A. Holzinger LV 444 - Graz University of...

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A. Holzinger LV 444.152

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LackofIntegratedSystemsClinicalWorkplaceefficiencyCloudComputing(Privacy,Security,Safetyissues)SoftwareasaService(aselectricityisalready)Althoughwewritetheyear2014– andwearenowinthecomputingbusinesssince1970– formorethanfourdecades– thereisstillthelackofintegratedsystems,moreoverthelackofdataintegration.Amajorissueisindatafusion.Thenextproblemisintheclinicalworkplaceefficiency.Itisnotenoughjusttodelivermoreandmoredatatotheclinician– theyarealreadyoverwhelmedbythemassesofdata.Theyareinterestedinrelevantdata,andrelevantinformationtosupportknowledgeanddecisionmaking.Thereisalottodointhenextyears.

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Wehavealreadyheardaboutworkflowsandhowimportanttheyare.PleaserememberthataVon‐Neumannmachineisamathematicalprocessor,henceisgoodinprocessingnumbers‐ mathematically.Modellingisanapproachtomathematizeourworld.Whatcannotbemodelledinamathematicalwaycannotbeprocessedbyacomputer.Inthisslideweseeatypicalmedicalworkflowontheexampleofradiology– fromadmissionofthepatienttothedischarge.Usecasediagramsdescribesequencesofactions,providingmeasurablevaluestoactors.Agoodoverviewisgivenby(Juan,Ma&Chen,2005).

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Rememberwhatwelearnedabouttherelationshipsofdata,informationandknowledgeandthattheknowledgegainedistheessentialpartindecisionmaking,whichresultsinanappropriateaction.Doneverforgetthatclinicalmedicineisnotatheoretical,butanactionscience(inGerman:“Handlungswissenschaft”).Inthisslideontheleftweseethe“knowledgeelements”(gainedclinicalinformation,policies,standardoperatingprocedures,clinicalguidelines,etc.)asabasisfordecisionmaking.

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ThecoreelementofSlide10‐3isappliedineverystageofworkflowsfromthelargescale(worldhealthmanagement,countrypoliciesetc.)tothesmallscale(eventhandling).

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Aworkflowconsistsofasequenceofconnectedsteps,withtheemphasisontheflowparadigm.Aworkflowcanbeseenasanabstractionoftherealworld.Workflowmodelingisbasicallytheprocessofsimplifyingreality(withalltheproblemsanddangersofoversimplificationinvolved).Themodelingisbasedonfactsgatheredduringobservationsandweneedtoacceptthatthisrepresentationcanneverbeperfect.Expectationsfromamodelshouldbelimitedtotheintentionswithwhichitisdesignedfor,beitproblemsolvingorunderstandingofsystemintricacies.Aworkflowmanagementsystemisdesignedspecificallytocomposeandexecuteaseriesofcomputationaland/ordatamanipulationsteps.Intheresearchareathereisthevisionofe‐Science,i.e.distributedscientistsbeingabletocollaborateonconductinglargescaleexperimentsandknowledgediscoveryapplicationsusingdistributedsystemsofcomputingresources,datasets,anddevices.Workflowmodelingistheprocessofsimplifyingthereal‐world;Modelingisbasedonfactsgatheredduringobservationsandweneedtoacceptthatthisrepresentationcanneverbeperfect;Expectationsfromamodelshouldbelimitedtotheintentionswithwhichitisdesignedfor,beitproblemsolvingorunderstandingofsystemintricacies,i.e.elaboratelycomplexdetails(Malhotraetal.,2007).

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A workflowW is defined as a process that contains tasks T, and the respective rules

on how those tasks are executed:

W:= (T, P, C, A, S0) where

T = {T1, T2, … Tm } A set of tasks, m 1

P = (pij)m x m Precedence matrix of the task set

C = (cij)m x m Conflict matrix of the task set

A = A(T1), A(T2), …, A™) Pre‐Condition set for each task

S0 {0, 1, 2, 3m } is the initial state

Formoreinformationpleasereferto:(Wangetal.,2008)

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HereyoucanseethemodelofthedefinedworkflowfromSlide10‐6andthemathematicalrepresentation(Wangetal.,2008).P=(pij)mxmPrecedencematrixofthetasksetC=(cij)mxmConflictmatrixofthetaskset

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Inthisslideyouseethedescriptionofareal‐worldexamplebytheuseoftheUMLandacorrespondingusecasediagram(Holzingeretal.,2010).TheUnifiedModelingLanguage(UML)isastandardized(ISO/IEC19501:2005),modelinglanguagedevelopedfromthesoftwareengineeringdomain(Oestereich,1999).UMLincludesasetofgraphicnotationtechniquestocreatevisualmodelsofobject‐orientedsystems.Originally,itwasdevelopedby(Booch,1994)and(Booch,Rumbaugh &Jacobson,1999).Itwasadoptedasastandardin1997bytheOMG(ObjectManagementGroup)andhasbeenmanagedbythisorganizationeversince.ThecurrentversionoftheUMLis2.4.1publishedbytheOMGinAugust2011.

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Althoughthisslideisovercrowdedandhardtoread– theadvantageishavingagoodoverviewontheusageofdifferentdiagrams– enablingdifferentviewsfordifferentpeople.ForStakeholdersusecasediagramsdescribesequencesofactions,providingmeasurablevaluestoactors.Classdiagramsshowinterrelationships,inheritance,aggregation,association,operationsandattributes.Sequencediagramsareinteractiondiagramswhichdetailshowoperationsarecarriedout,whichmessagesaresentandatwhichtime.Communication/Collaborationdiagramsshowthemessageflowbetweenobjectsandimplytherelationshipsbetweenclasses.Componentdiagramsareusedasanarchitecture‐levelartifactDeploymentdiagramsmodelthestaticviewoftherun‐timeconfigurationofprocessingnodesandthecomponentsthatrunonthosenodes;thisshowsalsohardware&softwarerequirements.ActivityDiagramsformodellingthelogicandStateMachinediagramsshowtoanalyststhepossiblestatesofobjectsandtransitionsthatcausechanges.

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Timeismoney.Nowhereelse thiscomesoutsoclearlyasinthemedicalarea.Usually,yourlastminutesoflifearethemostexpensiveone.

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Thisisanexampleofhowatypicalhospitalworkflowlookslikeandinthefollowingwewillseewhatcomputersciencecandotohelptomakesuchaworkflowmuchmoreeffective.Thisexampleisfromanoutpatientuniversityclinicwherequestionnairesareveryimportantforsupportingresearchinfightingskincancer(Holzinger,Sammer &Hofmann‐Wellenhof,2006),(Holzingeretal.,2011).Lookattheslide:Whenthepatientsarriveatthecentraladministrationdeskoftheoutpatientclinic,amedicalnursehandsthemoverapaperquestionnaire.Thepatientisaskedtocompletethequestionnairealoneandreturnittothenurse,wheretheyarecollectedtogetherforthemedicaldoctor.Theoretically,thedoctorcanperusethepaperquestionnaireduringthetreatment,butconcentrationisusuallylimitedtothepatientandtheElectronicPatientRecord(EPR)displayedontheclinicalworkplacemonitor.Mostoften,thequestionnairesarejustgatheredandmanuallytypedintoaseparateelectronicdatabaseaftertheclinicisclosed– inthesparetimeofthedoctor.Moreover,theseparatedatabasehasnodirectconnectiontotheelectronicpatientrecordoftheEnterpriseHospitalInformationSystem(EHIS).Consequently,alotofeffortisspentjustontyping.Letuslooktothenextslide,whatwecandofromacomputerscienceperspectivetosavetimeandeffort.

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Inthenewworkflow,thepatientreportstothecentraladministrationdeskoftheoutpatientclinic.There,theyareregisteredanywayviatheMEDOCShospitalinformationsystemadministrationprogram.Thiswillnowbeusedasanpatientidentifier.Attheclinicalworkplace,alistofthewaitingpatients,whohavebeenregisteredalreadyinthesystem butnotyetreleasedbyamedicaldoctor,isdisplayed,flaggedtoshowwhetherornottheyhavealreadyfilledoutaquestionnaire.Thisisindicatedbymeansoftextand/orasymbolanddifferentiatesbetweenaquestionnairewhichhasbeenmadeavailabletothepatient,aquestionnairefilledoutonthecurrentday;andaquestionnaire,whichwascompletedbythepatientduringapreviousvisit(non‐currentdate)andisstillavailable.Whennoquestionnaireisavailabletheflagcolumnremainsempty.Themedicaldoctororthenursingstaffofthecliniccandecidewhetherthepatientshouldcompleteaquestionnaireandwhetherthisshouldbethelongortheshortversion.ClickingontherelevanticongeneratestheemptyquestionnaireandregistersitinMEDOCSusingauniqueidentificationcodewhichidentifiesthepatientunequivocallyastheuser.UsinganXMLcommunication,thepatientidentificationnumber(PID),theuniquenumberofthedocument(documentnumberatthetopofthequestionnaire)andanyfurtherdata(e.g.name,dateofbirth)considerednecessarybyMoCoMED‐Graz,aretransmitted.Attheterminal,thepatientisequippedwithatouchbasedTabletPCandacode,withwhichhe/shecanlogintoMoCoMED‐Grazandcompletethequestionnairefollowingatouchbasedapplication.TheauthenticationatMoCoMED‐Grazisnecessaryfordatasecurityreasons,sothatnopatientcanaccessotherdataandpatientsavoidmistakesorerrors.Thecodeisauniqueidentificationnumber,generatedbyandlinkedwiththeenterprisehospitalinformationsystemspatientrecordMEDOCS,ensuringthattheproperpatiententersthedata.Anincorrectcodeentrypromptsanerrormessageandthedataisnotacceptedbythesystem.Afterthequestionshavebeenansweredandthequestionnaireiscompleted,MoCoMED‐GraztransfersthequestionnairedirectlyintotheMEDOCSsystem.ThecorrespondingcolumninMEDOCSnowshowsthestatus“questionnairewasfilledoutonthecurrentday”.Assoonasthepatienthascompletedthequestionnaire,theXMLfilecontainingtheanswersisstoredontheserverandsubsequentlytransferredtoMEDOCSbyusingaremotefunctioncall(RFC).TheXMLdocumentcontainingallanswersofapatientincludes,ofcourse,theuniqueidentificationofeach.Thisprojectservesasanexampleofhowcomputerapplicationcanbenefitallthreegroupsofpeople:patients,medicalprofessionalsandhospitalmanagers.Patientswereverysatisfiedwiththefrontendoftheapplication.Medicalprofessionalscouldsaveupto90%(!)oftheirformerlywastedtime;whichultimatelysavesmoneyforthehospitalmanager.Mostimportant,thequalityofthemedicalserviceisincreased,sincethenewlycreatedworkflowbringstogetherpatientsanddoctorsinfrontoftheclinicalworkplace,tocheckwhetherallentriesarecorrect.Sincerobust,reliable,lightandunobtrusive,uncomplicated,appealinghardwareisanessentialpartofthesuccessofsuchanapplicationinareal‐lifehospital,theselectionofappropriatehardwareisanessentialsuccessfactor.Formoredetailsreferto(Holzingeretal.,2011).

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Hereyouseethearchitectureofthisapplication.PAT=Patient,MED=medicaldoctor.Fordetailssee(Holzingeretal.,2011).

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Fromthehospitalmanagers´ pointofview,thismethodmayserveasavaluabletooltoachieveextensivesurveillancedatawithlimitedresources,toreducehumanerrorstoaminimum,andtocreatestandardizeddatasetsforfurtheranalyses,thusimprovingskincancerpreventionandqualityofcare.Aspatientswereactivelyintegratedintotheirtreatmentprocessandprovidedwithausefulwayofspendingtheirwaitingtime,thismayalsoleadtoasubstantialimprovementinpatientcareservices,andthereforeincreasedpatientsatisfaction.,Apartfromthetimesavingbenefit,animportantaspectforthehealthsystemingeneral,whichisalsorelevanttothehospitalmanagersintermsofqualityofpatienttreatmentistheincreasedpatientempowerment.Forclearlydepictingthebenefitforthehospitalmanagement,ascenarioanalysishasbeenmadebycalculatingthefactsinthisparticularoutpatientcliniconthebasisofN=30patientsaday,250daysayear.Scenario1(withoutmobilecomputers):Adoctorcoststhehospitalapprox.44EURperhour=0.73EURperminute.Withanaverageof10minutesperpatient,the300minutesofextraeffortrequiredbythedoctorstotranscribethequestionnairesareequivalentto219EURperday=55kEURperyearandthereistheadditionalriskoflostandmissingdata.Wealsotestedthealternativeoflettingcopytypiststranscribethedata:Theyarefastermedian=7minutes(min:5minutes;max:8minutes),however,sincetheyarenotmedicalprofessionalstheymakemoreerrors,whichcannotbecorrectedwithoutextracosts.Calculatingonthebasisoftheiraveragehourlywagesresultsinacostof19EURperhour=0.32EURperminute,wehavecostsofapprox.17kEURperannum.Scenario2(usingtwomobilecomputers):DevelopmentCosts:7PersonMonths=28kEURHardwareCosts:3.2kEUROriginalcostofacquisition=31.2kEURAnnualservicecosts:0.5Personmpy =2kEURThereductiontoonly30minutesofthemedicaldoctorstimeperdayisequivalentto22EURperdayorapprox.5.5kEURperyear.Totalannualcosts=7.5kEURAssuminganaveragelifespanof4years,thisamountstoatotalof31.2+(4*7.5)=61.2kEUR,or15.3kEURperannum.Maximumtotalpossiblecostsavingperyear:55kEUR– 15.3kEUR=39.7kEURMinimumtotalpossiblecostsavingperyear:23.5kEUR– 15.3kEUR=8.2kEURYouclearlyseethebenefitofsuchanapplication– reachedthroughcarefulworkflowoptimization.

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Finally,haveaviewonthefront‐endofthisapplication – fromthepatientside.

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Whatcanwelearnoutofthisproject:Mostofallyoumustacknowledgethatdifferentpeoplehavedifferentviews,differentexpectationsanddifferentgoals.Toprovideaclearbenefit,anapplicationshouldsatisfydifferentrequirementsandmostofallshouldbringaclear– measurable(!)– benefit.Timetoperformataskisstillamajorissue,easytomeasureandpays‐off.Timeismoney.Ifyousavetimeofamedicalprofessional,yousavemoney,butatthesametimeyouenhancequality!Forevaluationpurposestheecologicalsystemstheoryby(Bronfenbrenner,1977)isuseful,whichoriginatesfromchilddevelopmenttheoryanddescribestheinteractionbetweenvariousenvironmentsusingalayerstructure– eachhavinganeffectonachild’sdevelopment.Originally,Bronfenbrenner describedfivesuchlayers:

a)themicrosystem,whichencompassesrelationshipsandinteractionswithintheperson’sdirectenvironment– fromtheindividualpersons’pointofview.b)themesosystem,whichdescribestheinteractionbetweenthemicrosystemandthec)theexosystem ,whichdefinesthelargersocialsysteminwhichthepersondoesnotfunctiondirectly.d)themacrosystem,whichincludestheculturalvalues,customs,andlawse)thechronosystem,whichencompassesthedimensionoftimeasitrelatestoapersons’environment.Theessenceisthatinteractionsatouterlevelshavealwaysimpactontheinnerstructures.Forourpurpose,weinstrumentalized onlythreeofBronfenbrenners layers:microsystem,mesosystem andmacrosystem andwethemintoourcontext:1)themicrosystemrelatestotheenduserandtheirimmediateenvironment(endusercenteredhuman‐computerinteraction:usertasks,patientempowerment,…)2)themesosystem relatestothemedicalprofessionalsandtheirenvironment(professionalprocesscenteredhuman‐computerinteraction:worktasks,medicalprocesses,socialcontext,i.e.discussingthemedicaldatatogetherwiththepatient–stronginfluenceonpatientempowerment,…)

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Wecansummarize:Adata‐drivenprocedureconsistingofoneormoretransformationprocessescanbeseenasnodesandthuscanberepresentedasadirectedgraph,wherethedirectionistime– i.e.theorderoftransformationsandasetoftransformationrules.Thedatafloworiginsfromasourcetoadestination(orresult)viaaseriesofdatamanipulationsandthespecificationisdesignedinaWorkflowDesignSystem(modelingcomponent)andthenrunbyaWorkflowManagementSystem(executioncomponent)(Hasanetal.,2006).

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(Romano,2008)describedthecomponentsofaWMSinthebioinformaticsdomain.Note:WMS=asystemthatdefines,createsandmanagestheexecutionofworkflows.Itsmaincomponentsinclude:1)agraphicalinterfaceforcomposingworkflows,enteringdata,watchingexecution,displayingresults;2)andataarchivetostoreworkflowdescriptions,resultsofexecutionsandrelatedtraces;3)aregistryofavailableservices,eitherlocalorremote,4)aschedulerabletoinvokeservicesincludedintheworkflowattheappropriatetime,5)asetofprogramminginterfacesabletodialoguewithremoteservices,6)amonitortoolforcontrollingtheexecutionoftheworkflow,7)asetofvisualizationcapabilitiesfordisplayingdifferenttypesofresults.

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RemembertheclassicarchitectureofaHospitalInformationSystemwhichwehavealreadydiscussedin→Lecture4.Managingallclinicalinformationisachallengeimplyinghugeconstraints,becausehealthcareprovidersusetechnologyinaubiquitousmanner.Medicalinformationsystems(e.g.,HospitalInformationSystems(HIS),PictureArchivingandCommunicationSystems(PACS),RadiologyInformationSystems(RIS)andLaboratoryInformationSystems(LIS))areusedinparalleltogetherandareoftenheterogeneous.Aprocess‐orientedHIShastobemodifiedwheneverthebusinessprocesschanges,i.e.,itmustbeadjustabletoprocesschangesandtochangingorganizationalstructuresveryquicklyandatreasonablecosts(Dadam,Reichert&Kuhn,2000).

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Thereisaneedtointegratethevarioustheoreticalframeworksandformalismsformodelingclinicalguidelines,workflows,andpathways,inordertomovebeyondprovidingsupportforindividualclinicaldecisionsandtowardtheprovisionofprocess‐oriented,patient‐centeredHISthatformallymodelguidelines,workflows,andcarepathways(Gooch&Roudsari,2011).Historically,wedeterminebetweenthreedifferentsystemarchitectures:1970+“VerticalApproach”– monolithicmainframes:Centralcomputersystemsmainlyforaccounting,typical“dataprocessing”(“EDV”).1985+“HorizontalApproach”– evolutionarysystems:Departmentalclinicalinformationsystems,localareanetworks,distributedsystems.2000+“IntegratedApproach”– open,distributedsystems:HospitalIntranets,networkedelectronicpatient/healthrecord,mobilecomputing,“informationqualityfocus”(Holzinger,2002).

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Astandarduniversalintegratedarchitecturecontainsadatacenter– fusingtogetherthedatafromthemaindatabases(patientrecords,laboratoryinformationsystem,PACSstorage,etc.)andaintegratedviewintermsofaclinicalworkplace(ElAzami,Cherkaoui Malki &Tahon,2012).

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Comingbacktoagrandchallenge:dataintegrationanddatafusioninthelifesciences:Thereisaneedtointegratethevarioustheoreticalframeworksandformalismsformodelingclinicalguidelines,workflows,andpathways,inordertomovebeyondprovidingsupportforindividualclinicaldecisionsandtowardtheprovisionofprocess‐oriented,patient‐centeredHISthatformallymodelguidelines,workflows,andcarepathways.Oneapproachcanbeseeninthisslide,wheredifferentworkflowmodelsanddatamodelsandknowledgemodelsarecombinedandusedfortheoverallclinicalprocessmodel(Gooch&Roudsari,2011).

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Variousmedicaldepartmentsgenerateimagesorvideosformedicaldocumentation.Althoughtheseimagesarelightweightfromatechnologicalperspective,theworkflowsforimagegenerationandviewingareverydiverse(Bellon etal.,2011).Inprimarydiagnosisimagesmustoftenbeacquiredinaseparatestepbeforediagnosisispossible,e.g.whenimagesaregeneratedusingionizingradiation,radiowaves,laserbeams(e.g.opticalcoherencetomography,retinalthicknessanalysis,etc.)orfluorescence(fluoresceinangiography,etc.).Incontrast,inpathologyusingvisuallightmicroscopydiagnosiscanbeperformedbydirectobservation,butevenforthisapplicationthereareadvantagesobtaininganimagefirstbyusingthecomputerasadigitalmicroscope.Such“virtualmicroscopy”imagescontainmanythousandpixelsalongeachdirection.Thishugestorage(muchhigherthaninradiology)makesroutineusedifficult.Workflowsinmanycasesaresimilartoradiology,however,notinthecompletelydifferentclassofapplicationsinwhichimagesorshortvideosequencesarenotneededforprimarydiagnosis,butareobtainedforlaterreference,e.g.tofacilitatediscussionwithcolleagues,todocumentthecase,orforcommunicationwiththepatient(leftintheSlide).Forsuch“referenceimages,qualityusuallyisnotaconcernandtechnologicalneedsarelow.InmanycasestheacquisitiondevicesareconsumerproductssuchasdigitalphotocamerasthatdonotsupportDICOMrelatedconcepts.Forexample,manysystemsinophthalmologyoutputreportsintheformofadocumentcontainingtext,numbers,graphs,andsomeimages(rightintheSlide).EvenifsomenewequipmentmightbeabletogenerateaDICOMstructuredreport,mostsystemsjustgenerateoutputonpaper.AneasybutefficientwaytocapturethelatterdocumentsintoanelectronicsystemistoreplacethetraditionalpaperprinterbyavirtualprinterthatgeneratesPDF.Inathirdclassofapplicationsthereisareal‐timeaspect,forexampleinsurgery(endoscopiccamerasforkeyholesurgery,fluoroscopicimagingequipment,vitalsignsmonitors,surgicalrobots,imageprocessingapplicationsforintra‐surgicalguidanceetc.).

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APACS(PictureArchivingandCommunicationSystem)isstillprimarilyassociatedwithradiology,butcanhandleimagesfromvariousmedicalsources,includingultrasound(US),magneticresonance(MR),positronemissiontomography(PET),computationaltomography(CT),endoscopy(ES),mammograms(MG),etc.IntheSlideaboveweseethefirstcommercialPACSinstallationintheUS– aFujiCR‐101systemattheOsner Clinics,NewOrleans.BelowweseeaPACSconsolefrom1990(Huang,2011).Note:AlthoughtheconceptofPACSwasdevelopedinEuropeduringthelate1970s,nocommercialsystemwascompletedatthattime.ThefirstPACSimplementationstookplaceintheUnitedStatesintheearly1980s,e.g.atPennsylvaniaUniversity,UCLA,KansasCityUniversityandtheOsner Clinics,NewOrleans.SomemoreorlesssuccessfulPACSdevelopmentsalsotookplaceinEuropeinthe1980s– andGrazwasamongstthefirstPACSinstallations.Mostsystemscouldbecharacterizedbytheirfocusonasingledepartment,suchasradiologyornuclearmedicine.Hospital‐widePACSevolvedintheearly1990sinLondon(HammersmithHospital)andVienna(SMZO)(Lemke,2003),(Lemke,2011).

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Atypicalworkflowcanbeseeninthisslide:Thedarkovalsymbolsindicatetheactivitystepsoftheclinicalprocessfromexaminationtotherapyplanningonalowgranulationlevel.Brightrectangularsymbolsindicatethepersonnelinvolvementintheactivitysteps,lightbeigeovalsymbolsindicateITsystemsupportforthegivenactivities,anddarkrectangularsymbolsindicatethefunctionalitiesofmedicalworkstationssupportingthegivenactivities(Lemke&Berliner,2011),(Lemke,2011).

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InthisslideweseethePACSbasiccomponentsanddataflow;HIS:HospitalInformationSystem;RIS:RadiologyInformationSystem.Systemintegrationandclinicalimplementationaretwoothernecessarycomponentsduringtheimplementationafterthesystemisphysicallyconnected.ApplicationServersandWebServersconnectedtothePACScontrollerenrichthePACSinfrastructureforotherclinical,researchandeducationapplications(Huang,2011).Note:Imagingmodalities arethedifferentimagegeneratingdevices,e.g.CT,PET,MR,etc.(hasnothingtodowiththemodalityknownfrommultimediatheory)

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Rememberthatwealready learnedabouttheimportanceofstandardsforbothtechnologyanddata.

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Inthecontextofhospitalinformationsystemsingeneralandwithmedicalimaginginparticular,threestandardshaveasignificantimportance:DICOM,HL7andLOINC(Bui&Taira,2010):DICOM3.0– DigitalImagingandCommunicationinMedicine(1993)is…1)asetofprotocolsfornetworkcommunication;2)asyntaxandsemanticsforcommandsandinfo;3)asetofmediastorageservices(standardcompliant);HL7‐ HealthLevel7…1)HL7v2.xisamessagingprotocol,toprovideexchangeoftextualhealthcaredatabetweenhospitalinformationsystems;2)ReferenceImplementationModel(RIM)containsdatatypes,classes,statediagrams,usecasemodels,antterminologytoderivedomain‐specificinformationmodels;3)ClinicalDocumentArchitecture(CDA)isadocumentmarkupstandardtospecifystructureandsemanticsofclinicaldocumentsinXML;LOINC‐ LogicalObservationIdentifierNamesandCodesisusedfor…1)Laboratorydata(e.g.molecularpathologyobservationsusedforidentificationofgeneticmutations,tumorgenes,genedeletions,etc.);2)ClinicalObservations(e.g.non‐laboratorydiagnosticstudies,criticalcare,nursingmeasures,patienthistory,instrumentsurveys,etc.);3)Claimsattachments(e.g.handlesthedefinitionofnewLOINCtermsandcodestomanageclaims‐relateddataetc.).

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InthiscompactoverviewweseetheISOOSIReferenceLayermodelshowingthemostcommonprotocolsanddatastandards,fromthephysicalleveluptotheapplicationlevel(=level7).HL7(HealthLevel7)isbothanorganizationandastandard,whichwasfoundedin1987aimingatageneralstandardforhospitalinformationsystems.Theorganizationwasaccreditedin1994bytheAmericanNationalStandardsInstitute.ThenameisareferencetotheseventhlayeroftheISOOSIReferencelayermodelakaapplicationlayerandindicatesthatitfocusesonthatlayer,independentofthelayers.AllrelevantinformationcanberetrievedfromtheWebsite:http://www.hl7.org

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Communicationofimagesbetweenmedicalimagingsystemsandamongtheirapplicationshasalwaysbeendifficultbecauseofthemultipleplatformsandvendor‐specificcommunicationprotocolsanddataformats.TheDICOMstandard,developedin1992byajointcommitteeformedbytheAmericanCollegeofRadiology(ACR)andtheNationalElectricalManufacturersAssociation(NEMA),isintendedtoprovideconnectivityandinteroperabilityformultivendorimagingequipment,allowingcommunicationofimagesandexchangeofinformationamongtheseindividualsystems.MedicalimagesaredefinedinDICOMasinformationobjectsordatasets.Aninformationobjectrepresentsaninstanceofareal‐worldinformationobject(i.e.,animage)andiscomposedofmultipledataelementsthatcontaintheencodedvaluesofattributesofthatobject.Eachdataelementismadeofthreefields:thedataelementtag,thevaluelength,andthevaluefield.Thedataelementtagisauniqueidentifierconsistingofagroupnumberandanelementnumberinhexadecimalnotationandisusedtoidentifythespecificattributeoftheelement(Wong&Lou,2009).Lookattheslide(leftside):Eachdataelementisuniquelyidentifiedbyitscorrespondingtagcomposedofagroupnumberandanelementnumber.Pixeldataoftheimageisstoredinelement0010withingroup7FE0.Lookattherightside:ADICOMfileconsistsofafilemeta‐informationheaderandaninformationobject(imagedataset).Thefilemeta‐informationheaderismadeofafilepreamble,aDICOMprefix,andmultiplefilemeta‐elements.(Wong&Lou,2009).

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Thisisjustanexample:AspecialDICOMSupplementdefinesawaytostoreandcommunicatemeshesasDICOMinstances,allowingthestorageofthemeshestogetherwiththeimagesonaPACSserver– meshesareimportantforcomputerassistedsurgery(Lemke&Berliner,2011).

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InthelastyearsmanychangesincomputerandcommunicationtechnologyhavepushedthelimitsofPACSbeyondthetraditionalsystemarchitectureprovidingnewperspectivesandinnovativeapproachestoatraditionallyconservativemedicalcommunity.TechnologiessuchastheWeb,wirelessnetworking,OpenSourcesoftwareandrecentemergenceofcybercommunitiesandsocialnetworkshaveimposedanacceleratedpaceintheprogressofcomputerandtechnologyinfrastructureapplicabletomedicalimagingapplications.Inthisslideweseesomemodernapproaches:IndustryhasstartedtoadoptOSIRIXasabasefornewbusinessmodelswheretheyprovidethesupportandintegrationofservicesaswellastrainingandcustomizationofgenericplatforms.SeveralcertifiedversionsforEuropeandforFDAintheUShavealreadyappearedonthemarketrecently.Andfinally,andprobablymostimportantly,theacademiccommunityhasstartedtoregroupitseffortstosupportandpromoteOpenSourceinitiativesinmedicalimagingandmedicalinformatics(Ratib,Rosset &Heuberger,2011).OSIRIXsoftwareprogramanditssourcecodeareavailableunderOpenSourcelicensingagreementandcanbedownloadedfreeofchargeat:http://www.osirix‐viewer.com

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Thisslideshowanexamplebusinessusecaserelatedtoalaboratoryresultsmessage,aswellasaV2.4andav3representation.Thev3messageisbaseduponthenormativeXMLITS1.0andschemafromtheMay2006InformativeEditionofHL7v3.Theusecaseisthecompletionofaserumglucoselaboratoryresultof182mg/dL authoredbyHowardH.Hippocrates.ThelaboratorytestwasorderedbyPatriciaPrimaryforpatientEveE.Everywoman.TheusecasetakesplaceintheUSRealm.Seemoredetailsvia:http://www.ringholm.com/docs/04300_en.htm

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ThisslideshowsaPACSconsoleandatypicalPACS‐Viewer,whichrunsmeanwhileonstandardplatformssuchasMacorWindows.

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InthisslideweseeadvancedimagedisplayandanalysistoolsadaptedtomultimodalityimagingtechniquessuchashybridPET‐CTimagesshowingmulti‐planarreformattingoffusedimages(backwindow)aswellasvolumerenderingandsegmentationoftumoroutlinefromPETimages(frontwindow).Developmentofcommercialsystemsdrivenbymedicalimagingmanufacturerslagsbehindtheincreasingdemandforsuchadvancedprocessingtools.Industryusuallyfollowsresearchandclinicalvalidationslowlyandrequiresseveralyearsbeforereleasingnewproductsonthemarket.Thecertificationprocesseswithinthemedicalareaarelonglastingandcostly;thereforeeachvendortriestoselltheiravailableproductsaslongaspossible.AlthoughOpenSourceandfreesoftwareisbecomingmorewidelyadoptedinthemedicalcommunityitisstillrarethatahospital(especiallyapublicone)adoptthesetotheirdailyroutine.Privatehospitalsaremoreopenforadvancedtechnologiesingeneralastheyhaveusuallyashorterdecisionchaininthehospitalmanagement.OpenSourcewouldnotonlyprovideacosteffectivealternative,but,becausetheyarebeingdevelopedbyacommunityofdevelopersfromthefield,thesoftwaretoolscanbecustomizedtomatchtheneedsandspecificusageinclinicalsetupsoutsideradiology.AlsoOpenSourcehavelessrestrictionsonprovidingnewinnovativeandchallengingviewingandanalysistoolsthatrespondtousersdemandsevenbeforeindustryandcommercialvendorsidentifythesenewtrendsaspotentialsourceofrevenue(Ratib,Rosset &Heuberger,2011).

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ThisslideshowsanOsiriX integratedRIS–PACSinterface:aquerylistforretrievalfromPACSandimagelistforagivenPACS‐retrievedexamination.Note:TheRadiologicalInformationSystem(RIS)isoftenpartofthegeneralHospitalInformationSystem(HIS).TheincreasingavailabilityofsuchintegratedRIS–PACSsolutionsforimagereadingandreportingofmedicalimagingexaminationshasfuelledthedevelopmentofintegratedtoolsfordigitalimageprocessing.Thisevolutionrepresentsafurthersteptowardstotalintegrationofallinstrumentsneededforinterpretationandreportingofdiagnosticimagingexaminationsinahealthserviceenvironment,i.e.atauniversalclinicalworkplace.Technicalproblemshavebeenfaced,especiallyinearlytimes,duetostringenthardwareandsoftwarerequirementsforaccomplishingsuchtasks(Faggioni etal.,2011).Moreinformationabouttheopen‐sourcesoftwareOsiriX canbefoundhere:http://www.osirix‐viewer.com

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Radiologistswereeversincethedriversinimagingtechnologiesandtheyconstantlyareadoptingadvancedtechnologiesintoroutine.HereanexampleoftheapplicationofVirtualRealityinmedicalimaging(Faggioni etal.,2011).

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Meanwhilemanypreprocessingandimagingprocessingtechniquesareintegratedintheradiologicalworkplaceascanbeseenhereontheexampleofaworkflowoftheautomatedassessmentoftheskeletalmaturity.Regionsthatmaydeliverfalsepositivesareexcludedfromtheanalysis.Duetotheindividualvariability,somelandmarksmaybepointedinordertopreciselydefinethesizeoftheRegionofInterest(RoI).Typically,twotypesofRoIs aredefined:Thefirstone,usuallyofarectangularshape,shrinkstheareatobesearchedandpermitsrobustsegmentationprocedures.Theseregionsarepointedbyradiologistsasareasofastrongdiscriminativepowerthatfeaturesignificantchangesduringthedevelopmentoftheprocesstobedescribed.Asanexample,distal,middle,andproximalregionsinthephalangeshavebeenpointedbyradiologistasareasverysensitivetothedevelopmentoftheskeletalsystem.‘Themoredistalthebetter’istheiropinion.Anotherregionpointedbyradiologistsincludesthecarpalbones.Theyhappentobegoodindicatorsattheearlystageoftheskeletaldevelopment.TheothertypeoftheRoIs isrelatedtoanatomicalstructures.Ifanabnormaltissueissearchedwithinacertainstructure(lung,liver,brain,etc.),thisstructurehastobesegmentedinthefirstplace.Therequiredaccuracyofthedelineationdependsonapossiblelocationofthepathologicaltissuewithinthisstructure.Ifthetissueisattachedtotheborderand,inaddition,itspixel(voxel)intensityissimilartotheintensityoftheneighbourhood,aproblemdependentprocedurehastobedevelopedinordertodelineatethestructure(Piętka etal.,2011).

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InSlide10‐33wehavediscussedtheadvantagesofOpenSourcesoftware.Attention:MedicalcertificationssuchasFDAintheUSandCEmarkinginEuropedonotapplytoOpenSourcesoftware!Thesecertificationsrequirealegalcommercialentitytobeidentifiedastheowneroftheproductandwarrantthelegalliabilityofitsdistributionandcommercialsupport.OpenSourcesoftwarebeingoftendevelopedoutsidecommercialenterprises;suchasacademicgroupsoruniversityresearchlabs,donothavetheproperlegalstructuretoapplyforsuchcertifications.Also,mostOpenSourceproductsbeingdistributedfreeofchargelackthelegalbindingbetweentheproviderandtheuserthatisrequiredforsoftwaredistributionunderFDAandCEcertification.

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Forsurethefuturehospitalinformationsystemswillhavethreecomponents1)theworld(eventhehospitalworld)oftomorrowwillbemobile2)thedatawillbestoredinthecloudaswellassoftware‐as‐a‐servicewillbeused(Keyproblem:Privacy,Security,SafetyandDataProtection).3)ContentAnalyticswillbeintegratedastoolswithintheclinicalworkplace

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Innovativesolutionsforrapidandrobusttransferofverylargedatafilesareemergingandwillprobablychangesignificantlythecurrentlimitationsinthenextfewyears.Onlinefreefiletransferproviderssuchasyousendit(http://www.yousendit.com)havealreadybecomeverypopularforconvenienttransferoflargefiles,notifyingtherecipientbyEmailwhenthefileisavailableforhimtodownload.However,thesepublicserviceslacktheperformanceandsecuritythatwouldberequiredfortransferringmedicaldata.ExamplesareOpenSourcesoftwaresolutionssuchastheXebra softwareframeworkforWeb‐baseddistributionandvisualizationofmedicalimaging(http://www.hxti.com/technology/xebra.html).MajorstandardizationeffortsarebeingdeployedaspartoftheIHE(IntegratingtheHealthcareEnterprise)initiativetodevelopnewcommunicationprofilesandguidelinesforexchangingmedicaldataandimages.TheCross‐DocumentSharing(XDS)anIHEprofileforexchangingdocumentshasledtoanextensionspecificformedicalimages(XDS‐i)thatismoresuitableforexchangeoflargemedicalimagingfiles.IncompliancewithDICOMstandardsanextensionforimagetransfercalledWADO(WebAccesstoDICOMObjects)isnowbeing adoptedinreplacementoftraditionalC‐move(aDICOMserviceformovingdata)allowingmoreflexibilityandbetterperformance.Theseemergingstandardarealreadybeingadoptedinlargemetropolitanorevennationalprojects.ArecentexampleofsuchdeploymentsistheCanadiannationaldiagnosticimagingrepository(DI‐r)whichconsolidatesimagingresultsandprovideasharedPACSapplicationaspartofthenationalinteroperableelectronichealthrecord(Ratib,Rosset &Heuberger,2011).

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CloudbasedcomputingfollowstheSaaS‐Paradigm(SoftwareasaService)andoffersapay‐per‐usebasedvirtualinfrastructure,madedynamicallyscalablebytheabilitytospawnanddestroyvirtualmachineinstancesondemand.Thisallowsvirtualserverstobecreatedasneededtomeetcurrentdemandandthenscaledbackwhenstrainonthesystemisreduced,loweringresourceusageandcost.Inthisexampleweseesuchansystemarchitecture:(a)Overallsystemarchitectureincludesthemobileconsolecomponentandtheremoteprocessingserver(ExpertSystem)whichperformsthecomputation‐extensivework.(b)MobileConsoleArchitecture.Theconsolehasoneormoredataacquisitiondevices,acommunicationmoduleandadisplaycapability.(c)ServerArchitecture.Containsacommunicationmodule,aprocessingengine,avisualizationengineandanexpertassessmentmechanism(Mohammed,Servos&Fiaidhi,2011).Theusefulnessofmobilecomputingapplicationsinthemedicaldomainiscommonlyaccepted.Suchsystemsareabletofacilitateefficientandeffectivepatientcareinformationinputandaccessatthepointofpatientcareresultinginanimprovementofthequalityofservices(Holzingeretal.,2011).Problemsincludeissuesofusability,privacyandsecurity.

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Thisimageillustratesthedeliveryofhealthdataandinformationfromacloudcomputingenvironment(Botts etal.,2010).Themainproblemsinvolvedarelegalones:Privacy,Security,SafetyandDataProtection(Weippl,Holzinger&Tjoa,2006).

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Theproblems – challengesofthefutureareinthemassesofcomplexinformation–nohumancankeepupwithmassivedatasets– forthisweneedmachinelearning.

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HospitalInformationSystemscontain– toalargepart– unstructuredinformation.Suchunstructuredinformationisthesubsetofinformation,wheretheinformationitselfdescribespartsofwhatconstitutesassignificantwithinit,orinotherwords‐ structureandinformationarenotcompletelyseparable.Thebestexampleforsuchunstructuredinformationistext(inthemedicalareaoften– notquitecorrectlycalled“freetext”).Althoughsuchtextcaneasilybecreatedbymedicalprofessionals,thesupportofautomaticanalysesforknowledgediscoveryisextremelydicult.Wefollowthedefinitionthatknowledgeconsistsofasetofhypotheses,andknowledgediscoveryistheprocessoffindingorgeneratingnewhypothesesbymedicalprofessionalswiththeaimofgettinginsightintothedata.InthefuturetheHCI‐KDDapproachwillbemostimportant,i.e.withthehumanexpertintheloopmatchingthebestoftwoworlds:humanintelligencewithcomputationalintelligence(Holzingeretal.,2013).Onegoalforthefutureistocombinethethreeworlds:WatsonTechnology(=synonymformachinelearning)onmobilecomputersandcloudcomputing.Thevisionistoallowtostatequestionstothedata,i.e.amedicaldoctormightsay:“Watson,whatwasconspicuouswithinthehistoryofpatientXwithinthelasttwoyears?”.IBM– withWatsonandwithitsJeopardyexperience‐ isdevelopingthetechnologytobeabletohandlecomplexquestionsacrosshealthcarewiththeaim(strategicallyputtowards2020)toprovideamedicalassistant.MakingWatsonacapableassistantwillrequiremuchresearchandadvancesinseveralareas,becausethecurrentWatsonneeds10racksofIBMPower750serverslocatedinYorktownHeights,NY.Thatcomparestoapprox.6,000desktopcomputers.Youcanfindmoreinformationvia:http://www‐01.ibm.com/software/ecm/offers/programs/icpa.htmlIBMContentandPredictiveAnalyticsforHealthcarehttp://www.youtube.com/watch?v=1X5agzCsXEI

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My DEDICATION is to make data valuable … Thank you!

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NumerousOpenSourceinitiativesinmedicineleadingtoinnovativeandcosteffectiveinformationsystemssupportingelectronicpatientrecordapplicationsandmedicalimagingandPACShaveemergedintherecentyears.Recentreportsshowedthatadoptionofcomputerizedmedicalrecordsandmedicalinformaticsinmedicinehavesignificantlylaggedbehindexpectationsduetothreemajorbarriers:excessivecost,thetransienceofvendors,and

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Advancedimageprocessingandanalysistoolsarebeingaddedtotheprogrameveryday.DevelopersfromallaroundtheworldhavecontributedtotheextensionofOSIRIXbyaddinginnovativeandspecializedimageprocessingfeatures.Furthermore,theOSIRIXsoftwarearchitectureallowsforseparateprocessingmodulestobeaddedtotheprogramasplug‐ins.Suchplug‐inswillbeimbeddedintheprogramwhenitislaunchedbuttheydonothavetobeintegratedinthecoreofthemainprogram.Theseexternalplug‐inscouldalsobecomponentsthatarenotsharedasOpenSourcesoftwarebutcouldbeprotectedasbinarymodulesorevensoldascommercialextensionstotheOSIRIXplatform.

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ThishistoricalreviewofPACScoversthePACSdevelopmentintheUSAduringthepast28yearsfrom1982to2010.ManyimportanteventstriggeredthesuccessfuljourneyofPACSfromitsinfancytomaturation.Amongthesearethededicationofkeypioneers’contributions,thebehindthesceneheroesintroducingthecomputedradiography,opticaljukebox,high‐resolutionmultiplescreenworkstations,DICOMstandard,IHEworkflowprofiles,resilientsoftwareoperatingsystem,high‐speedcommunicationnetworks,andthesystemintegrationconcept.

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MR=Magnetic ResonanceCT=ComputedTomographyPET=PositronemissiontomographyDSA=Digitalsubtractionangiography

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(a)VistA Imagingdisplaysthepatientrecordwithimages.CourtesyofDrs.H.RutherfordandR.Dayhoff;(b)theHongKongHospitalAuthority(HKHA)centralarchive,ePR withimageintegrationandworkflowsteps.ThisdesignwasbasedontheexistingHKHAclinicalinformationsystems(CMS)(courtesyofDr.Cheungetal.).

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(a)VistA Imagingdisplaysthepatientrecordwithimages.CourtesyofDrs.H.RutherfordandR.Dayhoff;(b)theHongKongHospitalAuthority(HKHA)centralarchive,ePR withimageintegrationandworkflowsteps.ThisdesignwasbasedontheexistingHKHAclinicalinformationsystems(CMS)(courtesyofDr.Cheungetal.).

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Thisillustratesameta‐architectureconceptofahighlevelSASmodularstructure.Thehighlevelmodulesareabstractedfromspecific,recentlydevelopedCAS/IGTsystems.MostR&DandcommercialSASsystemsarelimitedtoproprietyimplementationsofsomeofthesefunctionalities.Acentralpositionisoccupiedbythe“Kernelforworkflowandknowledgeanddecisionmanagement”.Itprovidesthestrategicintelligenceforpreoperativeplanningandintraoperativeexecution.Often,thismodule(orpartsofit)isintegratedintootherengines.Modular,scalableanddistributableTIMMScomponents actsynergisticallytoprovidefunctionalityandutilitythatexceedthesumoftheirparts.Thesecomponentsinclude:1.Seven“engines”– orsoftwaremodulesthatcanbeexecutedonanappropriatecomputingmachine– thatworkindependentlyanddependentlytoaccountforallfacetsofcomplexmedicalandsurgicalprocedures.Thesevenenginesare:1.intraoperativeimagingandbiosensorsengine,2.modelling engine,3.simulationengine,4.Kernelforworkflowandknowledgeanddecisionmanagementengine,5.visualizationrepresentationmanagerengine,6.interventionengine,and7.validationengine.2.Associatedrepositories– integratedhardwareandsoftwarestructurethatstoresandmakesavailabledataand/ordataprocessingtools– linkedtoeachofthesevenengines.3.Additionalrepositorieswhichareprovidedfor:1.models(modelsaredefinedassimulatedobjectsandmayrepresentpatient‐specificinformation,implants,etc.)and2.referencessuchasworkflowmodels,evidence‐basedmedicaldata,case‐basedmedicaldata.AnICTinfrastructureenablesintercommunicationandinteractivityamongallTIMMSorS‐PACScomponents.Theengines,tools,repositories,ICTinfrastructureanddatasources– includingtheoperativeteam– arelinkedthroughadistributednetwork,providingfullfunctionalityofTIMMS,includingplanning,guidance,learning,anddataminingandprocessing.

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A. Holzinger LV 444 - Graz University of...

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