressed using the iconography and grammar of the Unified Modelling Language (UML), the HL7 Reference Information Model (RIM), and a Web Ontology Language (OWL). ISO 14199:2015 establishes the links between protocol-driven research and its associated regulatory artefacts including the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, or device on a human, animal, or other subject or substance along with all associated regulatory artefacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting.

ISO/TR 17522:2015 is applicable to the developments of smart health applications available anywhere, anytime and supporting new health businesses based on the smart devices. This Technical Report is to investigate the areas of ongoing developments and analyses of emerging interoperability standards for smart mobile devices.

ISO/TR 28380-3:2014 describes the general methodology to analyse interoperability requirements in support of a use case to produce the selection and combination of the relevant Profiles specified in TR 28380-2. It is illustrated by applying this methodology to a small number of examples. It also identifies and proposes a high-level quantification of the benefits gained by the use of a profile based specification of interoperability. Finally this technical report will discuss the approach to effectively test interoperability from the specific of the standards and profiles, up to the level of business use cases. ISO/TR 28380‑1 is a companion to this part of ISO/TR 28380-3:2014. A wide portfolio of such profiles for Integration, Security, and Semantic Content is now available across various domains of healthcare clinical specialities and technologies, as described in ISO/TR 28380‑2. The reader of ISO/TR 28380-3:2014 is encouraged to be familiar with this process followed by IHE in developing its Profiles as it builds upon ISO/TR 28380‑1 and ISO/TR 28380‑2 by addressing a number of key issues to support eHealth projects across all sectors of health to more effectively deploy standards-based interoperability between software applications and devices, including within healthcare organizations and across healthcare and home settings.

ISO/TR 19231:2014 surveys ongoing national mHealth projects in LMIC, to which some emerging technologies such as zero configuration and proximity computing are applicable, especially when the information and communication technology (ICT) infrastructure is not established in those countries. The scope is constrained to mHealth use cases and technologies for information and communication infrastructures that are useful for LMICs. In addition, the purpose of this Technical Report is to survey not only national mHealth projects in LMICs, but also possible mHealth frameworks that might be used.

The Health Level Seven (HL7) Reference Information Model (RIM) is a static model of health and health care information as viewed within the scope of HL7 standards development activities. It is the combined consensus view of information from the perspective of the HL7 working group and the HL7 international affiliates. The RIM is the ultimate source from which all HL7 version 3.0 protocol specification standards draw their information-related content. In the context of ISO TC215 – Health Informatics, the RIM provides a reference model that has been and will likely continue to be used in developing further health informatics specifications.

ISO/IEEE 11073-10103:2014 extends the base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.

ISO/IEEE 11073-10102:2014 extends the IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g. ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional "global" and "per-lead" numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined.

ISO/TR 28380-1:2014 describes how the Integrating the Healthcare Enterprise (IHE) process specifies and facilitates profiles of selected standards to support carefully defined healthcare tasks that depend on electronic information exchange. It accelerates the worldwide adoption of standards targeted at achieving interoperability between software applications within healthcare enterprises and across healthcare settings. The Integration and Content Profiles are specified in ISO 28380-2.

ISO/TR 28380-2:2014 describes the most recent Integrating the Healthcare Enterprise (IHE) Profiles developed by IHE. These profiles of selected standards support carefully defined healthcare-related tasks that depend on information exchange. It accelerates the worldwide adoption of standards targeted to achieving the interoperability of health information between software applications within enterprises and across various care settings. Each available Integration or Content Profile is described with reference to the specification provided. ISO/TR 28380‑1 is a companion to ISO/TR 28380-2:2014. The reader is encouraged to be familiar with the process followed by IHE in developing the Integration and Content Profiles described in ISO/TR 28380-2:2014.

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).

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.

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.

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.

This Technical Report covers aspects of federations of Clinical Document Registries (CDRs) including cases where the whole content of a CDR has been replicated in another CDR of the same federation. More specifically, the following aspects are covered. a) Recommendations for the creation and management of federations of CDRs and federation metadata. b) Creation and management of federated replicas, including specifications to create, remove and maintain federated replicas as well as metadata for them. c) Use cases of federations with query processing examples, including various use cases of federations of CDRs, together with examples of query processing policies to enhance the performance and fault-tolerance. d) Processing of queries in the presence of federations and replicas: the presence of federated replicas might affect the semantics of both local and federated queries. Informative examples to define exact behaviours of processing the queries are given. NOTE It is assumed that the problem of patient identification has been solved in a way that is beyond the scope of this Technical Report, such as IHE XCPD (Cross-Community Patient Discovery) Profile. Some potential issues that will not be addressed in this Technical Report include patient identity management, potential limitations of registries due to jurisdictional policies or requirements, and how replicates are handled.

ISO 10159:2011 specifies the format of a manifest of web access reference pointers, information object identifiers, information object filenames and associated information required by a target IT system. This enables local web access to the referenced information objects when a package containing the referencing document, the manifest and the objects (stored in files) is sent from a source clinical domain to a target clinical domain in which the server references are different from those in the source clinical domain.

ISO 21090:2011 - provides a set of datatype definitions for representing and exchanging basic concepts that are commonly encountered in healthcare environments in support of information exchange in the healthcare environment; - specifies a collection of healthcare-related datatypes suitable for use in a number of health-related information environments; - declares the semantics of these datatypes using the terminology, notations and datatypes defined in ISO/IEC 11404, thus extending the set of datatypes defined in that standard; - provides UML definitions of the same datatypes using the terminology, notation and types defined in Unified Modelling Language (UML) version 2.0; - specifies an XML (Extensible Mark-up Language) based representation of the datatypes. The requirements which underpin the scope reflect a mix of requirements gathered primarily from HL7 Version 3 and ISO/IEC 11404, and also from CEN/TS 14796, ISO 13606 (all parts) and past ISO work on healthcare datatypes. ISO 21090:2011 can offer a practical and useful contribution to the internal design of health information systems, but is primarily intended to be used when defining external interfaces or messages to support communication between them.

ISO/TS 27790:2009 specifies a general purpose document registry framework for transmitting, storing and utilizing documents in clinical and personalized health environments. It is quite broad in its applicability to realise the goal of sharing health related documents spanning a broad spectrum of health domains such as healthcare specialities covering laboratory, cardiology, eye care, etc and the many areas of personalized health. ISO/TS 27790:2009 also references a number of companion standards-based specifications that offer optional extensions to enhance the basic capabilities offered by IHE XDS. It references the support of the following. An XDS extension supporting the fragmentation of the content of the documents into two parts: a header fragment and a body fragment. This separation scheme enhances confidentiality because the gathering both of header and body and their relational information involves cracking into multiple repository servers. This has been developed as an IHE Korean Extension on the IHE XDS Profile. A series of security- and privacy-related IHE profiles, such as Patient Identification Cross-Referencing (PIX), Patient Demographics Query (PDQ), Basic Patient Privacy Consent (BPPC), Cross-Enterprise User Assertion (XUA).

ISO 27932:2009 covers the standardization of clinical documents for exchange.

ISO 27951:2009 seeks to establish an international framework for the development of an application programming interface (API) that can be used by messaging software when accessing terminological content. It is not intended to be a complete terminology service in and of itself.

ISO 27931:2009 establishes an application protocol for the electronic exchange of data in healthcare environments.

ISO/TR 21730:2007 provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective electromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given recognize the different resources, needs, concerns and environments of healthcare organizations around the world, and provide detailed management guidelines for healthcare organizations that desire full deployment of mobile wireless communication and computing technology throughout their facilities. In addition, suggestions are included for selective restrictions in cases where healthcare organizations have decided that comprehensive management procedures are not feasible, practical or desirable at the present time. The recommendations herein distinguish between wireless technology controlled by the facility and used by doctors and staff for healthcare-specific communication and health informatics transport versus non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients or the healthcare organization workforce.

ISO 18232:2006 specifies the encoding and length for globally unique identifiers for data objects used in healthcare exchanged as alphanumeric strings.

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.

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 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.

ISO/TR 16056-1:2004 gives a brief introduction to interoperability of telehealth systems and networks, along with definitions of telehealth and related terms. An informative annex describing the Telehealth Technical Reference Architecture has also been included to describe more clearly the various components of a telehealth system and the elements that need to be addressed in formulating a set of requirements for these various components. The scope of the document does not include conformity and interoperability tests or functional specifications for telehealth systems and networks.

ISO/TR 16056-2:2004 builds on the introduction to telehealth described in Part 1: Introduction and definitions, and focuses on the technical standards related to real-time applications (including video, audio, and data conferencing) and interoperability aspects of telehealth systems and networks. Specifically, this document addresses four main areas: Standards for real-time telehealth systems: The document describes the technical standards related to real-time telehealth applications, including audio, video, and data conferencing capabilities. It also identifies gaps, overlaps and inconsistencies in the standards, and provides some guidance about how they need to evolve. Interoperability issues in telehealth applications: The document examines interoperability aspects of real-time multimedia conferencing standards and telehealth products, and identifies areas of concern from the interoperability perspective that need to be resolved. Requirements for interoperable telehealth systems and networks: The document defines interoperability requirements at different levels of interaction between telehealth systems and provides some guidelines on how interoperability can be achieved. Framework for interoperable architectures: The document identifies interoperable building blocks for telehealth solutions and interactions between these building blocks, and explores the possibility of standardization of these building blocks. The scope of the document does not include conformity and interoperability tests or functional specifications for telehealth systems and networks.