1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | DRAFT FOR DEVELOPMENT DD ENV 13607:2000 IC
2、S 35.240.80 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Health informatics Messages for the exchange of information on medicine prescriptionsThis British Standard, having been prepared under the direction of the DISC Board, was published under the authority of the Standard
3、s Committee and comes into effect on 15 August 2000 BSI 08-2000 ISBN 0 580 35483 0 DD ENV 13607:2000 Amendments issued since publication Amd. No. Date Comments National foreword This Draft for Development is the English language version of ENV 13607:2000. This publication is not to be used as a Brit
4、ish Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature due to the limited duration of the European prestandard. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained
5、. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion into a European Standard. A review of this publication will be initiated 2 years after its publication by the European organiz
6、ation so that a decision can be taken on its status at the end of its three-year life. The commencement of the review period will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether t
7、o support the conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST/35, Health Informatics, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause nu
8、mber and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may b
9、e found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, the ENV title page, pages 2 to 1
10、31 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.EUROPEANPRESTANDARD PRNORMEEUROPENNE EUROPISCHEVORNORM ENV13607 May2000 ICS35.240.80 Englishversion HealthinformaticsMessagesfortheexchangeofinformation onmedicineprescriptions ThisEu
11、ropeanPrestandard(ENV)wasapprovedbyCENon29July1999asaprospectivestandardforprovisionalapplication. TheperiodofvalidityofthisENVislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequestedto submittheir comments,particularlyonthequestionwhethertheENVcanbeconvertedintoaEuropeanStandard.
12、CENmembersarerequiredtoannouncetheexistenceofthisENVinthesamewayasforanENandtomaketheENVavailablepromp tly atnationallevelinanappropriateform.Itispermissibletokeepconflictingnationalstandardsinforce(inparalleltothe ENV)untilthefinal decisionaboutthepossibleconversionoftheENVintoanENisreached. CENmem
13、bersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG C
14、entralSecretariat:ruedeStassart,36B1050Brussels 2000CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENV13607:2000EPage2 ENV13607:2000 Contents Foreword 4 Introduction . 5 1 Scope. 6 2 Normativereferences 7 3 Normativedefinitionsandabbreviations . . 8
15、4 Requirements. 12 4.1 Generalconformancerequirements . 12 4.2 Implementationrecommendations . 12 5 Communicationrolesandsupportedservices . 13 5.1 General 13 5.2 Communicationroles. 13 5.3 Communicationroles,servicesandGeneralMessageDescriptions 14 5.4 Messagesequences. . 15 6 Hierarchicalgeneralme
16、ssagedescriptions(HGMD). 2 0 6.1 IntroductiontoHGMDs. 20 6.2 TextualdescriptionofrequirementscommontoallHGMDs 20 6.3 NewPrescriptionMessage 21 6.4 Prescriptioncancellationmessage . 25 6.5 Prescriptionquerymessage . 27 6.6 Prescriptionsetlistmessage . . 30 6.7 Prescriptionsetselectionmessage . 33 6.8
17、 Prescriptiondispensingreportmessage . 35 6.9 Prescriptiondispensingreportcancellationmessage. 40 7 Domaininformationmodel(DIM) . 41 7.1 Introduction . 41 7.2 Toplevelmodels(informative) . 42 7.3 Generalmessagesubsystem . . 44 7.4 Specificmessagesubsystem 48 7.5 Communicatingpartiessubsystem . . 53
18、7.6 Healthcareagentsubsystem . 56 7.7 Prescriptionsetsubsystem . 60 7.8 Subjectofcaresubsystem. . 62 7.9 Prescriptionitemsubsystem . . 68 7.10 Paymentguarantorandconditionssubsystem. 76 7.11 Deliveryinformationsubsystem. . 79 7.12 Subclasses 81 7.13 Compounddatatypes 93 7.14 Simpledatatypes . 95 Ann
19、exA (informative) Typicalscenariosfortheuseofmessagesinthemedical practitioner/veterinarian/pharmacistenvironment. . 96 AnnexB (informative) Howtoreadthemodels. 99 AnnexC (informative)Compoundandsimpledatatypes:. 104 Rationaleandhowtousethedatatypesinmessages . 104 AnnexD (informative)Examplesofnewp
20、rescriptionmessagepopulatedwithdata 108Page3 ENV13607:2000 Figures FIGURE 1P RESCRIPTIONMESSAGES , DIRECTCOMMUNICATION 15 FIGURE 2D ISPENSINGREPORTMESSAGES , DIRECTTRANSMISSION 16 FIGURE 3Q UERYSERVICEMESSAGECOMMUNICATION . 17 FIGURE 4Q UERYSERVICEMESSAGECOMMUNICATION , DIRECTPRESCRIPTIONSETSELECTIO
21、N . 18 FIGURE 5D ISPENSINGREPORTMESSAGESINVOLVINGRELAYINGAGENT 19 FIGURE 6I MPLEMENTATIONOFAHEALTHCAREAGENTCOMMUNICATINGPARTY 21 FIGURE 7N EWPRESCRIPTIONMESSAGE GMD 23 FIGURE 8N EWPRESCRIPTIONMESSAGE HGMD . 24 FIGURE 9P RESCRIPTIONCANCELLATIONMESSAGE GMD 26 FIGURE 10P RESCRIPTIONCANCELLATIONMESSAGE
22、HGMD. 27 FIGURE 11P RESCRIPTIONQUERYMESSAGE GMD 28 FIGURE 12P RESCRIPTIONQUERYMESSAGE HGMD . 29 FIGURE 13P RESCRIPTIONSETLISTMESSAGE GMD 31 FIGURE 14P RESCRIPTIONSETLISTMESSAGE HGMD. 32 FIGURE 15P RESCRIPTIONSETSELECTIONMESSAGE GMD. 34 FIGURE 16P RESCRIPTIONSETSELECTIONMESSAGE HGMD . 35 FIGURE 17P R
23、ESCRIPTIONDISPENSINGREPORTMESSAGE GMD 38 FIGURE 18P RESCRIPTION DISPENSING REPORT MESSAGE HGMD . 39 FIGURE 19P RESCRIPTIONDISPENSINGREPORTCANCELLATIONMESSAGE GMD 40 FIGURE 20P RESCRIPTIONDISPENSINGREPORTCANCELLATIONMESSAGE HGMD. 41 FIGURE 21T OPLEVEL DOMAIN INFORMATION MODEL 42 FIGURE 22D OMAIN INFO
24、RMATION MODEL 43 FIGURE 23G ENERALMESSAGESUBSYSTEM . 44 FIGURE 24S PECIFICMESSAGESUBSYSTEM 48 FIGURE 25C OMMUNICATINGPARTIESSUBSYSTEMANDITSASSOCIATIONS . 53 FIGURE 26H EALTHCAREAGENTSUBSYSTEMANDITSASSOCIATIONS 56 FIGURE 27P RESCRIPTIONSETSUBSYSTEMANDITSASSOCIATIONS 60 FIGURE 28S UBJECTOFCARESUBSYSTE
25、MANDITSASSOCIATIONS 62 FIGURE 29P RESCRIPTIONITEMSUBSYSTEMANDITSASSOCIATIONS 68 FIGURE 30P AYMENTGUARANTORANDCONDITIONSSUBSYSTEMANDITSASSOCIATIONS . 76 FIGURE 31D ELIVERYINFORMATIONSUBSYSTEMANDITSASSOCIATIONS 79 FIGURE B.1R EPRESENTATIONOFCLASSESINDIAGRAMS . 99 FIGURE B.2R EPRESENTATIONOFPACKAGESIND
26、IAGRAMS 99 FIGURE B.3I LLUSTRATIONSOFCLASSES A AND B ASSPECIALISATIONSOF CLASS C 100 FIGURE B.4I LLUSTRATIONSOFCLASSES A AND B ASSPECIALISATIONSOFTHEABSTRACT CLASS C . 100 FIGURE B.5I LLUSTRATIONOFAGGREGATIONRELATIONSHIPS 101 FIGURE B.6I LLUSTRATIONOFACOMPOSITIONRELATIONSHIP 101 FIGURE B.7I LLUSTRAT
27、IONOFASSOCIATIONSBETWEENCLASSES 102 FIGURE B.8I LLUSTRATIONOFASSOCIATIONSBETWEENPACKAGES 102 FIGURE B.9I LLUSTRATIONOFCONSTRAINTSONRELATIONSHIPS 103Page4 ENV13607:2000 Foreword ThisEuropeanPrestandardhasbeenpreparedbyTechnicalCommitteeCEN/TC251“Healthinformatics“,the secretariatofwhichisheldbySIS. A
28、ccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoannouncethisEuropeanPrestandard:Austria,Belgium,CzechRepublic,Denmark, Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain, Sweden,Switzerlandan
29、dtheUnitedKingdom. ThisEuropeanPrestandardcomplieswiththethirdeditionofISO/IECDirectives,part3,1997. AllannexesofthisEuropeanPrestandardareinformative.Page5 ENV13607:2000 Introduction Theuseofdataprocessingandtelecommunicationscapabilitieshavemadepossibletheinterchangeof informationinmachinereadable
30、andmachineprocessableformats.Asautomatedinterchangeofinformationin healthcareincreases,itisessentialtoprovideappropriateinformationinterchangestandards. Computersystemsarenowusedbymanyhealthcarepersonsforthestorageandprocessingofinformation. Physicians,dentists,andveterinariansrequest,viaaprescripti
31、onmessage,thatpharmacistsdispensemedicines andappliancesforthetreatmentofpatients/animalsbyaprocesscommonlycalled”prescribing”. Standardsarerequiredtofacilitateelectronictransferofprescriptionmessagesandreportsbetweenthemany systemscurrentlyused.Informationtransferredintheprescriptionmessageandanyre
32、portspassingbetween healthcarepartiesformpartoftheinformationsystemofeachofthecommunicatingparties.Electronictransfer oftheseprescriptionmessagesandreportsreducestheneedformanualentryandtheriskoftranscriptionerrors. Italsoresultsingreaterefficiencyleadingtobetterhealthcareprovision. Thisstandardrequ
33、iresmedicinalproductstobedefinedinawaythatsignificantlyreducestheriskof misinterpretationofissuedprescriptionmessages.Thefollowingshouldbeparticularlynoted: Officialnamesortitlesofmedicinesshouldbeusedastheymayotherwisebemisinterpreted; Thestrengthandquantitytobecontainedincapsules,lozenges,tablets,
34、etc.shouldbestated; Instructionsforuseshoulddescribepreciselyhowandinwhichcasesthemedicinalproductisused.Page6 ENV13607:2000 HealthinformaticsMessagesfortheexchange ofinformationonmedicineprescriptions 1Scope ThisEuropeanPrestandardspecifiesgeneralmessagesforelectronicinformationexchangebetweencompu
35、ter systemsusedbyhealthcarepartiesprescribing,dispensingoradministeringmedicinalproducts/medicinal appliances a) .ThecontentandstructureofthemessagesspecifiedinthisEuropeanprestandardhavebeen developedwiththeaimofoptimisingthesafetyofprescribinganddispensingandtofacilitatecompliance monitoringandsec
36、ureaudittrails. WhenevermedicinalproductsarementionedwithinthisEuropeanprestandard,medicinalappliancesmaybe substitutediftheyservesimilarpurposesandcanberepresentedinsimilarwaysinamessageasmedicinal products. ThisEuropeanprestandardisapplicabletomessagesforelectronicinformationexchangeofprescription
37、sets issued(i.e.prescribed)byhealthcarepersons(andpossiblyotherpersonswhoonthisoccasionactashealthcare persons)authorisedbynationalregulations. ThisEuropeanprestandardisapplicabletomessagesforelectronicinformationexchangeofprescriptionsets sentbyaprescribertoadispensinghealthcareparty(dispensingagen
38、t)andtohealthcarepersons/organisations orofficialauthoritiesaspermittedbynationalregulation.ThisEuropeanprestandardisalsoapplicableto messagesforelectronicinformationexchangeofprescriptionsetssentbytheprescribertoarelayingagentand fromarelayingagenttoadispensingagent. NOTE ArelayingagentisaspecialEl
39、ectronicMessageHandlingServicefromwhereoneandonlyonedispensing agentmayretrieveanysingleprescriptionset;onceonly,upontherequestofthepartyforwhomtheprescriptionmessageis issuedortheiragent. ThisEuropeanprestandardisapplicabletomessagesforelectronicinformationexchangeofprescriptionsets issuedforsingle
40、humanpatients,singleanimals,agroupofanimals,forpersonalusebytheprescriberorfor useattheprescriberspremiseswithoutspecifiedenduser.Thecategoriesforwhichanyauthorisedprescriber mayprescribeareregulatednationally. ThisEuropeanprestandardspecifiesamessage, newprescriptionmessage, forelectronicprescribin
41、gof medicinalproducts/medicinalappliancessentfromtheprescribertoadispensingagent,possiblyviaarelaying agent. ThisEuropeanprestandardspecifiesmessagesforretrievalofanewprescriptionmessagetemporarilystoredby arelayingagent.ThisEuropeanprestandardspecifies: Prescriptionquerymessage queryingifanyorspeci
42、fiedprescriptionset(s)existforasinglesubjectof careatarelayingagentmatchingasetofselectioncriteria .Thismessageissentfromadispensingagent toarelayingagent. Prescriptionsetlistmessage listingtheprescriptionset(s)(andthecontainedprescriptionitems)storedat arelayingagentinreplytoaprescriptionquerymessa
43、ge.Thismessageissentfromarelayingagenttoa dispensingagent. Prescriptionsetselectionmessage forrequestingarelayingagenttotransmitnewprescription message(s)referencedbyoneormoreprescriptionsetidentifier(s).Identifiersareeitherobtainedbya previousprescriptionquerymessage/prescriptionsetlistmessageorsup
44、pliedbythesubjectofcareor animalcarerwithoutapreviousquery.Themessageissentfromadispensingagenttoarelayingagent whowillrespondbysendingthenewprescriptionmessagesidentifiedbytheprescriptionsetselection message. NOTE Theabovethreemessagesalwayshandleprescriptionsetsasawhole,asingleprescriptionitemina prescriptionsetcannotbehandledindividually.Locallyitmaybeagreedtoallowonlyoneprescriptionitemper prescriptionset,thuspermittingindividualhandlingofprescriptionitems. a) Notallmedicinalappliancescanbeprescribed,thiswilld
