This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case’ scenario for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). Whilst the data set is minimal and non-exhaustive, it provides a robust, well-defined core set of data items. The tight focus on this use case also enables the IPS to be used in pl...view more

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    • Standard
      76 pages
      English language
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    • Draft
      75 pages
      English language

This document enables the advancement of interoperability from the data/information exchange paradigm to knowledge sharing at decreasing level of abstraction, starting at IT concept level (semantic coordination) through business domain concept level (agreed service function level cooperation), domain level (cross-domain cooperation) up to individual context (skills-based end-user collaboration). The document defines a model and framework for a harmonized representation of existing or intended sy...view more

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    • Standard
      23 pages
      English language
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    • Standard
      27 pages
      French language
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    • Draft
      23 pages
      English language

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification (wrist) bands, identification tags or other objects, to enable automatic data capture using data carriers in the care delivery process. It provides for a unique SoC identification that can be used for other purposes, such as recording the identity of the SoC in individual health records. This document serves as a reference for any organization ...view more

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    • Standard
      51 pages
      English language
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    • Standard
      56 pages
      French language
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    • Draft
      51 pages
      English language

This document presents a methodology which supports and enables the development of standards based business and information architectures that contribute to good quality of healthcare and patient safety. The methodology is used to develop descriptions of healthcare enterprises from different aspects. Those aspects are covering what, how, where, who, when, why[1] and are based on standards.

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    • Technical specification
      72 pages
      English language
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    • Draft
      74 pages
      English language

This document provides guidance and requirements for the description, planning and development of new systems, as well as for the integration of existing information systems, both within one enterprise and across different healthcare organizations, through an architecture integrating the common data and business logic into a specific architectural layer (i.e. the middleware), distinct from individual applications and accessible throughout the whole information system through services, as shown i...view more

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    • Standard
      66 pages
      English language
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    • Standard
      71 pages
      French language
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    • Draft
      66 pages
      English language

This document specifies the fundamental characteristics of the information model implemented by a specific architectural layer (i.e. the service architecture) of the information system to provide a comprehensive and integrated storage of the common enterprise data and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967‑1. The information model is specified in this document without any explicit or implicit assumption on the physical technologies, ...view more

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    • Standard
      54 pages
      English language
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    • Standard
      55 pages
      French language
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    • Draft
      55 pages
      English language

This document specifies the fundamental characteristics of the computational model implemented by a specific architectural layer of the information system (i.e. the service architecture) to provide a comprehensive and integrated interface to the common enterprise information and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967‑1. The computational model is specified without any explicit or implicit assumption about the physical technologies, t...view more

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    • Standard
      33 pages
      English language
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    • Standard
      35 pages
      French language
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    • Draft
      33 pages
      English language

This document specifies the information architecture required for interoperable communications between systems and services that need or provide EHR data. This document is not intended to specify the internal architecture or database design of such systems. The subject of the record or record extract to be communicated is an individual person, and the scope of the communication is predominantly with respect to that person's care. Uses of healthcare records for other purposes such as administrati...view more

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    • Standard
      12 pages
      English language
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    • Standard
      13 pages
      French language

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components) that need to access or provide EHR data, or as the representation of EHR data within a distributed (federat...view more

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    • Standard
      71 pages
      English language
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    • Standard
      75 pages
      French language

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representa...view more

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    • Standard
      78 pages
      English language
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    • Standard
      81 pages
      French language

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representa...view more

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    • Standard
      95 pages
      English language
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    • Standard
      98 pages
      French language

The purpose of ISO/TS 18864:2017 is to define objective, reliable and reproducible quality metrics for detailed clinical models (DCM). ISO/TS 18864:2017 specifies the principal metrics which are necessary and sufficient to evaluate DCMs. The intended audiences of this document are: - DCM developers, all users of information represented using DCMs, and evaluators of DCM quality; - clinical and IT professionals of healthcare institutions; - technical staff in the healthcare technology industry; - ...view more

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    • Technical specification
      29 pages
      English language

ISO/TR 19669:2017 specifies a use case development methodology, facilitated by a dynamic catalogue of re-usable components. Use cases are a basic tool in describing requirements for health and healthcare settings, service provision, information technology and software products. Use case development often follows a uniform template with components such as actors, roles, scenarios, event steps, actions, data objects/elements and requirements statements. ISO/TR 19669:2017 includes a basic use case ...view more

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    • Technical report
      27 pages
      English language

ISO/HL7 16527 PHR-S FM:2016 defines a standardized model of the functions that may be present in PHR Systems. It is beyond the scope of the PHR system to control the use (or intended use) of PHR data. On the contrary, it is within the scope of the PHR system to manage the authorization of an individual (or other application). Those parties are then responsible for using the data for appropriate (or intended) purposes. The system manufacturers specify "intended and permitted use of PHR data" in t...view more

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    • Standard
      66 pages
      English language

ISO/TS 13972:2015: Describes requirements and recommended methods against which clinicians can gather, analyse and, specify the clinical context, content, and structure of Detailed Clinical Models. Defines Detailed Clinical Models (DCMs) in terms of an underlying logical model. They are logical models of clinical concepts and can be used to define and to structure clinical information. Describes requirements and principles for DCMs, meta-data, versioning, content and context specification, data ...view more

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    • Technical specification
      56 pages
      English language

ISO 10781:2015 provides a reference list of functions that may be present in an Electronic Health Record System (EHR-S). The function list is described from a user perspective with the intent to enable consistent expression of system functionality. This EHR-S Functional Model, through the creation of Functional Profiles for care settings and realms, enables a standardized description and common understanding of functions sought or available in a given setting (e.g. intensive care, cardiology, of...view more

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    • Standard
      69 pages
      English language
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    • Standard
      88 pages
      French language

ISO/TR 14639:2014 provides a guide to best practice business requirements and principles for countries and their subordinate health authorities planning and implementing the use of information and communications technology (ICT) to support the delivery and development of healthcare. A business reference architecture is described in terms of components and capabilities that health authorities may use as a framework for building their own eHealth architectures and also for measuring the maturity o...view more

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    • Technical report
      143 pages
      English language

ISO/TS 18530:2014 outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as wrist bands, identification tags or other objects, to enable automatic data capture using data carriers in the care delivery process. ISO/TS 18530:2014 provides for a unique SoC identification that may be used for other purposes, such as recording the identity of the SoC in medical health records. ISO/TS 18530:2014 serves as a reference for any organizati...view more

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    • Technical specification
      56 pages
      English language

ISO/TR 14639-1:2012 aims to identify the business requirements of an eHealth architecture as well as providing a generic and comprehensive context description to inform architectural structuring of Health Information Systems (HIS). ISO/TR 14639-1:2012 reviews international experiences in the construction of national eHealth architectures and introduces a methodology for strategic development of HIS.

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    • Technical report
      57 pages
      English language

ISO/TS 22220:2011 indicates the data elements and structure suited to accurate and procedurally appropriate and sensitive identification of individuals in health care in a face-to-face setting supported by computer technology, or through interactions between computer systems. It provides guidelines for improving the positive identification of subjects of care within and between health care organizations. ISO/TS 22220:2011 defines demographic and other identifying data elements suited to capturin...view more

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    • Technical specification
      88 pages
      English language
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    • Technical specification
      91 pages
      French language

ISO 18308:2011 defines the set of requirements for the architecture of a system that processes, manages and communicates electronic health record (EHR) information: an EHR architecture. The requirements are formulated to ensure that these EHRs are faithful to the needs of healthcare delivery, are clinically valid and reliable, are ethically sound, meet prevailing legal requirements, support good clinical practice and facilitate data analysis for a multitude of purposes. ISO 18308:2011 does not s...view more

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    • Standard
      25 pages
      English language
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    • Standard
      27 pages
      French language

ISO 21667:2010 establishes a common health indicators conceptual framework, and is intended to foster a common vocabulary and conceptual definitions for the resultant framework. The framework defines the appropriate dimensions and sub-dimensions required to describe the health of the population and performance of a health care system, is sufficiently broad (high-level) to accommodate a variety of health care systems, and is comprehensive, encapsulating all of the factors related to health outcom...view more

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    • Standard
      20 pages
      English language

ISO/TS 29585:2010 has three sections, 1) general considerations of design and deployment, 2) data aggregation and data modelling and 3) architecture and technology, and is intended to provide an overall set of guidelines for clinical data warehouse deployment supported by useful descriptions concerning different data aggregation and modelling approaches as well as particular aspects of information architecture that contribute to successful deployment. The first section is of particular interest ...view more

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    • Technical specification
      57 pages
      English language

ISO 12967-3:2009 specifies the fundamental characteristics of the computational model to be implemented by a specific architectural layer of the information system (i.e. the middleware) to provide a comprehensive and integrated interface to the common enterprise information and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967-1. The computational model is specified without any explicit or implicit assumption about the physical technologies, to...view more

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    • Standard
      27 pages
      English language
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    • Standard
      29 pages
      French language

ISO 12967-1:2009 provides guidance for the description, planning and development of new systems, as well as for the integration of existing information systems, both within one enterprise and across different healthcare organizations, through an architecture integrating the common data and business logic into a specific architectural layer (i.e. the middleware), distinct from individual applications and accessible throughout the whole information system through services.

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    • Standard
      51 pages
      English language
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    • Standard
      53 pages
      French language

ISO 12967-2:2009 specifies the fundamental characteristics of the information model to be implemented by a specific architectural layer (i.e. the middleware) of the information system to provide a comprehensive and integrated storage of the common enterprise data and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967-1. The information model is specified without any explicit or implicit assumption on the physical technologies, tools or solutions...view more

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    • Standard
      58 pages
      English language
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    • Standard
      58 pages
      French language

ISO/TR 12773-2:2009 reviews a series of initiatives and implementations worldwide that for purposes of this Technical Report are collectively called health summary records (HSRs). It provides an environmental scan and descriptive information on HSR initiatives internationally, including “lessons learned”. The environmental scan was completed by performing web searches and obtaining publicly available documentation on key projects. Project sponsors and/or authorities were contacted as needed to g...view more

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    • Technical report
      47 pages
      English language

ISO/TR 12773-1:2009 is based on a comprehensive review of a series of initiatives and implementations worldwide that for the purposes of this Technical Report are collectively called health summary records (HSRs). Project sponsors and/or authorities were contacted as needed to gather additional information and clarify questions or issues arising out of the review. ISO/TR 12773-1:2009 defines and describes HSRs in general as well as specific instances of HSRs and their most common use cases. It s...view more

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    • Technical report
      29 pages
      English language

The focus of ISO/TR 22221:2006 is clinical databases or other computational services, hereafter referred to as a clinical data warehouse (CDW), which maintain or access clinical data for secondary use purposes. The goal is to define principles and practices in the creation, use, maintenance and protection of a CDW, including meeting ethical and data protection requirements and recommendations for policies for information governance and security. A distinction is made between a CDW and an operati...view more

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    • Technical report
      42 pages
      English language

ISO/TR 20514:2005 describes a pragmatic classification of electronic health records, provides simple definitions for the main categories of EHR and provides supporting descriptions of the characteristics of electronic health records and record systems.

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    • Technical report
      27 pages
      English language
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    • Technical report
      29 pages
      French language

ISO TR 17119:2005 provides a common description framework for health informatics standards artefacts. The aim of the health informatics profiling framework (HIPF) is to provide a consistent method for describing and classifying artefacts within the domain of health informatics standards. The HIPF establishes common concepts and a vocabulary for describing the complex domain of various informatics standards initiatives and their supporting artefacts. The use of the HIPF should promote the reuse o...view more

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    • Technical report
      28 pages
      English language

ISO/TS 22220:2009 indicates the data elements and structure suited to accurate and procedurally appropriate and sensitive identification of individuals in health care in a face-to-face setting supported by computer technology, or through interactions between computer systems. It provides guidelines for improving the positive identification of subjects of care within and between health care organizations. ISO/TS 22220:2009 defines demographic and other identifying data elements suited to capture,...view more

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    • Technical specification
      90 pages
      English language

ISO 13606-1:2008 specifies the communication of part or all of the electronic health record (EHR) of a single identified subject of care between EHR systems, or between EHR systems and a centralized EHR data repository. It may also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components) that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) re...view more

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    • Standard
      83 pages
      English language
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    • Standard
      85 pages
      French language

ISO 17120:2004 specifies country identifier standards suitable for use within health informatics applications and standards development by health informatics planners, developers, implementers and analysts.

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    • Technical specification
      12 pages
      English language

ISO/TS 21667:2004 establishes a common health indicators conceptual framework for the field of health informatics. It is intended to foster a common vocabulary and conceptual definitions for a framework which defines the appropriate dimensions and subdimensions required to describe the health of the population and performance of a health care system, which is sufficiently broad (high-level) to accommodate a variety of health care systems, and which is comprehensive, encapsulating all of the fact...view more

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    • Technical specification
      20 pages
      English language

The purpose of ISO/TS 18308:2004 is to assemble and collate a set of clinical and technical requirements for an electronic health record architecture (EHRA) that supports using, sharing, and exchanging electronic health records across different health sectors, different countries, and different models of healthcare delivery. It gives requirements for the architecture but not the specifications of the architecture itself.

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    • Technical specification
      28 pages
      English language