SIST-TS CEN/TS 15699:2009
(Main)Health informatics - Clinical knowledge resources - Metadata
Health informatics - Clinical knowledge resources - Metadata
This Technical Specification 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.
Medizinische Informatik - Klinische Wissensressourcen - Metadaten
Informatique de Santé - Ressources des connaissances cliniques - Métadonnées
Zdravstvena informatika - Viri kliničnega znanja - Metapodatki
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN/TS 15699:2009
01-april-2009
=GUDYVWYHQDLQIRUPDWLND9LULNOLQLþQHJD]QDQMD0HWDSRGDWNL
Health informatics - Clinical knowledge resources - Metadata
Medizinische Informatik - Klinische Wissensressourcen - Metadaten
Informatique de Santé - Ressources des connaissances cliniques - Métadonnées
Ta slovenski standard je istoveten z: CEN/TS 15699:2009
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN/TS 15699:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN/TS 15699:2009
TECHNICAL SPECIFICATION
CEN/TS 15699
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
January 2009
ICS 35.240.80
English Version
Health informatics - Clinical knowledge resources - Metadata
Informatique de Santé - Ressources des connaissances Medizinische Informatik - Klinische Wissensressourcen -
cliniques - Métadonnées Metadaten
This Technical Specification (CEN/TS) was approved by CEN on 6 November 2008 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 15699:2009: E
worldwide for CEN national Members.
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Contents Page
Foreword . 3
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Introduction to metadata . 7
4.1 Purpose and format . 7
4.2 Sources of generally useful metadata elements. 7
4.3 Sources of medical metadata . 7
4.4 Characteristics of the metadata element set . 8
5 Metadata element structure for medical knowledge resources . 8
5.1 Introduction to the medical metadata elements . 8
5.2 Resource form . 8
5.3 Intended use .12
5.4 Subject and scope .14
5.5 Identification and source .16
5.6 Quality control .20
Annex A (informative) List of metadata elements .22
Annex B (informative) Class diagram .29
Bibliography .30
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Foreword
This document (CEN/TS 15699:2009) has been prepared by Technical Committee CEN/TC 251 “Health
informatics”, the secretariat of which is held by NEN.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, 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 the United Kingdom.
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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
th
label 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.
1
COM(2002) 667, eEurope 2002: Quality Criteria for Health related Websites.
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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 (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.
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1 Scope
This Technical Specification 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.
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.
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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 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 15836:2003]
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 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 15836:2003].
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, GEM (Guidelines Element
Model, The US National Guidelines Center (NGC).
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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 Technical Specification is such a
specialisation for the medical knowledge domain.
5 Metadata element structure for medical knowledge resources
5.1 Introduction to the medical metadata elements
This clause introduces 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 herein. Most of these come from the
Dublin Core indicate by (DC) below. In a few cases, this structure also proposes a substructure of
specialisation of metadata element. Where elements or sub-elements are defined in this Health Care
Technical Specification, it is indicated by (HC). The syntax for expressing this may vary dependent on the
format of the metadata expression e.g. XML. Some examples are given in Annex A.
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:
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Document
Database for human reading
Database for automatic processing
Software
Hardware
It is recommended that these terms are complemented by a type specifier.
5.2.2.2 Document
Element name: Type.Document (HC)
Definition: Type of knowledge resource as a text document possibly with images in essentially free format
for human reading
Specifiers of Type.Document:
a) Journal_article
b) Book_chapter
c) Book
d) Report
e) Abstract
f) Patient_information
g) FAQ
NOTE 1 Frequently Asked Questions.
h) Algorithm
NOTE 2 Formal description of a procedure e.g. a calculation method.
i) Clinical guideline
j) Policy-strategy
k) Information_standard
l) Teaching_material
NOTE 3 This includes learning / self-learning materials.
m) Archetype
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NOTE 4 This is a special form of constrained information model to describe a part of an Electronic Health Record
as described by EN 13606-2 or OpenEHR.
n) Terminological_resource
o) Metainformation
NOTE 5 Information about other resources (bibliography, catalogue, reviews, gateway, search engine).
NOTE 6 The Metainformation may also be used to specialise a Database type.
p) Case_report
q) Proposal
NOTE 7 This term may be used to label a plan for a project.
r) Event
NOTE 8 This term may be used to label invitations, descriptions and schedules of meetings and other events
where people meet.
s) Service_description
NOTE 9 Service in this context may include health care services as well as other services e.g. IT-related.
t) Product_information
5.2.2.3 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.Database for human reading:
a) Journal
b) Metainformation
c) Terminology
d) Guideline_collection
e) Discussion_list
5.2.2.4 Database for automatic processing
Element name: Type.DatabaseforAutoprocessing (HC)
Definition: Type of knowledge resource with structured data made available to external software
systems
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NOTE This includes also settings of a hardware device which may be stored on e.g. a ROM memory.
Specification of content: No advice (free text)
5.2.2.5 Software
Element name: Type.Software (HC)
Definition: Type of knowledge resource with embedded knowledge information to be executed on
external system
Specification of content: No advice (free text)
5.2.2.6 Hardware device
Element name: Type.Device (HC)
Definition: Type of knowledge resource with embedded software and knowledge
Specification of content: No advice (free text)
NOTE The content of this may consider using the EN/ISO/IEEE 11073-10101:2004 Health informatics - Point-of-
care medical device communication - Part 10101: Nomenclature.
5.2.3 Format
Element name: Format (DC)
Definition: Physical or digital manifestation of the resource (DC)
Specifiers for Format:
a) Web_page
b) Image
c) Service
d) Sound
e) Text
f) Forum
g) Web_site
h) Interactive
For electronic resources, use the MIME media types (for more information, see http://www.isi.
...
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