Application of risk management for IT-networks incorporating medical devices – Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software Category Standard Organisation ISO ID IEC 80001-1:2021 Type Standard Version 2 Access Fees apply to access Status Active Created Sep-21 This document specifies general requirements for organisations in the application of risk management before, during and after the connection of a health IT system within a health IT infrastructure.
Application of risk management for IT-networks incorporating medical devices – Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples Category Technical Report Organisation ISO ID IEC/TR 80001-2-1:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-12 This technical report is a step-by-step guide for the application of practical risk management when creating or changing a medical IT network. It is intended for use in conjunction with the IEC 80001-1 risk management standard.
Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls Category Technical Report Organisation ISO ID IEC/TR 80001-2-2:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-12 This technical report creates a framework for the disclosure of security-related capabilities and risks necessary for managing risk when connecting medical devices to IT networks. It also supports the security dialogue surrounding IEC 80001-1 and informs the responsibility agreements specified in that standard.
Application of risk management for IT-networks incorporating medical devices – Part 2-3: Guidance for wireless networks Category Technical Report Organisation ISO ID IEC/TR 80001-2-3:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-12 This technical report supports healthcare delivery organisations in risk management for medical IT networks that incorporate one or more wireless links.
Application of risk management for IT-networks incorporating medical devices – Part 2-4: General implementation guidance for Healthcare Delivery Organizations Category Technical Report Organisation ISO ID IEC/TR 80001-2-4:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-12 This technical report helps healthcare delivery organisations assess the impact of IEC 80001-1 on the organisation and establish a series of business-as-usual processes to manage risk in the creation, maintenance and upkeep of medical IT networks.
Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance for distributed alarm systems Category Technical Report Organisation ISO ID IEC/TR 80001-2-5:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-14 This technical report provides guidance for responsible organisations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems.
Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2 Category Technical Report Organisation ISO ID IEC/TR 80001-2-8:2016 Type Standard Version 1 Access Fees apply to access Status Active Created May-16 This technical report provides guidance to health delivery organisations and medical device manufacturers on the application of the framework outlined in IEC/TR 80001-2-2 for the communication of medical device security needs, risks and controls.
Application of risk management for IT-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities Category Technical Report Organisation ISO ID IEC/TR 80001-2-9:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Jan-17 This technical report establishes a security case framework and provides guidance to healthcare delivery organisations and medical device manufacturers for identifying, developing, interpreting, updating and maintaining security cases for networked medical devices.
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 Category Technical Report Organisation ISO ID ISO/TR 80001-2-7:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Apr-15 The purpose of this report is to provide guidance to healthcare delivery organisations on self-assessment of their conformance against IEC 80001‑1.
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements Category Technical Report Organisation ISO ID ISO/TR 80001-2-6:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-14 This report provides guidance on implementing responsibility agreements, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a medical device into an IT network in order to support compliance with IEC 80001-1.
Automatic identification and data capture techniques - Bar code print quality test specification - Linear symbols Category Standard Organisation ISO Type Standard Version 2016 Status Active This standard describes ISO/IEC 15416:2016, Automatic identification and data capture techniques - Bar code print quality test specification - Linear symbols and supports consistent use in digital health settings.
Business requirements for health summary records – Part 1: Requirements Category Technical Report Organisation ISO ID ISO/TR 12773-1:2009 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-09 This document defines and describes health summary records based on a comprehensive review a series of initiatives and implementations worldwide.
Business requirements for health summary records – Part 2: Environmental scan Category Technical Report Organisation ISO ID ISO/TR 12773-2:2009 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-09 This document provides an environmental scan and descriptive information on health summary record initiatives worldwide, including lessons learned.
Clinical genomics data sharing specification for next-generation sequencing Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 23357:2023 Genomics informatics — Clinical genomics data sharing specification for next-generation sequencing and supports consistent use in digital health settings.
Data Exchange Standards — Health Level Seven Version 2.5 — An application protocol for electronic data exchange in healthcare environments Category Standard Organisation ISO ID ISO/HL7 27931:2009 Type Standard Version 1 Access Fees apply to access Status Active Created 2009 Updated 2023 This standard sets an application protocol for the electronic exchange of data in healthcare environments.
Data Exchange Standards — HL7 Clinical Document Architecture Category Standard Organisation ISO ID ISO/HL7 27932:2009 Type Standard Version 2 Access Fees apply to access Status Active Created 2009 Updated 2020 This standard specifies the structure and semantics of a clinical document for exchange.
Genomics informatics — Data elements and their metadata for describing the microsatellite instability (MSI) information of clinical massive parallel DNA sequencing Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 4425:2023 Genomics informatics — Data elements and their metadata for describing the microsatellite instability (MSI) information of clinical massive parallel DNA sequencing and supports consistent use in digital health settings.
Genomics informatics — Data elements and their metadata for describing the tumor mutation burden (TMB) information of clinical massive parallel DNA sequencing Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 4424:2023 Genomics informatics — Data elements and their metadata for describing the tumor mutation burden (TMB) information of clinical massive parallel DNA sequencing and supports consistent use in digital health settings.
Genomics informatics — Description rules for genomic data for genetic detection products and services Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 8392:2023 Genomics informatics — Description rules for genomic data for genetic detection products and services and supports consistent use in digital health settings.
Genomics informatics — Omics Markup Language (OML) Category Standard Organisation ISO ID ISO 21393:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-21 This document applies to the data exchange format that is designed to facilitate exchanging omics data around the world without forcing changes of any database schema. It specifies the characteristics of OML from 4 perspectives: informatics, molecular, application and biological species.
Genomics informatics — Phenopackets: A format for phenotypic data exchange Category Standard Organisation ISO ID ISO 4454:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-22 This standard specifies a uniform, machine-readable, phenotypic description of an individual, patient or sample in the context of rare disease, common/complex disease or cancer.
Genomics informatics — Reliability assessment criteria for high-throughput gene-expression data Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 22690:2021 Genomics informatics — Reliability assessment criteria for high-throughput gene-expression data and supports consistent use in digital health settings.
Genomics informatics — Requirements for interoperable systems for genomic surveillance Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 8376:2023 Genomics informatics — Requirements for interoperable systems for genomic surveillance and supports consistent use in digital health settings.
Genomics informatics — Structured clinical gene fusion report in electronic health records Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 22693:2021 Genomics informatics — Structured clinical gene fusion report in electronic health records and supports consistent use in digital health settings.
Genomics informatics— Quality control metrics for DNA sequencing Category Technical Specification Organisation ISO Type Standard Version 2020 Status Active This technical specification describes ISO/TS 22692:2020 Genomics informatics— Quality control metrics for DNA sequencing and supports consistent use in digital health settings.
Health informatics - Automatic identification and data capture marking and labelling Category Standard Organisation ISO ID ISO 18530:2021 Type Standard Version 1 Access Fees apply to access Status Active Created 2021 Updated 2023 This document outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification tags or wrist bands, to enable automatic data capture using data carriers when delivering care.
Health Informatics - Methodology for analysis of business and information needs of health enterprises to support standards based architectures Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 22272:2021 Health Informatics - Methodology for analysis of business and information needs of health enterprises to support standards based architectures and supports consistent use in digital health settings.
Health informatics – Categorial structure for terminological systems of human anatomy Category Standard Organisation ISO ID ISO 16278:2016 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-16 This document defines the characteristics required to describe the organisation and content of human anatomy within a terminological system.
Health informatics – Clinical information models – Characteristics, structures and requirements Category Standard Organisation ISO ID ISO 13972:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Feb-22 This document specifies clinical information models (CIMs) as concepts that can be used to define and to structure information for various purposes in health care.
Health informatics – Clinical knowledge resources – Metadata Category Standard Organisation ISO ID ISO 13119:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Oct-22 This document specifies several metadata elements that describe resources containing medical knowledge.
Health informatics – Development of terms and definitions for health informatics glossaries Category Standard Organisation ISO ID ISO 17439:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-22 This document supports the standardisation of health informatics glossaries by setting out the requirements that terms, definitions and metadata should meet to be included in these glossaries.
Health informatics – Digital imaging and communication in medicine (DICOM) including workflow and data management Category Standard Organisation ISO ID ISO 12052:2017 Type Standard Version 2 Access Fees apply to access Status Active Created Aug-17 This standard facilitates the production, management and exchange of digital medical images and information by specifying protocols, command syntax and semantics, media storage services for devices and a file format and medical directory structure for interchange media.
Health informatics – Electronic health record communication – Part 1: Reference model Category Standard Organisation ISO ID ISO 13606-1:2019 Type Standard Version 2 Access Fees apply to access Status Active Created Jun-19 This document is Part 1 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 1 contains an Information Viewpoint specification, as defined by ISO/IEC 10746-1.
Health informatics – Electronic health record communication – Part 3: Reference archetypes and term lists Category Standard Organisation ISO ID ISO 13606-3:2019 Type Standard Version 2 Access Fees apply to access Status Active Created Jun-19 This document is Part 3 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 3 defines term lists that specify the set of values for each attribute of the Reference Model defined in ISO 13606-1.
Health informatics – Electronic health record communication – Part 4: Security Category Standard Organisation ISO ID ISO 13606-4:2019 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-19 This document is Part 4 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 4 describes a methodology for specifying the privileges necessary to access EHR data.
Health informatics – Electronic health record communication – Part 5: Interface specification Category Standard Organisation ISO ID ISO 13606-5:2019 Type Standard Version 2 Access Fees apply to access Status Active Created Jun-19 This document is Part 5 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 5 specifies the information architecture required for interoperable communications between systems and services that need or provide EHR data.
Health informatics – Electronic health record communication –Part 2: Archetype interchange specification Category Standard Organisation ISO ID ISO 13606-2:2019 Type Standard Version 2 Access Fees apply to access Status Active Created Jun-19 This document is Part 2 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 2 defines the Archetype Model to be used to represent Archetypes when communicating between repositories and archetype services.
Health informatics – Explicit time-related expressions for healthcare-specific problems Category Standard Organisation ISO ID ISO 12381:2019 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-19 This standard specifies a set of representational primitives and semantic relations for the unambiguous representation of explicit time-related expressions in health informatics.
Health informatics – HL7 Electronic Health Record-System Functional Model Category Standard Organisation ISO ID ISO 10781:2023 Type Standard Version 2.1 Access Fees apply to access Status Active Created Nov-23 This document describes the EHR-S Functional Model (EHR-S FM), which sets out standardised functional profiles for different healthcare settings (e.g. intensive care, cardiology, office practice in one country or primary care in another country).
Health informatics – HL7 Personal Health Record System Functional Model, Release 2 (PHR-S FM) Category Standard Organisation ISO ID ISO 16527:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-23 This document defines a standardised model of the functions that may be present in personal health record (PHR) systems.
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging Category Standard Organisation ISO ID ISO 11239:2023 Type Standard Version 2 Access Fees apply to access Status Active Created Jun-23 This standard specifies the data elements, structures and relationships required for the exchange of identifying information for pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products.
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on substances Category Standard Organisation ISO ID ISO 11238:2018 Type Standard Version 2 Access Fees apply to access Status Active Created Jul-18 This document provides an information model that enables the definition and identification of substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics.
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information Category Standard Organisation ISO ID ISO 11615:2017 Type Standard Version 2 Access Fees apply to access Status Active Created Oct-17 This standard defines the data elements and structural relationships required for the unique identification and detailed description of medicinal products.
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information – Amendment 1 Category Standard Organisation ISO ID ISO 11615:2017/Amd 1:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Aug-22 This document adds an additional annex to ISO 11615:2017. The annex specifies class name and attribute translations and synonyms for the identification of medicinal products.
Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of units of measurement Category Standard Organisation ISO ID ISO 11240:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-12 This standard specifies rules and requirements regarding the coded representation of units of measurement for the purpose of data interchange between computer applications.
Health informatics – Identification of medicinal products – Data elements and structures for unique identification and exchange of regulated pharmaceutical product information Category Standard Organisation ISO ID ISO 11616:2017 Type Standard Version 2 Access Fees apply to access Status Active Created Oct-17 This standard defines the data elements, structures and relationships required for the exchange of regulated information to uniquely identify pharmaceutical products.
Health informatics – Information models – Biomedical Research Integrated Domain Group (BRIDG) Model Category Standard Organisation ISO ID ISO 14199:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Sep-15 This document defines a set of models collectively referred to as the Biomedical Research Integrated Domain Group (BRIDG) model. This model enables semantic interoperability within the biomedical and clinical research domain and between the research and healthcare domains.
Health informatics – Messages and communication – Web access reference manifest Category Standard Organisation ISO ID ISO 10159:2011 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-11 This standard 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.
Health informatics – Point-of-care medical device communication – Part 90101: Analytical instruments – Point-of-care test Category Standard Organisation ISO ID ISO 11073-90101:2008 Type Standard Version 1 Access Fees apply to access Status Active Created Jan-08 This interface standard establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators and clinical information systems.
Health informatics – Service architecture (HISA) – Part 1: Enterprise viewpoint Category Standard Organisation ISO ID ISO 12967-1:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Nov-20 This standard provides guidance and requirements for the description, planning and development of new systems and the integration of existing information systems.
Health informatics – Service architecture (HISA) – Part 2: Information viewpoint Category Standard Organisation ISO ID ISO 12967-2:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Nov-20 This standard specifies the fundamental characteristics of the information model implemented by the service architecture of a healthcare information system.
Health informatics – Service architecture (HISA) – Part 3: Computational viewpoint Category Standard Organisation ISO ID ISO 12967-3:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Nov-20 This standard specifies the fundamental characteristics of the computational model implemented by the service architecture layer architectural layer of an information system.
Health informatics – Syntax to represent the content of healthcare classification systems – Classification Markup Language (ClaML) Category Standard Organisation ISO ID ISO 13120:2019 Type Standard Version 2 Access Fees apply to access Status Active Created Apr-19 This document describes Classification Markup Language (ClaML), which formally represents the content and hierarchical structure of healthcare classification systems for the safe exchange and distribution of data and structure between organisations and dissimilar software products.
Health informatics – System of concepts to support continuity of care Category Standard Organisation ISO ID ISO 13940:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-15 This document defines the generic concepts needed to achieve continuity of care, including both the content and context of healthcare services.
Health informatics — A case study on establishing standardized measurement data in cardiac examination reports Category Technical Report Organisation ISO ID ISO/TR 23358:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-22 This document reposts a case study on how to establish and maintain standardised Cardiac examination – export measurement data (CE-EMD).
Health informatics — Applications of machine learning technologies in imaging and other medical applications Category Technical Report Organisation ISO ID ISO/TR 24291:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-21 This document lists examples of and defines categories of use cases for machine learning in medicine for clinical practice. It also defines the clinical usages and necessities of the artificial intelligence in medicine.
Health informatics — Audit trails for electronic health records Category Standard Organisation ISO ID ISO 27789:2021 Type Standard Version 2 Access Fees apply to access Status Active Created Oct-21 This standard specifies a common framework for audit trails for electronic health records, in terms of audit trigger events and audit data, to keep the complete set of personal health information auditable across information systems and domains.
Health informatics — Automatic identification and data capture marking and labelling — Subject of care and individual provider identification Category Standard Organisation ISO ID ISO 18530:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Jan-21 This standard sets out the data elements and structure needed for accurate, sensitive and procedurally appropriate subjects of care (SoC) and individual provider identification.
Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products Category Specification Organisation ISO ID ISO/TS 17251:2023 Type Standard Version 2 Access Fees apply to access Status Active Created Feb-23 This specification specifies the business requirements for the structured content of structured or semi-structured dose instructions for recording dose instructions in the electronic health record, supporting clinical decision support, and exchanging medication orders, as applicable to primary, secondary and tertiary care.
Health Informatics — Business requirements for a syntax to exchange structured dose information for medicinal products Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 17251:2023 Health Informatics — Business requirements for a syntax to exchange structured dose information for medicinal products and supports consistent use in digital health settings.
Health informatics — Capacity-based eHealth architecture roadmap – Part 1: Overview of national eHealth initiatives Category Technical Report Organisation ISO ID ISO/TR 14639-1:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-12 This document identifies the business requirements of an eHealth architecture, and provides a generic and comprehensive context description to inform architectural structuring of a health information system (HIS).
Health informatics — Capacity-based eHealth architecture roadmap – Part 2: Architectural components and maturity model Category Technical Report Organisation ISO ID ISO/TR 14639-2:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-14 This document provides a guide to best-practice business requirements and principles relating to information and communications technology (ICT) for the delivery and development of healthcare. It applies to countries and their subordinate health authorities that are planning or implementing ICT to support healthcare.
Health Informatics — Categorial structure for Chinese materia medica products manufacturing process Category Technical Specification Organisation ISO Type Standard Version 2020 Status Active This technical specification describes ISO/TS 23303:2020 Health Informatics — Categorial structure for Chinese materia medica products manufacturing process and supports consistent use in digital health settings.
Health Informatics — Categorial structure for representation of 3D human body position system — Part 1: Bones Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 23541-1:2021 Health Informatics — Categorial structure for representation of 3D human body position system — Part 1: Bones and supports consistent use in digital health settings.
Health informatics — Categorial structure for representation of herbal medicaments in terminological systems Category Specification Organisation ISO ID ISO/TS 18062:2016 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-16 This specification aims to (a) specify the minimal characterising generic concepts for herbal medicaments in terminological systems, which are needed for terms used to identify herbal medicines regulated by medicine regulatory agencies, and (b) facilitate consistency and interoperability of the terms and their designating concepts in terminological systems.
Health Informatics — Categorial structure for representation of herbal medicaments in terminological systems Category Technical Specification Organisation ISO Type Standard Version 2016 Status Active This technical specification describes ISO/TS 18062:2016 Health Informatics — Categorial structure for representation of herbal medicaments in terminological systems and supports consistent use in digital health settings.
Health Informatics — Categorial structure for representation of traditional Chinese medicine clinical decision support system Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 5346:2022 Health Informatics — Categorial structure for representation of traditional Chinese medicine clinical decision support system and supports consistent use in digital health settings.
Health informatics — Categorial structure for terminological systems of surgical procedures Category Standard Organisation ISO ID ISO 1828:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Sep-12 This standard specifies the minimal characteristics of a categorial structure for terminological systems of surgical procedures. It also specifies the minimal domain constraints to support interoperability, comparability and the exchange of meaningful information on surgical procedures.
Health Informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 5118:2022 Health Informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine and supports consistent use in digital health settings.
Health informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points Category Specification Organisation ISO ID ISO/TS 16843-1:2016 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-16 This specification specifies the categorial structure in the subject field of acupuncture by defining a set of domain constraints of sanctioned characteristics each composed of a semantic link and an applicable characterising category in order to represent the concept of acupuncture point.
Health Informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points Category Technical Specification Organisation ISO Type Standard Version 2016 Status Active This technical specification describes ISO/TS 16843-1:2016 Health Informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points and supports consistent use in digital health settings.
Health informatics — Categorial structures for representation of acupuncture — Part 2: Needling Category Specification Organisation ISO ID ISO/TS 16843-2:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-15 The purpose of this specification is to specify categorial structures in the subject field of acupuncture by defining a set of domain constraints for use in terminological resources.
Health Informatics — Categorial structures for representation of acupuncture — Part 2: Needling Category Technical Specification Organisation ISO Type Standard Version 2015 Status Active This technical specification describes ISO/TS 16843-2:2015 Health Informatics — Categorial structures for representation of acupuncture — Part 2: Needling and supports consistent use in digital health settings.
Health informatics — Categorial structures for representation of acupuncture — Part 3: Moxibustion Category Specification Organisation ISO ID ISO/TS 16843-3:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-17 This specification aims to specify categorial structure in the field of moxibustion by defining a set of domain constraints for use in terminological resources.
Health Informatics — Categorial structures for representation of acupuncture — Part 3: Moxibustion Category Technical Specification Organisation ISO Type Standard Version 2017 Status Active This technical specification describes ISO/TS 16843-3:2017 Health Informatics — Categorial structures for representation of acupuncture — Part 3: Moxibustion and supports consistent use in digital health settings.
Health informatics — Categorial structures for representation of acupuncture — Part 4: Meridian and collateral channels Category Specification Organisation ISO ID ISO/TS 16843-4:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-17 This specification specifies the categorial structure in the subject field of meridian and collateral by defining a set of domain constraints of sanctioned characteristics, each composed of a semantic link and an applicable characterising category in order to represent the concept of meridian and collateral.
Health Informatics — Categorial structures for representation of acupuncture — Part 4: Meridian and collateral channels Category Technical Specification Organisation ISO Type Standard Version 2017 Status Active This technical specification describes ISO/TS 16843-4:2017 Health Informatics — Categorial structures for representation of acupuncture — Part 4: Meridian and collateral channels and supports consistent use in digital health settings.
Health Informatics — Categorial structures for representation of acupuncture — Part 5: Cupping Category Specification Organisation ISO ID ISO/TS 16843-5:2019 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-19 This specification aims to specify categorial structure in the field of cupping by defining a set of domain constraints for use in terminological resources.
Health Informatics — Categorial structures for representation of acupuncture — Part 5: Cupping Category Technical Specification Organisation ISO Type Standard Version 2019 Status Active This technical specification describes ISO/TS 16843-5:2019 Health Informatics — Categorial structures for representation of acupuncture — Part 5: Cupping and supports consistent use in digital health settings.
Health informatics — Categorial structures for representation of acupuncture — Part 6: Acupuncture effects Category Specification Organisation ISO ID ISO/TS 16843-6:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-22 This specification specifies the categorial structure in the field of acupuncture effects by defining a set of domain constraints of sanctioned characteristics, each consisting of a semantic link and an applicable characterising category.
Health Informatics — Categorial structures for representation of acupuncture — Part 6: Acupuncture effects Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 16843-6:2022 Health Informatics — Categorial structures for representation of acupuncture — Part 6: Acupuncture effects and supports consistent use in digital health settings.
Health informatics — Categorial structures for representation of nursing practice in terminological systems Category Standard Organisation ISO ID ISO 18104:2023 Type Standard Version 3 Access Fees apply to access Status Active Created Dec-23 This standard specifies the characteristics of categorial structures representing nursing practice. The overall aim of this standard is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes.
Health Informatics — Categorial structures for the representation of the decocting process in traditional Chinese medicine Category Technical Specification Organisation ISO Type Standard Version 2019 Status Active This technical specification describes ISO/TS 22773:2019 Health Informatics — Categorial structures for the representation of the decocting process in traditional Chinese medicine and supports consistent use in digital health settings.
Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine Category Specification Organisation ISO ID ISO/TS 16277-1:2015 Type Standard Version 1 Access Fees apply to access Status Active Created May-15 This specification defines a categorial structure for clinical findings in terminological systems for traditional Chinese medicine, traditional Japanese medicine and traditional Korean medicine.
Health Informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine Category Technical Specification Organisation ISO Type Standard Version 2015 Status Active This technical specification describes ISO/TS 16277-1:2015 Health Informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine and supports consistent use in digital health settings.
Health Informatics — Classification of traditional Chinese medicine data sets Category Technical Specification Organisation ISO Type Standard Version 2019 Status Active This technical specification describes ISO/TS 22558:2019 Health Informatics — Classification of traditional Chinese medicine data sets and supports consistent use in digital health settings.
Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles Category Standard Organisation ISO ID ISO 18812:2003 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-03 This standard describes messages for the transfer of data between analytical instruments (AIs) and laboratory information systems (LISs) within a clinical laboratory.
Health Informatics — Clinical document registry federation Category Technical Report Organisation ISO ID ISO/TR 13128:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-12 This document defines a logical structure for the federation of clinical document registries (CDRs) that does not require any conformance criteria. It sets out a list of basic functional recommendations and configuration parameters for CDR federations, as well as to provide several use cases.
Health Informatics — Clinical particulars — Core principles for the harmonization of therapeutic indications terms and identifiers Category Technical Specification Organisation ISO Type Standard Version 2024 Status Active This technical specification describes ISO/TS 5499:2024 Health Informatics — Clinical particulars — Core principles for the harmonization of therapeutic indications terms and identifiers and supports consistent use in digital health settings.
Health informatics — Clinical stakeholder participation in the work of ISO TC 215 Category Technical Report Organisation ISO ID ISO/TR 11487:2008 Type Standard Version 1 Access Fees apply to access Status Withdrawn Created Dec-08 This report clarifies and confirms TC 215 support for clinical stakeholder participation. It also makes recommendations to the TC and national member organisations on approaches to improving clinical stakeholder participation, based on examples of existing effective participation models.
Health informatics — Cloud computing considerations for the security and privacy of health information systems Category Technical Report Organisation ISO ID ISO/TR 21332:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-21 This document provides an overview of security and privacy considerations for electronic health records (EHRs) in a cloud-computing service.
Health informatics — Common terminology services Category Standard Organisation ISO ID ISO/HL7 27951:2009 Type Standard Version 1 Access Fees apply to access Status Active Created 2009 Updated 2020 This standard 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.
Health Informatics — Conceptual data model for Chinese medicinal herbs Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 5569:2023 Health Informatics — Conceptual data model for Chinese medicinal herbs and supports consistent use in digital health settings.
Health Informatics — Conceptual framework for patient findings and problems in terminologies Category Technical Specification Organisation ISO Type Standard Version 2010 Status Active This technical specification describes ISO/TS 22789:2010 Health Informatics — Conceptual framework for patient findings and problems in terminologies and supports consistent use in digital health settings.
Health Informatics — Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records Category Technical Specification Organisation ISO Type Standard Version 2042 Status Active This technical specification describes ISO/TS 20428:2017 Health Informatics — Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records and supports consistent use in digital health settings.
Health informatics — Datasets and data structure for clinical and biological evaluation metrics in radiotherapy Category Technical Report Organisation ISO ID ISO/TR 24290:2023 Type Standard Version 1 Access Fees apply to access Status Active Created May-23 This document reports on the datasets and a data structure for reporting clinical and biological evaluation metrics (CBEMs) in relation to radiotherapy.
Health informatics — Device interoperability Part 10421: Personal health device communication — Device specialization — Peak expiratory flow monitor (peak flow) Category Standard Organisation ISO Type Standard Version 2024 Status Active This document establishes a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers.
Health informatics — Device interoperability Part 10425: Personal health device communication — Device specialization — Continuous Glucose Monitor (CGM) Category Standard Organisation ISO Type Standard Version 2024 Status Active This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers
Health informatics — Device interoperability Part 10471: Personal health device communication — Device specialization — Independent living activity hub Category Standard Organisation ISO Type Standard Version 2024 Status Active This international standard defines ISO/IEEE 11073-10471:2024 Health Informatics — Device Interoperability — Part 10471: Personal Health Device Communication — Device Specialization — Independent Living Activity Hub. It supports plug-and-play communication between independent living activity hubs and other personal health devices to ensure consistent, interoperable data exchange in home and telehealth settings.
Health informatics — Device interoperability – Part 10101: Point-of-care medical device communication — Nomenclature Category Standard Organisation ISO ID ISO/IEEE 11073-10101:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Aug-20 This standard defines a nomenclature for communicating information from point-of-care medical devices, with a focus on acute-care medical devices and patient vital signs information.
Health informatics — Device interoperability – Part 10201: Point-of-care medical device communication — Domain information model Category Standard Organisation ISO ID ISO/IEEE 11073-10201:2020 Type Standard Version 2 Access Fees apply to access Status Active Created May-20
Health informatics — Device interoperability – Part 10201: Point-of-care medical device communication — Domain information model Category Standard Organisation ISO ID ISO/IEEE 11073-10201:2020 Type Standard Version 2 Access Fees apply to access Status Active Created May-20 This standard defines a general object-oriented information model that may be used to structure information and identify services used in point-of-care medical device communications.
Health informatics — Device interoperability – Part 10407: Personal health device communication — Device specialization — Blood pressure monitor Category Standard Organisation ISO ID ISO/IEEE 11073-10407:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Dec-22 This standard establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics — Device interoperability – Part 10408: Personal health device communication — Device specialization — Thermometer Category Standard Organisation ISO ID ISO/IEEE 11073-10408:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Dec-22 This standard establishes a normative definition of communication between personal telehealth thermometer devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics — Device interoperability – Part 10415: Personal health device communication — Device specialization — Weighing scale Category Standard Organisation ISO ID ISO/IEEE 11073-10415:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Dec-22 This standard establishes a normative definition of communication between personal telehealth weighing scale devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics — Device interoperability – Part 10420: Personal health device communication — Device specialization — Body composition analyzer Category Standard Organisation ISO ID ISO/IEEE 11073-10420:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Dec-22 This standard establishes a normative definition of the communication between personal body composition analyser agents and managers in a way that enables plug-and-play interoperability.
Health informatics — Device interoperability – Part 20601: Personal health device communication — Application profile — Optimized exchange protocol Category Standard Organisation ISO ID ISO/IEEE 11073-20601:2022 Type Standard Version 3 Access Fees apply to access Status Active Created Dec-22 This standard defines modelling techniques and an optimised exchange protocol for implementers of personal health devices to create interoperability between device types and vendors.
Health informatics — Device interoperability – Part 20701: Point-of-care medical device communication — Service oriented medical device exchange architecture and protocol binding Category Standard Organisation ISO ID ISO/IEEE 11073-20701:2020 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-20 This standard provides a service-oriented medical device architecture and communication protocol specification. It applies to point-of-care (PoC) medical devices and medical IT systems in a distributed system that need to exchange data or safely control networked PoC medical devices
Health informatics — Device interoperability – Part 40101: Foundational — Cybersecurity — Processes for vulnerability assessment Category Standard Organisation ISO ID ISO/IEEE 11073-40101:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-22 This standard defines an iterative, systematic, scalable, and auditable approach to identifying cyber security vulnerabilities and estimating risk for personal health devices and point-of-care devices.
Health informatics — Device interoperability – Part 40102: Foundational — Cybersecurity — Capabilities for mitigation Category Standard Organisation ISO ID ISO/IEEE 11073-40102:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-22 This standard defines a security baseline of application-layer cyber security mitigation techniques personal health device and point-of-care device interfaces.
Health informatics — Device interoperability — Personal health device communication — Device specialization — Medication monitor Category Standard Organisation ISO Type Standard Version 2024 Status Active This standard specifies how medication monitoring devices exchange information with managing systems such as mobile phones, personal computers, and other health appliances. It forms part of the ISO/IEEE 11073 device communication family and provides a consistent framework for interoperability across home and telehealth environments.
Health informatics — Directory services for healthcare providers, subjects of care and other entities Category Standard Organisation ISO ID ISO 21091:2013 Type Standard Version 1 Access Fees apply to access Status Active Created Feb-13 This standard defines minimal specifications for healthcare directory services. It provides the common directory information and services needed to support the secure exchange of healthcare information over public networks.
Health Informatics — Document registry framework Category Technical Specification Organisation ISO Type Standard Version 2009 Status Active This technical specification describes ISO/TS 27790:2009 Health Informatics — Document registry framework and supports consistent use in digital health settings.
Health Informatics — Dynamic on-demand virtual private network for health information infrastructure Category Technical Report Organisation ISO ID ISO/TR 11636:2009 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-09 This document describes the threats anticipated in a healthcare network, as well as how a dynamic on-demand VPN is applied in the healthcare field.
Health informatics — Electronic health record — Definition, scope and context Category Technical Report Organisation ISO ID ISO/TR 20514:2005 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-05 This document describes a pragmatic classification of electronic health records (EHRs). It provides simple definitions for the main categories of EHR and provides supporting descriptions of the characteristics of EHRs and EHR systems.
Health informatics — Framework for healthcare and related data reporting Category Standard Organisation ISO ID ISO 29585:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-23 This standard deals with the reporting of data to support improved public health, more effective health care and better health outcomes. It provides guidance and requirements for those developing or deploying a healthcare data reporting service, addressing data capture, processing, aggregation and data modelling, and architecture and technology approaches.
Health Informatics — Framework of event data and reporting definitions for the safety of health software Category Technical Specification Organisation ISO Type Standard Version 2040 Status Active This technical specification describes ISO/TS 20405:2018 Health Informatics — Framework of event data and reporting definitions for the safety of health software and supports consistent use in digital health settings.
Health informatics — Functional and structural roles Category Standard Organisation ISO ID ISO 21298:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Feb-17 This standard defines a model for expressing functional and structural roles for health professionals and consumers and populates the model with a basic set of roles for international use in health applications.
Health informatics — Genomic Sequence Variation Markup Language (GSVML) Category Standard Organisation ISO ID ISO 25720:2009 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-09 This standard applies to the data exchange format that is designed to facilitate the exchange of the genomic sequence variation data around the world, without forcing change of any database schema.
Health informatics — Guidance on health information privacy education in healthcare organizations Category Technical Report Organisation ISO ID ISO/TR 18638:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-17 This document provides guidance for healthcare organisations to establish and improve health information privacy education for their workforce.
Health informatics — Guidance on standards for enabling safety in health software Category Technical Report Organisation ISO ID ISO/TR 17791:2013 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-13 This document provides guidance to National Member Bodies and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software.
Health informatics — Guidance on the identification and authentication of connectable Personal Healthcare Devices (PHDs) Category Technical Report Organisation ISO ID ISO/TR 22696:2020 Type Standard Version 1 Access Fees apply to access Status Active Created May-20 This document gives guidance for managing healthcare-service security using connectable personal health devices (PHDs).
Health informatics — Guidelines for terminology development organizations Category Technical Report Organisation ISO ID ISO/TR 12309:2009 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-09 This document specifies the principles and processes that should be followed by developers of healthcare terminologies to support international healthcare terminology standardisation.
Health informatics — Guidelines on data protection to facilitate transborder flows of personal health data Category Standard Organisation ISO ID ISO 22857:2013 Type Standard Version 2 Access Fees apply to access Status Active Created Dec-13 This standard provides guidance on data protection requirements to facilitate the transfer of personal health data across national or jurisdictional borders.
Health informatics — Harmonized data types for information interchange Category Standard Organisation ISO ID ISO 21090:2011 Type Standard Access Fees apply to access Status Active Created Feb-11 This standard provides a set of datatype definitions for representing and exchanging basic concepts that are commonly encountered in healthcare environments.
Health informatics — Health cards — General characteristics Category Standard Organisation ISO ID ISO 20301:2014 Type Standard Version 2 Access Fees apply to access Status Active Created Jan-14 This standard describes general characteristics of machine-readable cards used in the field of healthcare. It focuses on cards of ID-1 type that are issued for healthcare services that crosses the borders of two or more countries or areas.
Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers Category Standard Organisation ISO ID ISO 20302:2022 Type Standard Version 3 Access Fees apply to access Status Active Created Jan-22 This document specifies a numbering system and registration procedure for identifying healthcare application providers and health card holders for the purpose of information exchange through the use of healthcare cards.
Health informatics — Health indicators conceptual framework Category Standard Organisation ISO ID ISO 21667:2010 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-10 This standard establishes a common health indicators conceptual framework, and aims to foster a common vocabulary and conceptual definitions for the framework. The framework defines the appropriate dimensions and sub-dimensions required to describe the health of the population and performance of a healthcare system.
Health informatics — Health informatics profiling framework Category Technical Report Organisation ISO ID ISO/TR 17119:2005 Type Standard Version 1 Access Fees apply to access Status Active Created Jan-05 This document provides a common description framework for health informatics standards artefacts – the health informatics profiling framework (HIPF).
Health Informatics — Hierarchical file structure specification for secondary storage of health-related information Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 24289:2021 Health Informatics — Hierarchical file structure specification for secondary storage of health-related information and supports consistent use in digital health settings.
Health informatics — HL7 version 3 — Reference information model — Release 4 Category Standard Organisation ISO ID ISO/HL7 21731:2014 Type Standard Version 2 Access Fees apply to access Status Active Created 2014 Updated 2020 The Health Level Seven (HL7) Reference Information Model (RIM) is a static model of health and healthcare information in the context of developing HL7 standards.
Health Informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances Category Technical Specification Organisation ISO Type Standard Version 1984 Status Active This technical specification describes ISO/TS 19844:2018 Health Informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances and supports consistent use in digital health settings.
Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms Category Technical Report Organisation ISO ID ISO/TR 14872:2019 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-19 This document describes the core principles and a proposed service-delivery model for terminology maintenance services in support of 5 International Standards on the Identification of Medicinal Products (IDMP).
Health Informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information Category Technical Specification Organisation ISO Type Standard Version 2044 Status Active This technical specification describes ISO/TS 20443:2017 Health Informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information and supports consistent use in digital health settings.
Health Informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information Category Technical Specification Organisation ISO Type Standard Version 2045 Status Active This technical specification describes ISO/TS 20451:2017 Health Informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information and supports consistent use in digital health settings.
Health Informatics — Identification of subjects of health care Category Technical Specification Organisation ISO Type Standard Version 2011 Status Active This technical specification describes ISO/TS 22220:2011 Health Informatics — Identification of subjects of health care and supports consistent use in digital health settings.
Health informatics — IHE global standards adoption – Part 1: Process Category Technical Report Organisation ISO ID ISO/TR 28380-1:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Feb-14 This document describes how the IHE process specifies and facilitates profiles of selected standards to support carefully defined healthcare tasks that depend on electronic information exchange.
Health informatics — IHE global standards adoption – Part 2: Integration and content profiles Category Technical Report Organisation ISO ID ISO/TR 28380-2:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Feb-14 This document describes the most recent profiles developed by the Integrating the Healthcare Enterprise (IHE) initiative.
Health informatics — IHE global standards adoption – Part 3: Deployment Category Technical Report Organisation ISO ID ISO/TR 28380-3:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-14 This document aims to structure and facilitate adoption and deployment of health interoperability standards in a broad range of eHealth projects, including regional and national programs.
Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance – Part 1: Framework for adverse event reporting Category Standard Organisation ISO ID ISO/HL7 27953-1:2011 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-11 Updated Oct-12 This standard provides a common messaging format for transmitting individual case safety reports for adverse drug reactions, adverse events, product problems and consumer complaints that can occur upon the administration or use of one or more products.
Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance – Part 2: Human pharmaceutical reporting requirements for ICSR Category Standard Organisation ISO ID ISO/HL7 27953-2:2011 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-11 Updated Oct-12 This standard provides a common set of data elements and a messaging format for transmitting individual case safety reports for adverse drug reactions, adverse events, infections, and incidents that can occur from the administration of one or more human pharmaceutical products to a patient, regardless of source and destination
Health Informatics — Information model for quality control of traditional Chinese medicinal products Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 5044:2023 Health Informatics — Information model for quality control of traditional Chinese medicinal products and supports consistent use in digital health settings.
Health Informatics — Information model of combination of decoction pieces in Chinese medicines Category Technical Specification Organisation ISO Type Standard Version 2018 Status Active This technical specification describes ISO/TS 22835:2018 Health Informatics — Information model of combination of decoction pieces in Chinese medicines and supports consistent use in digital health settings.
Health informatics — Information security management for remote maintenance of medical devices and medical information systems – Part 2: Implementation of an information security management system (ISMS) Category Technical Report Organisation ISO ID ISO/TR 11633-2:2021 Type Standard Version 2 Access Fees apply to access Status Active Created Feb-21 This document provides a guideline for the implementation of an information-security management system by showing practical examples of risk analysis on remote maintenance services. It applies to information systems in healthcare facilities provided by vendors of medical devices or health information systems.
Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis Category Specification Organisation ISO ID ISO/TS 11633-1:2019 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-19 This specification focuses on remote maintenance services (RMSs) for information systems in healthcare facilities as provided by vendors of medical devices and health information systems.
Health informatics — Interoperability and compatibility in messaging and communication standards — Key characteristics Category Technical Report Organisation ISO ID ISO/TR 18307:2001 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-01 This document describes a set of key characteristics to achieve interoperability and compatibility in exchanging health information between systems.
Health informatics — Interoperability and integration reference architecture — Model and framework Category Standard Organisation ISO ID ISO 23903:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Apr-21 This standard enables the advancement of interoperability from the data/information exchange paradigm to knowledge sharing at decreasing level of abstraction.
Health informatics — Interoperability of public health emergency preparedness and response information systems Category Standard Organisation ISO ID ISO 5477:2023 Type Standard Version 1 Access Fees apply to access Status Active Created 2023 This standard provides business rules for public health emergency preparedness and response (PH EPR) information systems.
Health informatics — Interoperability of telehealth systems and networks – Part 1: Introduction and definitions Category Technical Report Organisation ISO ID ISO/TR 16056-1:2004 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-04 This document briefly introduces the interoperability of telehealth systems and networks, and defines telehealth and related terms.
Health informatics — Interoperability of telehealth systems and networks – Part 2: Real-time systems Category Technical Report Organisation ISO ID ISO/TR 16056-2:2004 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-04 This document focuses on the technical standards related to the real-time applications (including video, audio, and data-conferencing) and interoperability aspects of telehealth systems and networks.
Health informatics — Introduction to Ayurveda informatics Category Technical Report Organisation ISO ID ISO/TR 4421:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-23 This document seeks to establish a baseline understanding of the Ayurvedic medicine system to support standardisation across countries and healthcare organisations.
Health informatics — Medical waveform format — Part 1: Encoding rules Category Standard Organisation ISO ID ISO 22077-1:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Jan-22 This standard specifies how medical waveforms, such as electrocardiogram, electroencephalogram, spirometry waveform and so on, are described for interoperability among healthcare information systems.
Health informatics — Medical waveform format — Part 2: Electrocardiography Category Standard Organisation ISO ID ISO 22077-2:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-23 This standard defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiography waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups.
Health informatics — Medical waveform format — Part 3: Long-term electrocardiography Category Standard Organisation ISO ID ISO 22077-3:2023 Type Standard Access Fees apply to access Status Active Created Aug-23 This standard defines the application of medical waveform format encoding rules (MFER) to describe long-term electrocardiography waveforms measured in physiological laboratories and healthcare clinics.
Health Informatics — Medical waveform format — Part 4: Stress test electrocardiography Category Technical Specification Organisation ISO Type Standard Version 2077 Status Active This technical specification describes ISO/TS 22077-4:2019 Health Informatics — Medical waveform format — Part 4: Stress test electrocardiography and supports consistent use in digital health settings.
Health Informatics — Medical waveform format — Part 5: Neurophysiological signals Category Technical Specification Organisation ISO Type Standard Version 2077 Status Active This technical specification describes ISO/TS 22077-5:2021 Health Informatics — Medical waveform format — Part 5: Neurophysiological signals and supports consistent use in digital health settings.
Health informatics — Medication management concepts and definitions Category Technical Report Organisation ISO ID ISO/TR 20831:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-17 This document defines the various concepts and terminologies used in the pharmacy domain relating to creating medication lists from existing data.
Health Informatics — Messages and communication — Format of length limited globally unique string identifiers Category Standard Organisation ISO ID ISO 18232:2006 Type Standard Version 1 Access Fees apply to access Status Active Created Apr-06 This standard specifies a common format for the exchange of commonly used globally unique identifiers (GUIs) expressed as alphanumeric strings.
Health Informatics — Ophthalmic examination device data — Part 1: General examination devices Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 22218-1:2023 Health Informatics — Ophthalmic examination device data — Part 1: General examination devices and supports consistent use in digital health settings.
Health Informatics — Ophthalmic examination device data — Part 2: Specular microscope Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 22218-2:2023 Health Informatics — Ophthalmic examination device data — Part 2: Specular microscope and supports consistent use in digital health settings.
Health informatics — Patient healthcard data – Part 1: General structure Category Standard Organisation ISO ID ISO 21549-1:2013 Type Standard Version 2 Access Fees apply to access Status Active Created Jun-13 This standard defines a general structure for the different types of data to be defined in other parts of ISO 21549 using UML notation.
Health informatics — Patient healthcard data – Part 2: Common objects Category Standard Organisation ISO ID ISO 21549-2:2014 Type Standard Version 2 Access Fees apply to access Status Active Created Feb-14 This standard describes and defines the Common Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 3: Limited clinical data Category Standard Organisation ISO ID ISO 21549-3:2014 Type Standard Version 2 Access Fees apply to access Status Active Created Feb-14 This standard describes and defines the Limited Clinical Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 4: Extended clinical data Category Standard Organisation ISO ID ISO 21549-4:2014 Type Standard Version 2 Access Fees apply to access Status Active Created Feb-14 This standard describes and defines the Extended Clinical Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 5: Identification data Category Standard Organisation ISO ID ISO 21549-5:2023 Type Standard Version 3 Access Fees apply to access Status Active Created Oct-23 This standard describes and defines the basic structure of the identification data objects held on healthcare data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
Health informatics — Patient healthcard data – Part 6: Administrative data Category Standard Organisation ISO ID ISO 21549-6:2008 Type Standard Version 1 Access Fees apply to access Status Active Created Apr-08 This standard specifies the basic structure of the data contained within the administrative data data object.
Health informatics — Patient healthcard data – Part 7: Medication data Category Standard Organisation ISO ID ISO 21549-7:2024 Type Standard Version 3 Access Fees apply to access Status Active Created Feb-24 This standard specifies the basic structure of the data contained within the medication data object.
Health informatics — Patient healthcard data – Part 8: Links Category Standard Organisation ISO ID ISO 21549-8:2010 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-10 This standard defines a way to facilitate access to distributed patient records and/or administrative information using healthcards.
Health informatics — Person-owned document repository for PHR applications and health information exchange Category Technical Report Organisation ISO ID ISO/TR 20055:2018 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-18 This document describes the concept of a person-owned repository (PoR) of health documents
Health informatics — Personal health data generated on a daily basis Category Technical Report Organisation ISO ID ISO/TR 21835:2020 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-20 This document provides an environmental scan of common health-related data elements that are combined with electronic health records (EHRs), patient portals and personal health record (PHR) systems. These data elements are captured in various ways, such as mobile and smart phones, and remote monitoring devices.
Health informatics — Personal health device communication – Part 00103: Overview Category Standard Organisation ISO ID ISO/IEEE 11073-00103:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-15
Health informatics — Personal health device communication – Part 10207: Domain information and service model for service-oriented point-of-care medical device communication Category Standard Organisation ISO ID ISO/IEEE 11073-10207:2019 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-19 This standard provides a Participant Model derived from the ISO/IEEE11073-10201 Domain Information Model.
Health informatics — Personal health device communication – Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) Category Standard Organisation ISO ID ISO/IEEE 11073-10406:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-12 This standard provides a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10417: Device specialization — Glucose meter Category Standard Organisation ISO ID ISO/IEEE 11073-10417:2017 Type Standard Version 3 Access Fees apply to access Status Active Created Apr-17 This standard establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10418: Device specialization — International Normalized Ratio (INR) monitor Category Standard Organisation ISO ID ISO/IEEE 11073-10418:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-14 This standard establishes a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10419: Device specialization — Insulin pump Category Standard Organisation ISO ID ISO/IEEE 11073-10419:2019 Type Standard Version 2 Access Fees apply to access Status Active Created Mar-19 This standard establishes a normative definition of communication between personal telehealth insulin pump devices and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10421: Device specialization — Peak expiratory flow monitor (peak flow) Category Standard Organisation ISO ID ISO/IEEE 11073-10421:2012 Type Standard Version 1 Access Fees apply to access Status Withdrawn Created Nov-12 This standard establishes a normative definition of communication between personal telehealth peak expiratory flow monitor devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10422: Device specialization — Urine analyser Category Standard Organisation ISO ID ISO/IEEE 11073-10422:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-17 This standard establishes a normative definition of communication between personal telehealth urine analyser devices and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) Category Standard Organisation ISO ID ISO/IEEE 11073-10424:2016 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-16 This standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment (SABTE) devices and managers, in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10425: Device specialization — Continuous glucose monitor (CGM) Category Standard Organisation ISO ID ISO/IEEE 11073-10425:2019 Type Standard Version 3 Access Fees apply to access Status Superseded Created Mar-19 This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10427: Device specialization — Power status monitor of personal health devices Category Standard Organisation ISO ID ISO/IEEE 11073-10427:2018 Type Standard Version 1 Access Fees apply to access Status Active Created Jan-18 This standard establishes a normative definition of communication between devices containing a power source and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10441: Device specialization — Cardiovascular fitness and activity monitor Category Standard Organisation ISO ID ISO/IEEE 11073-10441:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-15 This standard establishes a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10442: Device specialization — Strength fitness equipment Category Standard Organisation ISO ID ISO/IEEE 11073-10442:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-15 This standard establishes a normative definition of the communication between personal strength fitness devices and managers in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication – Part 10471: Device specialization - Independent living activity hub Category Standard Organisation ISO ID ISO/IEEE 11073-10471:2010 Type Standard Version 1 Access Fees apply to access Status Superseded Created May-10 This standard establishes a normative definition of the communication between independent-living activity hubs and managers in a way that enables plug-and-play interoperability.
Health Informatics — Personal health device communication – Part 10472: Device specialization — Medication monitor Category Standard Organisation ISO ID ISO/IEEE 11073-10472:2012 Type Standard Version 1 Access Fees apply to access Status Withdrawn Created Nov-12 This standard establishes a normative definition of communication between personal telehealth medication monitor devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor – Technical Corrigendum 1 Category Standard Organisation ISO ID ISO/IEEE 11073-10418:2014/Cor 1:2016 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-16 This corrigendum contains corrected errors and that apply to ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication – Part 10418: Device specialization — International Normalized Ratio (INR) monitor.
Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) – Technical Corrigendum 1 Category Standard Organisation ISO ID ISO/IEEE 11073-10424:2016/Cor 1:2018 Type Standard Version 1 Access Fees apply to access Status Active This corrigendum contains corrected errors that apply to ISO/IEEE 11073-10424:2016 Health informatics — Personal health device communication – Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE).
Health informatics — Personal health records — Definition, scope and context Category Technical Report Organisation ISO ID ISO/TR 14292:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-12 This document gives a definition of a personal health record (PHR) to help clarify the types of records that should be called PHRs.
Health informatics — Personalized digital health — Digital therapeutics health software systems Category Technical Report Organisation ISO ID ISO/TR 11147:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-23 This standard lists characteristics of digital therapeutics (DTx) software which generate and deliver medical interventions.
Health informatics — Point-of-care medical device communication – Part 10102: Nomenclature — Annotated ECG Category Standard Organisation ISO ID ISO/IEEE 11073-10102:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-14 This standard extends IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology.
Health informatics — Point-of-care medical device communication – Part 10103: Nomenclature — Implantable device, cardiac Category Standard Organisation ISO ID ISO/IEEE 11073-10103:2014 Type Standard Access Fees apply to access Status Active Created Mar-14 This standard extends IEEE 11073 to support terminology for implantable cardiac devices.
Health informatics — Point-of-care medical device communication – Part 20101: Application profiles — Base standard Category Standard Organisation ISO ID ISO/IEEE 11073-20101:2004 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-14 This standard provides the upper layer services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications.
Health informatics — Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services Category Standard Organisation ISO ID ISO/IEEE 11073-20702:2018 Type Standard Access Fees apply to access Status Active Created Sep-18 This standard defines a communication protocol specification for a 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 by profiling web service specifications.
Health informatics — Point-of-care medical device communication – Part 30200: Transport profile — Cable connected Category Standard Organisation ISO ID ISO/IEEE 11073-30200:2004 Type Standard Access Fees apply to access Status Active Created Dec-04 This standard describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices.
Health informatics — Point-of-care medical device communication – Part 30400: Interface profile — Cabled Ethernet Category Standard Organisation ISO ID ISO/IEEE 11073-30400:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-11 This standard addresses the application of the Ethernet family (IEEE Std 802.3-2008) of protocols for use in medical device communication.
Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected – Amendment 1 Category Standard Organisation ISO ID ISO/IEEE 11073-30200:2004/Amd 1:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-15 This amendment applies to ISO/IEEE 11073-30200:2004 Health informatics — Point-of-care medical device communication – Part 30200: Transport profile — Cable connected.
Health informatics — Point-of-care medical device communication — Transport profile — Cable connected (Amendment 1) Category Standard Organisation ISO Type Standard Version 2015 Status Active Health informatics — Point-of-care medical device communication — Transport profile — Cable connected (Amendment 1)
Health informatics — Principles and data requirements for consent in the collection, use or disclosure of personal health information Category Specification Organisation ISO ID ISO/TS 17975:2022 Type Standard Version 2 Access Fees apply to access Status Active Created Nov-22 This specification defines the set of frameworks of consent for the collection, use and/or disclosure of personal information by healthcare practitioners or organisations that are frequently used to obtain agreement to process the personal health information of subjects of care.
Health Informatics — Principles and data requirements for consent in the collection, use or disclosure of personal health information Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 17975:2022 Health Informatics — Principles and data requirements for consent in the collection, use or disclosure of personal health information and supports consistent use in digital health settings.
Health informatics — Principles and guidelines for the measurement of conformance in the implementation of terminological systems Category Technical Report Organisation ISO ID ISO/TR 12310:2015 Type Standard Version 1 Access Fees apply to access Status Active Created May-15 This document provides a framework of good practices for terminology system maintenance and principles to ensure conformance for EHR systems.
Health informatics — Principles of mapping between terminological systems Category Technical Report Organisation ISO ID ISO/TR 12300:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-14 This document establishes and harmonises the basic principles for developing, maintaining, and using maps in healthcare. It provides guidelines for good practice to underpin the mapping process.
Health informatics — Privilege management and access control — Part 1: Overview and policy management Category Standard Organisation ISO ID ISO 22600-1:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-14 ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.
Health informatics — Privilege management and access control — Part 2: Formal models Category Standard Organisation ISO ID ISO 22600-2:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-14 ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-2:2014 introduces the underlying paradigm of formal high-level models for architectural components.
Health informatics — Privilege management and access control — Part 3: Implementations Category Standard Organisation ISO ID ISO 22600-3:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-14 ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-3:2014 instantiates requirements for repositories for access control policies and requirements for privilege management infrastructures.
Health informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine Category Specification Organisation ISO ID ISO/TS 18790-1:2015 Type Standard Version 1 Access Fees apply to access Status Active Created May-15 This specification establishes common concepts and a vocabulary for describing the complex domain of various traditional Chinese medicine informatics standards initiatives and their supporting artefacts.
Health Informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine Category Technical Specification Organisation ISO Type Standard Version 2015 Status Active This technical specification describes ISO/TS 18790-1:2015 Health Informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine and supports consistent use in digital health settings.
Health Informatics — Provider identification Category Technical Specification Organisation ISO Type Standard Version 2010 Status Active This technical specification describes ISO/TS 27527:2010 Health Informatics — Provider identification and supports consistent use in digital health settings.
Health informatics — Provisions for health applications on mobile/smart devices Category Technical Report Organisation ISO ID ISO/TR 17522:2015 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-15 This document applies to the development of smart health applications and the support of new health businesses based on the smart devices.
Health informatics — Public key infrastructure — Part 1: Overview of digital certificate services Category Standard Organisation ISO ID ISO 17090-1:2021 Type Standard Version 3 Access Fees apply to access Status Active Created Mar-21 This standard defines the basic concepts underlying the use of digital certificates in health care and provides a scheme of interoperability requirements to establish a digital certificate-enabled secure communication of health information.
Health informatics — Public key infrastructure — Part 2: Certificate profile Category Standard Organisation ISO ID ISO 17090-2:2015 Type Standard Version 2 Access Fees apply to access Status Active Created Nov-15 This standard specifies the certificate profiles required to interchange health care information within a single organisation, between different organisations and across jurisdictional boundaries. It details the use made of digital certificates in the health industry and focuses, in particular, on specific healthcare issues relating to certificate profiles.
Health informatics — Public key infrastructure — Part 3: Policy management of certification authority Category Standard Organisation ISO ID ISO 17090-3:2021 Type Standard Version 2 Access Fees apply to access Status Active Created Mar-21 This standard gives guidelines for certificate management issues involved in deploying digital certificates in health care. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements.
Health informatics — Public key infrastructure — Part 4: Digital signatures for healthcare documents Category Standard Organisation ISO ID ISO 17090-4:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Oct-20 This standard 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.
Health informatics — Public key infrastructure — Part 5: Authentication using Healthcare PKI credentials Category Standard Organisation ISO ID ISO 17090-5:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-17 This standard defines the procedural requirements for validating an entity credential based on healthcare public key infrastructure (PKI) defined in the ISO 17090 series used in healthcare information systems including accessing remote systems.
Health informatics — Quality metrics for detailed clinical models Category Specification Organisation ISO ID ISO/TS 18864:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-17 The purpose of this specification is to define objective, reliable and reproducible quality metrics for detailed clinical models.
Health Informatics — Quality metrics for detailed clinical models Category Technical Specification Organisation ISO Type Standard Version 2017 Status Active This technical specification describes ISO/TS 18864:2017 Health Informatics — Quality metrics for detailed clinical models and supports consistent use in digital health settings.
Health informatics — Re-usable component strategy for use case development Category Technical Report Organisation ISO ID ISO/TR 19669:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-17 This document specifies a methodology for developing use cases, facilitated by a dynamic catalogue of re-usable components. It includes a basic use-case template and the methods of component identification, capture, cataloguing and reuse.
Health Informatics — Reference standards portfolio (RSP) — Clinical imaging Category Standard Organisation ISO ID ISO 21860:2020 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-20 This standard establishes the reference standards portfolio (RSP) for the clinical imaging domain.
Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes Category Technical Specification Organisation ISO Type Standard Version 2020 Status Active This technical specification describes ISO/TS 22756:2020 Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes and supports consistent use in digital health settings.
Health Informatics — Requirements for a record of a dispense of a medicinal product Category Technical Specification Organisation ISO Type Standard Version 1929 Status Active This technical specification describes ISO/TS 19293:2018 Health Informatics — Requirements for a record of a dispense of a medicinal product and supports consistent use in digital health settings.
Health Informatics — Requirements for customer-oriented health cloud service agreements Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 23535:2022 Health Informatics — Requirements for customer-oriented health cloud service agreements and supports consistent use in digital health settings.
Health Informatics — Requirements for electronic prescriptions Category Standard Organisation ISO Type Standard Version 2016 Status Active This standard describes ISO 17523:2016 Health Informatics — Requirements for electronic prescriptions and supports consistent use in digital health settings.
Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers Category Specification Organisation ISO ID ISO/TS 16791:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Sep-20 This specification 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.
Health Informatics — Requirements for international machine-readable coding of medicinal product package identifiers Category Technical Specification Organisation ISO Type Standard Version 2020 Status Active This technical specification describes ISO/TS 16791:2020 Health Informatics — Requirements for international machine-readable coding of medicinal product package identifiers and supports consistent use in digital health settings.
Health Informatics — Requirements for medication safety alerts Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 22703:2021 Health Informatics — Requirements for medication safety alerts and supports consistent use in digital health settings.
Health Informatics — Requirements for medicinal product dictionary systems for health care Category Technical Specification Organisation ISO Type Standard Version 1925 Status Active This technical specification describes ISO/TS 19256:2016 Health Informatics — Requirements for medicinal product dictionary systems for health care and supports consistent use in digital health settings.
Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment Category Specification Organisation ISO ID ISO/TS 14441:2013 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-13 This specification examines electronic patient record systems at the clinical point of care that are also interoperable with electronic health records (EHRs).
Health Informatics — Security and privacy requirements of EHR systems for use in conformity assessment Category Technical Specification Organisation ISO Type Standard Version 2013 Status Active This technical specification describes ISO/TS 14441:2013 Health Informatics — Security and privacy requirements of EHR systems for use in conformity assessment and supports consistent use in digital health settings.
Health informatics — Security requirements for archiving of electronic health records — Guidelines Category Technical Report Organisation ISO ID ISO/TR 21548:2010 Type Standard Version 1 Access Fees apply to access Status Active Created Feb-10 This document provides additional guidance for the implementation of the requirements set by ISO/TS 21547, Health informatics — Security requirements for archiving of electronic health records — Principles.
Health Informatics — Security requirements for archiving of electronic health records — Principles Category Technical Specification Organisation ISO Type Standard Version 2010 Status Active This technical specification describes ISO/TS 21547:2010 Health Informatics — Security requirements for archiving of electronic health records — Principles and supports consistent use in digital health settings.
Health informatics — Semantic network framework of traditional Chinese medicine language system Category Specification Organisation ISO ID ISO/TS 17938:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-14 This specification defines the structure of a semantic network by describing the semantic types and semantic relations of a traditional Chinese medicine language system.
Health Informatics — Semantic network framework of traditional Chinese medicine language system Category Technical Specification Organisation ISO Type Standard Version 2014 Status Active This technical specification describes ISO/TS 17938:2014 Health Informatics — Semantic network framework of traditional Chinese medicine language system and supports consistent use in digital health settings.
Health informatics — Sex and gender in electronic health records Category Technical Report Organisation ISO ID ISO/TR 9143:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-23 This specification’s purpose is to describe challenges with documenting and sharing sex and gender information in electronic health records (EHRs); identify the state of international standards and specifications that include sex and gender; and summarise findings and identify opportunities to improve clarity and consistency in use of sex and gender in EHRs.
Health informatics — Sharing of OID registry information Category Specification Organisation ISO ID ISO/TS 13582:2015 Type Standard Version 2 Access Fees apply to access Status Active Created Dec-15 This specification specifies the mandatory and optional information to be recorded in any registry of object identifiers (OIDs), using an information model. It specifies which parts of that information are to be regarded as public and which parts are to be subject to security and privacy requirements.
Health informatics — Standard communication protocol — Computer-assisted electrocardiography Category Standard Organisation ISO ID ISO 41064:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-23 This standard specifies the common conventions needed for the interchange of specific patient data (such as on demographics and recording conditions), electrocardiogram (ECG) signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results.
Health informatics — Survey of mHealth projects in low and middle income countries (LMIC) Category Technical Report Organisation ISO ID ISO/TR 19231:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Nov-14 This document surveys currently available eHealth frameworks and explores possible mobile health (mHealth) frameworks that could be used in low and middle income countries.
Health informatics — Terminological resources — Part 1: Characteristics Category Standard Organisation ISO ID ISO 17117-1:2018 Type Standard Version 1 Access Fees apply to access Status Active Created Apr-18 This standard defines universal and specialised characteristics of health terminological resources that make them fit for the purposes required of various applications.
Health informatics — Terminological resources — Part 2: Implementation Capability (TIC) Category Specification Organisation ISO ID ISO/TS 17117-2:2022 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-22 This specification defines the components (benchmarks) of capability of terminological resources implementation in healthcare software products, including electronic health record systems.
Health Informatics — Terminological resources — Part 2: Implementation Capability (TIC) Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 17117-2:2022 Health Informatics — Terminological resources — Part 2: Implementation Capability (TIC) and supports consistent use in digital health settings.
Health Informatics — Token-based health information sharing Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 22691:2021 Health Informatics — Token-based health information sharing and supports consistent use in digital health settings.
Health informatics — Traditional Chinese medicine literature metadata Category Specification Organisation ISO ID ISO/TS 17948:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Jul-14 This specification defines a core set of traditional Chinese medicine (TCM) literature metadata, describes the principles and methods of TCM metadata, and specifies the formal description of TCM metadata.
Health Informatics — Traditional Chinese medicine literature metadata Category Technical Specification Organisation ISO Type Standard Version 2014 Status Active This technical specification describes ISO/TS 17948:2014 Health Informatics — Traditional Chinese medicine literature metadata and supports consistent use in digital health settings.
Health Informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information Category Technical Specification Organisation ISO Type Standard Version 2022 Status Active This technical specification describes ISO/TS 5568:2022 Health Informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information and supports consistent use in digital health settings.
Health Informatics — Trusted end-to-end information flows Category Technical Specification Organisation ISO Type Standard Version 2018 Status Active This technical specification describes ISO/TS 21089:2018 Health Informatics — Trusted end-to-end information flows and supports consistent use in digital health settings.
Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices Category Technical Report Organisation ISO ID ISO/TR 21730:2007 Type Standard Version 2 Access Fees apply to access Status Active Created Feb-07 This document provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities to mitigate electromagnetic interference (EMI) hazards.
Health Informatics — Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce) Category Technical Specification Organisation ISO Type Standard Version 2019 Status Active This technical specification describes ISO/TS 22287:2019 Health Informatics — Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce) and supports consistent use in digital health settings.
Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle Category Standard Organisation ISO ID IEC 81001-5-1:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-21 This document defines the life cycle requirements for development and maintenance of health software needed to support conformance to IEC 62443-4-1, which concerns security for industrial automation and control systems.
Health software – Part 1: General requirements for product safety Category Standard Organisation ISO ID IEC 82304-1:2016 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-16 This document sets out the safety and security requirements for manufacturers of health software products that are designed to operate on general computing platforms without dedicated hardware.
Health software — Part 2: Health and wellness apps — Quality and reliability Category Technical Specification Organisation ISO Type Standard Version 2021 Status Active This technical specification describes ISO/TS 82304-2:2021 Health software — Part 2: Health and wellness apps — Quality and reliability and supports consistent use in digital health settings.
Health software, Part 2: Health and wellness apps - Quality and reliability Category Technical Specification Organisation ISO Type Standard Access Fees apply to access Status Active Created 2021 This document provides quality requirements for health apps and defines a health app quality label in order to visualise the quality and reliability of health apps.
Healthcare organization management — Hand hygiene performance Category Standard Organisation ISO ID ISO 23447:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Oct-23 This standard specifies hand hygiene training, compliance benchmarking, performance/feedback, and facility requirements for healthcare facilities that operate hand hygiene systems.
Healthcare organization management — Infection prevention and control (IPC) measures for cross-border workers Category Specification Organisation ISO ID ISO/TS 17371:2023 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-23 This specification specifies infection prevention and control measures for cross-border workers. It applies during a novel infectious disease outbreak when valid vaccines or drugs for treatment are not available. It can be used to maintain economic activities when a country that workers need to enter blocks its border due to a pandemic or epidemic.
Healthcare organization management — Infection prevention and control (IPC) measures for cross-border workers Category Technical Specification Organisation ISO Type Standard Version 2023 Status Active This technical specification describes ISO/TS 17371:2023 Healthcare organization management — Infection prevention and control (IPC) measures for cross-border workers and supports consistent use in digital health settings.
Healthcare organization management — Management systems for quality in healthcare organizations — Requirements Category Standard Organisation ISO ID ISO 7101:2023 Type Standard Version 1 Access Fees apply to access Status Active Created 2023 This standard provide organisations with requirements to deliver high-quality healthcare. It helps organisations navigate the complexities of healthcare, such as limited resources, ageing populations, and global pandemics.
Healthcare organization management — Pandemic response (respiratory) — Drive-through screening station Category Standard Organisation ISO ID ISO 5258:2022 Type Standard Version 1 Access Fees apply to access Status Active Created 2022 This standard specifies the operation of a drive-through screening station (DTSS) for mass testing as part of pandemic response management.
Healthcare organization management — Pandemic response (respiratory) — Walk-through screening station Category Standard Organisation ISO ID ISO 5472:2022 Type Standard Version 1 Access Fees apply to access Status Active Created 2022 This standard specifies the operation of a walk-through screening station (WTSS) for mass testing as part of pandemic response management (for example, during the COVID-19 pandemic).
Healthcare organization management — Pandemic response — Functional requirements for self-symptom checker app Category Standard Organisation ISO ID ISO 6028:2023 Type Standard Version 1 Access Fees apply to access Status Active Created 2023 This standard specifies the functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19.
Healthcare organization management — Pandemic response — Temporary medical facility Category Standard Organisation ISO ID ISO 5741:2023 Type Standard Version 1 Access Fees apply to access Status Active Created 2023 This standard focuses on the operation of temporary isolation and quarantine facilities.
Healthcare organization management — Pandemic response —Guidelines for respiratory infection prevention and control in hospitals Category Standard Organisation ISO ID ISO/PAS 18999:2024 Type Standard Version 1 Access Fees apply to access Status Active Created Jan-24 This standard provides comprehensive guidelines for pandemic response, particularly focusing on respiratory infection prevention and control in hospitals.
Healthcare organization management — Requirements for patient-centred staffing Category Standard Organisation ISO ID ISO 22956:2021 Type Standard Version 1 Access Fees apply to access Status Active Created Jun-21 This standard provides requirements for patient-centred staffing in healthcare settings. It is generic and applicable to any healthcare organisation.
Healthcare organization management — Vocabulary Category Standard Organisation ISO ID ISO 22886:2020 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-20 This standard defines terms used in healthcare organisation management.
Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging Category Technical Specification Organisation ISO Type Standard Version 2044 Status Active This technical specification describes ISO/TS 20440:2023 Health Informatics — Identification of medicinal products — Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging and supports consistent use in digital health settings.
Information model of Chinese materia medica processing Category Technical Specification Organisation ISO Type Standard Version 2020 Status Active This technical specification describes ISO/TS 21831:2020 Information model of Chinese materia medica processing and supports consistent use in digital health settings.
Information technology - Automatic identification and data capture techniques - Direct Part Mark (DPM) Quality Guideline Category Standard Organisation ISO Type Standard Version 2020 Status Active This standard describes ISO/IEC TR 29158:2020, Information technology - Automatic identification and data capture techniques - Direct Part Mark (DPM) Quality Guideline and supports consistent use in digital health settings.
Information technology - Automatic identification and data capture techniques - Unique identification, Part 2: Registration procedures Category Standard Organisation ISO Type Standard Version 2015 Status Active This standard describes ISO/IEC 15459-2:2015, Information technology - Automatic identification and data capture techniques - Unique identification, Part 2: Registration procedures and supports consistent use in digital health settings.
Information technology - Automatic identification and data capture techniques - Unique identification, Part 4: Individual products and product packages Category Standard Organisation ISO Type Standard Version 2014 Status Active This standard describes ISO/IEC 15459-4:2014, Information technology - Automatic identification and data capture techniques - Unique identification, Part 4: Individual products and product packages and supports consistent use in digital health settings.
Information technology - Automatic identification and data capture techniques - Unique identification, Part 6: Groupings Category Standard Organisation ISO Type Standard Version 2014 Status Active This standard describes ISO/IEC 15459-6:2014, Information technology - Automatic identification and data capture techniques - Unique identification, Part 6: Groupings and supports consistent use in digital health settings.
Information technology - Automatic identification and data capture techniques. Bar code symbol print quality test specification - Two-dimensional symbols Category Standard Organisation ISO Type Standard Version 2011 Status Active This standard describes ISO/IEC 15415:2011, Information technology - Automatic identification and data capture techniques. Bar code symbol print quality test specification - Two-dimensional symbols and supports consistent use in digital health settings.
Information technology - ISO 7-bit coded character set for information interchange Category Standard Organisation ISO Type Standard Version 1991 Status Active This standard describes ISO/IEC 646:1991, Information technology - ISO 7-bit coded character set for information interchange and supports consistent use in digital health settings.
Information technology -- Automatic identification and data capture techniques -- Code 128 bar code symbology specification Category Standard Organisation ISO Type Standard Version 2007 Status Active This standard describes ISO/IEC 15417:2007, Information technology -- Automatic identification and data capture techniques -- Code 128 bar code symbology specification and supports consistent use in digital health settings.
Information technology -- Automatic identification and data capture techniques -- EAN/UPC bar code symbology specification Category Standard Organisation ISO Type Standard Version 2009 Status Active This standard describes ISO/IEC 15420:2009, Information technology -- Automatic identification and data capture techniques -- EAN/UPC bar code symbology specification and supports consistent use in digital health settings.
Information technology -- Automatic identification and data capture techniques -- Guidelines for direct part marking (DPM) Category Standard Organisation ISO Type Standard Version 2008 Status Active This standard describes ISO/IEC TR 24720:2008, Information technology -- Automatic identification and data capture techniques -- Guidelines for direct part marking (DPM) and supports consistent use in digital health settings.
Information technology -- Automatic identification and data capture techniques -- QR Code bar code symbology specification Category Standard Organisation ISO Type Standard Version 2015 Status Active This standard describes ISO/IEC 18004:2015, Information technology -- Automatic identification and data capture techniques -- QR Code bar code symbology specification and supports consistent use in digital health settings.
Information technology -- Radio frequency identification for item management -- Part 6: Parameters for air interface communications at 860 MHz to 960 MHz Category Standard Organisation ISO Type Standard Version 2013 Status Active This standard describes ISO/IEC 18000-6:2013, Information technology -- Radio frequency identification for item management -- Part 6: Parameters for air interface communications at 860 MHz to 960 MHz and supports consistent use in digital health settings.
Information technology- Automatic identification and data capture Techniques - Bar code verifier conformance specification — Part 1: Linear symbols Category Standard Organisation ISO Type Standard Version 2006 Status Active This standard describes ISO/IEC 15426-1:2006, Information technology- Automatic identification and data capture Techniques - Bar code verifier conformance specification — Part 1: Linear symbols and supports consistent use in digital health settings.
Information technology- Automatic Identification and Data Capture Techniques-Data Matrix Bar Code Symbology Specification Category Standard Organisation ISO Type Standard Version 2024 Status Active This standard describes ISO/IEC 16022:2024, Information technology- Automatic Identification and Data Capture Techniques-Data Matrix Bar Code Symbology Specification and supports consistent use in digital health settings.
Information technology-Automatic identification and data capture techniques - Bar code verifier conformance specification — Part 2: Two-dimensional symbols Category Standard Organisation ISO Type Standard Version 2023 Status Active This standard describes ISO/IEC 15426-2:2023, Information technology-Automatic identification and data capture techniques - Bar code verifier conformance specification — Part 2: Two-dimensional symbols and supports consistent use in digital health settings.
Knowledge management of health information standards Category Technical Report Organisation ISO ID ISO/TR 13054:2012 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-12 This document describes a standards knowledge management methodology and metadata to help identify the existence of a health informatics standard, its developmental status, and its associated standards development organisation.
Medical device software - Software life cycle processes Category Standard Organisation ISO Type Standard Access Fees apply to access Status Active Created 2006 This standard provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. This standard provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities further divided into a set of tasks.
Medical devices — Application of risk management to medical devices Category Standard Organisation ISO Type Standard Version 2019 Status Active This standard describes ISO 14971:2019 Medical devices — Application of risk management to medical devices and supports consistent use in digital health settings.
Medical devices — Quality management systems — Requirements for regulatory purposes Category Standard Organisation ISO Type Standard Version 2016 Status Active This standard describes ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes and supports consistent use in digital health settings.
Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Category Standard Organisation ISO Type Standard Version 2015 Status Active This standard describes IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment and supports consistent use in digital health settings.
Packaging -- Labelling and direct product marking with linear bar code and two-dimensional symbols Category Standard Organisation ISO Type Standard Version 2017 Status Active This standard describes ISO 28219:2017, Packaging -- Labelling and direct product marking with linear bar code and two-dimensional symbols and supports consistent use in digital health settings.