FDA规则临床信息的收集传输和管理

WhatdoesRegulationMean?Fordevices,drugs,etc.,itmeansthemanufacturerisheldaccountableforGMPandQSRunderTitle21parts1to1299(e.g.,part801-Labeling,part820–QualitySystem)Abilitytoelectronicallyauthenticateispermittedunder21part11oftheFDAregulationsTheFDAissuedguidancedocumentswhichidentifyportionsoftitle21part11asbeingapplicableforclinicaltrialssubmissionsNOTE:ClinicalInformationmayberegulatedbyadditionalstateandfederalagencies.HIPAAisagoodexample.Confused?25Yearsintechnologydevelopment20YearsinHealthcareInformaticsWhenitcomestoFDA(HIPAA,andothers)regardingregulatoryrequirementsfortelemedicineandclinicaldata….andI’mstillconfused?ADeviceis…AccordingtotheFDA,adeviceis:"aninstrument,apparatus,implement,machine,contrivance,implant,invitroreagent,orothersimilarorrelatedarticle,includingacomponentpart,oraccessorywhichis:recognizedintheofficialNationalFormulary,ortheUnitedStatesPharmacopoeia,oranysupplementtothem,intendedforuseinthediagnosisofdiseaseorotherconditions,orinthecure,mitigation,treatment,orpreventionofdisease,inmanorotheranimals,orintendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals,andwhichdoesnotachieveanyofit'sprimaryintendedpurposesthroughchemicalactionwithinoronthebodyofmanorotheranimalsandwhichisnotdependentuponbeingmetabolizedfortheachievementofanyofitsprimaryintendedpurposes."Iftheprimaryintendeduseoftheproductisachievedthroughchemicalactionorbybeingmetabolizedbythebody,theproductisusuallyadrug.HumandrugsareregulatedbyFDA'sCenterforDrugEvaluationandResearch(CDER).Whenisadeviceadevice?DiagnosticPatientMonitoring–yesElectronicMedicalRecordSystems–no?ICUClinicalDataManagementSystems–no?AnesthesiaDataManagementSystems–dependsonwhoyouask?Telemedicine–maybe?

CaseHistory-ARKIVE1985-1986:Ohmedadevelopsasemiautomaticelectronicanesthesiarecordkeeperasan“accessory”toitsgasmachine1986Arkivefiles510(k)asananesthesiainformationsystem.FDAclassifiesArkiveagasmachineaccessory.FDAisinformedthatArkiveisastand-aloneinformationmanagementsystemandnotanaccessorytoanything.…FDAresponse–reclassifyArkive–nolongeranaccessory–it’snowa“gasmachine”?IsTelemedicinedevice?AlthoughFDAdoesnotregulatethedeliveryofhealthcareservicesorthetransmissionofinformationrelatedtocarebetweenphysiciansandpatients,FDAdoesregulatethecommercializationoftechnologiesassociatedwithhealthcaredelivery(devices).AsFDAhasstated;“Theuseofadvancedtelecommunicationstechnologytodeliverhealthcarebringswithitahostofconcernsaboutsafetyandeffectiveness.”InitsWhitePaper,FDA’sCenterforDevicesandRadiologicalHealth(CDRH)declaredthatmany“products”usedintelemedicinearemedicaldevicessubjecttoregulatoryauthority.ClinicalDataisRegulatedWhen:ItispartofaclinicaltrialItisembeddedaspartofaregulateddeviceThedataacquisitionisanaccessorytoaregulateddeviceAccessorytoaregulateddeviceisabitfuzzyInGeneralThecollection,transmission,andmanagementofclinicaldataforthepurposeofcaremanagementandmedicaltreatmentisnotusuallyregulatedbytheFDA(Mayberegulatedbyotheragenciesandlaws,e.g.,HIPAA)ReasonableeffortsshouldbeusedtoavoiddeliberateoraccidentaldisclosurePatientshaverightsunderstatelawsandHIPAAregardingprivacyanddisclosureBestPracticePoliciesandoperatingproceduresthatclearlydescribeyourorganization’scollectionanduseofclinicaldataBusinessAssociateAgreementunderHIPAABestpracticetoprotectapatient’sprivacyBestpracticetoensuresecuritythroughoutthenetworkRegularauditsthatvalidateyourprocessExampleofTechnologySecuritySummaryWithregardstoclinicalinformation,theFDAregulatesde