SIST ENV 13606-3:2003
(Main)Health informatics - Electronic healthcare record communication - Part 3: Distribution rules
Health informatics - Electronic healthcare record communication - Part 3: Distribution rules
This European Prestandard specifies data objects for describing rules for distribution or sharing of electronic healthcare Records in whole or in part. This European Prestandard establishes general principles for the interaction of these data objects with other components and mechanisms within an electronic healthcare record application, thereby controlling the distribution of electronic healthcare records in whole or in part. This European Prestandard establishes ways of creating information with associated security attributes.
Zdravstvena informatika –Komuniciranje z elektronskimi zapiski v zdravstvenem varstvu – 3. del: Pravila za razdeljevanje
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SLOVENSKI STANDARD
SIST ENV 13606-3:2003
01-oktober-2003
Zdravstvena informatika –Komuniciranje z elektronskimi zapiski v zdravstvenem
varstvu – 3. del: Pravila za razdeljevanje
Health informatics - Electronic healthcare record communication - Part 3: Distribution
rules
Ta slovenski standard je istoveten z:
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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.
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This document describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
— any organization that might be responsible for developing and maintaining such controlled vocabularies;
— any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
— owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
— other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
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This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
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— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
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— management of telehealth quality processes by the healthcare organization;
— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
— management of financial resources to support telehealth services;
— management of information management and security used in telehealth services;
— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
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