SIST EN ISO 13119:2013
(Main)Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)
Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012)
This International Standard 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. The metadata elements: a) support unambiguous and international understanding of important aspects to describe a resource e.g. purpose, issuer, intended audience, legal status and scientific background; b) are applicable to different kinds of digital resources e.g. recommendations resulting from the consensus of a professional group, regulation by a governmental authority, clinical trial protocol from a pharmaceutical company, scientific manuscript from a research group, advice to patients with a specific disease, review article; c) can be presented to human readers including health professionals, as well as citizens/patients; d) are potentially usable for automatic processing e.g. to support search engines to restrict matches to documents of a certain type or quality level. The metadata elements defined in this International Standard are not intended to: - describe documents about a single patient, such as medical records; - describe details of the medical content of the resource (but some idea of the content can be described via keywords or codes); - prescribe criteria for the quality of the resource content.
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13119:2013
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
SIST EN ISO 13119:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 13119:2013
---------------------- Page: 2 ----------------------
SIST EN ISO 13119:2013
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 13119:2013
EN ISO 13119:2012 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 13119:2013
EN ISO 13119:2012 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 13119:2013
---------------------- Page: 6 ----------------------
SIST EN ISO 13119:2013
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
---------------------- Page: 7 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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
---------------------- Page: 8 ----------------------
SIST EN ISO 13119:2013
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 2012 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 13119:2013
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
---------------------- Page: 10 ----------------------
SIST EN ISO 13119:2013
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 2012 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
This International Standard for metadata is based on the general purpose metadata standardization initiative
1)
Dublin Core which developed the first set of 15 metadata elements, later published as ISO 15836:2003, which
has been cancelled and replaced by ISO 15836:2009.
This International Standard provides an international set of health care specific extensions to this set. Some of
the issues covered by health specific metadata tags in the CEN/TS 15699 have been replaced by corresponding
Dublin Core qualifiers now available. This area is in rapid development.
The basic structure (taken from Dublin Core), with the extensions provided in this International Standard,
constitutes a source for possible use for a specific use case. An international set is certainly preferable when
there is an audience for the knowledge resource outside of the country of origin. This is common for clinical
knowledge resources in languages with users in many countries such as English, Spanish, French and Arabic.
However, for many use cases of metadata, it is important to provide a vocabulary that is easily understood,
perhaps also by laymen and corresponding to the language used in the resource itself. This International
Standard does in no way preclude the use of such national metadata vocabularies. However, even when this is
the case, this International Standard can serve as an inspiration for defining important metadata.
It should also be emphasized that the extensive set of possible metadata elements defined in this International
Standard is usually useful only as a subset for a specific set of resources. The compilation of a possible application
profile with a minimum set of metadata elements for various purposes may be the scope of future work.
1) The Dublin Core Metadata Initiative (www.dublincore.org).
vi © ISO 2012 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 13119:2013
INTERNATIONAL STANDARD ISO 13119:2012(E)
Health informatics — Clinical knowledge resources — Metadata
1 Scope
This International Standard 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.
The metadata elements:
a) support unambiguous and international understanding of important aspects to describe a resource e.g.
purpose, issuer, intended audience, legal status and scientific background;
b) are applicable to different kinds of digital resources e.g. recommendations resulting from the consensus of
a professional group, regulation by a governmental authority, clinical trial protocol from a pharmaceutical
company, scientific manuscript from a research group, advice to patients with a specific disease, review article;
c) can be presented to human readers including health professionals, as well as citizens/patients;
d) are potentially usable for automatic processing e.g. to support search engines to restrict matches to
documents of a certain type or quality level.
The metadata elements defined in this International Standard are not intended to:
— describe documents about a single patient, such as medical records;
— describe details of the medical content of the resource (but some idea of the content can be described via
keywords or codes);
— prescribe criteria for the quality of the resource content.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
medical knowledge
field of knowledge pertaining to the structure, function or dysfunction of the human body and how these can be
influenced by external or internal factors and interventions
NOTE This does not only refer to physicians; all health professionals have medical knowledge according to this definition.
2.2
clinical knowledge
part of medical knowledge pertaining to the promotion of good health and the management and prevention
of ill health
NOTE This is used to diagnose, treat and alleviate disease/dysfunction.
2.3
knowledge resource
collection of knowledge about a subject area collected for a purpose and made available to a user through
some means
2.4
metadata
data that defines and describes other data
© ISO 2012 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
2.5
lifecycle
〈information resource〉 sequence of events that mark the development and use of an information resource
NOTE Adapted from ISO 15836:2009, definition 3.1.2.
EXAMPLE Conception of an invention, creation of a draft, revision of an article, publication of a book, acquisition by
a library, transcription to magnetic disk, migration to optical storage, translation into English and derivation of a new work
(e.g. a film).
3 Introduction to metadata
3.1 Purpose and format
Metadata for a knowledge resource conveys information that is non-essential for the purpose of the document
but important for other purposes, such as:
— locating a knowledge resource depending on e.g. subject, area of applicability, form of presentation;
— assessing the quality of the knowledge, e.g. how old it is, how trustworthy the author is.
3.2 Sources of generally useful metadata elements
General metadata have been developed by an initiative from library science known as the Dublin Core Metadata,
adopted and published as ISO 15836:2009.
3.3 Sources of medical metadata
In the development of this International Standard, several sets of metadata particularly relevant for clinical
knowledge were used as input and/or inspiration, including Arden syntax and ISO 13606-3.
3.4 Characteristics of the metadata element set
In the element descriptions in 4.2 to 4.6, each element has a descriptive label intended to convey a common
understanding of the element, as well as a unique, machine-understandable, single-word name intended to
make the syntactic specification of elements simpler for encoding schemes.
Although some environments, such as HTML, are not case-sensitive, recommended practice is to always adhere to
the case conventions in the element names given to avoid conflicts in the event that the metadata are subsequently
extracted or converted to a case-sensitive environment, such as XML (Extensible Markup Language).
Each element is optional and repeatable. Metadata elements may appear in any order. The ordering of multiple
occurrences of the same element (e.g. Creator) may have a significance intended by the provider, but ordering
is not guaranteed to be preserved in every system.
To promote global interoperability, a number of the element descriptions suggest a controlled vocabulary for
the respective element values. The Dublin Core set assumes that different domains develop, where necessary,
controlled vocabularies as specifiers of the content of the general purpose Dublin Core metadata element set
and adds other metadata elements as required by the domain. This International Standard is a specialization
for the medical knowledge domain.
The Dublin Core initiative is providing valuable informative material concerning the use of metadata and system
implementation advice.
2 © ISO 2012 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
4 Metadata element structure for medical knowledge resources
4.1 Introduction to the medical metadata elements
This clause establishes a categorisation of clinical knowledge resources that is intended to facilitate finding
appropriate metadata elements. These metadata element groups are not intended to be represented as actual
metadata for the knowledge resources.
For each Metadata Element Name, there is a proposed way of expressing the content of that metadata, often by
using a controlled vocabulary presented or referenced in this International Standard. Most of these come from
the Dublin Core, indicated by (DC). In these cases, additional information may be found in ISO 15836:2009.
In a few cases, this structure also proposes a substructure of specialization of the metadata elements. Where
elements or sub-elements are defined in this health care International Standard, it is indicated by (HC). The
syntax for representing metadata may vary, depending on the format of the metadata expression e.g. XML.
NOTE This International Standard is based on the original expression of metadata elements with qualifiers expressed
using the dot-notation (e.g. Type.Text). The Dublin Core Metadata Initiative has also provided an alternative expression
based on an abstract model and provisions of individual metadata properties in the Resource Description Framework
(RDF) of the World Wide Web consortium.
For the purpose of navigation among the many metadata elements of this International Standard, they are
presented under a set of group headings. These are not to be implemented as metadata tags in resources.
4.2 Resource form
4.2.1 Group description
The resource form group of metadata describes the form of delivery of knowledge from the resource.
4.2.2 Type
4.2.2.1 General
Element name: Type (DC)
Definition: nature or genre of the content of the resource (DC).
Health care specific specialization: the following terms may be used to describe Type:
— Text
— Database for human reading
— Interactive resource
— Moving image
— Still image
— Sound
— Dataset
— Software
— Hardware device
It is recommended that these terms are complemented by a type specifier as given below.
© ISO 2012 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
4.2.2.2 Text
Element name: Type.Text (DC)
Definition: a resource consisting primarily of words for reading.
NOTE A resource (often called document) which contains still images in addition to the words shall be designated
type Text.
EXAMPLES Books, letters, dissertations, poems, newspapers, articles and archives of mailing lists. Note that
facsimiles or images of texts are still of the genre Text.
Specifiers of Type.Text health care specific (HC):
a) Journal_article
b) Book_chapter
c) Book
d) Report
e) Abstract
f) Patient_education_handout
NOTE This is information directed towards a patient/subject of care about a particular health issue. This includes
medication inserts in medicinal products.
g) FAQ
NOTE FAQ stands for Frequently Asked Questions.
h) Algorithm
NOTE Formal description of a procedure e.g. a calculation method.
i) Clinical_guideline
NOTE This is defined in EN 13940 as “set of systematically developed statements to assist the decision of
health care parties about health care activities to be provided with regard to a health issue in specified clinical
circumstances”.
j) Policy_strategy
NOTE A document that is a policy or a strategy for the operation of health care services.
k) Information_standard
NOTE A standard relating to health information and health informatics.
l) Teaching_material
NOTE This includes learning/self-learning materials.
m) Computable_clinical_information_model
NOTE This includes, for example, the special form of constrained information model used to describe a part of
an Electronic Health Record as described by ISO 13606-2 or OpenEHR (see http://www.openehr.org/home.html).
Also, HL7-based templates could be tagged with this.
n) Terminological_resource
o) Metainformation
NOTE Information about other resources (bibliography, catalogue, reviews, gateway, search engine).
4 © ISO 2012 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
p) Case_report
q) Proposal
NOTE This term should be used to label a plan for a project.
r) Event
NOTE This term may be used to label properties of an event such as invitations, descriptions and schedules of
meetings and other events where people meet. It is not used to described the outcome of an event.
s) Service_description
NOTE Service in this context may include health care services as well as other services e.g. IT-related.
t) Product_information
u) Critically_appraised_topic
NOTE An answer to a clinically focused/structured question, which has been produced from a search and
appraisal of the evidence, within a short timeframe. The answer cannot be considered to be a systematic review due
to the rapid nature of production. It includes all topics produced by question-answering services.
v) Known_uncertainty
NOTE Therapeutic uncertainties identified through systematic reviews, clinical guidelines and other formal
mechanisms.
w) Observational_study
NOTE Studies in which patient or health professional preference determines whether a patient receives
treatment or control. This is used for cohort studies and case-controlled studies.
x) Qualitative_study
NOTE Studies which research social, emotional and experiential phenomena in health care.
y) Randomized_controlled-trial
NOTE Experiment in which individuals are randomly allocated to receive or not to receive an experimental
preventative, therapeutic or diagnostic procedure and then followed to determine the effect of the intervention.
z) Research_study
NOTE Research studies not included in any of the other publication types. This is used for case study and case
series. This is not to be used unless all other publication types have been excluded.
aa) Review
NOTE A non-systematic literature review, topic overview or descriptive article.
bb) Systematic_review
NOTE A review of a clearly formulated question that uses systematic and explicit methods to identify, select and
critically appraise relevant research, and to collect and analyse data from the studies that are included in the review.
Statistical methods (meta-analysis) may or may not be used to analyse and summarize the results of the included studies.
If the review does not state it is systematic, or no details of the searching methods are given, Review should be used.
cc) Structured_abstract
NOTE An abstract of a single journal article with headings that conform to one of the agreed protocols for
reporting research results (e.g. sample, data collection, data analysis, results, discussion) that also contains a
commentary on or appraisal of the article.
dd) Care_pathway
© ISO 2012 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 13119:2013
ISO 13119:2012(E)
4.2.2.3 Database for human reading
Element name: Type.DatabaseforHumans (HC)
Definition: type of knowledge resource with structured data and established retrieval functions for human reading.
Specifiers of Type.DatabaseforHumans:
a) Journal
b) Metainformation
c) Terminology
d) Guideline_collection
4.2.2.4 Interactive resource
Element name: Type.InteractiveResource (DC)
Definition: a resource requiring interaction from the user to be understood, executed, or experienced.
EXAMPLES Forms on web pages, applets, multimedia learning objects, chat ser
...
SLOVENSKI STANDARD
oSIST prEN ISO 13119:2011
01-marec-2011
=GUDYVWYHQDLQIRUPDWLND9LULNOLQLþQHJD]QDQMD0HWDSRGDWNL ,62',6
Health informatics - Clinical knowledge resources - Metadata (ISO/DIS 13119:2011)
Medizinische Informatik - Klinische Wissensressourcen - Metadaten (ISO/DIS
13119:2011)
Informatique de santé - Ressources des connaissances cliniques - Métadonnées
(ISO/DIS 13119:2011)
Ta slovenski standard je istoveten z: prEN ISO 13119
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 13119:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 13119:2011
---------------------- Page: 2 ----------------------
oSIST prEN ISO 13119:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 13119
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2011
ICS 35.240.80 Will supersede CEN/TS 15699:2009
English Version
Health informatics - Clinical knowledge resources - Metadata
(ISO/DIS 13119:2011)
Informatique de santé - Ressources des connaissances Medizinische Informatik - Klinische Wissensressourcen -
cliniques - Métadonnées (ISO/DIS 13119:2011) Metadaten (ISO/DIS 13119:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 13119:2011: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 13119:2011
prEN ISO 13119:2011 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 13119:2011
prEN ISO 13119:2011 (E)
Foreword
This document (prEN ISO 13119:2011) 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 document is currently submitted to the parallel Enquiry.
This document will supersede CEN/TS 15699:2009.
3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 13119:2011
---------------------- Page: 6 ----------------------
oSIST prEN ISO 13119:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 13119
ISO/TC 215 Secretariat: ANSI
Voting begins on Voting terminates on
2011-01-27 2011-06-27
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Health informatics — Clinical knowledge resources — Metadata
Informatique de santé — Ressources des connaissances cliniques — Métadonnées
ICS 35.240.80
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the European Committee for Standardization (CEN), and
processed under the CEN-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2011
---------------------- Page: 7 ----------------------
oSIST prEN ISO 13119:2011
ISO/DIS 13119
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2011 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 13119:2011
ISO/CD 13119
Contents Page
1 Scope . 9
2 Normative references . 9
3 Terms and definitions. 9
4 Introduction to metadata. 11
4.1 Purpose and format. 11
4.2 Sources of generally useful metadata elements . 11
4.3 Sources of medical metadata. 11
4.4 Characteristics of the metadata element set . 11
5 Metadata element structure for medical knowledge resources. 12
5.1 Introduction to the medical metadata elements . 12
5.2 Resource form. 12
5.2.1 Group description. 12
5.2.2 Type. 12
5.2.3 Format. 17
5.2.4 Language . 18
5.3 Intended use. 18
5.3.1 General. 18
5.3.2 Audience. 18
5.3.3 Situation. 19
5.3.4 Clinical process stage. 20
5.4 Subject and scope . 20
5.4.1 Group description. 20
5.4.2 Subject . 20
5.4.3 Description . 21
5.4.4 Coverage. 21
5.4.5 Inclusion criteria . 21
5.4.6 Exclusion criteria. 21
5.4.7 Relation. 21
5.5 Identification and source . 22
5.5.1 Group description. 22
5.5.2 Identifier. 22
5.5.3 Title. 22
5.5.4 Creator . 22
5.5.5 Creator Contact Information. 22
5.5.6 Date created . 23
5.5.7 Date available. 23
5.5.8 Date issued. 23
5.5.9 Status . 23
5.5.10 Rights management. 24
5.5.11 Publisher. 24
5.5.12 Publisher type . 24
5.5.13 Publisher contact information. 25
5.5.14 Contributor . 25
5.5.15 Citation. 25
5.5.16 Source. 26
5.6 Quality control. 26
5.6.1 Group description. 26
5.6.2 Evidence grading. 26
5.6.3 Recommendation Strength. 26
5.6.4 Risk class . 27
© ISO 2009 – All rights reserved iii
DRAFT 2011
---------------------- Page: 9 ----------------------
oSIST prEN ISO 13119:2011
ISO/CD 13119
Annex A (informative) List of metadata elements . 28
Annex B (informative) Class diagram. 36
iv © ISO 2009 – All rights reserved
DRAFT 2011
---------------------- Page: 10 ----------------------
oSIST prEN ISO 13119:2011
ISO/CD 13119
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 Technical Committee ISO/TC 215, and by Technical Committee CEN/TC 251, in
collaboration.
This EN ISO standard is a revision of the CEN/TS 15699:2009 Health informatics clinical knowledge
resources – Metadata.
© ISO 2009 – All rights reserved v
DRAFT 2011
---------------------- Page: 11 ----------------------
oSIST prEN ISO 13119:2011
ISO/CD 13119
Introduction
The internet is rapidly changing the way we access medical knowledge. Health professionals use web based
knowledge sources and digital documents are provided from databases and via e-mail. Also the
patients/citizens 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 amongst 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
1
related websites .
One way to help navigate in the multitude of information of various quality is to establish a “Trustmark” to label
th
web documents that meet certain criteria. This was proposed in the TEAC-Health project of the 4 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:
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 documents 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 processes behind
their development, which may put 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 requirement for
legislation and control procedures, but 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 researcher's protocols for clinical trials.
In some cases, document type may have legal implications - a health professional is obliged to follow them,
or they may define the officially recommended treatment. Some guidelines are based on extensive high
quality scientific review/meta quality systems involving scientific reviews and can be influenced also by other
1
COM(2002) 667, eEurope 2002: Quality Criteria for Health related Websites.
vi © ISO 2009 – All rights reserved
DRAFT 2011
---------------------- Page: 12 ----------------------
oSIST prEN ISO 13119:2011
ISO/CD 13119
(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 standard will not only be useful for the assessment of a knowledge resource but also to facilitate search
and retrieval of knowledge resources.
This international standard for metadata is based on the general purpose metadata standardization initiative
2
Dublin Core which developed the first set of fifteen metadata elements later approved by ISO and published
first in 2003 and recently in a revised version as ISO 15386:2009.
This International Standard provides an international set of health care sepcific extensions to this set. Some of
the issues covered by health specific metadata tags in the CEN/TS 15699 has now been replaced by
corresponding Dublin Core qualifiers now available. This area is in a rapid development.
The basic structure (taken from Dublin Core) and the extensions provided in this standard shall be regarded
as a source for possile use for a specific use case. An international set is certainly preferable when there is an
audience for the knowledge resource outside of the country of origin. This is common for clinical knowledge
resources in languages with users in many countries such as English, Spanish, French and Arabic.
However, for many use cases of metadata it is important to provide a vocabulary that is easy understood
perhaps also by laymen and corresponding to the language used in the resource itself. This International
Standard does in no way preclude the use of such national metadata vocabularies. However, even when this
is the case, this international standard can serve as an inspiration for defining important metadata.
It should also be emphasized that the extensive set of possible metadata elements defined herein will usually
be useful only as a subset for a specific set of resources. The compilation of a possible application profile with
a minimum set of metadata elements for various purposes may be the scope of future work.
2
The Dublin Core Metadata Intitiative - www.dublincore.org
© ISO 2009 – All rights reserved vii
DRAFT 2011
---------------------- Page: 13 ----------------------
oSIST prEN ISO 13119:2011
---------------------- Page: 14 ----------------------
oSIST prEN ISO 13119:2011
ISO/DIS 13119
Health informatics — Clinical knowledge resources —
Metadata
1 Scope
This International Standard defines a number of metadata elements that describe documents containing
medical knowledge, primarily 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 the medical literature.
The metadata should:
• support unambiguous and international understanding of important aspects to describe a document
e.g. purpose, issuer, intended audience, legal status and scientific background;
• be applicable to different kinds of digital documents
e.g. recommendation from consensus of a professional group, regulation by a governmental
authority, clinical trial protocol from a pharmaceutical company, scientific manuscript from a
research group, advice to patients with a specific disease, review article;
• be possible to present to human readers
including health professionals as well as citizens/patients
• be potentially usable for automatic processing
e.g. to support search engines to restrict matches to documents of a certain type or quality level.
The metadata here described is not intended to:
• describe documents about a single patient, such as medical records;
• describe details of the medical content of the document (but some idea of the content can be
described via keywords or codes);
• prescribe criteria for the quality of the document content.
2 Normative references
Not applicable.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
9
DRAFT 2011
---------------------- Page: 15 ----------------------
oSIST prEN ISO 13119:2011
ISO/DIS 13119
3.1
medical knowledge
field of knowledge pertaining to the structure, function or dysfunction of the human body and how these
can be influenced by external or internal factors and interventions
NOTE Medical does not imply “physician” – all health professionals have medical knowledge according to this
definition.
3.2
clinical knowledge
part of medical knowledge pertaining promoting good health and the management and prevention of ill
health
NOTE Used to diagnose, treat and alleviate disease/dysfunction.
3.3
knowledge resource
collection of knowledge about a subject area collected for a purpose and made available to a user as
some manifestation
3.4
metadata
data that defines and describes other data
[ISO 1087-1:2000]
3.5
lifecycle [of information resource]
sequence of events that mark the development and use of an information resource
[ISO 15836:2009]
EXAMPLE Conception of an invention, creation of a draft, revision of an article, publication of a book, acquisition
by a library, transcription to magnetic disk, migration to optical storage, translation into English and derivation of a new
work (e.g. a movie).
10
DRAFT 2011
---------------------- Page: 16 ----------------------
oSIST prEN ISO 13119:2011
ISO/DIS 13119
4 Introduction to metadata
4.1 Purpose and format
Metadata for a knowledge resource will convey information that is non-essential for the purpose of the
document, but important for other purposes, such as:
• locating a knowledge resource depending on e.g. subject, area of applicability, form of
presentation;
• assessing quality of the knowledge, e.g. how old it is, how trustworthy the author is.
4.2 Sources of generally useful metadata elements
General metadata have been developed by an initiative from library science known as the Dublin Core
Metadata, adopted and published as an ISO standard [ISO 15836:2009].
4.3 Sources of medical metadata
In the development of this document several sets of metadata particularly relevant for clinical knowledge
were used as input and/or inspiration, including Arden syntax, ENV 13606-3 (now published as EN ISO
13606-3), GEM (Guidelines Element Model, The US National Guidelines Center (NGC).
4.4 Characteristics of the metadata element set
In the element descriptions below, each element has a descriptive label intended to convey a common
semantic understanding of the element, as well as a unique, machine- understandable, single-word name
intended to make the syntactic specification of elements simpler for encoding schemes.
Although some environments, such as HTML, are not case-sensitive, the best practice recommended is to
always adhere to the case conventions in the element names given below to avoid conflicts in the event
that the metadata is subsequently extracted or converted to a case- sensitive environment, such as XML
(Extensible Markup Language).
Each element is optional and repeatable. Metadata elements may appear in any order. The ordering of
multiple occurrences of the same element (e.g. Creator) may have a significance intended by the provider,
but ordering is not guaranteed to be preserved in every system.
To promote global interoperability, a number of the element descriptions suggest a controlled vocabulary
for the respective element values. The Dublin Core set assumes that different domains develop where
necessary controlled vocabularies as specialisations of the content of the general purpose metadata
element set and adding other metadata elements as required. This International Standard is such a
specialisation for the medical knowledge domain.
The Dublin Core intiative is providing a num
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.