35.240.80 - IT applications in health care technology
ICS 35.240.80 Details
IT applications in health care technology
IT-Anwendungen in der Medizin
Applications des TI dans les technologies de la santé
Uporabniške rešitve IT v zdravstveni tehniki
General Information
Frequently Asked Questions
ICS 35.240.80 is a classification code in the International Classification for Standards (ICS) system. It covers "IT applications in health care technology". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 1179 standards classified under ICS 35.240.80 (IT applications in health care technology). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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- Amendment308 pagesEnglish languagee-Library read for1 day
This document describes a methodology for specifying the privileges necessary to access electronic health record (EHR) data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1 [17].
This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points to technical solutions and standards that specify details on services meeting these security needs.
NOTE Security requirements for EHR systems not related to the communication of EHRs are outside the scope of this document.
- Draft38 pagesEnglish languagee-Library read for1 day
This document specifies interoperability requirements for personal health decision support (PHDS) services between actors in the PHDS environment, which include PHDS services, data providers, and PHDS clients. It includes requirements for data exchange, validation, and error handling among participants to support accurate and timely decision-making. It also describes the privacy and security considerations for PHDS. However, the specifics of how PHDS services are developed or implemented are not covered.
- Draft17 pagesEnglish languagee-Library read for1 day
This document specifies requirements and recommendations for remote maintenance services (RMSs) of medical devices and medical information systems in healthcare facilities (HCFs). This document is applicable to HCFs and remote service centres (RSCs) providing remote maintenance services for medical devices and medical information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.
- Technical specification19 pagesEnglish languagesale 15% off
This document describes a methodology for specifying the privileges necessary to access electronic health record (EHR) data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1 [17]. This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points to technical solutions and standards that specify details on services meeting these security needs. NOTE Security requirements for EHR systems not related to the communication of EHRs are outside the scope of this document.
- Standard23 pagesEnglish languagesale 15% off
- Standard26 pagesFrench languagesale 15% off
This document specifies interoperability requirements for personal health decision support (PHDS) services between actors in the PHDS environment, which include PHDS services, data providers, and PHDS clients. It includes requirements for data exchange, validation, and error handling among participants to support accurate and timely decision-making. It also describes the privacy and security considerations for PHDS. However, the specifics of how PHDS services are developed or implemented are not covered.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.
- Draft35 pagesEnglish languagee-Library read for1 day
This document defines the requirements for a system of concepts for different aspects of the provision of care encompassing social care as well as clinical care. The focus of this document is continuity of care.
This document defines requirements for a system of concept definitions needed to describe health and care businesses. Concept systems conforming to this document can be used to support the development of:
logical reference models within the information viewpoint as a common basis for semantic interoperability on international, national or local levels;
information systems;
information for specified types of care processes.
This document does not specify how to perform specific care processes. This document does not cover research processes in the context of social and clinical care, welfare and educational processes.
- Draft173 pagesEnglish languagee-Library read for1 day
This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.
- Standard31 pagesEnglish languagesale 15% off
- Standard32 pagesFrench languagesale 15% off
This document specifies procedures for gene expression-based similarity calculation between human pluripotent stem cell (hPSC)-derived organoids and a pre-defined data set of gene expression profiles in normal tissues. This document covers situations where the gene expression in the organoids have been quantified in a way functionally similar to the samples in the pre-defined dataset, and it is not intended for medical decisions.
- Technical specification12 pagesEnglish languagesale 15% off
- Amendment308 pagesEnglish languagee-Library read for1 day
This document defines the requirements for a system of concepts for different aspects of the provision of care encompassing social care as well as clinical care. The focus of this document is continuity of care. This document defines requirements for a system of concept definitions needed to describe health and care businesses. Concept systems conforming to this document can be used to support the development of: logical reference models within the information viewpoint as a common basis for semantic interoperability on international, national or local levels; information systems; information for specified types of care processes. This document does not specify how to perform specific care processes. This document does not cover research processes in the context of social and clinical care, welfare and educational processes.
- Standard151 pagesEnglish languagesale 15% off
- Standard288 pagesEnglish languagesale 15% off
- Standard305 pagesFrench languagesale 15% off
This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification41 pagesEnglish languagee-Library read for1 day
This document indicates the data elements and structure suited to accurately and consistently identify persons (including subjects of care), healthcare providers and healthcare organizations. The data elements names and definitions are provided in Clause 3; the full data element definitional structure is given in Clauses 5, 6 and 7. This document identifies conformance requirements in the following use cases: Populate and manage an index or registry. This can include the storage of a person, healthcare provider or organization within an index or registry. Record or share information for administrative purposes. Record or share information for clinical purposes. Application of this document will increase the capacity for data access. Authorization of such access is determined by the application of legislation, organizational policies and guidelines, and professional ethics. It is recognized that specific applications might require additional data to fulfil their purpose, such as value sets or adjustments to conformance requirements. This document provides a generic set of identifying information, which is application-independent. Implementations in different healthcare environments and national settings can require the establishment of data sub-sets, additional guidelines and rules in the use of the data elements. The following are outside the scope of this document: Additional factors to be considered in providing access to distributed person data, including privacy, security, authentication, access and data transfer mechanisms. Collection and processing of data for purposes other than the identification of persons and their associated records, even though some of the data elements collected for identification can be used for other purposes such as the determination and delivery of care, the compilation of statistics, contact tracing and reimbursement. This includes clinical content, care processes and financial identifiers not used for person or provider identification. Handling of person electronic consent in forms and other use cases, although this can be considered for addition by implementers and dependent on electronic signature policy for medical records. Naming conventions, and rules for specifying data element names and data element definitions.
- Technical specification53 pagesEnglish languagesale 15% off
This document provides guidance on applying the set of user accessibility needs (UANs) to the procurement, development and evaluation of ICT products and services. This includes guidance on documenting the application of user accessibility needs. Applying user accessibility needs helps improve accessibility for all users and in particular for users with special needs that might otherwise be overlooked.
- Standard15 pagesEnglish languagesale 15% off
This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification41 pagesEnglish languagee-Library read for1 day
This document provides requirements and recommendations related to the concepts required to associate pharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical product identifiers and the related elements are intended to represent pharmaceutical products as defined within a medicinal product by a medicines regulatory authority. While the ISO standards on IDMP can be applied to off-label usage of medicinal products, such applications are currently outside of the scope of this document.
Reference to ISO 11238, ISO 11239, ISO 11240, ISO 11615, HL7 V3 messaging standards (HL7 Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured Product Labelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context of this document.
- Technical specification75 pagesEnglish languagee-Library read for1 day
ISO TS 24971-2:2026 This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification32 pagesEnglish languagesale 15% off
This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification32 pagesEnglish languagesale 15% off
This document provides requirements on identification and labelling of medicinal products from the point of manufacturing of packaged medicinal product to the point of dispensing the product.
This document outlines commonly accepted international practices for automatic identification and data capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare facilities and all parties involved in labelling and distribution of packaged medicinal products. These users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio frequency identification (RFID); that technology is not addressed in this document except as for information.
- Standard47 pagesEnglish languagee-Library read for1 day
This document describes a standardized methodology and framework for the development and representation of an ontology that supports a global, open-source approach to implementing the ISO standards on the identification of medicinal products (IDMP) (ISO 11615, ISO/TS 20443, ISO/TS 20451, ISO 11238; ISO/TS 19844, ISO 11239, ISO/TS 20440, and ISO 11240). Realization of the full potential of IDMP requires fully self-describing data. For this purpose, this document describes a methodology and framework that complements the existing conceptual and logical models in the ISO documents on IDMP with an IDMP ontology that enables deep, semantic interoperability based on findable, accessible, interoperable and reusable (FAIR) data principles. This methodology and framework enhance the usage of the IDMP data model as the foundation of medicinal product identification and will ultimately enable collaboration towards drug safety and overall operational efficiency.
This document also describes a methodology for the agile adaptation of the ISO documents on IDMP in connection with cross-jurisdictional IDMP-related legislation and initiatives. This document is intended to be complementary to and independent from formal regulatory guidance. Thus, it enables cross-jurisdictional consistency and supports stakeholders in their regional implementations of IDMP standards. This document does not mandate any specific ontology as an implementation tool, nor is it an instructional guideline on how to build ontologies, which is out of scope of this document.
This document includes key use cases described in the ISO documents on IDMP ISO 11615, ISO 11238 and ISO/TS 19844, as well as further use cases arising from the comprehensive deployment of the ISO documents on IDMP via an ontological framework. Thus, an ontology that represents the IDMP standards aims to cover the complete collection of ISO standards on IDMP regarding key interoperability issues that implementing stakeholders are facing.
- Technical specification40 pagesEnglish languagee-Library read for1 day
Within the field of health informatics, the DICOM (digital imaging and communication in medicine) standard addresses the exchange of digital images, and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information, such as Picture Archiving anc Communication System (PACS), Hospital Information System (HIS) and Radiology Information System (RIS).
This document is equivalent to part 1 of DICOM. As such, it normatively describes the content of DICOM (Clause 6) and the requirements to make a claim of conformance (Clause 5).
The DICOM standard is applicable to diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. It is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments.
- Standard26 pagesEnglish languagee-Library read for1 day
This document provides requirements and recommendations related to the concepts required to associate pharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical product identifiers and the related elements are intended to represent pharmaceutical products as defined within a medicinal product by a medicines regulatory authority. While the ISO standards on IDMP can be applied to off-label usage of medicinal products, such applications are currently outside of the scope of this document.
Reference to ISO 11238, ISO 11239, ISO 11240, ISO 11615, HL7 V3 messaging standards (HL7 Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured Product Labelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context of this document.
- Technical specification75 pagesEnglish languagee-Library read for1 day
This document reports on data structure for the video data, image recording device and related clinical information. This document includes data from endoscopic video and clinical information, but not static single images or audio data that can also be recorded through these types of devices. This document does not cover the remaining data processing for data delivery to users. Figure 2 illustrates the scope of the document.
- Technical report8 pagesEnglish languagesale 15% off
This document provides requirements and recommendations related to the concepts required to associate pharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical product identifiers and the related elements are intended to represent pharmaceutical products as defined within a medicinal product by a medicines regulatory authority. While the ISO standards on IDMP can be applied to off-label usage of medicinal products, such applications are currently outside of the scope of this document. Reference to ISO 11238, ISO 11239, ISO 11240, ISO 11615, HL7 V3 messaging standards (HL7 Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured Product Labelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context of this document.
- Technical specification66 pagesEnglish languagesale 15% off
This document describes a standardized methodology and framework for the development and representation of an ontology that supports a global, open-source approach to implementing the ISO standards on the identification of medicinal products (IDMP) (ISO 11615, ISO/TS 20443, ISO/TS 20451, ISO 11238; ISO/TS 19844, ISO 11239, ISO/TS 20440, and ISO 11240). Realization of the full potential of IDMP requires fully self-describing data. For this purpose, this document describes a methodology and framework that complements the existing conceptual and logical models in the ISO documents on IDMP with an IDMP ontology that enables deep, semantic interoperability based on findable, accessible, interoperable and reusable (FAIR) data principles. This methodology and framework enhance the usage of the IDMP data model as the foundation of medicinal product identification and will ultimately enable collaboration towards drug safety and overall operational efficiency.
This document also describes a methodology for the agile adaptation of the ISO documents on IDMP in connection with cross-jurisdictional IDMP-related legislation and initiatives. This document is intended to be complementary to and independent from formal regulatory guidance. Thus, it enables cross-jurisdictional consistency and supports stakeholders in their regional implementations of IDMP standards. This document does not mandate any specific ontology as an implementation tool, nor is it an instructional guideline on how to build ontologies, which is out of scope of this document.
This document includes key use cases described in the ISO documents on IDMP ISO 11615, ISO 11238 and ISO/TS 19844, as well as further use cases arising from the comprehensive deployment of the ISO documents on IDMP via an ontological framework. Thus, an ontology that represents the IDMP standards aims to cover the complete collection of ISO standards on IDMP regarding key interoperability issues that implementing stakeholders are facing.
- Technical specification40 pagesEnglish languagee-Library read for1 day
This document provides requirements on identification and labelling of medicinal products from the point of manufacturing of packaged medicinal product to the point of dispensing the product.
This document outlines commonly accepted international practices for automatic identification and data capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare facilities and all parties involved in labelling and distribution of packaged medicinal products. These users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio frequency identification (RFID); that technology is not addressed in this document except as for information.
- Standard47 pagesEnglish languagee-Library read for1 day
This document describes a standardized methodology and framework for the development and representation of an ontology that supports a global, open-source approach to implementing the ISO standards on the identification of medicinal products (IDMP) (ISO 11615, ISO/TS 20443, ISO/TS 20451, ISO 11238; ISO/TS 19844, ISO 11239, ISO/TS 20440, and ISO 11240). Realization of the full potential of IDMP requires fully self-describing data. For this purpose, this document describes a methodology and framework that complements the existing conceptual and logical models in the ISO documents on IDMP with an IDMP ontology that enables deep, semantic interoperability based on findable, accessible, interoperable and reusable (FAIR) data principles. This methodology and framework enhance the usage of the IDMP data model as the foundation of medicinal product identification and will ultimately enable collaboration towards drug safety and overall operational efficiency. This document also describes a methodology for the agile adaptation of the ISO documents on IDMP in connection with cross-jurisdictional IDMP-related legislation and initiatives. This document is intended to be complementary to and independent from formal regulatory guidance. Thus, it enables cross-jurisdictional consistency and supports stakeholders in their regional implementations of IDMP standards. This document does not mandate any specific ontology as an implementation tool, nor is it an instructional guideline on how to build ontologies, which is out of scope of this document. This document includes key use cases described in the ISO documents on IDMP ISO 11615, ISO 11238 and ISO/TS 19844, as well as further use cases arising from the comprehensive deployment of the ISO documents on IDMP via an ontological framework. Thus, an ontology that represents the IDMP standards aims to cover the complete collection of ISO standards on IDMP regarding key interoperability issues that implementing stakeholders are facing.
- Technical specification32 pagesEnglish languagesale 15% off
This document provides requirements on identification and labelling of medicinal products from the point of manufacturing of packaged medicinal product to the point of dispensing the product. This document outlines commonly accepted international practices for automatic identification and data capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare facilities and all parties involved in labelling and distribution of packaged medicinal products. These users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio frequency identification (RFID); that technology is not addressed in this document except as for information.
- Standard39 pagesEnglish languagesale 15% off
- Standard42 pagesFrench languagesale 15% off
This document specifies a general-purpose document registry framework for transmitting, storing and utilizing documents in clinical and personalized health environments. It is quite broad in its applicability to realise the goal of sharing health-related documents spanning a broad spectrum of health domains such as healthcare specialities covering laboratory, cardiology, eye care, etc. and the many areas of personalized health. This document also supports shared document registration and retrieval via the federation of documents’ registries (IHE Cross-Community Access) in terms of individual users to reduce health information extrusion possibilities. This document supports the sharing of documents of any standardized content in the context of healthcare and well-being. It describes the means of locating and accessing shared documents among a diverse set of health organizations. It is designed to leverage existing health informatics for structuring and semantically rich health information, if so desired. It does not require the development of new health informatics standards.
- Technical specification12 pagesEnglish languagesale 15% off
This standard defines an object-oriented abstract information model to represent a PHD and the observations generated by a PHD. It specifies what information needs to be present and the relationships between the informational elements in the model. It models observations in a generic way by focusing on the information content contained in the presentation of health measurements. The modeling follows the practice of ISO/IEEE 11073-20601 [B12] where Unified Modeling Language (UML) is used to describe a set of objects and the relationship between the objects.7 Tables provide descriptions of the attributes in the objects. IEEE 11073-10101™ nomenclature terms are used to express clinical content. This standard provides guidance as to what an exchange protocols needs to communicate to properly represent health observations, but is not, in itself, sufficient to be an exchange protocol. However, the content model defined herein does have sufficient detail to help organizations validate that there is no loss of the semantic content induced by data exchanges in a protocol adhering to this standard. This standard does not define a security framework.
- Standard95 pagesEnglish languagee-Library read for1 day
This document provides information security controls, including implementation guidance, for health organizations. It is based on ISO/IEC 27002:2022
In addition to generic ICT equipment and software used in many other environments, the scope of this document includes software and systems specifically for healthcare, such as electronic health record systems and medical devices incorporating health software. Such medical devices can be programmed or programmable and can contain software, firmware or both.
Other digital equipment (such as that for environmental and infection control, building management, and physical security), which can be used in premises where healthcare is provided, is also in scope.
This document applies to information in all its aspects, whatever form the information takes (including text and numbers, sound recordings, drawings, images and video), by whatever means it has been acquired or captured, whatever means are used to store it (such as printing or writing on paper or storage electronically), and whatever means are used to transfer or exchange it (orally, by hand, by post, movement of storage media, direct links or networking).
This document is for organizations of all types and sizes that provide healthcare or are custodians of personal health information for other reasons. The information that they are responsible for can be stored and processed in many possible ways and locations, including on premises or in the cloud, but remains in scope.
This document applies to all physical settings where healthcare is intended to be delivered, such as hospitals, clinics and other locations or facilities designated for healthcare purposes such as ambulances and mobile imaging or diagnostic units. It also applies to care provided elsewhere, such as in residential premises. In addition to the range of settings, this document applies to all methods of service provision including remote or virtual healthcare.
- Standard83 pagesEnglish languagee-Library read for1 day
This document establishes a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and 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. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability.
This document defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device is used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic.
- Standard77 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for genetic data analysis relating to direct-to-consumer (DTC) testing, including preprocessing, detection site, evaluation models, the use of databases and the elements of assessment reports. This document applies to the analysis of genetic data from DTC testing without the involvement of a health care provider.
- Technical specification14 pagesEnglish languagesale 15% off
Within the field of health informatics, the DICOM (digital imaging and communication in medicine) standard addresses the exchange of digital images, and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information, such as Picture Archiving anc Communication System (PACS), Hospital Information System (HIS) and Radiology Information System (RIS).
This document is equivalent to part 1 of DICOM. As such, it normatively describes the content of DICOM (Clause 6) and the requirements to make a claim of conformance (Clause 5).
The DICOM standard is applicable to diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. It is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments.
- Standard26 pagesEnglish languagee-Library read for1 day
Within the field of health informatics, the DICOM (digital imaging and communication in medicine) standard addresses the exchange of digital images, and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information, such as Picture Archiving anc Communication System (PACS), Hospital Information System (HIS) and Radiology Information System (RIS). This document is equivalent to part 1 of DICOM. As such, it normatively describes the content of DICOM (Clause 6) and the requirements to make a claim of conformance (Clause 5). The DICOM standard is applicable to diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. It is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments.
- Standard16 pagesEnglish languagesale 15% off
- Standard17 pagesFrench languagesale 15% off
This document establishes the information model of traditional Chinese medicine (TCM) clinical studies by defining categories and their attributes designed to extract patient, intervention, comparison and outcomes (PICO) data elements from the reports of TCM clinical studies.
- Technical specification7 pagesEnglish languagesale 15% off
This document supports interchangeability of digital signatures and the prevention of incorrect or illegal digital signatures by providing minimum requirements and formats for generating and verifying digital signatures and related certificates. This document describes the common technical, operational, and policy requirements to enable digital certificates to be used in protecting the exchange of healthcare information within a single domain, between domains, and across jurisdictional boundaries. The purpose of this document is to create a platform for global interoperability. It specifically supports digital certificate enabled communication across borders but can also provide guidance for the national or regional deployment of digital certificates in healthcare. This document defines the provable compliance with a public key infrastructure (PKI) policy necessary in the domain of healthcare. It specifies a method of adopting long-term signature formats to ensure integrity and non-repudiation in long-term electronic preservation of healthcare information. This document provides healthcare-specific PKI (HPKI) profiles of digital signature based on the ISO/ETSI standard profiles specified in CAdES (CMS Advanced Electronic Signature)[1], XAdES (XML Advanced Electronic Signature), PAdES (PDF Advanced Electronic Signature)[2] and the ETSI standard specified in JAdES (JSON Advanced Electronic Signature)[13].
- Standard31 pagesEnglish languagesale 15% off
This document defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It covers only 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.
This document helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. In order to do that, this document focuses on defining characteristics and functions of terminological resources in healthcare that can be used to identify different types of terminological resources for categorization purposes.
NOTE 1 Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past.
The following aspects are not covered in 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;
NOTE 2 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 classification systems 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;
NOTE 3 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.
- Standard32 pagesEnglish languagee-Library read for1 day
This document reviews the literature regarding human-computer interaction (HCI) theory and user-centred design (UCD) principles in the design and development of electronic health information record systems (HIRS). The focus is on some unintended consequences of HIRS design decisions over the last 15 years and the way that application of HCI and UCD to HIRS data analytics, data representation, and clinical decision support can help to alleviate HIRS-associated clinician burden.
- Technical report23 pagesEnglish languagesale 15% off
This standard defines an object-oriented abstract information model to represent a PHD and the observations generated by a PHD. It specifies what information needs to be present and the relationships between the informational elements in the model. It models observations in a generic way by focusing on the information content contained in the presentation of health measurements. The modeling follows the practice of ISO/IEEE 11073-20601 [B12] where Unified Modeling Language (UML) is used to describe a set of objects and the relationship between the objects.7 Tables provide descriptions of the attributes in the objects. IEEE 11073-10101™ nomenclature terms are used to express clinical content. This standard provides guidance as to what an exchange protocols needs to communicate to properly represent health observations, but is not, in itself, sufficient to be an exchange protocol. However, the content model defined herein does have sufficient detail to help organizations validate that there is no loss of the semantic content induced by data exchanges in a protocol adhering to this standard. This standard does not define a security framework.
- Standard95 pagesEnglish languagee-Library read for1 day
This document provides information security controls, including implementation guidance, for health organizations. It is based on ISO/IEC 27002:2022
In addition to generic ICT equipment and software used in many other environments, the scope of this document includes software and systems specifically for healthcare, such as electronic health record systems and medical devices incorporating health software. Such medical devices can be programmed or programmable and can contain software, firmware or both.
Other digital equipment (such as that for environmental and infection control, building management, and physical security), which can be used in premises where healthcare is provided, is also in scope.
This document applies to information in all its aspects, whatever form the information takes (including text and numbers, sound recordings, drawings, images and video), by whatever means it has been acquired or captured, whatever means are used to store it (such as printing or writing on paper or storage electronically), and whatever means are used to transfer or exchange it (orally, by hand, by post, movement of storage media, direct links or networking).
This document is for organizations of all types and sizes that provide healthcare or are custodians of personal health information for other reasons. The information that they are responsible for can be stored and processed in many possible ways and locations, including on premises or in the cloud, but remains in scope.
This document applies to all physical settings where healthcare is intended to be delivered, such as hospitals, clinics and other locations or facilities designated for healthcare purposes such as ambulances and mobile imaging or diagnostic units. It also applies to care provided elsewhere, such as in residential premises. In addition to the range of settings, this document applies to all methods of service provision including remote or virtual healthcare.
- Standard83 pagesEnglish languagee-Library read for1 day
This document establishes a normative definition of communication between personal telehealth peak flow monitoring devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, and 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. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability.
This document defines a common core of functionality of a peak-flow monitoring device. The use case is restricted to personal respiratory monitoring and therefore does not include hospital-based spirometry. Continuous and high-acuity monitoring (e.g., for emergency response) are outside the scope of the use case. In the context of personal health devices, a peak flow meter is a device is used to measure the respiratory function of those managing respiratory conditions such as asthma and chronic obstructive pulmonary disease. The ability to identify declining respiratory status prior to the need for acute intervention improves the quality of life for the individual while reducing the overall costs of care. Respiratory status data are collected by a personal respiratory monitoring device and forwarded to a central data repository for review and action by a health care provider. The data are episodic in nature and are forwarded at designated intervals or when the person is symptomatic.
- Standard77 pagesEnglish languagee-Library read for1 day
This document presents a case study of a quality management process to support the integration of medical information storage within a hierarchical storage structure, across multiple medical sites. This case study examines how it was used within the MID-NET® Project,[5] utilizing the hierarchical storage structure conformant with ISO/TS 24289. This document does not address issues related to the protection of patient privacy, network security, or the management of patient identifiers and information processes.
- Technical report16 pagesEnglish languagesale 15% off
This document provides information security controls, including implementation guidance, for health organizations. It is based on ISO/IEC 27002:2022 In addition to generic ICT equipment and software used in many other environments, the scope of this document includes software and systems specifically for healthcare, such as electronic health record systems and medical devices incorporating health software. Such medical devices can be programmed or programmable and can contain software, firmware or both. Other digital equipment (such as that for environmental and infection control, building management, and physical security), which can be used in premises where healthcare is provided, is also in scope. This document applies to information in all its aspects, whatever form the information takes (including text and numbers, sound recordings, drawings, images and video), by whatever means it has been acquired or captured, whatever means are used to store it (such as printing or writing on paper or storage electronically), and whatever means are used to transfer or exchange it (orally, by hand, by post, movement of storage media, direct links or networking). This document is for organizations of all types and sizes that provide healthcare or are custodians of personal health information for other reasons. The information that they are responsible for can be stored and processed in many possible ways and locations, including on premises or in the cloud, but remains in scope. This document applies to all physical settings where healthcare is intended to be delivered, such as hospitals, clinics and other locations or facilities designated for healthcare purposes such as ambulances and mobile imaging or diagnostic units. It also applies to care provided elsewhere, such as in residential premises. In addition to the range of settings, this document applies to all methods of service provision including remote or virtual healthcare.
- Standard72 pagesEnglish languagesale 15% off
- Standard82 pagesFrench languagesale 15% off
This document showcases existing practices to monitor supply chains as implemented in the healthcare supply chains, by making use of medicines verification or authentication systems, or both, traceability tools, safe communication technology solutions, and more. This document also discusses the potential benefits of expanding the identification of medicinal products (IDMP) to provide global identifiers for medicinal products, ingredients and batches. It also addresses potential pathways to a global registration system.
- Technical report13 pagesEnglish languagesale 15% off
This document describes the core principles for supporting the development, implementation and ongoing maintenance of IDMP identifiers and terminologies. This document provides considerations for the evaluation and/or design when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.
- Technical report15 pagesEnglish languagesale 15% off
This document defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It covers only 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.
This document helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. In order to do that, this document focuses on defining characteristics and functions of terminological resources in healthcare that can be used to identify different types of terminological resources for categorization purposes.
NOTE 1 Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past.
The following aspects are not covered in 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;
NOTE 2 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 classification systems 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;
NOTE 3 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.
- Standard32 pagesEnglish languagee-Library read for1 day