1、 Reference number ISO/TR 22221:2006(E) ISO 2006TECHNICAL REPORT ISO/TR 22221 First edition 2006-11-01 Health informatics Good principles and practices for a clinical data warehouse Informatique de sant Principes et indications dexploitation dun entrept de donnes cliniques ISO/TR 22221:2006(E) PDF di
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6、f the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reservedISO/TR 22221:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introdu
7、ction v 1 Scope 1 2 Terms and definitions .1 3 Data warehouse features for a health organization .3 3.1 General3 3.2 Quality assurance and care delivery .4 3.3 Evaluation and innovation of health procedures and technologies 4 3.4 Disease surveillance, epidemiology, and public health 4 3.5 Planning a
8、nd policy.5 3.6 Knowledge discovery5 3.7 Education5 4 Description in detail of each category.5 4.1 General5 4.2 Quality assurance and care delivery .5 4.3 Services and technology evaluation and innovation.6 4.4 Disease surveillance, epidemiology and public health .7 4.5 Planning and policy.7 4.6 Kno
9、wledge discovery8 4.7 Education8 5 Governance and ethics considerations of clinical data 9 5.1 General9 5.2 Governance requirements for data integrity and management9 5.3 Perspectives of individual and social protection.13 5.4 Policies about people18 5.5 Security review and audit .18 6 Architecture1
10、9 6.1 Existing work on data warehousing 19 6.2 Characteristics of a clinical data warehouse20 6.3 Methodology for clinical data warehouse development25 6.4 Basic data models .26 6.5 Security and privacy33 7 Metadata and education34 7.1 Importance of metadata 34 7.2 Collection mechanisms.34 7.3 Owner
11、ship 34 7.4 Common definitions and standardization.35 7.5 Data quality.35 7.6 Change management 35 7.7 Education35 8 Analytical and reporting tools35 8.1 General35 8.2 Deployment approaches .36 8.3 Enterprise business intelligence suites 36 9 Organizational approach.38 9.1 General38 9.2 Multidiscipl
12、inary approach .39 Bibliography 40 ISO/TR 22221:2006(E) iv ISO 2006 All rights reservedForeword 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 t
13、hrough 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 colla
14、borates 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 Sta
15、ndards. 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. In exceptional circumstances, when a technical committee has coll
16、ected data of a different kind from that which is normally published as an International Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not h
17、ave to be reviewed until the data it provides are considered to be no longer valid or useful. 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/TR
18、22221 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO/TR 22221:2006(E) ISO 2006 All rights reserved v Introduction 0.1 General A clinical data warehouse (CDW) is regarded as conceptually distinct from the clinical data repository of an operational electronic health record. It
19、 is as yet a largely under-implemented and under-exploited resource which, however, has many possible features with health care, education and research aspects. Such features include: quality assurance, feedback to individuals and teams of caregivers, infectious disease or medication surveillance, a
20、nd evaluation of organizational continuity as patients move between organizations. Such data are also a crucial link between individual care, organizational and public health needs. The CDW can provide a system view of different perspectives and levels of activity that cannot be provided easily and
21、properly by an operational system; these different levels and perspectives can require different characteristics of the associated datasets. This data access also has social, legal and ethical, epidemiological and informatics challenges, which may variably impact the use dimensions of a CDW. This wi
22、ll be of particular importance as pedigree and genetic data content of CDWs increases over time. 0.2 Purpose of this Technical Report The data warehouse is not yet widely used by health organizations. There still is no common knowledge and understanding about the creation and exploitation of data wa
23、rehouse features by health organizations. The purpose of this Technical Report is to enable the different CDW users to have a uniform understanding of a CDW, including both general principles and particular characteristics of different major use perspectives. 0.3 Benefits of this Technical Report Th
24、e CDW is presently a largely under-exploited resource of invaluable information for supporting the service, research and educative missions of the health system. It enables practice assessment as well as knowledge discovery, but it also has the potential to support more efficient and effective innov
25、ation, as well as being an essential tool for interdisciplinary collaboration. This Technical Report is intended to help orientate future developments by creating the preliminary work for a technical specification of a clinical data warehouse and leading to the development of standards for different
26、 use applications. 0.4 Target users Target users include all stakeholders in the health system, public and private, including (but not limited to): clinicians and para-clinical personnel, administrators, educators, epidemiologists, economists, ISO/TR 22221:2006(E) vi ISO 2006 All rights reserved res
27、earchers, system developers, data and modelling specialists, accreditation organizations, citizen organizations, and policy makers. TECHNICAL REPORT ISO/TR 22221:2006(E) ISO 2006 All rights reserved 1 Health informatics Good principles and practices for a clinical data warehouse 1 Scope The focus of
28、 this Technical Report is clinical databases or other computational services, hereafter referred to as a clinical data warehouse (CDW), which maintain or access clinical data for secondary use purposes. The goal is to define principles and practices in the creation, use, maintenance and protection o
29、f a CDW, including meeting ethical and data protection requirements and recommendations for policies for information governance and security. A distinction is made between a CDW and an operational data repository part of a health information system: the latter may have some functionalities for secon
30、dary use of data, including furnishing statistics for regular reporting, but without the overall analytical capacity of a CDW. This Technical Report complements and references standards for electronic health records (EHR), such as ISO/TS 18308, and contemporary security standards in development. Thi
31、s Technical Report addresses the secondary use of EHR and other health-related and organizational data from analytical and population perspectives, including quality assurance, epidemiology and data mining. Such data, in physical or logical format, have increasing use for health services, public hea
32、lth and technology evaluation, knowledge discovery and education. This Technical Report describes the principles and practices for a CDW, in particular its creation and use, security considerations, and methodological and technological aspects that are relevant to the effectiveness of a clinical dat
33、a warehouse. Security issues are extended with respect to the EHR in a population-based application, affecting the care recipient, the caregiver, the responsible organizations and third parties who have defined access. This Technical Report is not intended to be prescriptive either from a methodolog
34、ical or a technological perspective, but rather to provide a coherent, inclusive description of principles and practices that could facilitate the formulation of CDW policies and governance practices locally or nationally. 2 Terms and definitions For the purposes of this document, the following term
35、s and definitions apply. 2.1 clinical data repository CDR operational data store that holds and manages clinical data collected from service encounters at point of service locations EXAMPLE Point of service locations include hospitals and clinics. NOTE Data from a CDR can be fed to the EHR for that
36、client, such that the CDR is recognized as a source system for the EHR. The CDR can be used to trigger alerts in real time. 2.2 clinical data warehouse CDW grouping of data accessible by a single data management system, possibly of diverse sources, pertaining to a health system or sub-system and ena
37、bling 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 time; however, depending on the rapidity of transfer of data to the data
38、warehouse, and data integrity, near real time applications are not excluded. ISO/TR 22221:2006(E) 2 ISO 2006 All rights reserved2.3 dashboard user interface based on predetermined data fields that facilitate domain-specific data queries, and suited to regular use with minimal training 2.4 data dicti
39、onary database used for data that refers to the use and structure of other data, i.e. a database for the storage of metadata ISO/IEC 11179-1:2004 2.5 data mart subject area of interest within the data warehouse EXAMPLE An inpatient data mart. NOTE Data marts can also exist as a stand-alone database
40、tuned for query and analysis, independent of a data warehouse. 2.6 data warehouse subject-oriented, integrated, time-variant and non-volatile collection of data NOTE The term “data warehouse” is attributed to Inmon 1 . 2.7 drill down exploration of multidimensional data which makes it possible to mo
41、ve down from one level of detail to the next depending on the granularity of data EXAMPLE Number of patients by departments and/or by services. 2.8 episode of care identifiable grouping of health care-related activities characterized by the entity relationship between the subject of care and a healt
42、h care provider, such grouping determined by the health care provider ISO/TS 18308:2004 2.9 health indicator single summary measure, most often expressed in quantitative terms, that represents a key dimension of health status, the health care system, or related factors NOTE A health indicator is to
43、be informative and also sensitive to variations over time and across jurisdictions. ISO/TS 21667:2004 2.10 metadata information stored in the data dictionary that describes the content of a document NOTE In a data warehouse context, metadata are data structure, constraints, types, formats, authoriza
44、tions, privileges, relationships, distinct values, value frequencies, keywords, and users of the database sources loaded in the data warehouse and the data warehouse itself. Metadata help users, developers and administrators for information management. ISO/TR 22221:2006(E) ISO 2006 All rights reserv
45、ed 3 2.11 online analytical processing OLAP set of applications developed for facilitating the collection, analysis and reporting of multidimensional data NOTE The term “OLAP” is attributed to Codd 3 . 2.12 organization group of people that have their own structure rules and culture in order to work
46、 together to achieve goals and/or to provide services through processes, equipments and technologies, etc. 2.13 performance indicator measure that supports evaluation of an aspect of performance and its change over time 2.14 persistent data data in a final form intended as a permanent record, such t
47、hat any subsequent modification is recorded together with the original data 2.15 roll up method of regrouping and aggregating multidimensional data to move up the hierarchy into larger units EXAMPLE Weekly count of patients aggregated by quarter or by year. 2.16 secondary data use use of data for ad
48、ditional purposes other than the primary reason for their collection, adding value to this data 2.17 star schema dimensional modelling concept that refers to a collection of fact and dimension tables 3 Data warehouse features for a health organization 3.1 General The roles and capacities of each of
49、the operational databases and informational databases or data warehouses are complementary. An operational database is designed to perform transactions such as adding, changing or deleting a patient. It has a limited capacity for data analysis supporting online care delivery. Secondary data use refers to the exploitation of already existing persistent data. The concept of a clinical data warehouse refers to a set of secondary data for analytic purposes relevant to a health organization. As health care ta
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