EN ISO 13119:2012
(Main)Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)
Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)
ISO 13119:2012 specifies a number of metadata elements that describe resources containing medical knowledge. It is primarily applicable to digital documents provided as web resources, accessible from databases or via file transfer, but can be applicable also to paper documents, e.g. articles in medical literature.
Medizinische Informatik - Klinische Wissensressourcen - Metadaten (ISO 13119:2012)
Informatique de santé - Ressources des connaissances cliniques - Métadonnées (ISO 13119:2012)
L'ISO 13119:2012 spécifie un certain nombre d'éléments de métadonnées qui décrivent des ressources contenant des connaissances médicales, principalement des documents numériques fournis sous forme de ressources Web accessibles à partir de bases de données ou par transfert de fichier, mais qui peuvent être applicables également à des documents papiers, par exemple des articles de publications médicales.
Zdravstvena informatika - Viri kliničnega znanja - Metapodatki (ISO 13119:2012)
Ta mednarodni standard določa več metapodatkovnih elementov, ki opisujejo vire z medicinskim znanjem. Uporablja se zlasti za digitalne dokumente, ki se zagotovijo kot spletni viri ter so dostopni v zbirkah podatkov ali prek prenosa datotek, lahko pa se uporablja tudi za papirne dokumente, npr. članke v medicinski literaturi. Metapodatkovni elementi: a) podpirajo jasno in mednarodno razumevanje pomembnih vidikov za opis vira, npr. njegov namen, izdajatelj, ciljno občinstvo, pravni status in znanstveno ozadje; b) se uporabljajo za različne vrste digitalnih virov, npr. za priporočila, ki izhajajo iz soglasja strokovne skupine, predpise vladnega organa, protokole kliničnega preskušanja iz farmacevtske družbe, znanstvene rokopise raziskovalne skupine, nasvete bolnikom z določeno boleznijo, pregledne članek; c) se lahko predložijo bralcem, tudi zdravstvenim delavcem in državljanom/bolnikom; d) se lahko uporabljajo pri samodejni obdelavi, npr. za podporo iskalnikov, da se zadetki omejijo na dokumente določene vrste ali ravni kakovosti. Metapodatkovni elementi iz tega mednarodnega standarda niso namenjeni: – opisovanju dokumentov o posameznem bolniku, npr. zdravstvenih kartotek, – opisovanju podrobnosti medicinske vsebine vira (vsebino je do določene mere mogoče opisati s ključnimi besedami ali šiframi), – določanju meril za kakovost vsebine vira.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2013
1DGRPHãþD
SIST-TS CEN/TS 15699:2009
=GUDYVWYHQDLQIRUPDWLND9LULNOLQLþQHJD]QDQMD0HWDSRGDWNL ,62
Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)
Medizinische Informatik - Klinische Wissensressourcen - Metadaten (ISO 13119:2012)
Informatique de santé - Ressources des connaissances cliniques - Métadonnées (ISO
13119:2012)
Ta slovenski standard je istoveten z: EN ISO 13119:2012
ICS:
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.
EUROPEAN STANDARD
EN ISO 13119
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 35.240.80 Supersedes CEN/TS 15699:2009
English Version
Health informatics - Clinical knowledge resources - Metadata
(ISO 13119:2012)
Informatique de santé - Ressources des connaissances Medizinische Informatik - Klinische Wissensressourcen -
cliniques - Métadonnées (ISO 13119:2012) Metadaten (ISO 13119:2012)
This European Standard was approved by CEN on 31 October 2012.
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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13119:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 13119:2012) has been prepared by Technical Committee CEN/TC 251 “Health
informatics", the secretariat of which is held by NEN, in collaboration with Technical Committee ISO/TC 215
"Health informatics".
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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
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 CEN/TS 15699:2009.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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.
INTERNATIONAL ISO
STANDARD 13119
First edition
2012-11-01
Health informatics — Clinical knowledge
resources — Metadata
Informatique de santé — Ressources des connaissances
cliniques — Métadonnées
Reference number
ISO 13119:2012(E)
©
ISO 2012
ISO 13119:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 13119:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Terms and definitions . 1
3 Introduction to metadata . 2
3.1 Purpose and format . 2
3.2 Sources of generally useful metadata elements . 2
3.3 Sources of medical metadata . 2
3.4 Characteristics of the metadata element set . 2
4 Metadata element structure for medical knowledge resources . 3
4.1 Introduction to the medical metadata elements . 3
4.2 Resource form . 3
4.3 Intended use . 8
4.4 Subject and scope .10
4.5 Identification and source . 11
4.6 Quality control .14
Annex A (informative) List of metadata elements .16
Annex B (informative) Class diagram.21
Bibliography .23
ISO 13119:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 13119 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 251, Health informatics, in collaboration with ISO Technical Committee ISO/TC 215, Health informatics,
in accordance with the agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This International Standard is a revision of CEN/TS 15699:2009, Health informatics — Clinical knowledge
resources — Metadata.
iv © ISO 2012 – All rights reserved
ISO 13119:2012(E)
Introduction
The internet is rapidly changing the way we access medical knowledge. Health professionals use web-based
knowledge sources while digital documents are provided from databases and via e-mail. Also, patients and
the general public turn to the internet, particularly in those countries in Europe where more than 50 % of
households already have internet access in their homes. The European Commission eEurope action plan 2002
describes the following challenge:
“Health-related information is among the most frequently accessed information on the Internet. Yet at present,
the European citizen has very few resources with which to assess the quality and authenticity of this vital
information.”
The European Commission has in response to this requirement published a set of quality criteria for health-
[18]
related websites .
One way to help navigate the multitude of information of varying quality is to establish a “Trustmark” to label
web documents that meet certain criteria. This was proposed in the TEAC-Health project of the 4th framework
and was the basis for the start of the MEDCERTAIN project started in September 2000. There are, however,
other possible solutions as well that may have advantages and may exist in parallel. A trustmark indicating a
“minimum” level of trustworthiness requires the following elements.
a) A set of quality requirements. This might be very difficult to agree on as relevant for all contexts. The
agreed criteria may be regarded as too low or too high for certain purposes.
b) Third party control by governmental bodies or professional associations of all possible resources to
receive the mark.
c) Reliance on a self-declaration by the issuer in which case the user of the information has no real guarantee
that the criteria are met even if the mark is there.
Instead of reviewing the actual content of the medical knowledge resources, we can define the processes
behind their development, which may impose requirements on professional education, quality assurance
principles in general, scientific reviews, etc.
This whole area requires collaboration of many different parties with different roles. Important work has started
in several professional associations and among web publishers of health information. Health authorities in
many countries, and in collaboration with the Commission, have considered the possible requirements for
legislation and control procedures; generally, the conclusions have been that rather than trying to ban bad
quality information, one should facilitate for the citizens as well as for the health professionals to find the type
of information they request where quality criteria behind a knowledge resource are easily accessible.
One feasible and important approach is to establish a set of metadata to describe the content and procedures
behind its production.
Many different types of documents are produced with the broad intent of providing “clinical knowledge”, e.g.
advice to patients for certain clinical problems, reports of research in the medical literature, guidelines issued
by governmental authorities and researchers’ protocols for clinical trials.
Some types of documents may have legal implications; a health professional is obliged to follow them, or
they may define the officially recommended treatment. This International Standard aims to make the type of
document explicit. Some guidelines are based on extensive high quality scientific review/meta quality systems
involving scientific reviews and can be influenced also by other (e.g. financial) considerations. In many areas of
clinical care, the patients and professionals use advice of lesser status produced by one or a group of qualified
experts. Such clinical guidelines are increasingly available on the internet and it is very important to provide
information to assist in judgment about the nature, status and scientific background of such documents.
This International Standard will not only be useful for the assessment of a knowledge resource but also to
facilitate search and retrieval of knowledge resources.
ISO 13119:2012(E)
This International Standard for metadata is based on the general pu
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