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1、CompliancewithFDARegulations:Collecting,TransmittingandManagingClinicalInformationDanCPettusSeniorVicePresidentiMetrikus,Inc.WhatdoesRegulationMean?Fordevices,drugs,etc.,itmeansthemanufacturerisheldaccountableforGMPandQSRunderTitle21parts1to1299(e.g.,par
2、t801-Labeling,part820–QualitySystem)Abilitytoelectronicallyauthenticateispermittedunder21part11oftheFDAregulationsTheFDAissuedguidancedocumentswhichidentifyportionsoftitle21part11asbeingapplicableforclinicaltrialssubmissionsNOTE:ClinicalInformationmayber
3、egulatedbyadditionalstateandfederalagencies.HIPAAisagoodexample.Confused?25Yearsintechnologydevelopment20YearsinHealthcareInformaticsWhenitcomestoFDA(HIPAA,andothers)regardingregulatoryrequirementsfortelemedicineandclinicaldata….andI’mstillconfused?ADevi
4、ceis…AccordingtotheFDA,adeviceis:"aninstrument,apparatus,implement,machine,contrivance,implant,invitroreagent,orothersimilarorrelatedarticle,includingacomponentpart,oraccessorywhichis:recognizedintheofficialNationalFormulary,ortheUnitedStatesPharmacopoei
5、a,oranysupplementtothem,intendedforuseinthediagnosisofdiseaseorotherconditions,orinthecure,mitigation,treatment,orpreventionofdisease,inmanorotheranimals,orintendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals,andwhichdoesnotachieveanyofi
6、t'sprimaryintendedpurposesthroughchemicalactionwithinoronthebodyofmanorotheranimalsandwhichisnotdependentuponbeingmetabolizedfortheachievementofanyofitsprimaryintendedpurposes."Iftheprimaryintendeduseoftheproductisachievedthroughchemicalactionorbybeingme
7、tabolizedbythebody,theproductisusuallyadrug.HumandrugsareregulatedbyFDA'sCenterforDrugEvaluationandResearch(CDER).Whenisadeviceadevice?DiagnosticPatientMonitoring–yesElectronicMedicalRecordSystems–no?ICUClinicalDataManagementSystems–no?AnesthesiaDataMana
8、gementSystems–dependsonwhoyouask?Telemedicine–maybe?CaseHistory-ARKIVE1985-1986:Ohmedadevelopsasemiautomaticelectronicanesthesiarecordkeeperasan“accessory”toitsgasmachine1986Arkivefiles510(k)asananesthesiainformationsystem
