EN ISO 13119:2012

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
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Tel. + 41 22 749 01 11
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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 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

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 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

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 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

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 coll
...