The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices. It identifies the functional components, their communication relationships as well as the binding of the components and communication relationships to protocol specifications.

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This standard formalises the dataset required to share information about the medical background and history of a patient from the patient’s country of affiliation with a healthcare professional in another country where unscheduled treatment is required. It uses the European guidelines (version 2, November 2016) as an official source for the requirements.
The scope for the ‘Patient Summary for Unscheduled, Cross-border Care’ standard is of international significance. This standard, therefore, complements co-ordinated international efforts to maximise its utility and value, providing an interoperable dataset specification.
The dataset is minimal and non-exhaustive, providing a robust, well-defined set of items that are specialty-agnostic, condition-independent and usable by all clinicians for the unscheduled care of a person. The dataset will also be usable as a valuable subset of data items for scheduled care. The dataset enables cross-border application and it will support national communication of patient summary data, thereby providing wider applicability and greater benefit from the standard for the continuity of care of a person in need.
This international standard does not cover workflow processes of data entry, data collection, the summarisation act nor subsequent data presentation. Implementation guidance for specifically European concerns, e.g., Directives, terminologies, formats etc., is in the associated Technical Specification.

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This document specifies a set of representational primitives and semantic relations needed for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time, and the exchange of time-related information that is expressed explicitly.
This document applies to both the representation of actual phenomena occurring in the real world (e.g. registrations in medical records) and to the description of concepts (e.g. medical knowledge bases).
This document is applicable to
a) developers of medical information systems where there might be a need for explicit time-related concepts for internal organization (e.g. temporal data bases, temporal reasoning systems),
b) information modellers or knowledge engineers building models for the systems mentioned in a),
c) experts involved in the development of semantic standards on precise subdomains in health care where time-related information needs to be covered, (e.g. in the study of pathochronology, i.e. the discipline dealing with the time course of specific diseases), and
d) developers of interchange formats for messages in which time-related information is embedded.
This document is not intended to be used directly for
— representing what is true in time,
— reasoning about time, or
— representation of metrological time.

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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.

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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.

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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 defines term lists that each specify the set of values for the particular attributes of the Reference Model defined in ISO 13606-1. It also defines normative and informative Reference Archetypes that enable frequently-occurring instances of EHR data to be represented within a consistent structure when communicated using this document.

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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) 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 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 standard series but such secondary uses might also find it useful.
This document defines an Archetype Model to be used to represent Archetypes when communicated between repositories, and between archetype services. It defines an optional serialised representation, which may be used as an exchange format for communicating individual archetypes. Such communication might, for example, be between archetype libraries or between an archetype service and an EHR persistence or validation service.

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This document describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1.
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 at 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.

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The main purpose of ClaML is to formally represent the content and hierarchical structure of healthcare classification systems in a markup language for the safe exchange and distribution of data and structure between organizations and dissimilar software products.
The scope of healthcare classification systems covered by this document encompasses terminologies, and is constrained to traditional paper-based systems (like ICD-10) and systems built according to categorial structures and a cross thesaurus (like ICNP)[2]. ClaML is intended for representation of healthcare classification systems in which classes have textual definitions, hierarchical ordering, named hierarchical levels (such as "chapter", "section"), inclusion and exclusion criteria, and codes. It is not intended to cover any formal representation, neither for definition or composition of concepts, nor for specification of classification rules. Systems with such formal specifications can at best be partially represented using ClaML, and are hence out of scope. Most of the notes and examples in this document relate to ICD. This is because ICD is the most common classification system in the scope of this document. As a highly complex classification system it is an inexhaustible source for examples of nearly any kind. But all these notes and examples represent also other similar classification systems, if applicable, which are usually less complex. An overview of currently known classification systems using ClaML is provided in a separate document which is electronically available (see 7.3).
This document is not intended to:
a) provide a normative syntax on how a healthcare classification system is to be constructed;
b) define link types between elements in a healthcare classification system (this is left to the developers of healthcare classification systems);
c) provide a representation for direct viewing or printing.

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This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

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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.

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ISO/TS 20443:2017 defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to 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 normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

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ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.
Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.

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ISO/TS 19293:2018 specifies requirements for a record of a dispense of a medicinal product.
It is intended to be adopted by detailed, implementable specifications, such as interoperability standards, system specifications, and regulatory programs.
ISO/TS 19293:2018 applies to information systems in which a dispense of a medicinal product is registered, and the systems that consume such information. These systems are usually in pharmacies or other healthcare institutions. This document does not necessarily apply to non-pharmacy shops or other non-clinical systems (e.g. supermarket cashiers).
The scope of ISO/TS 19293:2018 includes the activities relating to the dispensing of a medicinal product and the information content for the capture of structured information produced in those events.
These activities include any actual dispense, cancellation or other outcome that may have occurred at the time of planned or actual dispense. In other words, the dispense record also contains information that medication was expected to be dispensed but was not dispensed.

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ISO/IEEE 11073-10427:2018 establishes a normative defi nition of communication between devices containing a power source (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. Using existing terminology, information profi les, applica-tion profi le standards, and transport standards as defi ned in other ISO/IEEE 11073 standards, this standard de-fi nes a common core of communication functionality of personal health devices (PHDs) containing a battery, including: 1) current device power status (e.g., on mains or on battery); 2) power charge status (e.g., percent of full charge); and 3) estimated time remaining (e.g., minutes).

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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.

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ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient.
ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level.
References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017.
Medicinal products for veterinary use are out of scope of ISO 11616:2017.

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ISO 12052:2017, within the field of health informatics, 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.
ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying:
- for network communications, a set of protocols to be followed by devices claiming conformance to this document;
- the syntax and semantics of Commands and associated information which can be exchanged using these protocols;
- for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media;
- information that is to be supplied with an implementation for which conformance to this document is claimed.
ISO 12052:2017 does not specify:
- the implementation details of any features of the DICOM standard on a device claiming conformance;
- the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document;
- a testing/validation procedure to assess an implementation's conformance to this document.
ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field.
ISO 12052:2017 has been developed with an emphasis on 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. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments.
ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

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ISO/TS 19844:2016 is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.
ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances.
This second edition of the document addresses substances, Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G and H. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may be essential to distinguishing substances. This document addresses the following:
· Data elements necessary for defining Substances and Specified Substances Groups 1 to 3;
· The logical use of data elements as defined in ISO 11238;
· Substances and Specified Substances Groups 1 to 3 business rules for
- determining necessary data elements,
- distinguishing and defining materials according to ISO 11238,
- triggering the assignment of identifiers.
ISO/TS 19844:2016 does not address the following:
· Business processes for data management;
· Implementation of a specific data information system (e.g. a relational database schema);
· Normative messaging standards for substances;
· The maintenance of controlled vocabularies;
· The specific global identifier system that should be used;
· Nomenclature standards for substances.

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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.

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ISO/TS 19256:2016 defines the required characteristics for any MPD-system to support use cases in healthcare.
These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases.

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ISO 21298:2017 defines a model for expressing functional and structural roles and populates it with a basic set of roles for international use in health applications. Roles are generally assigned to entities that are actors. This will focus on roles of persons (e.g. the roles of health professionals) and their roles in the context of the provision of care (e.g. subject of care).
Roles can be structural (e.g. licensed general practitioner, non-licensed transcriptionist, etc.) or functional (e.g. a provider who is a member of a therapeutic team, an attending physician, prescriber, etc.). Structural roles are relatively static, often lasting for many years. They deal with relationships between entities expressed at a level of complex concepts. Functional roles are bound to the realization of actions and are highly dynamic. They are normally expressed at a decomposed level of fine-grained concepts.
Roles addressed in this document are not restricted to privilege management purposes, though privilege management and access control is one of the applications of this document. This document does not address specifications related to permissions. This document treats the role and the permission as separate constructs. Further details regarding the relationship with permissions, policy, and access control are provided in ISO 22600.

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Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal strength fitness 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. 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 optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth strength fitness devices. In this context, strength fitness devices are being used broadly to cover strength fitness devices that measure musculo-skeletal strength-conditioning activities.
Keywords: medical device communication, personal health devices, strength fitness equipment

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Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

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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.

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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).

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ISO 21549-7:2016 applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-7:2016 specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
- medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
- medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
- medication dispensed: the records of medications dispensed for the patient;
- medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
- physical or logical solutions for the practical functioning of particular types of data cards;
- how the message is processed further "downstream" of the interface between two systems;
- the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE Not only does the definition of "medicinal products" differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
ISO 21549-7:2016 describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
ISO 21549-7:2016 does not describe nor define the common objects defined within ISO 21549-2, even though they are referenced and utilized within this document.

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ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s).
It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard.
ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care.
It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected.
ISO 27799:2016 and ISO/IEC 27002 taken together define what is required in terms of information security in healthcare, they do not define how these requirements are to be met. That is to say, to the fullest extent possible, ISO 27799:2016 is technology-neutral. Neutrality with respect to implementing technologies is an important feature. Security technology is still undergoing rapid development and the pace of that change is now measured in months rather than years. By contrast, while subject to periodic review, International Standards are expected on the whole to remain valid for years. Just as importantly, technological neutrality leaves vendors and service providers free to suggest new or developing technologies that meet the necessary requirements that ISO 27799:2016 describes.
As noted in the introduction, familiarity with ISO/IEC 27002 is indispensable to an understanding of ISO 27799:2016.
The following areas of information security are outside the scope of ISO 27799:2016:
a) methodologies and statistical tests for effective anonymization of personal health information;
b) methodologies for pseudonymization of personal health information (see Bibliography for a brief description of a Technical Specification that deals specifically with this topic);
c) network quality of service and methods for measuring availability of networks used for health informatics;
d) data quality (as distinct from data integrity).

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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/TS 17251:2016 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.
NOTE See 2.9, note to entry, regarding the use of "medication order" and "prescription".
Comprehension of dose instructions by the patient is an overarching consideration for patient safety and the best patient outcomes. Related factors are discussed, but are not part of the primary scope.
It 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 ISO/TS 17251:2016 are:
- 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:
- wide range of knowledge about medicines that would be handled in drug knowledge databases and decision support systems;
- the complete medical record (EHR);
- a medicinal product dictionary.

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ISO/TS 20440:2016 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 Technical Specification, 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.
ISO/TS 20440:2016 is intended for use by:
- any organisation that might be responsible for developing and maintaining such controlled vocabularies;
- any regional authorities or software vendors who wish to use the controlled vocabularies in their own systems and need to understand how they are created;
- owners of databases who wish to map their own terms to a central list of controlled vocabularies;
- other users who wish to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
The terminology to be applied in the context of this Technical Specification and set out in ISO 11239 is under development. All codes, terms and definitions used as examples in this Technical Specification are provided for illustration purposes only, and are not intended to represent the final terminology.

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ISO 17523:2016 specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important for all electronic prescriptions.
ISO 17523:2016 is constrained to the content of the electronic prescription 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. 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 out of scope of this International Standard, because they are more or less country or region specific, due to differences in culture and in legislation of healthcare. However, requirements and content of electronic prescriptions within the context of jurisdictions have a relationship with these scenarios. The way in which electronic prescriptions are made available or exchanged also fall outside the scope of this International Standard.
ISO 17523:2016 is applicable to electronic prescriptions of medicinal products. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an electronic prescription, the requirements in this International Standard are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. An electronic prescription is an information object that authorizes a healthcare professional to legally dispense a medicinal product.
ISO 17523:2016 specifies a list of data elements that can be considered as essential for electronic prescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.).

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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 sleep apnea breathing therapy equipment (SABTE) 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, is established in this standard. 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 SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision.

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ISO/IEEE 11073-10419:2016 defines the device specialization for the insulin pump, being a specific agent type, and provides a description of the device concepts, its capabilities, and its implementation according to this standard.
ISO/IEEE 11073-10419:2016 is based on IEEE Std 11073-20601-2014, which in turn draw information from both ISO/IEEE 11073-10201:2004 [B7]2 and ISO/IEEE 11073-20101:2004 [B8]. The medical device encoding rules (MDERs) used within this standard are fully described in IEEE Std 11073-20601-2014.
ISO/IEEE 11073-10419:2016 reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B6] and adds new nomenclature codes for the purposes of this standard. Among this standard and IEEE Std 11073-20601-2014, all required nomenclature codes for implementation are documented.

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This part of ISO 21549 describes and defines the basic structure of the identification data objects held
on healthcare data cards, but does not specify particular data sets for storage on devices.
The detailed functions and mechanisms of the following services are not within the scope of this part of
ISO 21549 (although its structures can accommodate suitable data objects elsewhere specified):
— security functions and related services that are likely to be specified by users for data cards
depending on their specific application, e.g. confidentiality protection, data integrity protection and
authentication of persons and devices related to these functions;
— access control services;
— the initialization and issuing process (which begins the operating lifetime of an individual data
card, and by which the data card is prepared for the data to be subsequently communicated to it
according to this part of ISO 21549).
The following topics are therefore beyond the scope of this part of ISO 21549:
— physical or logical solutions for the practical functioning of particular types of data card;
— the forms that data take for use outside the data card, or the way in which such data are visibly
represented on the data card or elsewhere.

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ISO 16278:2016 defines the characteristics required to synthetically describe the organization and content of human anatomy within a terminological system. It is intended primarily for use with computer-based applications such as clinical electronic health records, decision support and for various bio-medical research purposes.
ISO 16278:2016 will serve to
- facilitate the construction of new terminological systems in a regular form which will increase their coherence and expressiveness,
- facilitate maintenance of human anatomy within terminological systems,
- increase consistency and coherence of existing terminological system,
- allow systematic cross-references between items of human anatomy in different types of terminological systems,
- facilitate convergence among human anatomy within terminological systems,
- make explicit the overlap for human anatomy between different health care domains terminological systems,
- provide elements for negotiation about integration of different terminological systems into information systems between the respective developers, and
- enable the systematic evaluation of human anatomy within terminological systems.
ISO 16278:2016 itself is not suitable or intended for use by, individual clinicians or hospital administrators.
The target groups for this International Standard are the following:
- designers of specialized standard healthcare terminological categorial structures;
- developers of healthcare terminological systems including classifications and coding systems;
- producers of services for terminological systems and designers of software including natural language processing;
- information modellers, knowledge engineers, and standards developers building models for health information management systems;
- developers of information systems that require an explicit representation of healthcare terminological systems;
- developers of marked-up standards for representation of healthcare documents.
ISO 16278:2016 does not include categorial structure that might be necessary for the description of developmental anatomy during the human life cycle, which includes prenatal development, post-natal growth and aging.
ISO 16278:2016 has been developed for use as an integrated part of computer-based applications and for the electronic healthcare record. It would be of limited value for manual use.
It is not the purpose of this International Standard to standardize the end user classification of human anatomy terminology or to conflict with the concept systems embedded in national practice and languages.

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ISO 13940:2015 defines a system of concepts for different aspects of the provision of healthcare.
The core business in healthcare is the interaction between subjects of care and healthcare professionals. Such interactions occur in healthcare/clinical processes and are the justification for the process approach of ISO 13940:2015. To be able to represent both clinical content and clinical context, ISO 13940:2015 is related to a generic healthcare/clinical process model as well as comprehensive concept definitions and concept models for the clinical, management and resource aspects of healthcare services.
In practice ISO 13940:2015 covers the concept definitions needed whenever structured information in healthcare is specified as a requirement. The definitions are intended to refer to the conceptual level only and not to details of implementation. ISO 13940:2015 will cover all levels of specifications in 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, and
information for specified types of clinical processes.

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ISO/TS 13972:2015:
Describes requirements and recommended methods against which clinicians can gather, analyse and, specify the clinical context, content, and structure of Detailed Clinical Models.
Defines Detailed Clinical Models (DCMs) in terms of an underlying logical model. They are logical models of clinical concepts and can be used to define and to structure clinical information.
Describes requirements and principles for DCMs, meta-data, versioning, content and context specification, data element specification and data element relationships, and provide guidance and examples.
Specifies DCM governance principles to ensure conceptual integrity of all DCM attributes and logical model accuracy.
Describes DCM development and the methodology principles for use that will support the production of quality DCMs to minimize risk and ensure patient safety.

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2014-03-04 GVN: Draft for minor revision received in ISO/CS (see notification of 2014-03-03 in dataservice).

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ISO 10781:2015 provides a reference list of functions that may be present in an Electronic Health Record System (EHR-S). The function list is described from a user perspective with the intent to enable consistent expression of system functionality. This EHR-S Functional Model, through the creation of Functional Profiles for care settings and realms, enables a standardized description and common understanding of functions sought or available in a given setting (e.g. intensive care, cardiology, office practice in one country or primary care in another country).

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ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions.
It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situation to a regional or even national situation.
It specifies the necessary component-based concepts and is intended to support their technical implementation. It will not specify the use of these concepts in particular clinical process pathways.
ISO 22600-3:2014 instantiates requirements for repositories for access control policies and requirements for privilege management infrastructures. It provides implementation examples of the formal models specified in ISO 22600‑2.

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ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions.
It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situation to a regional or even national situation.
It specifies the necessary component-based concepts and is intended to support their technical implementation. It will not specify the use of these concepts in particular clinical process pathways.
ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.

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ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions.
It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situation to a regional or even national situation.
It specifies the necessary component-based concepts and is intended to support their technical implementation. It will not specify the use of these concepts in particular clinical process pathways.
ISO 22600-2:2014 introduces the underlying paradigm of formal high-level models for architectural components. It is based on ISO/IEC 10746 (all parts) and introduces the domain model, the document model, the policy model, the role model, the authorization model, the delegation model, the control model, and the access control model.

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This Technical Report addresses the issue of multiple identifiers that may refer to the same person. It describes the management of patient identification and cross-referencing of identities and provides some practical guidance for addressing implementation of standards, reports, guidelines, methods, etc. The need to identify a person unambiguously is an important component for the interoperability of health information systems.
Within healthcare there is an essential requirement for good quality information, not least to uniquely identify an individual to ensure that the appropriate and relevant care can be delivered irrespective of geography, time and situation. To ensure that health care providers have access to information about an individual patient, it is vital that the patient can be reliably identified within a Health Care Information System. Currently, a given patient may have several identifiers corresponding to different geographical locations, different health care organisations or various specialities. The allocation of multiple identifiers and related processes increases the risk of identification error within one or more information systems and as a result, might compromise the safety of a patient.
The quality of identification ensures that health care providers have access to patient information, facilitating closer coordination and continuity of care, improving service in terms of prevention and follow-up. Quality will be pursued within the framework of:
—   medical care in a hospital information system (HIS): covering all the stages from patient identification to admittance to the health care organization or directly to the care unit or emergency care, through to the issuing of reports by the different health care services (medical and medico-technical services);
—   continuity of care;
—   patient mobility.
Because electronic heath care records may be updated by several and various healthcare providers over a long period of time, the patient identification needs to be formalized in such a way to ensure that the correct patient’s healthcare record is being accessed.
In the regions or the countries where a national unique patient identifier is not used, the patient is identified by using patient identifiers for each healthcare system, wherever the patient is registered. Even within an individual healthcare organization, the patient may be identified by a specific identifier for an individual ward or a medical support unit. To ensure the continuity of care and the sharing of patient information, it is necessary to reliably link together the different patient identities within what we will call a "patient identifier cross-reference domain".
The need to cross-reference identities appears when a healthcare provider wants to access all the healthcare information for one patient and that information is contained in different healthcare systems managed by several healthcare professionals or organisations.
In recent years, many research studies and implementations have taken place to try to resolve this issue. This document provides an overview and proposals for the management of the patient identities and the cross referencing of identities and provides guidance for authorities, organisations, project managers and users.

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ISO/IEEE 11073-10418:2013 establishes a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personal computers, personal health appliances and set top boxes) in a manner that enables plug-and-play interoperability. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards and transport standards. 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 functionality of INR devices is defined in ISO/IEEE 11073-10418:2013. In the context of personal health devices, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to ISO/IEEE 11073-20601:2010 are provided by ISO/IEEE 11073:10418:2013, and the measurement method is not specified.

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ISO/IEEE 11073-10102:2014 extends the IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g. ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional "global" and "per-lead" numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined.

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ISO 21549-4:2014 is applicable to situations in which clinical data additional to the limited clinical data defined in ISO 21549‑3 is recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-4:2014 specifies the basic structure of the data contained within the data object extended clinical data, but does not specify or mandate particular data sets for storage on devices.

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ISO 21549-3:2014 is applicable to situations in which limited clinical data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-3:2014 describes and defines the limited clinical data objects used in or referenced by patient healthcards using UML, plain text and abstract syntax notation (ASN.1).
ISO 21549-3:2014 specifies the basic structure of the data contained within the data object limited clinical data, but does not specify or mandate particular data sets for storage on devices.

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