ISO/TC 215 - Health informatics

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

This document specifies categorial structures within the subject field of acupuncture needling (specialized for using filiform needles) by defining a set of domain constraints. This document describes a concept system detailing domain constraints of sanctioned characteristics, each composed of a semantic link and an applicable characterizing category.

This document provides guidance on how four complementary international standards can be used in combination by developers of health ICT systems and infrastructures. These standards, three published by CEN and ISO and one by HL7, are — ISO 13940:2015, — ISO 13606-1:2019, — ISO 13606-3:2019, and — HL7 Fast Health Interoperability Resources (FHIR) Release 4. This document defines mappings between these standards: between ISO 13940 and HL7 FHIR in both directions, between ISO 13606 and HL7 FHIR in both directions, it proposes the content of an HL7 FHIR profile corresponding to the ISO 13606-1:2019 “COMPOSITION” class. It also provides guidance and worked examples of the mapping between ISO 13606-3 Reference Archetypes corresponding to ISO 13940 and HL7 FHIR. This document also summarizes the extent to which the source concept is broader than or narrower than the best fit target concept. It also highlights mapping issues that adopters will need to be mindful of, where the representation capability of the standards differs.

This document specifies a reference architecture for event-based syndromic surveillance systems for infectious diseases. The system reference architecture addresses architectural components including concepts, data sources, and outputs of syndromic surveillance system. From the perspective of the diagnostic process,[ REF Reference_ref_11 \r \h 11 08D0C9EA79F9BACE118C8200AA004BA90B0200000008000000110000005200650066006500720065006E00630065005F007200650066005F00310031000000 ] this document covers the processes from the symptom-onset stage to the health-behaviour stage, which is prior to the healthcare-encounter stage. Non-infectious health hazards, such as natural disasters, human-induced emergencies and chronic diseases, and their associated surveillance systems are beyond the scope of this document.

This document provides quality requirements for producing a quality map between terminological systems. This document establishes measures which can be used to assess the quality and utility of a map between terminological resources. These measures can be used to determine the types and conformance levels of a map and their impact on common use cases in healthcare.

This document provides a telehealth cybersecurity reference model of the overall security framework for systems and services applied to telehealth. This document contains a general description of: — factors of telehealth cybersecurity threats; — relationships between security risks and safety risks in telehealth services; — methodologies for defining security levels in telehealth services; — a cybersecurity reference model of telehealth services. Defining the specific type of telehealth services is not covered in this document.

This document specifies a reference model for virtual reality (VR)-based clinical practice simulation. This model includes components, relations, data element and types, and roles of the users.

This document provides guidelines for the self-assessment questionnaire systems to be used for health. This document includes the following: — structure and components of the self-assessment questionnaire systems; — guidelines for administering and managing the self-assessment questionnaire systems; — basic data elements for interacting with the self-assessment questionnaire systems. This document does not define the contents of the self-assessment questionnaire specialised in healthcare domains or departments. The questionnaires themselves are out of the scope of this document since they are dependent on the intended purpose of the self-assessment questionnaire systems.

This document provides terminological concepts for the representation of human body movement and establishes the categories and relationships of text-based terminology and time-dependent body movement in 3D data. This document does not cover 3D graphic user interface, data structure, implementation and guidelines.

This document provides a concept and overview of the overall cybersecurity framework for systems and services applied to telehealth. This document contains a general description of: — concept and introduction of telehealth cybersecurity; — actors of telehealth services; — activities of telehealth services; — environments of telehealth services; — variables of telehealth security.

This document specifies a framework for the interoperability of services and information tailored towards personalized digital health informatics. It establishes a common set of requirements and data specifications necessary for multi-level interoperability, as well as for dynamic consent and knowledge sharing.

This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organizations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties. An assurance case can be used to communicate information and knowledge about different risks to other roles. This document establishes: — an assurance case framework for HDOs and health software and MDMs for identifying, developing, interpreting, updating and maintaining assurance cases. — one of the possible means to bridge the gap between manufacturers and HDOs in providing adequate information to support the HDOs risk management of IT-networks; — best practice by leveraging ISO/IEC/IEEE 15026-2 and other standards to identify key considerations and for the structure and contents of an assurance case, e.g. iterative and continuous approaches; — example structure, method and format to improve the consistency and comparability of assurance cases. This document is applicable to all parties involved in the health software and health IT systems life cycle, including: a) organizations, health informatics professionals and clinical leaders specifying, acquiring, designing, developing, integrating, implementing and operating health software and health IT systems, for example health software developers and MDMs, system integrators, system administrators (including cloud and other IT service providers); b) healthcare service delivery organizations, healthcare providers and others who use health software and health IT systems in providing health services; c) governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in an organization’s ability to consistently provide safe, effective and secure health software, health IT systems and services; d) organizations and interested parties seeking to improve communication in managing safety, effectiveness and security risks through a common understanding of the concepts and terminology used in safety, effectiveness and security management; e) providers of training, assessment or advice in safety, effectiveness and security risk management for health software and health IT systems; f) developers of related safety, effectiveness and security standards. This document is for use by organizations and people who build, acquire, operate, maintain, use or decommission health software and health IT systems (including medical devices). It is applicable to all organizations involved, regardless of size, complexity or business model.

This document identifies specialized use cases related to the information exchange between clinical laboratories and portable polymerase chain reaction (PCR) devices designed for real-time testing to diagnose infectious diseases. This document introduces the portable PCR devices for point-of-care testing (POCT). Characteristic and differentiated use cases of these devices are listed separately from those that occur with portable POCT devices in existing clinical laboratory. This document is applicable, but not limited, to the following use cases of portable PCR devices for POCT: a) general test; b) reconciliation of patient information; c) cancel and rerun test; d) on-site quality control (QC) process. This document also provides guidelines on how to represent and exchange results from portable PCR testing devices in a POCT environment applicable to the use cases described above. This document is not intended to provide guidelines relating to traditional diagnostic testing results within a clinical laboratory and does not cover cybersecurity aspect.

The document defines the progression of implementation of terminology capability in information systems. This document does not specify requirements for any specific terminological resource. It is intended to provide a basis for conformance criteria for terminological resources capabilities in specific use cases. This document does not cover in detail the software being used, though the capabilities of that software are included and impact the level of maturity reached. This document is applicable to terminological resources of all types, terminologies, classifications, value sets, code systems, and value domains.

This document is complementary to the Biomedical Research Integrated Domain Group (BRIDG) model. It is a high-level overview of BRIDG in general and BRIDG version 5.3.1 in specific. This document also provides necessary links to artifacts that detail the changes between BRIDG v3.2 and BRIDG v5.3.1[5] and to the BRIDG Release Download page.

This document specifies categorial structures including characterizing categories, domain constraints and semantic links for the representation of preparation of a decoction – an Ayurvedic medicinal water. This document does not cover: — the specification of categorial structures for hot infusion and cold infusion; — the specification of categorial structures for the representation of post-manufacturing processes such as packaging and labelling of Ayurvedic medicinal water; — individual Ayurvedic or herbal medicinal products.

This document specifies the core elements, the description model and typical categories of internet healthcare service patterns. This document applies to the development and application of internet healthcare service patterns.

This document specifies an immunization categorial structure and data elements for use as the basis for an immunization registry and in digital health solutions that require interaction with the immunization registry and other systems in the management of immunization information. The data set includes data element descriptions, requirements, considerations for implementation and conformance with the following use cases: — populate an immunization registry; — record and/or share a current immunization event; — record and/or share a historic immunization event; — create and/or share an immunization history; — create an immunization reminder; — create anonymized immunization reports; — schedule a new immunization event. This document has adopted data element names from relevant ISO standards and leverages and elaborates on the immunization data element descriptions and constraints provided in HL7 specifications. The structure of the data element definition provides: — business rules and requirements (e.g. rationale for including the data element and how the data element supports the use case); — the meaning of absent data and how it can be addressed; — how to represent the data if more information is required to clarify data type use and will include value set considerations. The use case and related data elements out of scope for this document include adverse event following an immunization.

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).

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.

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.

This DOCVARIABLE "txtGorRPorSTD" \* MERGEFORMAT \*Lowerstandard 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 DOCVARIABLE "txtGorRPorSTD" \* MERGEFORMAT \*Lowerstandard 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.

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.

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.

The document defines a data set for the safe and timely transfer of haemodialysis procedure for end-stage renal disease (ESRD) patients. The necessary information for dialysis is provided through required, conditionally-required and optional data fields of the data set. Complicated use cases are also described in this document. This document does not cover general quality requirements or system requirements for haemodialysis.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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