1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13119:2012Health informatics Clinicalknowledge resources Metadata (ISO 13119:2012)BS EN ISO 13119:2012 BRITISH STANDARDNational forewordThis British Standard is the UK
2、implementation of EN ISO13119:2012. It supersedes DD CEN/TS 15699:2009 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its secretary.This public
3、ation does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 69482 0ICS 35.240.80Compliance with a British Standard cannot confer immunity fr
4、omlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13119 November 2012 ICS 35.240.80 Supersedes CEN
5、/TS 15699:2009English Version Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012) Informatique de sant - Ressources des connaissances cliniques - Mtadonnes (ISO 13119:2012) Medizinische Informatik - Klinische Wissensressourcen - Metadaten (ISO 13119:2012) This European Stan
6、dard 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
7、 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
8、 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, German
9、y, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR N
10、ORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13119:2012: EBS EN ISO 13119:2012EN ISO 13119:2012 (E) 3 Foreword This document (EN ISO 13119:2012) has been prepa
11、red 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 en
12、dorsement, 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 identifyin
13、g 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,
14、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. BS EN ISO
15、13119:2012ISO 13119:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Terms and definitions . 13 Introduction to metadata . 23.1 Purpose and format 23.2 Sources of generally useful metadata elements . 23.3 Sources of medical metadata . 23.4 Characteristics of t
16、he metadata element set . 24 Metadata element structure for medical knowledge resources . 34.1 Introduction to the medical metadata elements . 34.2 Resource form 34.3 Intended use . 84.4 Subject and scope .104.5 Identification and source . 114.6 Quality control 14Annex A (informative) List of metada
17、ta elements 16Annex B (informative) Class diagram21Bibliography .23BS EN ISO 13119:2012ISO 13119:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normal
18、ly 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
19、 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 Int
20、ernational 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 t
21、he 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 T
22、echnical 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 reserve
23、dBS EN ISO 13119:2012ISO 13119:2012(E)IntroductionThe 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,
24、 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.
25、 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-related websites18.One way to help navigate the multitu
26、de 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 possi
27、ble 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 re
28、garded 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 criteri
29、a 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 a
30、rea 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 requ
31、irements 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 kn
32、owledge 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 fo
33、r 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 officia
34、lly 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 area
35、s 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 scien
36、tific 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 vBS EN ISO 13119:2012ISO 13119:2012(E)This International Standard for met
37、adata is based on the general purpose metadata standardization initiative Dublin Core1)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
38、 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 provide
39、d 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
40、 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
41、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 Standa
42、rd 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 res
43、ervedBS EN ISO 13119:2012INTERNATIONAL STANDARD ISO 13119:2012(E)Health informatics Clinical knowledge resources Metadata1 ScopeThis International Standard specifies a number of metadata elements that describe resources containing medical knowledge. It is primarily applicable to digital documents pr
44、ovided 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, i
45、ntended 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 manu
46、script 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 document
47、s 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 keywor
48、ds or codes); prescribe criteria for the quality of the resource content.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1medical knowledgefield of knowledge pertaining to the structure, function or dysfunction of the human body and how these can
49、 be influenced by external or internal factors and interventionsNOTE This does not only refer to physicians; all health professionals have medical knowledge according to this definition.2.2clinical knowledgepart of medical knowledge pertaining to the promotion of good health and the management and prevention of ill healthNOTE This is used to diagnose, treat and alleviate disease/dysfunction.2.3knowledge resourcecollection of knowledge about a subject area collected for a purpose and made available to a user through some means2.4metadatadata that de
