Hälso- och sjukvårdsinformatik

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 8 aug 2026
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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).

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 11 sep 2026
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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.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 18 sep 2026
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This document outlines a core dataset designed for a concise dental data exchange intended to support continuity and coordination of care. It provides a conceptual framework for a dental data for exchange that can serve as the basis for implementation models. The content reflects an international perspective on organizing dental information for cross-border exchange. It offers guidance on the essential data elements that should be shared globally and proposes a standardized format for their representation. The document focuses on defining the structure of the data to be exchanged (“the what”) without prescribing the specific methods or technologies used for transmission (“the how”). It does not include guidance on operational workflows such as data entry, collection, summarization, or integration. Nor does it address the competencies required to perform those tasks. Furthermore, it is not intended as an implementation guide and does not cover the underlying technical infrastructure or the use of particular coding systems, data formats, or terminologies.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 25 sep 2026
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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 basic electrocardiograph (ECG) devices and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in ISO/IEEE11073-10406:2012. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena. ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 25 sep 2026
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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.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 26 sep 2026
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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

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 27 sep 2026
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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.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 27 sep 2026
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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 basic electrocardiograph (ECG) devices and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in ISO/IEEE11073-10406:2012. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena. ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 27 sep 2026
Se merSe mindre
 

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.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 27 sep 2026
Se merSe mindre
 

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

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 27 sep 2026
Se merSe mindre
 

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