ISO/TC 215 - Health informatics

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

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.

This document provides a referenced entry-level implementation template for traditional Chinese medicine decoction piece prescriptions based on HL7 CDA® Release 2.0 to support the data collection, transmission, storage and exchange of decoction piece prescriptions for electronic records. This document focuses on the description of core data of traditional Chinese medicine decoction piece prescriptions which constitute the 'medication administration' section of the clinical document body. This do...view more

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

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

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

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

This document supports interchangeability of digital signatures and the prevention of incorrect or illegal digital signatures by providing minimum requirements and formats for generating and verifying digital signatures and related certificates. This document describes the common technical, operational, and policy requirements that need to be addressed to enable digital certificates to be used in protecting the exchange of healthcare information within a single domain, between domains, and acros...view more

This document identifies quality metrics for the detection of DNA variants using next generation sequencing (NGS) technology. It also defines the data types, relationships, optionality, cardinalities and terminology bindings of the data. This document provides a basis for sharing and for the application of "high quality" genomic data and contributes to the realization of the precision medicine and the development of relevant industries. This document is intended to serve as a catalogue of sequen...view more

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base...view more

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 ongoi...view more

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.

The document gives guidance for managing healthcare service security using connectable personal health devices. This document considers unidirectional data uploading from the PHD to the gateway (manager device), however, there are many clinical use cases for bidirectional data exchange. This document is applicable to identification and authentication between the bidirectionally connected PHDs and gateway by providing possible use cases and the associated threats and vulnerabilities. Since some s...view more

The purpose of this document is to a) define a set of basic concepts required to describe formal concept representation systems, especially for health sciences, b) describe representation of concepts and characteristics, for use especially in formal computer-based concept representation systems, c) describe the characteristics which synthetically describe the organisation and content of a terminological system in health, d) support the development of specific standards on categorial structures f...view more

This document specifies the application, in the context of traditional Chinese medicine practice, of medical waveform format encoding rules (MFER) to pulse condition waveform as measured in physiological laboratories, hospitals, bed-wards, pharmacies, clinics, community health centres and home care check-ups using pulse condition devices.

The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices. It identifies the functional components, their communication relationships as well as the binding of the components and communication relationships to protocol specifications.

This document specifies an information model within the field of Chinese materia medica processing. It defines a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable information model. This model aims at representing the concepts applicable to Chinese materia medica processing in the making of decoction pieces. This document is not applicable to Japanese traditional Kampo medicine.

This document specifies the whole manufacturing process of Chinese materia medica products by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable categorial structure. It includes three process categories: processing, extracting and preparation. This document is not applicable to Japanese traditional KAMPO medicinal products.

This document aims to specify categorial structures in the field of decoction. This document describes a concept system detailing domain constraints of sanctioned characteristics, each composed of a semantic link and applicable characterizing categories. The following topics are out of scope of this document: — models of decoction pieces; — the specification of categorial structures for the representation of post or manufacturing processes of decoction such as packaging; — individual pharmaceuti...view more

This document describes requirements for collections of metadata about data elements and their containing models and datasets in a healthcare environment. The collection can serve as a repository or as dictionary describing a set of items in use in a particular domain, organisation or product for reference, or it can additionally serve as a registry, supporting the development and communication of standard items to an audience with shared goals. This document specifies standard refinements that ...view more

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 document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both t...view more

This document specifies a set of representational primitives and semantic relations needed for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time, and the ex...view more

This document defines the classification rules and coding scheme for traditional Chinese medicine (TCM) data sets. It is applicable for investigation and management of TCM data resources as well as the description, integration, publication, index and retrieval of the TCM data sets. This document excludes the Kampo medicine .

The purpose of this document is to describe the core principles and proposed service delivery model for supporting implementation and ongoing maintenance of IDMP terminologies. The information provided in this document can be used as evaluation and/or design criteria when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.

This document provides quality requirements for producing a quality map between terminological systems. This document establishes measures which can be used to assess the quality and utility of a map between terminological resources in order to determine the types and levels of measure required for common use cases in healthcare. NOTE Examples of such cases include conformity assessment.

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

This document describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1. This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points at technical solutions a...view more

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

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

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

This document establishes the core classification framework for the integration of clinical terms from traditional Chinese medicine (TCM) and Western medicine. This structure supports terminology integration in standardized electronic medical records, including professional clinical terms in TCM and Western medicine. Non-technical terms for electronic medical records are also included.

This document specifies the tasks, roles, and key skills, requirements and competencies for personnel involved in terminology services in healthcare organizations. This document specifies — terminology services in healthcare organizations including the selection, authoring, and deployment and use of terminology subsets and maps; developing and managing terminology management processes and health information management related policies; performing terminology business analysis; and supporting the...view more

The main purpose of ClaML is to formally represent the content and hierarchical structure of healthcare classification systems in a markup language for the safe exchange and distribution of data and structure between organizations and dissimilar software products. The scope of healthcare classification systems covered by this document encompasses terminologies, and is constrained to traditional paper-based systems (like ICD-10) and systems built according to categorial structures and a cross the...view more

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

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

This document aims to specify categorial structure in the field of cupping by defining a set of domain constraints for use within terminological resources. This document describes a concept system detailing the domain constraints of sanctioned characteristics, each composed of a semantic link and applicable characterizing categories.

The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073? Domain Information Model (IEEE 11073-10201? DIM). Furthermore, it utilizes the IEEE 11073 Nom...view more

This document specifies the information model within the subject field of combination of Chinese medicines. A set of domain constraints of sanctioned characteristics have been defined in the model. Domain constraints are achieved through a set of relationships. This document does not apply to Kampo medicine.

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.

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of infor...view more

This document provides a model framework for improving the surveillance and reporting of events with respect to the safety of health software. This document defines those data elements needed for identification of particular events including incidents, near-misses and unsafe conditions, as well as outlining good principles, relevant concepts and a process model for the recording, analysis and reporting of event-specific information related to the safety of health software.

ISO 17117-1:2018 defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It refers only to terminological resources that are primarily designed to be used for clinical concept representation or to those parts of other terminological resources designed to be used for clinical concept representation. ISO 17117-1:2018 helps users to assess whether a terminology has the characteristics or provides the ...view more

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

ISO/TS 19293:2018 specifies requirements for a record of a dispense of a medicinal product. It is intended to be adopted by detailed, implementable specifications, such as interoperability standards, system specifications, and regulatory programs. ISO/TS 19293:2018 applies to information systems in which a dispense of a medicinal product is registered, and the systems that consume such information. These systems are usually in pharmacies or other healthcare institutions. This document does not n...view more

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