35.240.80 - IT applications in health care technology

This document lists examples of and defines categories of use cases for machine learning in medicine for clinical practice. The developments and applications of machine learning technologies for artificial intelligence consist of 1) data collection and curation, 2) pre-processing, 3) model training and validation, and 4) medicine depending on various kinds of specialty including radiology, pathology, emergency medicine, dermatology, ophthalmology, anaesthesia, surgery, etc., and clinical setting...view more

This document gives guidelines for certificate management issues involved in deploying digital certificates in healthcare. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements. This document also identifies the principles needed in a healthcare security policy for cross-border communication and defines the minimum levels of security required, concentrating on aspects unique to healthcare.

This document defines the basic concepts underlying the use of digital certificates in healthcare and provides a scheme of interoperability requirements to establish a digital certificate-enabled secure communication of health information. It also identifies the major stakeholders who are communicating health-related information, as well as the main security services required for health communication where digital certificates can be required. This document gives a brief introduction to public k...view more

This document gives a guideline for implementation of an ISMS by showing practical examples of risk analysis on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices or health information systems in order to protect both sides' information assets (primarily the information system itself and personal health data) in a safe and efficient (i.e. economical) manner. This document consists of: — application of ISMS to RMS; —...view more

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification (wrist) bands, identification tags or other objects, to enable automatic data capture using data carriers in the care delivery process. It provides for a unique SoC identification that can be used for other purposes, such as recording the identity of the SoC in individual health records. This document serves as a reference for any organization ...view more

This document presents a methodology which supports and enables the development of standards based business and information architectures that contribute to good quality of healthcare and patient safety. The methodology is used to develop descriptions of healthcare enterprises from different aspects. Those aspects are covering what, how, where, who, when, why[1] and are based on standards.

This standard defines a nomenclature for communication of information from point-of-care medical
devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The
nomenclature also supports concepts in an object-oriented information model that is for medical device
communication.

This document specifies the fundamental characteristics of the information model implemented by
a specific architectural layer (i.e. the service architecture) of the information system to provide a
comprehensive and integrated storage of the common enterprise data and to support the fundamental
business processes of the healthcare organization, as defined in ISO 12967-1.
The information model is specified in this document without any explicit or implicit assumption on the
physical technolog...view more

This document provides guidance and requirements for the description, planning and development of
new systems, as well as for the integration of existing information systems, both within one enterprise
and across different healthcare organizations, through an architecture integrating the common data
and business logic into a specific architectural layer (i.e. the middleware), distinct from individual
applications and accessible throughout the whole information system through services, as sho...view more

This document specifies the fundamental characteristics of the computational model implemented
by a specific architectural layer of the information system (i.e. the service architecture) to provide
a comprehensive and integrated interface to the common enterprise information and to support
the fundamental business processes of the healthcare organization, as defined in ISO 12967-1. The
computational model is specified without any explicit or implicit assumption about the physical
technologi...view more

This document provides guidelines on identification and labelling of medicinal products from the point
of manufacture of packaged medicinal product to the point of dispensing the product.
This document outlines best practice for AIDC barcoding solutions for applications. Users can, however,
consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency
Identification (RFID).

This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as defined in Clause 4). An RSP lists the principle health information technology (HIT) standards that form the basis of implementing and deploying interoperable applications in the target domain. An RSP includes a description of the domain, a normative list of standards, and an informative framework for mapping the standards to example deployment use cases. The lists do not include standards that ...view more

This document specifies the fundamental characteristics of the computational model implemented by a specific architectural layer of the information system (i.e. the service architecture) to provide a comprehensive and integrated interface to the common enterprise information and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967‑1. The computational model is specified without any explicit or implicit assumption about the physical technologies, t...view more

This document provides guidance and requirements for the description, planning and development of new systems, as well as for the integration of existing information systems, both within one enterprise and across different healthcare organizations, through an architecture integrating the common data and business logic into a specific architectural layer (i.e. the middleware), distinct from individual applications and accessible throughout the whole information system through services, as shown i...view more

This document specifies the fundamental characteristics of the information model implemented by a specific architectural layer (i.e. the service architecture) of the information system to provide a comprehensive and integrated storage of the common enterprise data and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967‑1. The information model is specified in this document without any explicit or implicit assumption on the physical technologies, ...view more

This document specifies the requirements for developing a knowledge base for drug-related problems
that cohere with the intended drug use, to be used in rule-based clinical decision support systems
(CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development
and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to
develop a knowledge base, the topics to be considered by the developers of a knowledge ...view more

This document supports interchangeability of digital signatures and the prevention of incorrect or illegal digital signatures by providing minimum requirements and formats for generating and verifying digital signatures and related certificates. This document describes the common technical, operational, and policy requirements that need to be addressed to enable digital certificates to be used in protecting the exchange of healthcare information within a single domain, between domains, and acros...view more

This document identifies quality metrics for the detection of DNA variants using next generation sequencing (NGS) technology. It also defines the data types, relationships, optionality, cardinalities and terminology bindings of the data. This document provides a basis for sharing and for the application of "high quality" genomic data and contributes to the realization of the precision medicine and the development of relevant industries. This document is intended to serve as a catalogue of sequen...view more

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base...view more

This document specifies the common conventions required for the cart-to-host as well as cart-to-cart interchange of specific patient data (demographic, recording, ...), ECG signal data, ECG measurement and ECG interpretation results.
This document specifies the content and structure of the information which is to be interchanged between digital ECG carts and computer ECG management systems, as well as other computer systems where ECG data can be stored

This document defines a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object-oriented information model that is for medical device communication.

The scope of this project is to define a general object-oriented information model that may be used to
structure information and identify services used in point-of-care (POC) medical device communications.
The scope is primarily focused on acute care medical devices and the communication of patient vital signs
information.

This Technical Specification (TS) provides implementation guidance to support the use of the International Patient Summary dataset in a European context. The focus of this technical specification takes into consideration European specific jurisdictional requirements, needs and contexts that Europe requires to be satisfied for effective implementation. It addresses both functional and non-functional requirements for the dataset’s interchange. As part of the usability of the International Patient ...view more

This document provides an environmental scan of common data elements that are captured through various modalities such as cell phones, smart phones, mobile applications and remote monitoring devices that are combined with EHRs, patient portals and PHR systems which can ultimately be applicable to a variety of healthcare service environments. The Health-related data can be used to supplement existing clinical data, filling in gaps in information and providing a more comprehensive picture of ongoi...view more

The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care (POC) medical device communications. The scope is primarily focused on acute care medical devices and the communication of patient vital signs information.

The document gives guidance for managing healthcare service security using connectable personal health devices. This document considers unidirectional data uploading from the PHD to the gateway (manager device), however, there are many clinical use cases for bidirectional data exchange. This document is applicable to identification and authentication between the bidirectionally connected PHDs and gateway by providing possible use cases and the associated threats and vulnerabilities. Since some s...view more

The purpose of this document is to a) define a set of basic concepts required to describe formal concept representation systems, especially for health sciences, b) describe representation of concepts and characteristics, for use especially in formal computer-based concept representation systems, c) describe the characteristics which synthetically describe the organisation and content of a terminological system in health, d) support the development of specific standards on categorial structures f...view more

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.

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.

This document specifies the application, in the context of traditional Chinese medicine practice, of medical waveform format encoding rules (MFER) to pulse condition waveform as measured in physiological laboratories, hospitals, bed-wards, pharmacies, clinics, community health centres and home care check-ups using pulse condition devices.

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.

This document specifies the whole manufacturing process of Chinese materia medica products by defining a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable categorial structure. It includes three process categories: processing, extracting and preparation. This document is not applicable to Japanese traditional KAMPO medicinal products.

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, co...view more

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, co...view more

This document aims to specify categorial structures in the field of decoction. This document describes a concept system detailing domain constraints of sanctioned characteristics, each composed of a semantic link and applicable characterizing categories. The following topics are out of scope of this document: — models of decoction pieces; — the specification of categorial structures for the representation of post or manufacturing processes of decoction such as packaging; — individual pharmaceuti...view more

This document describes requirements for collections of metadata about data elements and their containing models and datasets in a healthcare environment. The collection can serve as a repository or as dictionary describing a set of items in use in a particular domain, organisation or product for reference, or it can additionally serve as a registry, supporting the development and communication of standard items to an audience with shared goals. This document specifies standard refinements that ...view more

This document specifies a set of representational primitives and semantic relations required 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 ...view more

This document defines the application of Medical waveform Format Encoding Rules (MFER) to describe stress test electrocardiography, which is one of the outputs of exercise, pharmacological and cardiopulmonary stress test. MFER performed in physiological laboratories, healthcare clinics, etc. This document covers not only the electrocardiogram waveform but also the description of related stress information and biological signals, e.g. blood pressure, respiration gas, SpO2, etc..

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 ex...view more

This document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both t...view more

This part of this multipart standard on Electronic Health Record Communication describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in Part 1 of this standard. This standard 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 requ...view more

This part of ISO 13606 specifies the information architecture required for interoperable communications between systems and services that need or provide EHR data. This part of ISO 13606 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 su...view more

This part of ISO 13606 is for the communication of part or all of the electronic health record (EHR) of a single identified subject of care between EHR systems, or between EHR systems and a centralized EHR data repository. It may 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)...view more

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 repre...view more

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 ex...view more

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 adminis...view more

This document defines the classification rules and coding scheme for traditional Chinese medicine (TCM) data sets. It is applicable for investigation and management of TCM data resources as well as the description, integration, publication, index and retrieval of the TCM data sets. This document excludes the Kampo medicine .

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 cros...view more

The purpose of this document is to describe the core principles and proposed service delivery model for supporting implementation and ongoing maintenance of IDMP terminologies. The information provided in this document can be used as evaluation and/or design criteria when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.