1、DD ISO/TS29585:2010ICS 35.240.80NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWDRAFT FOR DEVELOPMENTHealth informatics Deploymentof a clinical datawarehouseThis Draft for Developmentwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BS
2、I 2010ISBN 978 0 580 68277 3Amendments/corrigenda issued since publicationDate CommentsDD ISO/TS 29585:2010National forewordThis Draft for Development is the UK implementation of ISO/TS29585:2010.This publication is not to be regarded as a British Standard.It is being issued in the Draft for Develop
3、ment series of publications andis of a provisional nature. It should be applied on this provisional basis,so that information and experience of its practical application can beobtained.Comments arising from the use of this Draft for Development arerequested so that UK experience can be reported to t
4、he internationalorganization responsible for its conversion to an international standard.A review of this publication will be initiated not later than 3 years afterits publication by the international organization so that a decision can betaken on its status. Notification of the start of the review
5、period will bemade in an announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period,the responsible BSI Committee will decide whether to support theconversion into an international Standard, to extend the life of theTechnical Specifica
6、tion or to withdraw it. Comments should be sent tothe Secretary of the responsible BSI Technical Committee at BritishStandards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations r
7、epresented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.DD ISO/TS
8、29585:2010Reference numberISO/TS 29585:2010(E)ISO 2010TECHNICAL SPECIFICATION ISO/TS29585First edition2010-05-15Health informatics Deployment of a clinical data warehouse Informatique de sant Dploiement dun entrept des donnes cliniques DD ISO/TS 29585:2010ISO/TS 29585:2010(E) PDF disclaimer This PDF
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14、ntents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Abbreviated terms .4 5 Principle4 6 General considerations of deployment of a clinical data warehouse4 6.1 Overview.4 6.2 Requirements.6 6.3 Scope10 6.4 Planning and implementation 12 6.5 Design cons
15、iderations15 6.6 Data and metadata.19 6.7 Security and privacy .20 7 Clinical data warehouse: data aggregation and data modelling 25 7.1 Introduction25 7.2 Data and decision making 25 7.3 Defining CDW dimensions according to business need and relation to process27 7.4 Health system indicators31 8 Ar
16、chitecture and technology32 8.1 Introduction32 8.2 General characteristics.32 8.3 Existing work on data warehousing 33 8.4 Presentation layer outputs .46 8.5 Security.53 Bibliography56 DD ISO/TS 29585:2010ISO/TS 29585:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organizatio
17、n 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
18、 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. Inter
19、national 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. Publicat
20、ion as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: an ISO Publicly Available
21、Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the mem
22、bers of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Stan
23、dard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject
24、 of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 29585 was prepared by Technical Committee ISO/TC 215, Health informatics. DD ISO/TS 29585:2010ISO/TS 29585:2010(E) ISO 2010 All rights reserved vIntroduction This Technical Specification furthe
25、rs the work of ISO/TR 22221 by providing implementation guidance for a clinical data warehouse and describing general considerations of development and deployment, issues and applications of data aggregation and data modelling, and architecture and technology approaches. The role of the clinical dat
26、a warehouse is to enable data analyses in support of effective policies and decision-making, to improve quality of care, to improve health services organizations, as well as to influence learning and research. It will have relevance to both developing and more established health systems. It will ena
27、ble meaningful comparison of programmes and outcomes. Although data warehouse technologies are becoming increasingly used in non-healthcare sectors, their use in health is still at an early stage. ISO/TR 22221 had a primary goal of underpinning a coherent approach to the diverse and multi-stakeholde
28、r perspectives of secondary use of data from various health system sources. This Technical Specification is intended to have pragmatic relevance by indicating best practice in setting up a clinical data warehouse and in using it from data abstraction and architectural perspectives. The clinical data
29、 warehouse is distinguished by the complexity of the interactions of data and hence the challenges to provide adequate methods for evaluating process and outcomes of care for different populations and sub-populations. Currently such knowledge is relatively fragmented and it is too early to be integr
30、ated into an International Standard. A Technical Specification will however benefit progression to an International Standard by aligning emerging best practice from different international experience. The clinical data warehouse is also, in health informatics, the place of the intersection of health
31、 services delivery, organization and epidemiological expertise concerned with adequate and effective data abstraction and presentation for different decision-making contexts as presented in ISO/TR 22221. Good use of the clinical data warehouse will depend on furthering common approaches to frequentl
32、y used data abstractions that concern analysis of care delivery and organization. Effective data warehouse deployment will be enabled by promoting good practice in furnishing dynamically accessible, interpretable data combinations, which will depend on showing the relationship between clinical and h
33、ealth system need and the architectural properties of the data warehouse. This technical specification complements the ISO 13606 series in that competent extended use of data beyond immediate care delivery depends on the effective organization of the original source data. DD ISO/TS 29585:2010DD ISO/
34、TS 29585:2010TECHNICAL SPECIFICATION ISO/TS 29585:2010(E) ISO 2010 All rights reserved 1Health informatics Deployment of a clinical data warehouse IMPORTANT The electronic file of this document contains colours which are considered to be useful for the correct understanding of the document. Users sh
35、ould therefore consider printing this document using a colour printer. 1 Scope This Technical Specification has three sections, 1) general considerations of design and deployment, 2) data aggregation and data modelling and 3) architecture and technology, and is intended to provide an overall set of
36、guidelines for clinical data warehouse deployment supported by useful descriptions concerning different data aggregation and modelling approaches as well as particular aspects of information architecture that contribute to successful deployment. The first section is of particular interest to healthc
37、are decision-makers, including information technology managers, of requirements and procedures that support successful clinical data warehouse deployment. The second section supports the understanding, choice, instigation and evaluation of methods that ensure reliable selection and aggregation of pr
38、imary data for adequate compilation and presentation to support decisions this section is of particular interest to statisticians, epidemiologists, healthcare evaluation specialists and others. Section three is of particular interest to informaticians concerned with efficient architectures, data min
39、ing methods, dynamic data querying and visualization for clinical data warehouses. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the
40、 referenced document (including any amendments) applies. ISO/TR 22221, Health informatics Good principles and practices for a clinical data warehouse ISO/TS 25237, Health informatics Pseudonymization ISO 27799, Health informatics Information security management in health using ISO/IEC 27002 3 Terms
41、and definitions For the purposes of this document, the following terms and definitions apply. 3.1 clinical data repository CDR operational data store that holds and manages clinical data collected from service encounters at point of service locations NOTE Data from a CDR can be fed to the EHR for th
42、at client, such that the CDR is recognised as a source system for the EHR. The CDR can be used to trigger alerts in real time. DD ISO/TS 29585:2010ISO/TS 29585:2010(E) 2 ISO 2010 All rights reserved3.2 clinical data warehouse CDW grouping of data accessible by a single data management system, possib
43、ly of diverse sources, pertaining to a health system or sub-system and enabling secondary data analysis for questions relevant to understanding the functioning of that health system, and hence supporting proper maintenance and improvement of that health system NOTE A CDW tends not to be used in real
44、 time. However, depending on the rapidity of transfer of data to the data warehouse, and data integrity, near real-time applications are not excluded. 3.3 dashboard user interface based on predetermined reports, indicators and data fields, upon which the end user can apply filters and graphical disp
45、lay methods to answer predetermined business questions and which is suited to regular use with minimal training 3.4 data dictionary database used for data that refer to the use and structure of other data, i.e. a database for the storage of metadata 3.5 data mart subject area of interest within the
46、data warehouse (3.6) EXAMPLE An inpatient data mart. NOTE Data marts can also exist as a standalone database tuned for query and analysis, independent of a data warehouse. 3.6 data warehouse subject-oriented, integrated, time-variant and non-volatile collection of data NOTE See Reference 5. 3.7 data
47、 warehouse dimension subject-oriented, often hierarchical business relevant grouping of data 3.8 drill down exploration of multidimensional data which makes it possible to move down from one level of detail to the next depending on the granularity of data EXAMPLE Number of patients by departments an
48、d/or by services. 3.9 episode of care identifiable grouping of healthcare-related activities characterized by the entity relationship between the subject of care and a healthcare provider, such grouping determined by the healthcare provider ISO/TS 18308:2004, definition 3.23 3.10 health indicator si
49、ngle summary measure, most often expressed in quantitative terms, that represents a key dimension of health status, the healthcare system, or related factors NOTE A health indicator is informative and also sensitive to variations over time and across jurisdictions. ISO/TS 21667:2004, definition 3.1 DD ISO/TS 29585:2010ISO/TS 29585:2010(E) ISO 2010 All rights reserved 33.11 metadata information stored in the data dictionary which describes the content of a document NOTE In a data warehouse context, metadata are data structure