ISO/TC 215 - Health informatics

This document specifies requirements and recommendations for remote maintenance services (RMSs) of medical devices and medical information systems in healthcare facilities (HCFs). This document is applicable to HCFs and remote service centres (RSCs) providing remote maintenance services for medical devices and medical information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.

This document describes a methodology for specifying the privileges necessary to access electronic health record (EHR) data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1 [17]. This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points to technical solutions and standards that specify details on services meeting these security needs. NOTE Security requirements for EHR systems not related to the communication of EHRs are outside the scope of this document.

This document specifies interoperability requirements for personal health decision support (PHDS) services between actors in the PHDS environment, which include PHDS services, data providers, and PHDS clients. It includes requirements for data exchange, validation, and error handling among participants to support accurate and timely decision-making. It also describes the privacy and security considerations for PHDS. However, the specifics of how PHDS services are developed or implemented are not covered.

This document defines the terms used in the ISO standards on the identification of medicinal products (IDMP) and their related technical specifications.

This document specifies procedures for gene expression-based similarity calculation between human pluripotent stem cell (hPSC)-derived organoids and a pre-defined data set of gene expression profiles in normal tissues. This document covers situations where the gene expression in the organoids have been quantified in a way functionally similar to the samples in the pre-defined dataset, and it is not intended for medical decisions.

This document defines the requirements for a system of concepts for different aspects of the provision of care encompassing social care as well as clinical care. The focus of this document is continuity of care. This document defines requirements for a system of concept definitions needed to describe health and care businesses. Concept systems conforming to this document can be used to support the development of: logical reference models within the information viewpoint as a common basis for semantic interoperability on international, national or local levels; information systems; information for specified types of care processes. This document does not specify how to perform specific care processes. This document does not cover research processes in the context of social and clinical care, welfare and educational processes.

This document indicates the data elements and structure suited to accurately and consistently identify persons (including subjects of care), healthcare providers and healthcare organizations. The data elements names and definitions are provided in Clause 3; the full data element definitional structure is given in Clauses 5, 6 and 7. This document identifies conformance requirements in the following use cases: Populate and manage an index or registry. This can include the storage of a person, healthcare provider or organization within an index or registry. Record or share information for administrative purposes. Record or share information for clinical purposes. Application of this document will increase the capacity for data access. Authorization of such access is determined by the application of legislation, organizational policies and guidelines, and professional ethics. It is recognized that specific applications might require additional data to fulfil their purpose, such as value sets or adjustments to conformance requirements. This document provides a generic set of identifying information, which is application-independent. Implementations in different healthcare environments and national settings can require the establishment of data sub-sets, additional guidelines and rules in the use of the data elements. The following are outside the scope of this document: Additional factors to be considered in providing access to distributed person data, including privacy, security, authentication, access and data transfer mechanisms. Collection and processing of data for purposes other than the identification of persons and their associated records, even though some of the data elements collected for identification can be used for other purposes such as the determination and delivery of care, the compilation of statistics, contact tracing and reimbursement. This includes clinical content, care processes and financial identifiers not used for person or provider identification. Handling of person electronic consent in forms and other use cases, although this can be considered for addition by implementers and dependent on electronic signature policy for medical records. Naming conventions, and rules for specifying data element names and data element definitions.

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.

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.

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.

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.

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.

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.

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.

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.

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].

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.

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.

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.

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 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.

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.