EN ISO 16278:2016

Health informatics - Categorial structure for terminological systems of human anatomy (ISO 16278:2016)

ISO 16278:2016 defines the characteristics required to synthetically describe the organization and content of human anatomy within a terminological system. It is intended primarily for use with computer-based applications such as clinical electronic health records, decision support and for various bio-medical research purposes.
ISO 16278:2016 will serve to
-      facilitate the construction of new terminological systems in a regular form which will increase their coherence and expressiveness,
-      facilitate maintenance of human anatomy within terminological systems,
-      increase consistency and coherence of existing terminological system,
-      allow systematic cross-references between items of human anatomy in different types of terminological systems,
-      facilitate convergence among human anatomy within terminological systems,
-      make explicit the overlap for human anatomy between different health care domains terminological systems,
-      provide elements for negotiation about integration of different terminological systems into information systems between the respective developers, and
-      enable the systematic evaluation of human anatomy within terminological systems.
ISO 16278:2016 itself is not suitable or intended for use by, individual clinicians or hospital administrators.
The target groups for this International Standard are the following:
-      designers of specialized standard healthcare terminological categorial structures;
-      developers of healthcare terminological systems including classifications and coding systems;
-      producers of services for terminological systems and designers of software including natural language processing;
-      information modellers, knowledge engineers, and standards developers building models for health information management systems;
-      developers of information systems that require an explicit representation of healthcare terminological systems;
-      developers of marked-up standards for representation of healthcare documents.
ISO 16278:2016 does not include categorial structure that might be necessary for the description of developmental anatomy during the human life cycle, which includes prenatal development, post-natal growth and aging.
ISO 16278:2016 has been developed for use as an integrated part of computer-based applications and for the electronic healthcare record. It would be of limited value for manual use.
It is not the purpose of this International Standard to standardize the end user classification of human anatomy terminology or to conflict with the concept systems embedded in national practice and languages.

Medizinische Informatik - Kategoriale Struktur für terminologische Systeme der Anatomie des Menschen (ISO 16278:2016)

Diese Internationale Norm legt die erforderlichen Merkmale für die synthetische Beschreibung von Aufbau und Inhalt der Anatomie des Menschen innerhalb eines terminologischen Systems fest. Sie ist vorrangig für die Verwendung innerhalb computergestützter Anwendungen, wie z. B. klinische elektronische Gesundheitsakten, Entscheidungsunterstützung sowie für verschiedene biomedizinische Forschungszwecke vorgesehen.
Diese Internationale Norm dient folgenden Zwecken:
— vereinfachter Aufbau neuer terminologischer Systeme in geregelter Form zur Erhöhung ihrer Kohärenz und Ausdruckskraft;
— vereinfachte Pflege der Anatomie des Menschen innerhalb von terminologischen Systemen;
— erhöhte Konsistenz und Kohärenz vorhandener terminologischer Systeme;
— Ermöglichung systematischer Querverweise zwischen Elementen der Anatomie des Menschen in unterschiedlichen Typen von terminologischen Systemen;
— vereinfachte Konvergenz der Anatomie des Menschen innerhalb von terminologischen Systemen;
— Verdeutlichung der im Bereich der Anatomie des Menschen bestehenden Überlappungen mit unterschiedlichen terminologischen Systemen verschiedener Gesundheitsfachgebiete;
— Bereitstellung von Verhandlungsgrundlagen für die jeweiligen Entwickler in Hinblick auf die Integration verschiedener terminologischer Systeme in Informationssysteme;
— Ermöglichung der systematischen Bewertung der Anatomie des Menschen innerhalb von terminologischen Systemen.

Informatique de santé - Structure catégorielle des systèmes terminologiques de l'anatomie humaine (ISO 16278:2016)

ISO 16278:2016 définit les caractéristiques requises pour décrire de façon synthétique l'organisation et le contenu de l'anatomie humaine au sein d'un système terminologique. Elle est principalement prévue pour être utilisée avec des applications informatiques, telles que les dossiers informatisés de santé cliniques, l'aide à la décision et les différents objectifs de la recherche biomédicale.
ISO 16278:2016 servira à
-      faciliter l'élaboration de nouveaux systèmes terminologiques avec une régularité qui augmentera leur cohérence et leur expressivité,
-      faciliter la maintenance de l'anatomie humaine au sein des systèmes terminologiques,
-      augmenter l'homogénéité et la cohérence des systèmes terminologiques existants,
-      permettre de systématiser les références croisées entre les éléments d'anatomie humaine des différents types de systèmes terminologiques,
-      faciliter la convergence de l'anatomie humaine au sein des systèmes terminologiques,
-      expliciter le chevauchement de l'anatomie humaine entre les systèmes terminologiques des différents domaines de la santé,
-      fournir des éléments de négociation sur l'intégration de différents systèmes terminologiques dans des systèmes d'information aux développeurs respectifs, et
-      permettre de systématiser l'évaluation de l'anatomie humaine au sein des systèmes terminologiques.
ISO 16278:2016 en elle-même n'est pas adaptée, ni destinée à être utilisée individuellement par des cliniciens ou des administrateurs d'hôpitaux.
Les groupes cible de la présente Norme internationale sont:
-      les créateurs des structures catégorielles des terminologies de santé spécialisées et normalisées;
-      les développeurs de systèmes terminologiques de santé, y compris les classifications et les systèmes de codage;
-      les prestataires de services pour les systèmes terminologiques et les créateurs de logiciels incluant les applications travaillant sur le langage naturel;
-      les créateurs de modèles d'informations, les ingénieurs cogniticiens et les développeurs de normes qui construisent des modèles pour les systèmes de gestion des informations de santé;
-      les développeurs des systèmes d'information qui nécessitent une représentation explicite des systèmes terminologiques de santé;
-      les développeurs de normes de balisage pour la représentation des documents de santé.
ISO 16278:2016 n'aborde pas la structure catégorielle pouvant être nécessaire à la description de l'anatomie du développement au cours du cycle de vie de l'homme, comprenant le développement prénatal, la croissance postnatale et le vieillissement.
ISO 16278:2016 a été élaborée pour être utilisée en tant que partie intégrante des applications informatisées et pour le dossier informatisé de santé. Elle n'aurait que peu d'intérêt pour une utilisation manuelle.
L'objectif de la présente Norme internationale n'est pas de normaliser la classification de la terminologie de l'anatomie humaine de l'utilisateur final, ni d'entrer en conflit avec les systèmes de concepts inhérents à la pratique et aux langues nationales.

Zdravstvena informatika - Kategorijska struktura za terminologijo človeške anatomije (ISO 16278:2016)

Namen predlagane delovne postavke je razviti mednarodni standard za določanje lastnosti kategorijske strukture za človeško anatomijo, ki se bo uporabljal v terminoloških sistemih na področju zdravstva, z minimalnimi domenskimi omejitvami, s katerimi morajo biti skladne, za povezavo teh terminologij z informacijskim modelom EHR z namenom podpore izmenjave pomembnih informacij med različnimi elektronskimi zdravstvenimi zapisi (EHR), ki uporabljajo različne zdravstvene terminološke sisteme s človeško anatomijo in z različnimi nacionalnimi jeziki. Kategorijske strukture podpirajo medoperabilnost, tako da zagotavljajo splošne okvirje za a) razvoj terminoloških sistemov, ki se lahko med seboj povežejo, ter za b) analizo lastnosti različnih terminoloških sistemov, da se vzpostavi razmerje med njimi. Ta standard se uporablja za: – organizacije, ki se ukvarjajo z razvojem ali vzdrževanjem terminoloških sistemov, kot je določeno v standardu ISO 17115 2007 ter na podlagi človeške anatomije, in sicer za večnamenske kodirne sisteme na nacionalni ali mednarodni ravni; – organizacije, ki razvijajo in vzdržujejo orodja programske opreme, ki omogočajo analizo izrazov v naravnem kliničnem jeziku ter generiranje in preslikavo v glavne obstoječe zdravstvene terminološke sisteme. Evropski standard EN 15521 2007 se bo uporabljal kot izhodiščni dokument v povezavi z lastno revizijo v okviru CEN TC 251. Namenjen je za uporabo kot integriran del računalniških aplikacij in za elektronski zdravstveni zapis. Standard ni primeren oziroma namenjen za uporabo s strani posameznih zdravnikov ali upravnikov bolnišnic.

General Information

• Status: Published
• Publication Date: 22-Mar-2016
• Withdrawal Date: 29-Sep-2016
• ICS: 01.020 - Terminology (principles and coordination)
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Mar-2016
• Completion Date: 23-Mar-2016
• Ref Project: SIST EN ISO 16278:2016 - Health informatics - Categorial structure for terminologies systems of human anatomy (ISO 16278:2016)

Relations

• Replaces: EN 15521:2007 - Health informatics - Categorial structure for terminologies of human anatomy
• Effective Date: 20-Nov-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2016
1DGRPHãþD
SIST EN 15521:2008
=GUDYVWYHQDLQIRUPDWLND.DWHJRULMVNDVWUXNWXUD]DWHUPLQRORJLMRþORYHãNH
DQDWRPLMH,62
Health informatics - Categorial structure for terminologies systems of human anatomy
(ISO 16278:2016)
Medizinische Informatik - Kategoriale Struktur für Terminologien der Anatomie des
Menschen (ISO 16278:2016)
Informatique de santé - Structure catégorielle des terminologies d'anatomie humaine
(ISO 16278:2016)
Ta slovenski standard je istoveten z: EN ISO 16278:2016
ICS:
01.020 7HUPLQRORJLMDQDþHODLQ Terminology (principles and
NRRUGLQDFLMD coordination)
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16278
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2016
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 15521:2007
English Version
Health informatics - Categorial structure for terminological
systems of human anatomy (ISO 16278:2016)
Informatique de santé - Structure catégorielle des Medizinische Informatik - Kategoriale Struktur für
systèmes terminologiques de l'anatomie humaine (ISO terminologische Systeme der Anatomie des Menschen
16278:2016) (ISO 16278:2016)
This European Standard was approved by CEN on 15 January 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16278:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16278:2016) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2016, and conflicting national standards
shall be withdrawn at the latest by September 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN 15521:2007.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16278:2016 has been approved by CEN as EN ISO 16278:2016 without any modification.
INTERNATIONAL ISO
STANDARD 16278
First edition
2016-03-01
Health informatics — Categorial
structure for terminological systems
of human anatomy
Informatique de santé — Structure catégorielle des systèmes
terminologiques de l’anatomie humaine
Reference number
ISO 16278:2016(E)
©
ISO 2016
ISO 16278:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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ii © ISO 2016 – All rights reserved

ISO 16278:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 2
3 Categorial structure for terminologies of human anatomy description .3
3.1 Principles . 3
3.2 Anatomical categories (2.7) . 4
3.3 Precise goal of the categorial structure (2.10) . 6
3.4 List of anatomical relations (2.8) . 7
3.5 List of minimal anatomical domain constraints (2.9) . 9
4 Conformance . 9
Annex A (informative) A reference ontology for biomedical informatics: the Foundational
Model of Anatomy .10
Bibliography .16
ISO 16278:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2016 – All rights reserved

ISO 16278:2016(E)
Introduction
This International Standard specifies a categorial structure for terminologies of human anatomy.
Computer-based processing and the interchange of medical or clinical information requires various
kinds of terminological systems to represent that information, such as controlled vocabularies,
classifications, nomenclatures, terminologies and thesauri, with or without coding schemes.
The specific terminological issues in the field of health informatics are the following:
— large number of different terminological systems are available in different clinical specialties;
— large overlap among the subject fields involved;
— large number of codes and rubrics, typically in the order of magnitude of 10 000 to 100 000 entries,
in commonly used terminological systems;
— increasing need for re-use of coded data in different health-care contexts;
— polysemy across different clinical specialties and sometimes within them.
The integration of computer-based medical records and administrative information systems in
Electronic Health Records (EHR) require rationalization in the field, and a uniform way to represent
the meaning of medical concepts to ensure that the receiver EHR of a message will catch the meaning
introduced by the sender EHR and not only the string of characters embedded in it.
It is not possible to impose a rigid, uniform, standardized, natural language clinical terminology
on healthcare professional providers. Nevertheless, standards need to be provided for guiding
the development of terminologies in the different sub domains of healthcare to allow semantic
interoperability between them. To this end, a domain specific semantic representation has been
developed (EN 12264) and applied in a series of specific initiatives, including European Pre standards
(ENV), European Standards (EN) and International Standards (ISO) on various subject fields to
describe a set of categorial structures in partially overlapping subject fields. Human anatomy is
central to medical terminology (surgical procedures, carcinoma staging, annotation of radiological
findings, disease, clinical laboratory and so forth) and also to many scientific and bio-informatics study
beyond the scope of clinical medicine. In the US, the University of Washington has developed in the
public domain an anatomical terminology for EHR named the Digital Anatomist Foundational Model of
Anatomy (FMA for short), a reference ontology for biomedical informatics.
International Standardization efforts by CEN and ISO related to Electronic Health Records and semantic
interoperability have resulted in a number of categorial structures which are a step towards supporting
healthcare terminological systems with a full concept system or ontology that in turn will support
multipurpose uses and safe communication. In the present categorial structure standard, several of the
definitions of basic terms related to categorial structures have been updated to comply with the most
recent version of ISO 17115.
Adequate field testing in several countries, revision and integration have provided the comprehensive
basis for this International Standard.
INTERNATIONAL STANDARD ISO 16278:2016(E)
Health informatics — Categorial structure for
terminological systems of human anatomy
1 Scope
This International Standard defines the characteristics required to synthetically describe the
organization and content of human anatomy within a terminological system. It is intended primarily for
use with computer-based applications such as clinical electronic health records, decision support and
for various bio-medical research purposes.
This International Standard will serve to
— facilitate the construction of new
...