35.240.80 - IT applications in health care technology
ICS 35.240.80 Details
IT applications in health care technology
IT-Anwendungen in der Medizin
Applications des TI dans les technologies de la santé
Uporabniške rešitve IT v zdravstveni tehniki
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This document showcases existing practices to monitor supply chains as implemented in the healthcare supply chains, by making use of medicines verification or authentication systems, or both, traceability tools, safe communication technology solutions, and more. This document also discusses the potential benefits of expanding the identification of medicinal products (IDMP) to provide global identifiers for medicinal products, ingredients and batches. It also addresses potential pathways to a global registration system.
- Technical report13 pagesEnglish languagesale 15% off
This document describes the core principles for supporting the development, implementation and ongoing maintenance of IDMP identifiers and terminologies. This document provides considerations for the evaluation and/or design when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.
- Technical report15 pagesEnglish languagesale 15% off
This document defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It covers only terminological resources that are primarily designed to be used for clinical concept representation or to those parts of other terminological resources designed to be used for clinical concept representation.
This document helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. In order to do that, this document focuses on defining characteristics and functions of terminological resources in healthcare that can be used to identify different types of terminological resources for categorization purposes.
NOTE 1 Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past.
The following aspects are not covered in this document:
— evaluations of terminological resources;
— health service requirements for terminological resources and evaluation criteria based on the characteristics and functions;
— the nature and quality of mappings between different terminologies;
NOTE 2 It is unlikely that a single terminology will meet all the terminology requirements of a healthcare organization: some terminology providers produce mappings to administrative or classification systems such as the International Classification of Diseases (ICD). The presence of such maps would be a consideration in the evaluation of the terminology.
— the nature and quality of mappings between different versions of the same terminology;
NOTE 3 To support data migration and historical retrieval, terminology providers can provide maps between versions of their terminology. The presence of such maps would be a consideration in the evaluation of the terminology.
— terminology server requirements and techniques and tools for terminology developers;
— characteristics for computational biology terminology.
- Draft29 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It covers only terminological resources that are primarily designed to be used for clinical concept representation or to those parts of other terminological resources designed to be used for clinical concept representation. This document helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. In order to do that, this document focuses on defining characteristics and functions of terminological resources in healthcare that can be used to identify different types of terminological resources for categorization purposes. NOTE 1 Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past. The following aspects are not covered in this document: — evaluations of terminological resources; — health service requirements for terminological resources and evaluation criteria based on the characteristics and functions; — the nature and quality of mappings between different terminologies; NOTE 2 It is unlikely that a single terminology will meet all the terminology requirements of a healthcare organization: some terminology providers produce mappings to administrative or classification systems such as the International Classification of Diseases (ICD). The presence of such maps would be a consideration in the evaluation of the terminology. — the nature and quality of mappings between different versions of the same terminology; NOTE 3 To support data migration and historical retrieval, terminology providers can provide maps between versions of their terminology. The presence of such maps would be a consideration in the evaluation of the terminology. — terminology server requirements and techniques and tools for terminology developers; — characteristics for computational biology terminology.
- Standard23 pagesEnglish languagesale 15% off
- Standard25 pagesFrench languagesale 15% off
This document specifies the categorial structure within the subject field of acupuncture by defining a set of domain constraints of sanctioned characteristics, each composed of a semantic link and an applicable characterizing category, in order to represent the concept of acupuncture point.
- Standard10 pagesEnglish languagesale 15% off
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard59 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard85 pagesEnglish languagesale 10% offe-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models and application profile. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a user’s adherence to a medication regime.
- Standard82 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides the findings of a global, country-based survey on the current state, challenges and need for standardization in secondary use of clinical genomics data in medicine. This document excludes the primary use of clinical genomics data as well as specific data, metadata, or policies regarding the secondary use of clinical genomics data.
- Technical report13 pagesEnglish languagesale 15% off
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the core data set for a concise international patient summary (IPS), which supports continuity of care for a person and assists with coordination of their care.
This document provides an abstract definition of a patient summary from which derived models are implementable.
This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence, skills and competences, that results in the data summarization workflow. It is not an implementation guide that is concerned with the various technical layers beneath the application layer. Representation by various coding schemes, additional structures and terminologies are not part of this document.
- Standard94 pagesEnglish languagesale 10% offe-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined, for example, to determine when a person’s activities/behaviors have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagesale 10% offe-Library read for1 day
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard128 pagesEnglish languagesale 15% off
- Standard146 pagesFrench languagesale 15% off
This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the life cycle of health software and health IT systems, for the information exchange between the health software manufacturers (including medical device manufacturers), healthcare delivery organizations (HDOs) and other stakeholders. It is applicable to health software running on any platform and in any environment such as cloud, on premise or hybrid. While important security topics, the following are outside the scope of this document: a) the security policies of the HDO, b) the product and services security policies of the manufacturer, c) determinations of risk tolerance by the HDO or manufacturer, and d) clinical studies where there is a need to secure personal data. As security risks can be caused by any product on health IT systems and health IT Infrastructure, considerations in this document can be applied for other products that are not health software. IEC TS 81001-2-2:2025 withdraws and replaces: – IEC TR 80001-2-2, Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls – IEC TR 80001-2-8, Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 This document includes the following significant changes: a) Combines and updates the contents of IEC TR 80001-2-2 and IEC TR 80001-2-8; b) Extends the scope to health software instead to only medical device software; c) Aligns contents and definitions to ISO 81001-1:2021 and the updated IEC 80001-1; d) Removed the Configuration of Security Features (CNFS) capability, as any configurable security capability shall be clearly communicated. e) Provide security control mappings to several new standards, e.g. IEC TR 60601-4-5, IEC 62443-4-2, ISO/IEEE 11073-40102 and the recent versions of previous standards, e.g. ISO/IEC 27002 and NIST 800-53 version 5.
- Technical specification96 pagesEnglish languagesale 15% off
This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard59 pagesEnglish languagesale 10% offe-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined, for example, to determine when a person’s activities/behaviors have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between medication monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models and application profile. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for medication monitors. In this context, medication monitors are defined as devices that have the ability to determine and communicate (to a manager) measures of a user’s adherence to a medication regime.
- Standard82 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard85 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
The scope of this document is constrained to the content of the electronic prescription (ePrescription) itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. The ePrescription in the administrative workflow of reimbursement is not covered in this document.
This document specifies the requirements that apply to ePrescriptions. It describes generic principles that are considered important for all ePrescriptions.
This document is applicable to ePrescriptions of medicinal products for human use. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an ePrescription, the requirements in this document are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy.
This document does not limit the scope to any setting (community, institutional) and leaves it to the national bodies to decide on this matter.
This document specifies a list of data elements that can be considered as essential for ePrescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.). Ensuring the authenticity of these data elements is in scope and will have impact on the requirements of information systems.
Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are not covered in this document, because they are country-specific or region-specific, due to differences in culture and in legislation of healthcare. However, requirements and content of ePrescriptions within the context of jurisdictions have a relationship with these scenarios. This document also does not cover the way in which ePrescriptions are made available or exchanged, and the process of prescribing itself.
The logistic process of prescribing itself is not part of the scope. A prescription can either be sent (pushed) to a dispenser or either be retrieved (pulled) at the dispenser. However, the requirement for the prescription is described, that it will be able to function in both environments.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
The HL7 EHR System Functional Model 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, realms, services and specialties, 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).
The HL7 EHR-S Functional Model defines a standardized model of the functions that may be present in EHR
Systems. From the outset, a clear distinction between the EHR as a singular entity and systems that operate on
the EHR – i.e., EHR Systems is critical. This Standard makes no distinction regarding implementation - the EHRS
described in a Functional Profile may be a single system or a system of systems. Within the normative sections
of the Functional Model, the term “system” is used generically to cover the continuum of implementation options.
This includes “core” healthcare functionality, typically provided by healthcare-specific applications that manage
electronic healthcare information. It also includes associated generic application-level capabilities that are
typically provided by middleware or other infrastructure components. The latter includes interoperability and
integration capabilities such as location discovery and such areas as cross application workflow. Interoperability
is considered both from semantic (clear, consistent and persistent communication of meaning) and technical
(format, syntax and physical connectivity) viewpoints. Further, the functions make no statement about which
technology is used, or about the content of the electronic health record. The specifics of 'how' EHR systems are
developed or implemented is not considered to be within the scope of this model now or in the future. This EHRS
Functional Model does not address or endorse implementations or technology, nor does it include the data
content of the electronic health record.
Finally, the EHR-S Functional Model supports research needs by ensuring that the data available to researchers
follow the required protocols for privacy, confidentiality, and security. The diversity of research needs precludes
the specific listing of functions that are potentially useful for research.
This Functional Model is not:
• a messaging specification
• an implementation specification
• a conformance specification
• an EHR specification
• a conformance or conformance testing metric
• an exercise in creating a definition for an EHR or EHR-S
It is important to note that the EHR-S Function Model does not include a discussion of clinical processes or the
interaction of the healthcare actors. However, ISO 13940 Health Informatics – System of Concepts to Support
Continuity of Care, is an international standard that does outline key principles and processes in the provision of
healthcare. It is recommended that users of the EHR-S FM refer to this standard for clinical processes that EHR
systems support.
This EHR-S Functional Model package includes both Reference and Normative sections. Table 1 explains the
differences between Reference and Normative sections.Each section within this document is clearly labeled "Normative" if it is normative. For example, in section 5
(Overview) section 5.3 is normative. In section 7, Conformance Clause; sections 7.1 through 7.6 are normative.
In the external Annex A, Function List, the Function ID, Function Name, Function Statement, and Conformance
Criteria components are Normative in this Functional Model.
- Standard79 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the core data set for a concise international patient summary (IPS), which supports continuity of care for a person and assists with coordination of their care.
This document provides an abstract definition of a patient summary from which derived models are implementable.
This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence, skills and competences, that results in the data summarization workflow. It is not an implementation guide that is concerned with the various technical layers beneath the application layer. Representation by various coding schemes, additional structures and terminologies are not part of this document.
- Standard94 pagesEnglish languagesale 10% offe-Library read for1 day
This document reviews the structural changes that have been precipitated by the COVID-19 pandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19 pandemic on care settings such as home and community care, acute care and outpatient care are reviewed discussing how well these healthcare environments were prepared to address the encountered connectivity challenges from a standards point of view. The current standards landscape is reviewed and gaps are identified leading to recommendations for future standards work.
- Technical specification101 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the core data set for a concise international patient summary (IPS), which supports continuity of care for a person and assists with coordination of their care. This document provides an abstract definition of a patient summary from which derived models are implementable. This document does not cover the workflow processes of data entry, data collection, data summarization, subsequent data presentation, assimilation, or aggregation. Furthermore, this document does not cover the summarization act itself, i.e. the intelligence, skills and competences, that results in the data summarization workflow. It is not an implementation guide that is concerned with the various technical layers beneath the application layer. Representation by various coding schemes, additional structures and terminologies are not part of this document.
- Standard76 pagesEnglish languagesale 15% off
- Standard83 pagesFrench languagesale 15% off
This document 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).
- Standard79 pagesEnglish languagesale 10% offe-Library read for1 day
The scope of this document is constrained to the content of the electronic prescription (ePrescription) itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. The ePrescription in the administrative workflow of reimbursement is not covered in this document.
This document specifies the requirements that apply to ePrescriptions. It describes generic principles that are considered important for all ePrescriptions.
This document is applicable to ePrescriptions of medicinal products for human use. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an ePrescription, the requirements in this document are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy.
This document does not limit the scope to any setting (community, institutional) and leaves it to the national bodies to decide on this matter.
This document specifies a list of data elements that can be considered as essential for ePrescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.). Ensuring the authenticity of these data elements is in scope and will have impact on the requirements of information systems.
Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are not covered in this document, because they are country-specific or region-specific, due to differences in culture and in legislation of healthcare. However, requirements and content of ePrescriptions within the context of jurisdictions have a relationship with these scenarios. This document also does not cover the way in which ePrescriptions are made available or exchanged, and the process of prescribing itself.
The logistic process of prescribing itself is not part of the scope. A prescription can either be sent (pushed) to a dispenser or either be retrieved (pulled) at the dispenser. However, the requirement for the prescription is described, that it will be able to function in both environments.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
This document reviews the structural changes that have been precipitated by the COVID-19 pandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19 pandemic on care settings such as home and community care, acute care and outpatient care are reviewed discussing how well these healthcare environments were prepared to address the encountered connectivity challenges from a standards point of view. The current standards landscape is reviewed and gaps are identified leading to recommendations for future standards work.
- Technical specification101 pagesEnglish languagesale 10% offe-Library read for1 day
The scope of this document is constrained to the content of the electronic prescription (ePrescription) itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. The ePrescription in the administrative workflow of reimbursement is not covered in this document. This document specifies the requirements that apply to ePrescriptions. It describes generic principles that are considered important for all ePrescriptions. This document is applicable to ePrescriptions of medicinal products for human use. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an ePrescription, the requirements in this document are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. This document does not limit the scope to any setting (community, institutional) and leaves it to the national bodies to decide on this matter. This document specifies a list of data elements that can be considered as essential for ePrescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.). Ensuring the authenticity of these data elements is in scope and will have impact on the requirements of information systems. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are not covered in this document, because they are country-specific or region-specific, due to differences in culture and in legislation of healthcare. However, requirements and content of ePrescriptions within the context of jurisdictions have a relationship with these scenarios. This document also does not cover the way in which ePrescriptions are made available or exchanged, and the process of prescribing itself. The logistic process of prescribing itself is not part of the scope. A prescription can either be sent (pushed) to a dispenser or either be retrieved (pulled) at the dispenser. However, the requirement for the prescription is described, that it will be able to function in both environments.
- Standard24 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
This document reviews the structural changes that have been precipitated by the COVID-19 pandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19 pandemic on care settings such as home and community care, acute care and outpatient care are reviewed discussing how well these healthcare environments were prepared to address the encountered connectivity challenges from a standards point of view. The current standards landscape is reviewed and gaps are identified leading to recommendations for future standards work.
- Technical specification92 pagesEnglish languagesale 15% off
This document specifies categorial structures within the subject field of acupuncture needling (specialized for using filiform needles) by defining a set of domain constraints. This document describes a concept system detailing domain constraints of sanctioned characteristics, each composed of a semantic link and an applicable characterizing category.
- Standard8 pagesEnglish languagesale 15% off
This document provides guidance on how four complementary international standards can be used in combination by developers of health ICT systems and infrastructures. These standards, three published by CEN and ISO and one by HL7, are — ISO 13940:2015, — ISO 13606-1:2019, — ISO 13606-3:2019, and — HL7 Fast Health Interoperability Resources (FHIR) Release 4. This document defines mappings between these standards: between ISO 13940 and HL7 FHIR in both directions, between ISO 13606 and HL7 FHIR in both directions, it proposes the content of an HL7 FHIR profile corresponding to the ISO 13606-1:2019 “COMPOSITION” class. It also provides guidance and worked examples of the mapping between ISO 13606-3 Reference Archetypes corresponding to ISO 13940 and HL7 FHIR. This document also summarizes the extent to which the source concept is broader than or narrower than the best fit target concept. It also highlights mapping issues that adopters will need to be mindful of, where the representation capability of the standards differs.
- Technical specification225 pagesEnglish languagesale 15% off
This document specifies a reference architecture for event-based syndromic surveillance systems for infectious diseases. The system reference architecture addresses architectural components including concepts, data sources, and outputs of syndromic surveillance system. From the perspective of the diagnostic process,[ REF Reference_ref_11 \r \h 11 08D0C9EA79F9BACE118C8200AA004BA90B0200000008000000110000005200650066006500720065006E00630065005F007200650066005F00310031000000 ] this document covers the processes from the symptom-onset stage to the health-behaviour stage, which is prior to the healthcare-encounter stage. Non-infectious health hazards, such as natural disasters, human-induced emergencies and chronic diseases, and their associated surveillance systems are beyond the scope of this document.
- Technical specification11 pagesEnglish languagesale 15% off
This document provides quality requirements for producing a quality map between terminological systems. This document establishes measures which can be used to assess the quality and utility of a map between terminological resources. These measures can be used to determine the types and conformance levels of a map and their impact on common use cases in healthcare.
- Standard25 pagesEnglish languagesale 15% off
This document provides a telehealth cybersecurity reference model of the overall security framework for systems and services applied to telehealth. This document contains a general description of: — factors of telehealth cybersecurity threats; — relationships between security risks and safety risks in telehealth services; — methodologies for defining security levels in telehealth services; — a cybersecurity reference model of telehealth services. Defining the specific type of telehealth services is not covered in this document.
- Technical specification12 pagesEnglish languagesale 15% off
This document specifies a reference model for virtual reality (VR)-based clinical practice simulation. This model includes components, relations, data element and types, and roles of the users.
- Technical specification12 pagesEnglish languagesale 15% off
This document provides guidelines for the self-assessment questionnaire systems to be used for health. This document includes the following: — structure and components of the self-assessment questionnaire systems; — guidelines for administering and managing the self-assessment questionnaire systems; — basic data elements for interacting with the self-assessment questionnaire systems. This document does not define the contents of the self-assessment questionnaire specialised in healthcare domains or departments. The questionnaires themselves are out of the scope of this document since they are dependent on the intended purpose of the self-assessment questionnaire systems.
- Technical specification47 pagesEnglish languagesale 15% off
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard13 pagesEnglish languagesale 15% off
- Standard14 pagesFrench languagesale 15% off
This document provides terminological concepts for the representation of human body movement and establishes the categories and relationships of text-based terminology and time-dependent body movement in 3D data. This document does not cover 3D graphic user interface, data structure, implementation and guidelines.
- Technical specification9 pagesEnglish languagesale 15% off
This document provides a concept and overview of the overall cybersecurity framework for systems and services applied to telehealth. This document contains a general description of: — concept and introduction of telehealth cybersecurity; — actors of telehealth services; — activities of telehealth services; — environments of telehealth services; — variables of telehealth security.
- Technical specification11 pagesEnglish languagesale 15% off
This document specifies a framework for the interoperability of services and information tailored towards personalized digital health informatics. It establishes a common set of requirements and data specifications necessary for multi-level interoperability, as well as for dynamic consent and knowledge sharing.
- Technical specification15 pagesEnglish languagesale 15% off
This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organizations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties. An assurance case can be used to communicate information and knowledge about different risks to other roles. This document establishes: — an assurance case framework for HDOs and health software and MDMs for identifying, developing, interpreting, updating and maintaining assurance cases. — one of the possible means to bridge the gap between manufacturers and HDOs in providing adequate information to support the HDOs risk management of IT-networks; — best practice by leveraging ISO/IEC/IEEE 15026-2 and other standards to identify key considerations and for the structure and contents of an assurance case, e.g. iterative and continuous approaches; — example structure, method and format to improve the consistency and comparability of assurance cases. This document is applicable to all parties involved in the health software and health IT systems life cycle, including: a) organizations, health informatics professionals and clinical leaders specifying, acquiring, designing, developing, integrating, implementing and operating health software and health IT systems, for example health software developers and MDMs, system integrators, system administrators (including cloud and other IT service providers); b) healthcare service delivery organizations, healthcare providers and others who use health software and health IT systems in providing health services; c) governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in an organization’s ability to consistently provide safe, effective and secure health software, health IT systems and services; d) organizations and interested parties seeking to improve communication in managing safety, effectiveness and security risks through a common understanding of the concepts and terminology used in safety, effectiveness and security management; e) providers of training, assessment or advice in safety, effectiveness and security risk management for health software and health IT systems; f) developers of related safety, effectiveness and security standards. This document is for use by organizations and people who build, acquire, operate, maintain, use or decommission health software and health IT systems (including medical devices). It is applicable to all organizations involved, regardless of size, complexity or business model.
- Technical specification46 pagesEnglish languagesale 15% off
This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organizations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties. An assurance case can be used to communicate information and knowledge about different risks to other roles.
This document establishes:
- an assurance case framework for HDOs and health software and MDMs for identifying, developing, interpreting, updating and maintaining assurance cases.
- one of the possible means to bridge the gap between manufacturers and HDOs in providing adequate information to support the HDOs risk management of IT-networks;
- best practice by leveraging ISO/IEC/IEEE 15026-2 and other standards to identify key considerations and for the structure and contents of an assurance case, e.g. iterative and continuous approaches;
- example structure, method and format to improve the consistency and comparability of assurance cases.
This document is applicable to all parties involved in the health software and health IT systems life cycle, including:
a) organizations, health informatics professionals and clinical leaders specifying, acquiring, designing, developing, integrating, implementing and operating health software and health IT systems, for example health software developers and MDMs, system integrators, system administrators (including cloud and other IT service providers);
b) healthcare service delivery organizations, healthcare providers and others who use health software and health IT systems in providing health services;
c) governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in an organization’s ability to consistently provide safe, effective and secure health software, health IT systems and services;
d) organizations and interested parties seeking to improve communication in managing safety, effectiveness and security risks through a common understanding of the concepts and terminology used in safety, effectiveness and security management;
e) providers of training, assessment or advice in safety, effectiveness and security risk management for health software and health IT systems;
f) developers of related safety, effectiveness and security standards.
This document is for use by organizations and people who build, acquire, operate, maintain, use or decommission health software and health IT systems (including medical devices). It is applicable to all organizations involved, regardless of size, complexity or business model.
- Technical specification46 pagesEnglish languagesale 15% off
This document identifies specialized use cases related to the information exchange between clinical laboratories and portable polymerase chain reaction (PCR) devices designed for real-time testing to diagnose infectious diseases. This document introduces the portable PCR devices for point-of-care testing (POCT). Characteristic and differentiated use cases of these devices are listed separately from those that occur with portable POCT devices in existing clinical laboratory. This document is applicable, but not limited, to the following use cases of portable PCR devices for POCT: a) general test; b) reconciliation of patient information; c) cancel and rerun test; d) on-site quality control (QC) process. This document also provides guidelines on how to represent and exchange results from portable PCR testing devices in a POCT environment applicable to the use cases described above. This document is not intended to provide guidelines relating to traditional diagnostic testing results within a clinical laboratory and does not cover cybersecurity aspect.
- Technical specification16 pagesEnglish languagesale 15% off
The document defines the progression of implementation of terminology capability in information systems. This document does not specify requirements for any specific terminological resource. It is intended to provide a basis for conformance criteria for terminological resources capabilities in specific use cases. This document does not cover in detail the software being used, though the capabilities of that software are included and impact the level of maturity reached. This document is applicable to terminological resources of all types, terminologies, classifications, value sets, code systems, and value domains.
- Technical specification16 pagesEnglish languagesale 15% off