Informationsteknik, kontorsutrustning

This document outlines the conceptual framework and methodology for linking abstract concepts between BIM and GIS standards to facilitate BIM/GIS interoperability. This document provides the mechanisms to establish links between abstract concepts in both domains in terms of metamodels, abstract conceptual schemas and application schemas.

This document specifies additional requirements to ISO/IEC 17021-1. The requirements contained in this document, when implemented, support the demonstration of competence, consistency and reliability by the bodies performing auditing and certification of an artificial intelligence management system (AIMS) according to ISO/IEC 42001 for organizations that provide, develop or use AI systems. Certification of AIMS is a third-party conformity assessment activity (as described in ISO/IEC 17000:2020, 4.5), and bodies performing this activity are third-party conformity assessment bodies. This document also provides the necessary information and confidence to customers about the way certification has been granted. NOTE This document can be used as a criteria document for accreditation or peer assessment.

This document provides a high-level framework and guidance for the development and operation of conformity assessment schemes, including certification schemes, for artificial intelligence (AI) systems.

This standard proposal outlines artificial intelligence (AI) concepts, applications, and implications, as well as benefits, risks, governance framework, and scope for use by organizations within the context of project, programme, and portfolio management (P3M). This proposed standard is intended to supplement the other TC 258 standards and is in direct alignment with standards prepared by ISO/TC 258. This document provides guidance for organizations on what to consider when adopting or looking to improve on existing AI technologies that directly support P3M. This proposed standard is applicable to any organization, including public, private, and charitable, as well as to any type of project, regardless of purpose, delivery approaches, project or programme lifecycle model used, complexity, size, cost, or duration. This document also provides (P3M) practitioners (including top-level management, project managers, PMO’s, etc.) with AI-related guidance and consideration in the areas of security, privacy, transparency, and bias, as well as related data governance, ethical and risk considerations.

This document provides guidance for sectoral stakeholders and product manufacturers in generating ICT product-relevant information based on EN 18037. Sectoral stakeholders are supported in applying the risk and cybersecurity assessment methodology so that the information needs of product manufacturers are covered by the sectoral assessment report. Product manufacturers receive guidance in using methodology according to EN 18037 for own assumptions of their ICT product’s sector-specific risks and security requirements. This document uses a step-by-step approach for guiding sectoral stakeholders and product manufacturers through the assessment. For each step, the relevant information provided by EN 18037 is summarized or referenced and the enhancements or clarifications in support of the information needs of the ICT product manufacturers are pointed out. From the perspective of product manufacturers, the re-use of existing product-specific specifications and certification tools is of particular relevance. Therefore, this document provides guidance how the results of sectoral assessments according to EN 18037 can be connected with these specifications and tools.

This document specifies the evaluation of natural language processing systems, in the sense of measuring the quality of a system’s results to assess its functional suitability. It provides a definition of evaluation methods for those systems, together with guidance on how to select, implement and interpret those evaluation methods. This document covers quantitative metrics as well as other evaluation methods. It includes requirements on the implementation of the described metrics, and further requirements on the technical resources involved in the evaluation process.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices is defined in this standard.

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document useful. This Part 1 of the multipart series is an Information Viewpoint specification as defined by the Open Distributed Processing ? Reference model: Overview (ISO/IEC 10746-1). This document is not intended to specify the internal architecture or database design of EHR systems.

This document outlines a core dataset designed for a concise dental data exchange intended to support continuity and coordination of care. It provides a conceptual framework for a dental data for exchange that can serve as the basis for implementation models. The content reflects an international perspective on organizing dental information for cross-border exchange. It offers guidance on the essential data elements that should be shared globally and proposes a standardized format for their representation. The document focuses on defining the structure of the data to be exchanged (“the what”) without prescribing the specific methods or technologies used for transmission (“the how”). It does not include guidance on operational workflows such as data entry, collection, summarization, or integration. Nor does it address the competencies required to perform those tasks. Furthermore, it is not intended as an implementation guide and does not cover the underlying technical infrastructure or the use of particular coding systems, data formats, or terminologies.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in ISO/IEEE11073-10406:2012. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena. ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10417:2017 establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines (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, information models, 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 for personal telehealth glucose meters.

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

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

ISO 25237:2017 contains principles and requirements for privacy protection using pseudonymization services for the protection of personal health information. This document is applicable to organizations who wish to undertake pseudonymization processes for themselves or to organizations who make a claim of trustworthiness for operations engaged in pseudonymization services. ISO 25237:2017 - defines one basic concept for pseudonymization (see Clause 5), - defines one basic methodology for pseudonymization services including organizational, as well as technical aspects (see Clause 6), - specifies a policy framework and minimal requirements for controlled re-identification (see Clause 7), - gives an overview of different use cases for pseudonymization that can be both reversible and irreversible (see Annex A), - gives a guide to risk assessment for re-identification (see Annex B), - provides an example of a system that uses de-identification (see Annex C), - provides informative requirements to an interoperability to pseudonymization services (see Annex D), and - specifies a policy framework and minimal requirements for trustworthy practices for the operations of a pseudonymization service (see Annex E).

This document describes the key actors in the eCall chain of service provision in hybrid circuit switched/packet switched network environments as: 1) In-Vehicle System (IVS)/vehicle, 2) Mobile Network Operator (MNO), 3) Public Safety Answering Point (PSAP), and to provide conformance tests for actor groups 1) – 3). NOTE 1 Conformance tests are not appropriate nor required for vehicle occupants, although they are the recipient of the service. NOTE 2 Third party eCall systems (TPS-eCall) are not within the scope of this deliverable. This is because the core TPS-eCall standard (EN 16102) does not specify the communications link between the vehicle and the TPS service provider. NOTE 3 These conformance tests are partly based on the appropriate conformance tests from EN 16454 and CEN/prEN 17240. This deliverable therefore adapts and revises Conformance Test Protocols (CTP) from EN 16454 and CEN/prEN 17240 for hybrid circuit switched/packet switched network environments. This document complements EN 16454 and CEN/prEN 17240 and provides a suite of conformance tests for IVS equipment, MNOs and PSAPs, required to ensure and demonstrate compliance with CEN/prEN 17905. The scope covers conformance testing of new engineering developments, products and systems, and does not imply testing associated with individual installations in vehicles or locations.

This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. This document also establishes a coherent concepts and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.

This document is applicable to all parties involved in the health software and health IT systems life cycle including the following:

a) Organizations, health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating health software and health IT systems – for example health software developers and medical device manufacturers, 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 specifies the information architecture required for interoperable communications between systems and services that need or provide EHR data. This document is not intended to specify the internal architecture or database design of such systems. The subject of the record or record extract to be communicated is an individual person, and the scope of the communication is predominantly with respect to that person's care. Uses of healthcare records for other purposes such as administration, management, research and epidemiology, which require aggregations of individual people's records, are not the focus of this document but such secondary uses could also find the document useful. This document defines a set of interfaces to request and provide: — an EHR_EXTRACT for a given subject of care as defined in ISO 13606-1; — one or more ARCHETYPE(s) as defined in ISO 13606-2; — an EHR_AUDIT_LOG_EXTRACT for a given subject of care as defined in ISO 13606-4. This document defines the set of interactions to request each of these artefacts, and to provide the data to the requesting party or to decline the request. An interface to query an EHR or populations of EHRs, for example for clinical audit or research, are beyond its scope, although provision is made for certain selection criteria to be specified when requesting an EHR_EXTRACT which might also serve for population queries. This document defines the Computational Viewpoint for each interface, without specifying or restricting particular engineering approaches to implementing these as messages or as service interfaces. This document effectively defines the payload to be communicated at each interface. It does not specify the particular information that different transport protocols will additionally require, nor the security or authentication procedures that might be agreed between the communicating parties or required by different jurisdictions.

This document comprises multiple human and machine-readable resources with different roles that together define a vocabulary for representing some spatial information according to a data model and extensions to a query language for accessing that information. See the Introduction section 0.4 for details of the parts.

It does not define a comprehensive vocabulary for representing all spatial information: it only defines a core set of classes, properties and datatypes that can be used to construct query patterns. Many useful extensions to this vocabulary are possible, and we intend for the Semantic Web and Geospatial communities to develop additional vocabularies for describing spatial information.