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 1151 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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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.
- Draft36 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.
- Draft43 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 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 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 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.
- Draft23 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 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 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 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
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.
- Standard23 pagesEnglish languagesale 15% off
- Standard25 pagesFrench languagesale 15% off
This document specifies the categorial structure within the subject field of acupuncture by defining a set of domain constraints of sanctioned characteristics, each composed of a semantic link and an applicable characterizing category, in order to represent the concept of acupuncture point.
- Standard10 pagesEnglish languagesale 15% off
This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard59 pagesEnglish languagee-Library read for1 day
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard46 pagesEnglish languagee-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices 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 appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models and application profile. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a user’s adherence to a medication regime.
- Standard82 pagesEnglish languagee-Library read for1 day
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.
- Standard85 pagesEnglish languagee-Library read for1 day
This document provides the findings of a global, country-based survey on the current state, challenges and need for standardization in secondary use of clinical genomics data in medicine. This document excludes the primary use of clinical genomics data as well as specific data, metadata, or policies regarding the secondary use of clinical genomics data.
- Technical report13 pagesEnglish languagesale 15% off
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagee-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs 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 appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined, for example, to determine when a person’s activities/behaviors have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
- Standard46 pagesEnglish languagee-Library read for1 day
This document defines the core data set for a concise international patient summary (IPS), which supports continuity of care for a person and assists with coordination of their care.
This document provides an abstract definition of a patient summary from which derived models are implementable.
This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence, skills and competences, that results in the data summarization workflow. It is not an implementation guide that is concerned with the various technical layers beneath the application layer. Representation by various coding schemes, additional structures and terminologies are not part of this document.
- Standard94 pagesEnglish languagee-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagee-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard128 pagesEnglish languagesale 15% off
- Standard146 pagesFrench languagesale 15% off
This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the life cycle of health software and health IT systems, for the information exchange between the health software manufacturers (including medical device manufacturers), healthcare delivery organizations (HDOs) and other stakeholders. It is applicable to health software running on any platform and in any environment such as cloud, on premise or hybrid. While important security topics, the following are outside the scope of this document: a) the security policies of the HDO, b) the product and services security policies of the manufacturer, c) determinations of risk tolerance by the HDO or manufacturer, and d) clinical studies where there is a need to secure personal data. As security risks can be caused by any product on health IT systems and health IT Infrastructure, considerations in this document can be applied for other products that are not health software. IEC TS 81001-2-2:2025 withdraws and replaces: – IEC TR 80001-2-2, Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls – IEC TR 80001-2-8, Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 This document includes the following significant changes: a) Combines and updates the contents of IEC TR 80001-2-2 and IEC TR 80001-2-8; b) Extends the scope to health software instead to only medical device software; c) Aligns contents and definitions to ISO 81001-1:2021 and the updated IEC 80001-1; d) Removed the Configuration of Security Features (CNFS) capability, as any configurable security capability shall be clearly communicated. e) Provide security control mappings to several new standards, e.g. IEC TR 60601-4-5, IEC 62443-4-2, ISO/IEEE 11073-40102 and the recent versions of previous standards, e.g. ISO/IEC 27002 and NIST 800-53 version 5.
- Technical specification96 pagesEnglish languagesale 15% off
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs 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 appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined, for example, to determine when a person’s activities/behaviors have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
- Standard46 pagesEnglish languagee-Library read for1 day
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard46 pagesEnglish languagee-Library read for1 day
IEC TS 81001-2-2:2025 presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the life cycle of health software and health IT systems, for the information exchange between the health software manufacturers (including medical device manufacturers), healthcare delivery organizations (HDOs) and other stakeholders. It is applicable to health software running on any platform and in any environment such as cloud, on premise or hybrid.
While important security topics, the following are outside the scope of this document:
a) the security policies of the HDO,
b) the product and services security policies of the manufacturer,
c) determinations of risk tolerance by the HDO or manufacturer, and
d) clinical studies where there is a need to secure personal data.
As security risks can be caused by any product on health IT systems and health IT Infrastructure, considerations in this document can be applied for other products that are not health software.
IEC TS 81001-2-2:2025 withdraws and replaces:
– IEC TR 80001-2-2, Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls
– IEC TR 80001-2-8, Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
This document includes the following significant changes:
a) Combines and updates the contents of IEC TR 80001-2-2 and IEC TR 80001-2-8;
b) Extends the scope to health software instead to only medical device software;
c) Aligns contents and definitions to ISO 81001-1:2021 and the updated IEC 80001-1;
d) Removed the Configuration of Security Features (CNFS) capability, as any configurable security capability shall be clearly communicated.
e) Provide security control mappings to several new standards, e.g. IEC TR 60601-4-5, IEC 62443-4-2, ISO/IEEE 11073-40102 and the recent versions of previous standards, e.g. ISO/IEC 27002 and NIST 800-53 version 5.
- Technical specification103 pagesEnglish languagesale 15% off
This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard59 pagesEnglish languagee-Library read for1 day
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.
- Standard85 pagesEnglish languagee-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices 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 appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models and application profile. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a user’s adherence to a medication regime.
- Standard82 pagesEnglish languagee-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard78 pagesEnglish languagee-Library read for1 day
The scope of this document is constrained to the content of the electronic prescription (ePrescription) itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. The ePrescription in the administrative workflow of reimbursement is not covered in this document.
This document specifies the requirements that apply to ePrescriptions. It describes generic principles that are considered important for all ePrescriptions.
This document is applicable to ePrescriptions of medicinal products for human use. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an ePrescription, the requirements in this document are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy.
This document does not limit the scope to any setting (community, institutional) and leaves it to the national bodies to decide on this matter.
This document specifies a list of data elements that can be considered as essential for ePrescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.). Ensuring the authenticity of these data elements is in scope and will have impact on the requirements of information systems.
Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are not covered in this document, because they are country-specific or region-specific, due to differences in culture and in legislation of healthcare. However, requirements and content of ePrescriptions within the context of jurisdictions have a relationship with these scenarios. This document also does not cover the way in which ePrescriptions are made available or exchanged, and the process of prescribing itself.
The logistic process of prescribing itself is not part of the scope. A prescription can either be sent (pushed) to a dispenser or either be retrieved (pulled) at the dispenser. However, the requirement for the prescription is described, that it will be able to function in both environments.
- Standard32 pagesEnglish languagee-Library read for1 day
The HL7 EHR System Functional Model 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, realms, services and specialties, 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).
The HL7 EHR-S Functional Model defines a standardized model of the functions that may be present in EHR
Systems. From the outset, a clear distinction between the EHR as a singular entity and systems that operate on
the EHR – i.e., EHR Systems is critical. This Standard makes no distinction regarding implementation - the EHRS
described in a Functional Profile may be a single system or a system of systems. Within the normative sections
of the Functional Model, the term “system” is used generically to cover the continuum of implementation options.
This includes “core” healthcare functionality, typically provided by healthcare-specific applications that manage
electronic healthcare information. It also includes associated generic application-level capabilities that are
typically provided by middleware or other infrastructure components. The latter includes interoperability and
integration capabilities such as location discovery and such areas as cross application workflow. Interoperability
is considered both from semantic (clear, consistent and persistent communication of meaning) and technical
(format, syntax and physical connectivity) viewpoints. Further, the functions make no statement about which
technology is used, or about the content of the electronic health record. The specifics of 'how' EHR systems are
developed or implemented is not considered to be within the scope of this model now or in the future. This EHRS
Functional Model does not address or endorse implementations or technology, nor does it include the data
content of the electronic health record.
Finally, the EHR-S Functional Model supports research needs by ensuring that the data available to researchers
follow the required protocols for privacy, confidentiality, and security. The diversity of research needs precludes
the specific listing of functions that are potentially useful for research.
This Functional Model is not:
• a messaging specification
• an implementation specification
• a conformance specification
• an EHR specification
• a conformance or conformance testing metric
• an exercise in creating a definition for an EHR or EHR-S
It is important to note that the EHR-S Function Model does not include a discussion of clinical processes or the
interaction of the healthcare actors. However, ISO 13940 Health Informatics – System of Concepts to Support
Continuity of Care, is an international standard that does outline key principles and processes in the provision of
healthcare. It is recommended that users of the EHR-S FM refer to this standard for clinical processes that EHR
systems support.
This EHR-S Functional Model package includes both Reference and Normative sections. Table 1 explains the
differences between Reference and Normative sections.Each section within this document is clearly labeled "Normative" if it is normative. For example, in section 5
(Overview) section 5.3 is normative. In section 7, Conformance Clause; sections 7.1 through 7.6 are normative.
In the external Annex A, Function List, the Function ID, Function Name, Function Statement, and Conformance
Criteria components are Normative in this Functional Model.
- Standard79 pagesEnglish languagee-Library read for1 day
This document defines the core data set for a concise international patient summary (IPS), which supports continuity of care for a person and assists with coordination of their care.
This document provides an abstract definition of a patient summary from which derived models are implementable.
This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence, skills and competences, that results in the data summarization workflow. It is not an implementation guide that is concerned with the various technical layers beneath the application layer. Representation by various coding schemes, additional structures and terminologies are not part of this document.
- Standard94 pagesEnglish languagee-Library read for1 day
This document reviews the structural changes that have been precipitated by the COVID-19 pandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19 pandemic on care settings such as home and community care, acute care and outpatient care are reviewed discussing how well these healthcare environments were prepared to address the encountered connectivity challenges from a standards point of view. The current standards landscape is reviewed and gaps are identified leading to recommendations for future standards work.
- Technical specification101 pagesEnglish languagee-Library read for1 day