SIST EN ISO 13119:2023

SLOVENSKI STANDARD
oSIST prEN ISO 13119:2021
01-oktober-2021
Zdravstvena informatika - Viri kliničnega znanja - Metapodatki (ISO/DIS
13119:2021)
Health informatics - Clinical knowledge resources - Metadata (ISO/DIS 13119:2021)
Medizinische Informatik - Klinische Wissensresourcen - Metadaten (ISO/DIS
13119:2021)
Informatique de santé - Ressources des connaissances cliniques - Métadonnées
(ISO/DIS 13119:2021)
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 13119:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 13119:2021

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oSIST prEN ISO 13119:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13119
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-11 2021-11-03
Health informatics — Clinical knowledge resources —
Metadata
Informatique de santé — Ressources des connaissances cliniques — Métadonnées
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 13119:2021(E)
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. ISO 2021

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COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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ii © ISO 2021 – All rights reserved

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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Introduction to metadata . 2
4.1 Purpose and format . 2
4.2 Sources of generally useful metadata elements . 2
4.3 Sources of medical metadata . 2
4.4 Characteristics of the metadata element set . 2
5 Metadata element structure for medical knowledge resources . 3
5.1 Introduction to the medical metadata elements . 3
5.2 Resource form . 3
5.2.1 Group description . 3
5.2.2 Type . . 3
5.2.3 Format . 7
5.2.4 Language . 8
5.3 Intended use . 8
5.3.1 Group description . 8
5.3.2 Audience. 8
5.3.3 Situation . 9
5.3.4 Clinical process stage .10
5.4 Subject and scope .10
5.4.1 Group description .10
5.4.2 Subject.10
5.4.3 Description . . .10
5.4.4 Coverage .11
5.4.5 Inclusion criteria .11
5.4.6 Exclusion criteria .11
5.4.7 Relation .11
5.5 Identification and source .12
5.5.1 Group description .12
5.5.2 Identifier .12
5.5.3 Title .12
5.5.4 Creator .12
5.5.5 Creator contact information .12
5.5.6 Date created .12
5.5.7 Date available .13
5.5.8 Date issued .13
5.5.9 Status .13
5.5.10 Rights management . .13
5.5.11 Publisher .14
5.5.12 Publisher type .14
5.5.13 Publisher contact information .14
5.5.14 Contributor .15
5.5.15 Citation .15
5.5.16 Source .15
5.6 Quality control .15
5.6.1 Group description .15
5.6.2 Evidence grading .15
5.6.3 Recommendation Strength .16
5.6.4 Risk consequence class .16
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Annex A (informative) List of metadata elements .17
Annex B (informative) Class diagram .22
Bibliography .23
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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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO 13119:2012), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— A new Document Type has been added – Health Technology Assessment
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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Introduction
The internet is rapidly changing the way we access medical knowledge. Health professionals use web-
based knowledge sources and databases and also the patients/citizens turn to the web to search for
knowledge. There is a need for mechanisms to assess and clearly describe the quality and authenticity
of such knowledge sources. Rather than trying to ban bad quality information, we assist citizens, health
professionals and software developers to find the type of information they request by making quality
criteria behind a knowledge resource easily accessible.
This may be achieved by a combination of quality requirements with third party control by
governmental bodies or professional associations or reliance on a self-declaration by the issuer.
Instead of reviewing the content of the medical knowledge resources, we can define structures and
processes behind their development, including quality assurance principles in general, peer review,
professional education etc. This area requires collaboration among many types of actors such as
professional associations, publishers and health authorities.
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.
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 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 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
1)
initiative Dublin Core which developed the first set of fifteen metadata elements, later published as
ISO 15836:2003, which has been updated as ISO 15836-1:2017.
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 a rapid development.
The basic structure (taken from Dublin Core) and 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 laypersons 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 is also be emphasized that the extensive set of possible metadata elements defined in this International
Standard are usually useful only as a subset for a specific set of resources. The compilation of a possible
1) The Dublin Core Metadata Intitiative - www .dublincore .org
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application profile with a minimum set of metadata elements for various purposes may be the scope of
future work.
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oSIST prEN ISO 13119:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 13119:2021(E)
Health informatics — Clinical knowledge resources —
Metadata
1 Scope
This International Standard specifies a number of metadata elements that describe resources 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 elements:
— support unambiguous and international understanding of important aspects to describe a resource
e.g. purpose, issuer, intended audience, legal status and scientific background;
— are applicable to different kinds of digital resources, 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;
— are possible to present to human readers including health professionals as well as citizens/patients
— 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 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 15836-2:2017, Information and documentation — The Dublin Core metadata element set — Part 2:
DCMI properties and classes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 1 to entry: Medical does not imply “physician” – all health professionals have medical knowledge according
to this definition.
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3.2
clinical knowledge
part of medical knowledge pertaining promoting good health and the management and prevention of ill
health
Note 1 to entry: 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
[SOURCE: ISO/IEC 11179-3:2013, 3.2.74]
3.5
lifecycle of information a resource
sequence of events that mark the development and use of a resource
[SOURCE: ISO 15836-1:2017, 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 movie).
4 Introduction to metadata
4.1 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 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: parts 1 and 2].
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, ISO 13606-3, GEM (Guidelines Element
Model), The US National Guidelines Clearinghouse (NGC).
4.4 Characteristics of the metadata element set
In the element descriptions in clauses 5.2 – 5.6, 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, the best practice recommended
is to always adhere to the case conventions in the element names given to avoid conflicts in the event
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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 specifiers of the content of the general purpose
metadata element set and adding other metadata elements as required. This International Standard is a
specialisation for the medical knowledge domain.
The Dublin Core metadata intiative is providing valuable informative material concerning the use of
metadata and system implementation advice.
5 Metadata element structure for medical knowledge resources
5.1 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 indicate by (DC). Note that in these cases additional information may
be found in this standard [ISO 15836-1]. In a few cases, this structure also proposes a substructure of
specialisation 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
dependent on the format of the metadata expression e.g. XML.
NOTE This 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 in RDF of individual metadata properties.
For the purpose of navigation among the many metadata elements of this standard they are presented
under a set of Group Headings. These are not to be implemented as metadata tags in resources.
A list of all metadata elements is provided in Annex A and a diagram of all classes in Annex B.
5.2 Resource form
5.2.1 Group description
The resource form group of metadata describes the form of delivery of knowledge from the resource.
5.2.2 Type
5.2.2.1 General
Element name: Type (DC)
Definition: Nature or genre of the content of the resource (DC)
Healthcare specific specialisation: The following terms may be used to describe Type:
— Text
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— 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.
5.2.2.2 Text
Element name: Type.Text (DC)
Definition: A resource consisting primarily of words for reading
NOTE 1 A resource (often called document) which contains still images in addition to the words is designated
type Text.
Examples include books, letters, dissertations, poems, newspapers, articles, 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 2 Information directed towards a patient/subject of care about a particular health issue. This
includes medication inserts in medicinal products
g) FAQ
NOTE 3 Frequently Asked
...