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1、BRITISH STANDARD BS 8401:2003 Health informatics standards Status as of July 2001 Guide ICS 35.240.80 ? Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 This British Standard was published under the
2、 authority of the Standards Policy and Strategy Committee on 28 November 2003 BSI 28 November 2003 The following BSI references relate to the work on this British Standard Committee reference IST/35 Draft for comment 02/653351 DC ISBN 0 580 42772 2 Committees responsible for this British Standard Th
3、e preparation of this British Standard was entrusted to Technical Committee IST/35, Health informatics, upon which the following bodies were represented: AMS Consulting Association of Anaesthetists of GB and Ireland BCS British Computer Society BCS Nursing Specialist Group BMA British Medical Associ
4、ation BMA IT Committee BUPA British Institute of Radiology British Nuclear Medicine Society CAT Limited Computing Services and Software Association Conference of Royal Colleges Information DTI Health Systems Co-ordination ISSD Institute of Medical Laboratory Science Intellect NHS Executive Nine Tile
5、s Nottingham City Hospital NHS Trust Royal College of Radiologists Royal Hospital for Sick Children Royal Pharmaceutical Society of GB Society for Computing and Technology in Anaesthes University of Anaesthesia Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank
6、 University, London South Bank University, Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 BSI 28 November 2003 i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Terms definitions, acronyms and abbreviations1 3How standards are developed3 4Appli
7、cation areas5 5Healthcare informatics standards10 Annex A International Organization for Standardization (ISO)43 Annex B Joint Technical Committee One (JTC1)44 Annex C Comit Europen de Normalisation (CEN)45 Annex D (informative) National Standards Bodies46 Annex E (informative) Consortia and Profess
8、ional Bodies46 Annex F (informative) Other Standardization Bodies48 Bibliography49 Table 1 General healthcare5 Table 2 System architecture5 Table 3 Vocabulary, terminology and coding schemes6 Table 4 Security6 Table 5 Patient administration and electronic records6 Table 6 Diagnostic services7 Table
9、7 Pharmacy7 Table 8 Medical imaging and multimedia7 Table 9 Medical devices7 Table 10 Patient/health cards8 Table 11 Standards for standards developers8 Table 12 Superseded standards9 Table 13 PMEP specifications41 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08
10、 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 ii BSI 28 November 2003 Foreword This British Standard Guide has been prepared by Technical Committee IST/35. Since the end of the 1980s there has been considerable activity in the health informatics sector resulting in the publicatio
11、n of a large number of standards. These standards have been produced by a variety of formal standards bodies, covering a single country (e.g. BSI, ANSI), a region (CEN) or globally (ISO). In addition to these formal standards various industry consortia, professional bodies and similar organizations,
12、 e.g. DICOM (ACR/NEMA), HL7, ASTM and IEEE have issued informal standards. Additionally, many formal standards bodies have introduced a less formal standard, known as Industry Workshop Agreements or International Technical Agreements. The scope of this guide is limited to those standards and publica
13、tions approved by 9 July 2001. This British Standard Guide details the most important health informatics standards and equivalent publications relevant to the UK and explains how they relate to each other. There are a number of ways of using this Guide depending on the readers knowledge and understa
14、nding of standards, and what they wish to discover. The most common scenarios are. I have seen a reference to a standard and wish to find out more If it is an ISO standard, e.g. ISO/IEC 12345, find the ISO entry in the list in Clause 5, and look in the appropriate sub-section. Where standards are nu
15、mbered, each section is in ascending order. I am working in a particular area of healthcare (e.g. electronic healthcare records) and wish to find out which standards are relevant Find your field of interest in Clause 4, then look in the tables in the appropriate subsection. For instance, if your int
16、erest is in the communication of electronic patient records, find the appropriate area listed in Clause 4, i.e. “Patient administration and electronic records”. Then follow the reference to the appropriate table (Table 1) and find one or more standards concerning communication of electronic records
17、(i.e. ENV 13606). Then look up this standard in Clause 5 to find further information on that standard. I am interested in standards concerning a particular subject, e.g. EDIFACT messages Look up the subject in the index in Clause 4. Then either check the master reference to Clause 4 and follow the s
18、cenario above, or check the references to individual standards in Clause 5. I wish to find out more about who creates standards and why Read the annexes. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compli
19、ance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 51 and a back cover. The BSI copyright notice displayed in this document indicates when the document was l
20、ast issued. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 BSI 28 November 2003 1 1 Scope This British Standard gives guidance on the most important health informatics standards (and equivalent pu
21、blications) in use in, or appropriate for use in, the UK. The scope of this guide is limited to those standards and publications approved by 9 July 2001. It deals only with standards (either approved or in course of development) developed specifically for use in healthcare. For example, even though
22、lower-layer communications standards are widely used in health, their use is more or less exactly the same as in fields other than health, and they are therefore omitted. Conversely, where a standard has been developed specifically for use in healthcare even though the standard is of more general ap
23、plicability it has been included. This Guide is intended to be of use to: procurers of systems incorporating health informatics standards; implementers of such systems; suppliers of such systems; those responsible for selecting and approving health informatics standards, e.g. NHS Information Standar
24、ds Boards. It is also intended to be of use to: standards developers; policy makers; consultants; those with an interest in the development of health informatics standards. 2 Terms definitions, acronyms and abbreviations 2.1 Terms and definitions For the purposes of this guide, the following terms a
25、nd definitions apply. 2.1.1 health informatics application of information technology to healthcare 2.1.2 publicly available specification (PAS) standard not produced by a formal standards body NOTEFormal standards bodies, e.g. ISO, might publish PASs with a view to their becoming formal standards in
26、 due course. 2.1.3 laboratory information system (LIS) computer system for the processing results of tests performed in a hospital or other clinical laboratory 2.1.4 profile subset of a standard defined for particular purpose Licensed Copy: London South Bank University, London South Bank University,
27、 Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 2 BSI 28 November 2003 2.2 Acronyms and abbreviations For the purposes of this guide, the following acronyms and abbreviations apply. ACRAmerican College of Radiologists ANSIAmerican National Standards Institute ASTMAmerica
28、n Society for Testing and Materials BSBritish Standard BSIBritish Standards Institution CAPCollege of American Pathologists CDAClinical Document Architecture CDSCommissioning Data Set CENComit Europen de Normalisation (Europisches Komitee fr Normung/European Committee for Standardization) CENELECCom
29、it Europen de Normalisation Electrotechnique (Europisches Komitee fr Elektrotechnische Normung/European Committee for Electrotechnical Standardization) CPPCommunication Protection Profile CRCEN Report CWACEN Workshop Agreement DICOMDigital Imaging and Communications in Medicine DISPDraft Internation
30、al Standardized Profile DTRDraft Technical Report EDIElectronic Data Interchange EDIFACTElectronic Data Interchange for Administration, Commerce and Transport e-GIFe-Government Interoperability Framework EHRElectronic Health Record ENEuropenne Norme (European Standard/Europische Norm) ENVEuropenne N
31、ormes Vorausgabe (European Pre-standard) EPRElectronic Patient Record ETGEWOS Technical Guide EWOSEuropean Workshop for Open Systems FTPFile Transfer Protocol GPGeneral Practitioner HDFHL7 Message Development Framework HIFHealthcare Information Framework HISHospital Information System HL7Health Leve
32、l 7 ICDIntermittently Connected Device IECInternational Electrotechnical Commission IEEEThe Institute of Electrical and Electronics Engineers IETFInternet Engineering Task Force ISOInternational Organization for Standardization ISSSInformation Society Standardization System ITAIndustry Technical Agr
33、eement ITUInternational Telecommunications Union IWAInternational Workshop Agreement JTC1Joint Technical Committee 1 LISLaboratory Information System Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003
34、 BSI 28 November 2003 3 3 How standards are developed 3.1 Overview Many organizations produce standards. These can be divided into a number of broad groups: formal standards bodies (see 3.2); consortia and professional bodies (see 3.3); other standardization bodies (including national health service
35、s) (see 3.4). 3.2 Formal standards bodies 3.2.1 General Formal standards bodies are set up by national or international agreement. Neither national standards bodies nor international or European standards organizations have the legal authority to make the use of their standards mandatory. Although a
36、 specification takes the form of requirements, a legally binding obligation to comply is only created if conformity to it: a) is claimed in the trade description of a product, process or service; b) becomes a contractual requirement; c) is made mandatory by law or regulation. For example, the use of
37、 European standards (ENs) may be mandatory in public sector procurements within the European Union. Formal bodies fall into three main categories: international (see 3.2.2); regional (see 3.2.3); national (see 3.2.4). LOINCLogical Observation Identifiers Names and Codes MIVOCMedical Informatics Voca
38、bulary NEMANational Electronic Manufacturers Association NWCSNHS-wide Clearing Service OSIOpen Systems Interconnection PACSPicture Archiving and Communication System PASPublicly Available Specification PKIPublic Key Infrastructure QoSQuality of Service RFCRequest for Comment RISRadiology Information
39、 System SNOMEDSystemized Nomenclature of Medicine SNOMED CTSNOMEDClinical Terms SNOMED RTSNOMEDReference Terminology TCTechnical Committee TFTask Force TRTechnical Report TSTechnical Specification UMLUnified Modelling Language WDWorking Draft WGWorking Groups WIWork Item Licensed Copy: London South
40、Bank University, London South Bank University, Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 4 BSI 28 November 2003 3.2.2 International standards bodies There are three principal international standards bodies: the International Telecommunications Union (ITU); the Inter
41、national Organization for Standardization (ISO); the International Electrotechnical Commission (IEC). The ITU is principally produces telecommunications and associated standards. Though these can be used in healthcare, none are healthcare specific and hence no further information on ITU is included
42、in this standard. ISO (see Annex A) is responsible for the production of a number of healthcare standards. There is also a joint ISO/IEC committee (JTC1) (see Annex B), which, mainly for historical reasons, is responsible for a number of healthcare standards. The IEC produces electrotechnical standa
43、rds (e.g. electrical safety) and, while these are relevant to healthcare, none are healthcare specific and hence no further information on IEC is included in this standard. 3.2.3 Regional standards bodies CEN is the principal regional standards body (see Annex C). The vast majority of standards prod
44、uced for healthcare in Europe to date are European Pre-Standards (ENVs) rather than ENs. Unlike ENs, ENVs need not be mandated in procurement. 3.2.4 National standards bodies (NSB) Many national standards bodies publish their own local healthcare informatics standards. National standards can be used
45、 or adopted by other countries if they are particularly useful. Further information on national standards bodies is given in Annex D. 3.3 Consortia and professional bodies A number of professional bodies produce standards within their own field of expertise. Similarly, consortia can be formed to pro
46、duce standards where there is a particular need. These standards have no significance unless adopted by a formal standards body as many are but can in appropriate circumstances be specified in procurement. Details of relevant health informatics consortia and professional bodies are given in Annex E.
47、 3.4 Other standardization bodies In theory, any type of organization can produce a standard and enforce its use, provided it does not conflict with a standard that has legal significance. In practice this is done mainly where the organization has specific standards, e.g. data items or message struc
48、tures. Details of other standardization bodies relevant to health informatics can be found in Annex F. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8401:2003 BSI 28 November 2003 5 4 Application areas Cla
49、use 4 details which standards have been published for use in specific areas of healthcare. The areas are: General healthcare: Standards for general use across the healthcare domain (see Table 1); System architecture: Standards concerning the design of healthcare IT systems (see Table 2); Vocabulary, terminology and coding schemes: Standards defining/describing the use of healthcare vocabu