This document outlines the general requirements for conducting a multi-centre medical data collaborative analysis, covering various aspects such as system architecture, data storage, data standardization, collaborative research management and security. The data considered in this standard primarily encompasses electronic health record data for multi-centre collaborative researches, including structured data, medical text data, image data, etc. This standard is applicable to a wide range of individuals and institutions, including developers, maintainers, management personnel, researchers, and data-owning organizations.

  • Technical specification
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The document defines the data elements and the requisite metadata essential for implementing a structured clinical genomic sequencing report in electronic health records, particularly focusing on the genomic data generated by next-generation sequencing technology. This document: — defines the composition of a structured clinical sequencing report (see Clause 6); — defines the required data fields and their metadata for a structured clinical sequencing report (see Clause 7); — defines the optional data (see Clause 8); — covers the DNA-level variation from human samples using whole genome sequencing, whole exome sequencing, and targeted sequencing (disease-targeted gene panels) by next-generation sequencing technologies (though whole transcriptome sequencing and other technologies are important to provide better patient care and enable precision medicine, this document only deals with DNA-level changes); — covers mainly clinical applications and clinical research such as clinical trials and translational research which uses clinical data (basic research and other scientific areas are outside the scope of this document); — does not cover the other biological species, i.e. genomes of viruses and microbes; — does not cover the Sanger sequencing methods.

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This document provides the architecture of internet healthcare service network, including: — overview of internet healthcare service network; — infrastructure and deployment scheme of internet healthcare service network; — security of internet healthcare service network. This document mainly focuses on the engineering architecture and infrastructure deployment of healthcare information transmission among various healthcare organizations through services, as shown in Figure 1. The implementation of information systems and healthcare services within organizations is demonstrated in Annex A. This document applies to the construction and application of internet healthcare service network.

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This document describes the need for standardization of graphics and images in the health informatics domain. It focuses on the current status of adoption and presents an overview of the opportunities as well as challenges in creating sets of standardized images and graphics. A plan of action is proposed to serve as the future roadmap for implementation.

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This document specifies the tasks, roles, and key skills, requirements and competencies for personnel involved in terminology services in healthcare organizations. This document specifies: — terminology services in healthcare organizations including the selection, authoring, and deployment and use of terminology subsets, data sets and maps; developing and managing terminology management processes and health information management-related policies; performing terminology business analysis; and supporting the adoption, planning and deployment of terminologies; — workforce needs to perform these services; — job roles in the healthcare organizations and related organizations responsible for performing terminology related tasks; NOTE Examples of these roles include terminologist, terminology standards developer/manager, mapping specialist, data conversion analyst, interface analyst, coding specialist, data developer/designer, data modeller, and content manager [including Clinical Documentation Improvement (CDI) specialist]. — skill and competency level requirements to safely and effectively undertake each task, taking into account the focus of the task from the perspectives of health information and communication technology (HICT), information management, information governance including information privacy and security, clinical practice and healthcare decision making.

  • Standard
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ISO/TS 14265:2011 defines a set of high-level categories of purposes for which personal health information can be processed. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdictions, countries) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health records across organizational and jurisdictional boundaries.
The scope of application of ISO/TS 14265:2011 is limited to Personal Health Information as defined in ISO 27799, information about an identifiable person that relates to the physical or mental health of the individual, or to provision of health services to the individual.

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This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as
defined in Clause 4).
An RSP lists the principle health information technology (HIT) standards that form the basis of
implementing and deploying interoperable applications in the target domain.
An RSP includes a description of the domain, a normative list of standards, and an informative
framework for mapping the standards to example deployment use cases.
The lists do not include standards that are specifically national in scope.
The primary target audience for this document is policy makers (governmental or organizational),
regulators, project planners and HIT managers. This document will also be of interest to other
stakeholders such as equipment and HIT vendors, clinical and health information management (HIM)
professionals and standards developers.
The intended usage of this document is to inform decisions about selecting the standards that will form
the basis of integration projects in geographic regions or healthcare organizations. For example:
— What standards to use for capturing/encoding/exchanging certain types of information
— What standards to use for interfaces between the devices and information systems that support
information capture, management, exchange, processing and use
— What standards to use for specific use cases/deployment scenarios
The selected standards, and/or corresponding RSP clauses, might be useful when drafting project
specifications.
Figure 1 shows the conceptual organization of this document. The top part represents individual HIT
standards grouped under semantic, technical and functional interoperability categories. The bottom
part shows use cases for example implementation projects with a selected list of standards.
See the figure in the ISO standard

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This document specifies the characteristics of categorial structures, representing nursing practice. The overall aim of this document is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes. Categorial structures for nursing diagnoses, nursing actions, nurse sensitive outcomes and associated categories support interoperability by providing common frameworks with which to
a)       analyse the features of different terminologies, including pre- and post-coordinated expressions, those of other healthcare disciplines, and to establish the nature of the relationship between them,[3][4][5][6][7][8]
b)       develop terminologies for representing nursing diagnoses, nursing actions,[9][10][11][12] and nurse sensitive outcomes,
c)        develop terminologies that are able to be related to each other,[3][8][13] and
d)       establish relationships between terminology models, information models, including archetypes, and ontologies in the nursing domain.[14][15][16][45]
There is early evidence that the categorial structures can be used as a framework for analysing nursing practice,[17] for developing nursing content of electronic record systems,[18][19] document the value of nursing services provided and to make nursing’s contribution visible[16][36][47][50].

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The objective of this document is to establish common principles for the creation, assessment, selection and maintenance of maps between terminological resources used to describe and code IDMP therapeutic indications for investigational and medicinal products, medical devices, combination products, biologics and companion diagnostics. Core maintenance principles, such as reliability, reproducibility and quality assurance of the maps for future indication terminology use, are also discussed. The intended audience for this document includes:
a)       Global regulators, pharmaceutical/biopharmaceutical companies, Clinical Research Organizations (CROs) and universities/scientific institutes involved in the development, authorization and marketing of medicinal products
b)       Implementers of IDMP seeking more information about coding of Therapeutic Indications
c)        Healthcare providers
d)       Standards Organizations
e)       Implementers and software vendors developing and implementing terminology map sets
f)         Patients

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ISO 21549-7:2016 applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-7:2016 specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
- medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
- medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
- medication dispensed: the records of medications dispensed for the patient;
- medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
- physical or logical solutions for the practical functioning of particular types of data cards;
- how the message is processed further "downstream" of the interface between two systems;
- the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE Not only does the definition of "medicinal products" differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
ISO 21549-7:2016 describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
ISO 21549-7:2016 does not describe nor define the common objects defined within ISO 21549-2, even though they are referenced and utilized within this document.

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ISO 21549-5:2015 describes and defines the basic structure of the identification data objects held on healthcare data cards, but does not specify particular data sets for storage on devices.
The detailed functions and mechanisms of the following services are not within the scope of this part of ISO 21549 (although its structures can accommodate suitable data objects elsewhere specified):
- security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions;
- access control services;
- the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO 21549).
The following topics are therefore beyond the scope of this part of ISO 21549:
- physical or logical solutions for the practical functioning of particular types of data card;
- the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

  • Standard
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This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as defined in Clause 4).
An RSP lists the principle health information technology (HIT) standards that form the basis of implementing and deploying interoperable applications in the target domain.
An RSP includes a description of the domain, a normative list of standards, and an informative framework for mapping the standards to example deployment use cases.
The lists do not include standards that are specifically national in scope.
The primary target audience for this document is policy makers (governmental or organizational), regulators, project planners and HIT managers. This document will also be of interest to other stakeholders such as equipment and HIT vendors, clinical and health information management (HIM) professionals and standards developers.
The intended usage of this document is to inform decisions about selecting the standards that will form the basis of integration projects in geographic regions or healthcare organizations. For example:
—     What standards to use for capturing/encoding/exchanging certain types of information
—     What standards to use for interfaces between the devices and information systems that support information capture, management, exchange, processing and use
—     What standards to use for specific use cases/deployment scenarios
The selected standards, and/or corresponding RSP clauses, might be useful when drafting project specifications.

  • Standard
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This document applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
This document specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
—     medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
—     medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
—     medication dispensed: the records of medications dispensed for the patient;
—     medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
—     physical or logical solutions for the practical functioning of particular types of data cards;
—     how the message is processed further “downstream” of the interface between two systems;
—     the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE            Not only does the definition of “medicinal products” differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
This document describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This document does not describe nor define the common objects defined within ISO 21549-2.

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This document provides an overview of the segmentation process for medical image-based modelling of human bone. This document specifies a standardized process to improve the performance of human bone segmentation. This document is also applicable to medical 3D printing systems that include medical 3D modelling capabilities.

  • Standard
    26 pages
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This document applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. This document specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices. The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver. It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets. Medication data include the following four components: — medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies; — medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy; — medication dispensed: the records of medications dispensed for the patient; — medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense. The following topics are beyond the scope of this document: — physical or logical solutions for the practical functioning of particular types of data cards; — how the message is processed further “downstream” of the interface between two systems; — the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere. NOTE Not only does the definition of “medicinal products” differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders. This document describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1). This document does not describe nor define the common objects defined within ISO 21549-2.

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    42 pages
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  • Standard
    44 pages
    French language
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The objective of this document is to establish common principles for the creation, assessment, selection and maintenance of maps between terminological resources used to describe and code IDMP therapeutic indications for investigational and medicinal products, medical devices, combination products, biologics and companion diagnostics. Core maintenance principles, such as reliability, reproducibility and quality assurance of the maps for future indication terminology use, are also discussed. The intended audience for this document includes:
a)       Global regulators, pharmaceutical/biopharmaceutical companies, Clinical Research Organizations (CROs) and universities/scientific institutes involved in the development, authorization and marketing of medicinal products
b)       Implementers of IDMP seeking more information about coding of Therapeutic Indications
c)        Healthcare providers
d)       Standards Organizations
e)       Implementers and software vendors developing and implementing terminology map sets
f)         Patients

  • Technical specification
    32 pages
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The objective of this document is to establish common principles for the creation, assessment, selection and maintenance of maps between terminological resources used to describe and code IDMP therapeutic indications for investigational and medicinal products, medical devices, combination products, biologics and companion diagnostics. Core maintenance principles, such as reliability, reproducibility and quality assurance of the maps for future indication terminology use, are also discussed. The intended audience for this document includes: a) Global regulators, pharmaceutical/biopharmaceutical companies, Clinical Research Organizations (CROs) and universities/scientific institutes involved in the development, authorization and marketing of medicinal products b) Implementers of IDMP seeking more information about coding of Therapeutic Indications c) Healthcare providers d) Standards Organizations e) Implementers and software vendors developing and implementing terminology map sets f) Patients

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This document defines a set of high-level categories of purposes for which personal health information can be processed: collected, used, stored, accessed, analysed, created, linked, communicated, disclosed or retained. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organisation, regional health authority, jurisdiction, country) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health records across organisational and jurisdictional boundaries.
Health data that have been irreversibly de-identified are outside the scope of this document, but since de-identification processes often includes some degree of reversibility, this document can also be used for disclosures of de-identified and/or pseudonymised health data whenever practicable.
This classification, whilst not defining an exhaustive set of purposes categories, provides a common mapping target to bridge between differing national lists of purpose and thereby supports authorised automated cross-border flows of EHR data.

  • Technical specification
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This document defines a set of high-level categories of purposes for which personal health information can be processed: collected, used, stored, accessed, analysed, created, linked, communicated, disclosed or retained. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organisation, regional health authority, jurisdiction, country) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health records across organisational and jurisdictional boundaries. Health data that have been irreversibly de-identified are outside the scope of this document, but since de-identification processes often includes some degree of reversibility, this document can also be used for disclosures of de-identified and/or pseudonymised health data whenever practicable. This classification, whilst not defining an exhaustive set of purposes categories, provides a common mapping target to bridge between differing national lists of purpose and thereby supports authorised automated cross-border flows of EHR data.

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This document outlines the design principles and the service and standards requirements to enable an interoperable system for genomic surveillance (herein referred to as “federated surveillance system”), including data representation, discovery and analysis, and data linkage. Using select profiles this document applies to genomics digital systems, networks and platforms that enable a federated approach for researchers, clinicians, and patients in both the private and public sector at the local, regional, and international levels.

  • Technical specification
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This document specifies the characteristics of categorial structures, representing nursing practice. The overall aim of this document is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes. Categorial structures for nursing diagnoses, nursing actions, nurse sensitive outcomes and associated categories support interoperability by providing common frameworks with which to
a)       analyse the features of different terminologies, including pre- and post-coordinated expressions, those of other healthcare disciplines, and to establish the nature of the relationship between them,[3][4][5][6][7][8]
b)       develop terminologies for representing nursing diagnoses, nursing actions,[9][10][11][12] and nurse sensitive outcomes,
c)        develop terminologies that are able to be related to each other,[3][8][13] and
d)       establish relationships between terminology models, information models, including archetypes, and ontologies in the nursing domain.[14][15][16][45]
There is early evidence that the categorial structures can be used as a framework for analysing nursing practice,[17] for developing nursing content of electronic record systems,[18][19] document the value of nursing services provided and to make nursing’s contribution visible[16][36][47][50].

  • Standard
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This document identifies data elements and metadata to represent the information about tumor mutation burden (TMB) when reporting the value for the biomarker using clinical massive parallel DNA sequencing. This document covers the TMB status and related metadata such as mutation type, sequencing types, and target areas of sequencing from human samples for clinical practice and research. This document is not intended — to define experimental protocols or methods for calculating the value of tumor mutation burden, — for the other biological species, and — for the Sanger sequencing methods.

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The purpose of this document is to: — describe the current challenges with documenting and sharing sex and gender information in electronic health records. — identify the current state of international standards and specifications that include sex and gender. — summarize the findings and identify opportunities to improve clarity and consistency in the use of sex and gender in electronic health records.

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This document provides business rules for PH EPR information systems. It includes a description of the EPR information systems domain. It also includes an informative framework for mapping existing semantic interoperability standards for emergency preparedness and response to PH EPR information systems. The primary target audience for this document is policy makers (governmental or organizational), regulators, project planners and management of PH EPR information systems, PH EPR data analysts and informaticians. The contents is also of interest to other stakeholders such as incident managers, PH educators, standards developers and academia.

  • Standard
    59 pages
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This document specifies the characteristics of categorial structures, representing nursing practice. The overall aim of this document is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes. Categorial structures for nursing diagnoses, nursing actions, nurse sensitive outcomes and associated categories support interoperability by providing common frameworks with which to a) analyse the features of different terminologies, including pre- and post-coordinated expressions, those of other healthcare disciplines, and to establish the nature of the relationship between them,[3][4][5][6][7][8] b) develop terminologies for representing nursing diagnoses, nursing actions,[9][10][11][12] and nurse sensitive outcomes, c) develop terminologies that are able to be related to each other,[3][8][13] and d) establish relationships between terminology models, information models, including archetypes, and ontologies in the nursing domain.[14][15][16][45] There is early evidence that the categorial structures can be used as a framework for analysing nursing practice,[17] for developing nursing content of electronic record systems,[18][19] document the value of nursing services provided and to make nursing’s contribution visible[16][36][47][50].

  • Standard
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  • Standard
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ISO/HL7 16527 PHR-S FM:2016 defines a standardized model of the functions that may be present in PHR Systems. It is beyond the scope of the PHR system to control the use (or intended use) of PHR data. On the contrary, it is within the scope of the PHR system to manage the authorization of an individual (or other application). Those parties are then responsible for using the data for appropriate (or intended) purposes. The system manufacturers specify "intended and permitted use of PHR data" in their Terms of Service and Terms of Use agreements. This Functional Model is not: - a messaging specification; - an implementation specification; - a conformance specification; - a specification for the underlying PHR (i.e. the record itself); - an exercise in creating a definition for a PHR; - a conformance or conformance testing metric; - a requirement specification for a single PHR system (see Annex D, Anticipated Uses). The information exchange enabled by the PHR-S supports the retrieval and population of clinical documents and summaries, minimum data sets, and other input/outputs.

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

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This document describes and defines the basic structure of the identification data objects held on healthcare data cards, but it does not specify particular data sets for storage on devices.
This document does not apply to the detailed functions and mechanisms of the following services (although its structures can accommodate suitable data objects elsewhere specified):
—    security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions;
—    access control services;
—    the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this document).
Therefore, this document does not cover:
—    physical or logical solutions for the practical functioning of particular types of data card;
—    the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

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This document describes and defines the basic structure of the identification data objects held on healthcare data cards, but it does not specify particular data sets for storage on devices. This document does not apply to the detailed functions and mechanisms of the following services (although its structures can accommodate suitable data objects elsewhere specified): — security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions; — access control services; — the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this document). Therefore, this document does not cover: — physical or logical solutions for the practical functioning of particular types of data card; — the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

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This document specifies a conceptual data model for Chinese medicinal herbs (CMH). The organization of the data model for each CMH consists of its medicinal attributes, plant attributes, geographic attributes and identifications. This document is applicable to the establishment and maintenance of CMH databases.

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This standard establishes a normative definition of communication between personal telehealth insulin
pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other
ISO/IEEE 11073 standards including existing terminology, information profiles, application profile
standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in
telehealth environments, restricting optionality in base frameworks in favor of interoperability. This
standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the
administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous
insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

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ISO 17117-1:2018 defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It refers only to terminological resources that are primarily designed to be used for clinical concept representation or to those parts of other terminological resources designed to be used for clinical concept representation.
ISO 17117-1:2018 helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. The focus of this document is to define characteristics and functions of terminological resources in healthcare that can be used to identify different types of them for categorization purposes. Clauses 4 and 5 support categorization according to the characteristics and functions of the terminological resources rather than the name.
NOTE       Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past.
The target groups for this document are:
a)    organizations wishing to select terminological systems for use in healthcare information systems;
b)    developers of terminological systems;
c)    developers of terminology standards;
d)    those undertaking independent evaluations/academic reviews of terminological resources;
e)    terminology Registration Authorities.
ISO 17117-1:2018 contains general characteristics and criteria with which systems can be evaluated.
The following considerations are outside the scope of this document.
-      Evaluations of terminological resources.
-      Health service requirements for terminological resources and evaluation criteria based on the characteristics and functions.
-      The nature and quality of mappings between different terminologies. It is unlikely that a single terminology will meet all the terminology requirements of a healthcare organization: some terminology providers produce mappings to administrative or statistical classifications such as the International Classification of Diseases (ICD). The presence of such maps would be a consideration in the evaluation of the terminology.
-      The nature and quality of mappings between different versions of the same terminology. To support data migration and historical retrieval, terminology providers can provide maps between versions of their terminology. The presence of such maps would be a consideration in the evaluation of the terminology.
-      Terminology server requirements and techniques and tools for terminology developers.
-      Characteristics for computational biology terminology. Progress in medical science and in terminology science will necessitate updating of this document in due course.

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This document 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 checkups. It covers electrocardiography such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, and exercise tests that are measured by inspection equipment such as electrocardiographs and patient monitors that are compatible with MFER. Medical waveforms that are not in the scope of this document include Holter ECG, exercise stress ECG, and real-time ECG waveform encoding used for physiological monitors.

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This document defines the application of medical waveform format encoding rules (MFER) to describe long-term electrocardiography waveforms measured in physiological laboratories and health care clinics. It covers electrocardiography such as bipolar 2, 3-lead, 12-lead that are measured by medical equipment such as Holter electrocardiograph and patient physiological monitors that are compatible with MFER documents encoding rules (see ISO 22077-1).

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This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

  • Standard
    135 pages
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This document specifies:
—     the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

  • Standard
    37 pages
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This document specifies clinical sequencing information generated by massive parallel sequencing technology for sharing health information via massively parallel sequencing. This document covers the data fields and their metadata from the generation of sequence reads and base calling to variant evaluation and assertion for archiving reproducibility during health information exchange of clinical sequence information. However, the specimen collection, processing and storage, DNA extraction and DNA processing and library preparation, and the generation of test report are not in the scope of this document. This document hence defines the data types, relationship, optionality, cardinalities and bindings of terminology of the data. In essence, this document specifies: — the required data fields and their metadata from generation of sequence reads and base calling to variant evaluation and assertion for sharing clinical genomic sequencing data files generated by massively parallel sequencing technology, as shown in Figure 1; — the sequencing information from human samples using DNA sequencing by massively parallel sequencing technologies for clinical practice.

  • Technical specification
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This document specifies the common conventions required for the interchange of specific patient data (demographic, recording conditions ...), ECG signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results. This document specifies the content and structure of the information which may be interchanged between digital ECG electrocardiographs/devices and computer ECG management systems, as well as other computer or information systems (cloud, etc.) where ECG data can be stored. This document defines the way to describe and encode standard and medium to long-term electrocardiogram waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups, ambulatory and home care. It covers electrocardiograms such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, Holter ECGs and exercise ECGs that are recorded, measured and analysed by equipment such as electrocardiographs, patient monitors, wearable devices. It also covers intracardiac electrograms recorded by implantable devices as well as the analysis results of ECG analysis and interpretation systems and software that are compatible with SCP-ECG. ECG waveforms and data that are not in the scope of this document include real-time ECG waveform encoding and analysis used for physiological monitors, and intra-cardiac or extra cardiac ECG mapping.

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This document specifies an information model representing the quality control of the manufacturing process of traditional Chinese medicinal products by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship. It is applicable to the quality supervision and management of manufacturing process of Chinese materia medica. Japanese KAMPO medicine is outside the scope of this document.

  • Technical specification
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This document deals with the reporting of data to support improved public health, more effective health care and better health outcomes. This document 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. The role of a healthcare data reporting service is to enable data analyses in support of effective policies and decision making, to improve quality of care, to improve health services organizations and to influence learning and research. This document has relevance to both developing and more established health systems. It enables meaningful comparison of programs and outcomes.

  • Standard
    40 pages
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This document specifies:
—     the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

  • Standard
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This document describes 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.
Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

  • Technical specification
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This document specifies the requirements for medical image-based modelling for 3D printing for medical applications. It concerns accurate 3D data modelling in the medical field using medical image data generated from computed tomography (CT) devices. It also specifies the principal considerations for the general procedures of medical image-based modelling. It excludes soft tissue modelling from magnetic resonance image (MRI).

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This document seeks to establish a baseline understanding of Ayurvedic medicine system. It introduces various elements and processes inherent and integral to Ayurvedic diagnosis and treatment. It establishes concept models for Ayurvedic analysis of a subject which can potentially form the basis of system models. The following topics are out of scope of this document: — concept models and categorial structures for the individual elements of the concept models proposed. — individual Ayurvedic dosage forms or medicines or therapies.

  • Technical report
    21 pages
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This document specifies: — the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products; — a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; — a mechanism for the versioning of the concepts in order to track their evolution; — rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

  • Standard
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  • Standard
    29 pages
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This document lists characteristics of a category of health software: digital therapeutics (DTx). DTx products generate and deliver medical interventions that are based on clinical evidence, have demonstrable positive therapeutic impacts on patient health, and produce real-world outcomes. Product use cases (see Annex B) demonstrate the variety of products represented in this quickly growing industry. This document provides an overview of how DTx relates to other ecosystem constructs, including medical devices, software as a medical device (SaMD), software in a medical device (SiMD), and other digital health technologies (DHT). It also addresses relevant health and medical device software standards that have various degrees of applicability to DTx. The focus of this document is on therapeutic products that are used in the context of a disease, disorder, condition, or injury for human use. It does not address products that are intended for veterinary use or for general wellbeing. Additional exclusions of this document include DTx market access pathways (i.e. prescription, non-prescription pathways), medical device requirements, product risk assessment, clinical evidence requirements, data security, patient privacy considerations, and product authorization pathways.

  • Technical report
    21 pages
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This document reports on the datasets and a data structure for reporting clinical and biological evaluation metrics (CBEMs). The reporting of radiation dose estimates is outside the scope of this document. This document is applicable to CBEMs for external-beam radiation therapy (EBRT) modalities, but not CBEMs for brachytherapy or molecular radiotherapy. Various types of radiotherapy treatment modalities are available for cancer care. Consequently, there is a growing awareness of the need for objective schemes that will contribute to enable the selection of an appropriate radiotherapy treatment modality for individual patients. The use of CBEMs, the metrics associated with a certain radiotherapy treatment plan for a patient, is attracting attention for clinical purposes in the field of EBRT. In anticipation of the clinical use of CBEMs, the importance of research on clinical and scientific aspects of CBEMs is increasing, in concert with the importance of establishing a standardized data format for reporting of specifics of a CBEM.

  • Technical report
    12 pages
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ISO/IEEE 11073-10404:2010 establishes a normative definition of communication between personal telehealth pulse oximeter devices and computer engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards and transport standards. It specifies the use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability.
ISO/IEEE 11073-10404:2010 defines a common core of communication functionality for personal telehealth pulse oximeters and addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

  • Standard
    87 pages
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This document specifies requirements on the category definition and quality assessment of genomic data, including the content structure, attribute and description rules of data format, and the compilation rules of data format. This document applies to all the genomic data used for human genetic detection products and services. This document applies to genomic data processing and analysis, and to the quality evaluation/assessment of genomic data.

  • Technical specification
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