Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

This International Standard: — specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain; — establishes requirements for units in order to provide traceability to international metrological standards; — provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products, specifically in the context of medicinal product identification; — defines the requirements for the representation of units of measurement in coded form; — provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of this International Standard, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units. The scope of this International Standard is limited to the representation of units of measurement for data interchange between computer applications.

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.

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

This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case’ scenario for ‘unplanned, cross border care’ and is intended to be an international patient summary (IPS). Whilst the data set is minimal and non-exhaustive, it provides a robust, well-defined core set of data items. The tight focus on this use case also enables the IPS to be used in planned care. This means that both unplanned and planned care can be supported by this data set within local and national contexts, thereby increasing its utility and value. It uses the European Guideline from the eHN as the initial source for the patient summary requirements, then takes into consideration other international patient summary projects to provide an interoperable data set specification that has global application. This document provides an abstract definition of a Patient Summary from which derived models are implementable. Due to its nature therefore, readers should be aware that the compliance with this document does not imply automatic technical interoperability; this result, enabled by this document, can be reached with the conformity to standards indicated in the associated technical specification and implementation guides. 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/skill/competence that results in the data summarization workflow.