This document defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiography waveforms measured in physiological laboratories, hospital wards, clinics, and primary care medical checkups. It covers electrocardiography such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, and exercise tests that are measured by inspection equipment such as electrocardiographs and patient monitors that are compatible with MFER. Medical waveforms that are not in the scope of this document include Holter ECG, exercise stress ECG, and real-time ECG waveform encoding used for physiological monitors.

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This document defines the application of medical waveform format encoding rules (MFER) to describe long-term electrocardiography waveforms measured in physiological laboratories and health care clinics. It covers electrocardiography such as bipolar 2, 3-lead, 12-lead that are measured by medical equipment such as Holter electrocardiograph and patient physiological monitors that are compatible with MFER documents encoding rules (see ISO 22077-1).

  • Standard
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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.

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This document specifies:
—     the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

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This document specifies clinical sequencing information generated by massive parallel sequencing technology for sharing health information via massively parallel sequencing. This document covers the data fields and their metadata from the generation of sequence reads and base calling to variant evaluation and assertion for archiving reproducibility during health information exchange of clinical sequence information. However, the specimen collection, processing and storage, DNA extraction and DNA processing and library preparation, and the generation of test report are not in the scope of this document. This document hence defines the data types, relationship, optionality, cardinalities and bindings of terminology of the data. In essence, this document specifies: — the required data fields and their metadata from generation of sequence reads and base calling to variant evaluation and assertion for sharing clinical genomic sequencing data files generated by massively parallel sequencing technology, as shown in Figure 1; — the sequencing information from human samples using DNA sequencing by massively parallel sequencing technologies for clinical practice.

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This document specifies the common conventions required for the interchange of specific patient data (demographic, recording conditions ...), ECG signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results. This document specifies the content and structure of the information which may be interchanged between digital ECG electrocardiographs/devices and computer ECG management systems, as well as other computer or information systems (cloud, etc.) where ECG data can be stored. This document defines the way to describe and encode standard and medium to long-term electrocardiogram waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups, ambulatory and home care. It covers electrocardiograms such as 12-lead, 15-lead, 18-lead, Cabrera lead, Nehb lead, Frank lead, XYZ lead, Holter ECGs and exercise ECGs that are recorded, measured and analysed by equipment such as electrocardiographs, patient monitors, wearable devices. It also covers intracardiac electrograms recorded by implantable devices as well as the analysis results of ECG analysis and interpretation systems and software that are compatible with SCP-ECG. ECG waveforms and data that are not in the scope of this document include real-time ECG waveform encoding and analysis used for physiological monitors, and intra-cardiac or extra cardiac ECG mapping.

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This document specifies an information model representing the quality control of the manufacturing process of traditional Chinese medicinal products by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship. It is applicable to the quality supervision and management of manufacturing process of Chinese materia medica. Japanese KAMPO medicine is outside the scope of this document.

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This document deals with the reporting of data to support improved public health, more effective health care and better health outcomes. This document provides guidance and requirements for those developing or deploying a healthcare data reporting service, addressing data capture, processing, aggregation and data modelling and architecture and technology approaches. The role of a healthcare data reporting service is to enable data analyses in support of effective policies and decision making, to improve quality of care, to improve health services organizations and to influence learning and research. This document has relevance to both developing and more established health systems. It enables meaningful comparison of programs and outcomes.

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This document specifies:
—     the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

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This document describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

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This document specifies the requirements for medical image-based modelling for 3D printing for medical applications. It concerns accurate 3D data modelling in the medical field using medical image data generated from computed tomography (CT) devices. It also specifies the principal considerations for the general procedures of medical image-based modelling. It excludes soft tissue modelling from magnetic resonance image (MRI).

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This document seeks to establish a baseline understanding of Ayurvedic medicine system. It introduces various elements and processes inherent and integral to Ayurvedic diagnosis and treatment. It establishes concept models for Ayurvedic analysis of a subject which can potentially form the basis of system models. The following topics are out of scope of this document: — concept models and categorial structures for the individual elements of the concept models proposed. — individual Ayurvedic dosage forms or medicines or therapies.

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This document lists characteristics of a category of health software: digital therapeutics (DTx). DTx products generate and deliver medical interventions that are based on clinical evidence, have demonstrable positive therapeutic impacts on patient health, and produce real-world outcomes. Product use cases (see Annex B) demonstrate the variety of products represented in this quickly growing industry. This document provides an overview of how DTx relates to other ecosystem constructs, including medical devices, software as a medical device (SaMD), software in a medical device (SiMD), and other digital health technologies (DHT). It also addresses relevant health and medical device software standards that have various degrees of applicability to DTx. The focus of this document is on therapeutic products that are used in the context of a disease, disorder, condition, or injury for human use. It does not address products that are intended for veterinary use or for general wellbeing. Additional exclusions of this document include DTx market access pathways (i.e. prescription, non-prescription pathways), medical device requirements, product risk assessment, clinical evidence requirements, data security, patient privacy considerations, and product authorization pathways.

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This document specifies: — the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products; — a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; — a mechanism for the versioning of the concepts in order to track their evolution; — rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

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  • Standard
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This document reports on the datasets and a data structure for reporting clinical and biological evaluation metrics (CBEMs). The reporting of radiation dose estimates is outside the scope of this document. This document is applicable to CBEMs for external-beam radiation therapy (EBRT) modalities, but not CBEMs for brachytherapy or molecular radiotherapy. Various types of radiotherapy treatment modalities are available for cancer care. Consequently, there is a growing awareness of the need for objective schemes that will contribute to enable the selection of an appropriate radiotherapy treatment modality for individual patients. The use of CBEMs, the metrics associated with a certain radiotherapy treatment plan for a patient, is attracting attention for clinical purposes in the field of EBRT. In anticipation of the clinical use of CBEMs, the importance of research on clinical and scientific aspects of CBEMs is increasing, in concert with the importance of establishing a standardized data format for reporting of specifics of a CBEM.

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ISO/IEEE 11073-10404:2010 establishes a normative definition of communication between personal telehealth pulse oximeter devices and computer engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play (PnP) 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability.
ISO/IEEE 11073-10404:2010 defines a common core of communication functionality for personal telehealth pulse oximeters and addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

  • Standard
    87 pages
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This document specifies requirements on the category definition and quality assessment of genomic data, including the content structure, attribute and description rules of data format, and the compilation rules of data format. This document applies to all the genomic data used for human genetic detection products and services. This document applies to genomic data processing and analysis, and to the quality evaluation/assessment of genomic data.

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    17 pages
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This document identifies data elements and metadata to represent the information about microsatellite instability (MSI) for reporting the value of the biomarker using clinical massive parallel DNA sequencing. This document covers information about the MSI test result and related data, such as used resources, data generation condition, and data processing information which are helpful to clinical diagnosis and research. This document is not intended — for defining experimental protocols or methods for calculating the value of microsatellite instability (MSI), — for the other biological species than human resource, or — for the Sanger sequencing methods.

  • Technical specification
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This document describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

  • Technical specification
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This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing 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 and IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10420:2012 defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance.

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ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors.
ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

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    73 pages
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Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard defines a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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ISO/IEEE 11073-10415:2010 establishes a normative definition of communication between personal telehealth weighing scale devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth weighing scales.
ISO/IEEE 11073-10415:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

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ISO/IEEE 11073-10408:2010 establishes a normative definition of communication between personal telehealth thermometer devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth thermometers.
ISO/IEEE 11073-10408:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.

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This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
—    management of telehealth quality processes by the healthcare organization;
—    strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
—    healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
—    management of financial resources to support telehealth services;
—    management of information management and security used in telehealth services;
—    processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.

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This document describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts. This document is intended for use by: — any organization that might be responsible for developing and maintaining such controlled vocabularies; — any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created; — owners of databases who want to map their own terms to a standardized list of controlled vocabularies; — other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept. This document does not specify a particular terminology for the implementation of ISO 11239.

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    45 pages
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    45 pages
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This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

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This document specifies the measurement data output formats for devices used in general ophthalmic examiniations, including the following modalities: — Refractometer (REF) Refraction — Keratometer (KM) Corneal curvature — Tonometer (TM) Intraocular pressure — Lensmeter (LM) Spectacle lens power — Phoroptor (PHOR) Visual acuity This document only addresses text-based device reporting of ophthalmic examination device data (OEDD). Images generated as needed during an ophthalmic examination are outside the scope of this document.

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This document specifies the data output formats for the specular microscope. The data are usually sent from the specular microscope to either an ophthalmic information system (OIS) or a hospital information system (HIS). This document addresses text-based analysis reporting of the specular microscope measured and analysed data such as the central corneal thickness, the density of endothelial cells per 1 mm2, the coefficient variant, and the ratio of endothelial cells with a hexagonal shape.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (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, 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 document defines a common core of communication functionality for personal telehealth pulse oximeters.

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    85 pages
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Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth blood pressure monitor 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 document defines a common core of communication functionality for personal telehealth blood pressure monitors.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth thermometer 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 document defines a common core of communication functionality for personal telehealth thermometer devices.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth weighing scale 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 document defines a common core of communication functionality for personal telehealth weighing scales.

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Within the context of the ISO/IEEE 11073 personal health device standard family, this document defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This document establishes a common framework for an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal body composition analyzer agents and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established by this document 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 to restrict optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth body composition analyzers. In this context, the phrase “body composition analyzer” is used broadly to cover analyzing devices that measure body impedances and compute the various body components including body fat from the impedance.

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This part of IEC 63203-801 specifies the ultra-low power physical layer (PHY) Smart BAN. As the use of wearables and connected body sensor devices grows rapidly in the Internet of Things (IoT), Wireless Body Area Networks (BAN) facilitate the sharing of data in smart environments such as smart homes, smart life etc. In specific areas of digital healthcare, wireless connectivity between the edge computing device or hub coordinator and the sensing nodes requires a standardized communication interface and protocols. The present document describes the Physical Layer (PHY) specifications: - packet formats; - modulation; - forward error correction

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This part of IEC 63203-801 specifies low complexity Medium Access Control (MAC) for SmartBAN. As the use of wearables and connected body sensor devices grows rapidly in the Internet of Things (IoT), Wireless Body Area Networks (BAN) facilitate the sharing of data in smart environments such as smart homes, smart life etc. In specific areas of digital healthcare, wireless connectivity between the edge computing device or hub coordinator and the sensing nodes requires a standardized communication interface and protocols. The present document describes the MAC specifications: - Channel Structure, - MAC Frame Formats, - MAC functions.

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Within the context of the ISO/IEEE 11073 personal health device standard family, this document defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This document establishes a common framework for an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this DOCPROPERTY GorRPorSTD \*Lower \* MERGEFORMAT document establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (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, 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 DOCPROPERTY GorRPorSTD \*Lower \* MERGEFORMAT document defines a common core of communication functionality for personal telehealth pulse oximeters.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this DOCPROPERTY GorRPorSTD \*Lower \* MERGEFORMAT document establishes a normative definition of communication between personal telehealth thermometer 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 DOCPROPERTY GorRPorSTD \*Lower \* MERGEFORMAT document defines a common core of communication functionality for personal telehealth thermometer devices.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this DOCPROPERTY GorRPorSTD \*Lower \* MERGEFORMAT document establishes a normative definition of communication between personal telehealth weighing scale 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 DOCPROPERTY GorRPorSTD \*Lower \* MERGEFORMAT document defines a common core of communication functionality for personal telehealth weighing scales.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal body composition analyzer agents and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established by this document 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 to restrict optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth body composition analyzers. In this context, the phrase “body composition analyzer” is used broadly to cover analyzing devices that measure body impedances and compute the various body components including body fat from the impedance.

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth blood pressure monitor 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 document defines a common core of communication functionality for personal telehealth blood pressure monitors.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental
case data and CAD/CAM data between software systems.

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This document specifies a number of metadata elements that describe resources containing medical
knowledge, primarily digital documents provided as web resources, accessible from databases or via
file transfer, but can be applicable also to paper documents, e.g. articles in the medical literature.
The metadata elements
— support unambiguous and international understanding of important aspects to describe a resource,
e.g. purpose, issuer, intended audience, legal status and scientific background,
— are applicable to different kinds of digital resources, e.g. recommendation from consensus
of a professional group, regulation by a governmental authority, clinical trial protocol from a
pharmaceutical company, scientific manuscript from a research group, advice to patients with a
specific disease, review article,
— are possible to present to human readers including health professionals as well as individuals/
patients, and
— are potentially usable for automatic processing, e.g. to support search engines to restrict matches to
documents of a certain type or quality level.
The metadata elements defined in this document are not intended to
— describe documents about a single patient, such as medical records,
— describe details of the medical content of the resource (but some idea of the content can be described
via keywords or codes), or
— prescribe criteria for the quality of the resource content.

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This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
—    management of telehealth quality processes by the healthcare organization;
—    strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
—    healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
—    management of financial resources to support telehealth services;
—    management of information management and security used in telehealth services;
—    processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.

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This document reposts a case study on how to establish and maintain standardized cardiac examination export measurement data (CE-EMD), especially for enabling its secondary use for medical research. The document includes information for CE-EMD on: — Building a representative coalition of stakeholders to identify and establish specifications; — Standardizing both the content and format in reports; — Maintaining and extending the specifications over time. Out-of-scope for this document are any requirements for specific CE-EMD content or formatting. Also, this document is limited to cardiac examination reporting, and does not encompass other clinical care areas or reporting that have been standardized.

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