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GS1 EDI Healthcare Guidelines
Category
Guideline
Organisation
GS1
Type
Standard
Access
Open
Status
Active
The GS1 Electronic Data Interchange (EDI) Healthcare Guidelines provide global standards for electronic business messaging in the healthcare sector. This resource includes a model for healthcare supply chain processes, detailed descriptions of these processes and a set of specifications describing the information that should be included in electronic documents sent between business systems.
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
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Status
Active
Created
September 2021
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.
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
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Status
Active
Created
December 2021
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
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Status
Active
Created
October 2016
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.
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
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Status
Active
Created
July 2012
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
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Status
Active
Created
July 2012
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
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Status
Active
Created
July 2012
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
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Status
Active
Created
November 2012
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
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Status
Active
Created
December 2014
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
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Status
Active
Created
May 2016
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
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Status
Active
Created
January 2017
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.
Health informatics – Messages and communication – Web access reference manifest
Category
Standard
Organisation
ISO
ID
ISO 10159:2011
Type
Standard
Version
1
Access
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Status
Active
Created
December 2011
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 – HL7 Electronic Health Record-System Functional Model
Category
Standard
Organisation
ISO
ID
ISO 10781:2023
Type
Standard
Version
2.1
Access
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Status
Active
Created
November 2023
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 – 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
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Status
Active
Created
January 2008
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 – 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
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Status
Active
Created
July 2018
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 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
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Status
Active
Created
June 2023
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 units of measurement
Category
Standard
Organisation
ISO
ID
ISO 11240:2012
Type
Standard
Version
1
Access
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Status
Active
Created
November 2012
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 the unique identification and exchange of regulated medicinal product information
Category
Standard
Organisation
ISO
ID
ISO 11615:2017
Type
Standard
Version
2
Access
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Status
Active
Created
October 2017
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
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Status
Active
Created
August 2022
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 unique identification and exchange of regulated pharmaceutical product information
Category
Standard
Organisation
ISO
ID
ISO 11616:2017
Type
Standard
Version
2
Access
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Status
Active
Created
October 2017
This standard defines the data elements, structures and relationships required for the exchange of regulated information to uniquely identify pharmaceutical products.
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
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Status
Active
Created
August 2017
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 – Explicit time-related expressions for healthcare-specific problems
Category
Standard
Organisation
ISO
ID
ISO 12381:2019
Type
Standard
Version
1
Access
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Status
Active
Created
July 2019
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 – Service architecture (HISA) – Part 1: Enterprise viewpoint
Category
Standard
Organisation
ISO
ID
ISO 12967-1:2020
Type
Standard
Version
2
Access
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Status
Active
Created
November 2020
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
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Status
Active
Created
November 2020
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
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Status
Active
Created
November 2020
This standard specifies the fundamental characteristics of the computational model implemented by the service architecture layer architectural layer of an information system.
Health informatics – Clinical knowledge resources – Metadata
Category
Standard
Organisation
ISO
ID
ISO 13119:2022
Type
Standard
Version
2
Access
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Status
Active
Created
October 2022
This document specifies several metadata elements that describe resources containing medical knowledge.
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
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Status
Active
Created
April 2019
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 – Electronic health record communication – Part 1: Reference model
Category
Standard
Organisation
ISO
ID
ISO 13606-1:2019
Type
Standard
Version
2
Access
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Status
Active
Created
June 2019
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 2: Archetype interchange specification
Category
Standard
Organisation
ISO
ID
ISO 13606-2:2019
Type
Standard
Version
2
Access
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Status
Active
Created
June 2019
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 – 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
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Status
Active
Created
June 2019
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
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Status
Active
Created
June 2019
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
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Status
Active
Created
June 2019
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 – System of concepts to support continuity of care
Category
Standard
Organisation
ISO
ID
ISO 13940:2015
Type
Standard
Version
1
Access
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Status
Active
Created
December 2015
This document defines the generic concepts needed to achieve continuity of care, including both the content and context of healthcare services.
Health informatics – Clinical information models – Characteristics, structures and requirements
Category
Standard
Organisation
ISO
ID
ISO 13972:2022
Type
Standard
Version
1
Access
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Status
Active
Created
February 2022
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 – Information models – Biomedical Research Integrated Domain Group (BRIDG) Model
Category
Standard
Organisation
ISO
ID
ISO 14199:2015
Type
Standard
Version
1
Access
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Status
Active
Created
September 2015
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 – Categorial structure for terminological systems of human anatomy
Category
Standard
Organisation
ISO
ID
ISO 16278:2016
Type
Standard
Version
1
Access
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Status
Active
Created
March 2016
This document defines the characteristics required to describe the organisation and content of human anatomy within a terminological system.
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
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Status
Active
Created
December 2023
This document defines a standardised model of the functions that may be present in personal health record (PHR) systems.
Health informatics – Development of terms and definitions for health informatics glossaries
Category
Standard
Organisation
ISO
ID
ISO 17439:2022
Type
Standard
Version
1
Access
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Status
Active
Created
March 2022
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.
Abbreviations and acronyms used in LOINC
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document is an alphabetical list of the abbreviations and acronyms used across LOINC (Logical Observation Identifiers Names and Codes), a common language for identifying health measurements, observations and documents.
RELMA (Regenstrief LOINC Mapping Assistant): About Box
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
The RELMA About Box displays important information such as the version numbers of the RELMA program and LOINC database.
LOINC Search Syntax: Answer List Search
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document describes the RELMA Answer List Search screen and explains how to conduct a search and interpret the results.
RELMA (Regenstrief LOINC Mapping Assistant): Auto Mapper Search
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document introduces the RELMA Auto Mapper Search function and provides instructions for its use.
RELMA (Regenstrief LOINC Mapping Assistant): Community Mapping Repository
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document introduces the RELMA Community Mapping Repository, a database of local code mappings contributed by individual mappers, and provides instructions for uploading mappings to the repository.
RELMA (Regenstrief LOINC Mapping Assistant): Mapping Local Terms to LOINC – Conducting a search
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document assists RELMA users in performing different types of searches using the RELMA mapping screen.
LOINC Knowledge Base: Enriched Linkages between LOINC terms and LOINC Parts
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document describes the enhanced model of relationships between LOINC terms and LOINC Parts that was introduced in version 2.66. The model clarifies LOINC term labelling and defines 8 groups of LinkTypes.
LOINC Laboratory Mapping Guides
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This page contains links to 7 guides for using LOINC terms across the following laboratory domains: Allergy, Cell Markers, Chemistry, Drug and Toxicology, Hematology and Serology, Molecular Pathology, and Microbiology.
The LOINC Committee
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document describes the structure of the LOINC Committee and explains how users can formally apply for inclusion in one of its composite committees or subcommittees.
Using LOINC in HIPAA Attachments
Category
User guide
Organisation
LOINC
Type
Standard
Access
Open
Status
Active
This document provides guidance on using LOINC codes in electronic exchanges of attachments between payers and providers.