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 healthc...view more

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    • Technical specification
      22 pages
      English language
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    • Draft
      21 pages
      English language

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.

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    • Technical specification
      34 pages
      English language
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    • Draft
      32 pages
      English language

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 setting...view more

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    • Technical report
      14 pages
      English language
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    • Draft
      14 pages
      English language

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 ...view more

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    • Standard
      51 pages
      English language
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    • Draft
      51 pages
      English language

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.

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    • Standard
      1040 pages
      English language
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    • Draft
      1040 pages
      English language

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 ongoi...view more

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    • Technical report
      22 pages
      English language
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    • Draft
      22 pages
      English language

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.

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    • Standard
      168 pages
      English language
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    • Standard
      196 pages
      French language

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..

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    • Technical specification
      30 pages
      English language

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, an...view more

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    • Standard
      130 pages
      English language
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    • Standard
      151 pages
      French language

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 co...view more

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    • Standard
      81 pages
      English language
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    • Standard
      82 pages
      French language

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.

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    • Standard
      47 pages
      English language

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.

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    • Technical report
      11 pages
      English language

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 "orig...view more

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    • Technical specification
      85 pages
      English language

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 functionalit...view more

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    • Standard
      72 pages
      English language
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    • Standard
      84 pages
      French language

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 s...view more

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    • Standard
      17 pages
      English language
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    • Standard
      17 pages
      French language

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 di...view more

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    • Standard
      8 pages
      English language

ISO/TS 22077-2:2015 defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiogram waveforms measured in physiological laboratories, hospital wards, clinics, and primary care medical checkups. It covers electrocardiograms such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, and exercise tests that are measured by inspection equipment such as electrocardiographs and patient monitors that are compatible with MFER. Medica...view more

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    • Technical specification
      38 pages
      English language

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.

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    • Technical report
      17 pages
      English language

ISO/TS 22077-3:2015 defines the application of medical waveform format encoding rules (MFER) to describe long-term electrocardiogram waveforms measured in physiological laboratories and health care clinics. It covers electrocardiograms such as bipolar 2, 3-lead, 12-lead that are measured by medical equipment such as Holter electrocardiograph and patient physiological monitors that are compatible with the medical waveform format Encoding rules (MFER) Technical Specification (ISO 22077‑1).

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    • Technical specification
      29 pages
      English language

ISO 22077-1:2015 specifies how medical waveforms, such as electrocardiogram, electroencephalogram, spirometry waveform, etc., are described for interoperability among healthcare information systems. This International Standard 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 gi...view more

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    • Standard
      42 pages
      English language
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    • Standard
      36 pages
      English language
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    • Standard
      34 pages
      French language

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 effe...view more

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    • Technical report
      18 pages
      English language

ISO/TS 13131:2014 provides advice and recommendations on how to develop quality objectives and guidelines for telehealth services that use information and communications technologies (ICTs) to deliver healthcare over both long and short distances by using a risk management process. The following key requirements are considered when developing quality objectives and guidelines for telehealth services: management of telehealth quality processes by the healthcare organization; management of financi...view more

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    • Technical specification
      32 pages
      English language

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 ...view more

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    • Technical report
      13 pages
      English language

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 Inform...view more

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    • Standard
      47 pages
      English language

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 workfl...view more

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    • Standard
      117 pages
      English language
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    • Standard
      139 pages
      French language

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 system...view more

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    • Standard
      177 pages
      English language
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    • Standard
      176 pages
      French language

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.

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    • Technical report
      20 pages
      English language

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 ...view more

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    • Technical report
      11 pages
      English language

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 m...view more

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    • Standard
      64 pages
      English language
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    • Standard
      66 pages
      French language

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.

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    • Standard
      32 pages
      English language
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    • Standard
      37 pages
      French language

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 m...view more

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    • Standard
      53 pages
      English language
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    • Standard
      63 pages
      French language

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, applica...view more

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    • Standard
      66 pages
      English language
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    • Standard
      78 pages
      French language

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, infor...view more

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    • Standard
      54 pages
      English language
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    • Standard
      61 pages
      French language

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...view more

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    • Technical report
      9 pages
      English language

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 ...view more

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    • Standard
      9 pages
      English language

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 d...view more

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    • Standard
      195 pages
      English language
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    • Standard
      204 pages
      French language

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...view more

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    • Technical specification
      24 pages
      English language

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

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    • Standard
      153 pages
      English language
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    • Standard
      153 pages
      English language

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.

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    • Standard
      81 pages
      English language
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    • Standard
      81 pages
      English language

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

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    • Standard
      185 pages
      English language
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    • Standard
      185 pages
      English language

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 w...view more

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    • Technical report
      37 pages
      English language

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.

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    • Standard
      69 pages
      English language
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    • Standard
      67 pages
      French language

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 No...view more

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    • Standard
      78 pages
      English language

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.

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    • Standard
      59 pages
      English language

ISO 17432:2005 specifies a web-based service for accessing and presenting DICOM (Digital Imaging and Communications in Medicine) persistent objects (e.g. images, medical imaging reports). This is intended for distribution of results and images to healthcare professionals. It provides a simple mechanism for accessing a DICOM persistent object from HTML pages or XML documents, through HTTP/HTTPs protocol, using DICOM UIDs (Unique Identifiers). Data may be retrieved either in a presentation-ready f...view more

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    • Standard
      17 pages
      English language
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    • Standard
      18 pages
      French language

ISO/TS 16058:2004 addresses the technical and system components of the telehealth reference architecture for telelearning systems. It does so by defining technical requirements to be satisfied for a compliant telelearning system. A compliant system will help to ensure that the telelearning technologies deployed for healthcare telelearning are capable of appropriately supporting and delivering distance learning as well as interoperating with disparate telelearning systems that are also compliant ...view more

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    • Technical specification
      37 pages
      English language

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 ...view more

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    • Technical report
      45 pages
      English language

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...view more

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    • Technical report
      17 pages
      English language