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CONSUMERCONSENTOPTIONSFORELECTRONICHEALTHINFORMATIONEXCHANGE:POLICYCONSIDERATIONSANDANALYSISPREPAREDBY:MelissaM.Goldstein,JDAlisonL.Rein,MSAssociateResearchProfessorDirectorDepartmentofHealthPolicyAcademyHealthSchoolofPublicHealthandHealthServicesWithResearchAssistanceFrom:PenelopeP.HughesJulieK.Lappas,JDScottA.WeinsteinBenjaminWilliamsThispaperisintendedto:•Helpidentifyissuesandchallengesassociatedwith5coreconsentmodelsforelectronichealthinformationexchange•Providebasicdefinitionsfortheconsumerconsentdiscussion,andpointoutsometimesdivergentstakeholderperspectives•Exploretheconsentmodelsofasmallsetofelectronicexchangeefforts,andlearnmoreabouttheirrationale•ConsiderandanalyzesomepossibleconsequencesassociatedwithdifferentconsentapproachesThispaperisNOTintendedto:•Representacomprehensiveanalysisoftheelectronichealthinformationexchangelandscape•Representacomprehensivereviewofexistingconsentmodelsasappliedinactiveelectronicexchangeefforts•Bedirectiveorsuggest“ananswer”Whatiscovered•Definitionof5coreconsentmodels•Granularityandconsent•SelectU.S.andInternationalexamplesofexchange•Analysisandimpactofconsentmodels–Ethicalconsiderations–Process,logisticalandtechnicalconsiderations–Legalframework–Stakeholderperspectives5BasicConsentModels•NoConsent•Opt-out•Opt-outwithexceptions•Opt-in•Opt-inwithrestrictionsGranularityObservations•ByDataType:Fewexamples,butmanyexchangescurrentlyhavelimiteddataavailable(e.g.,labtestsonly);manyexchangesexcludesourcesofpotentially-sensitiveinformation•ByProvider:Someexamplesofsequesteringdatafromspecifiedproviderorganizations;fewerbyindividualprovider•ByTimeRange:Rare,butevidencedinsomespecificusecases(e.g.,emergencysituations)•ByPurpose:Mostonlyexchangeinformationfortreatmentpurposes;someforpublichealthresearchandsurveillanceStakeholderPerspectives•PatientsWant:–Meaningfulcontroloverandprotectionoftheirhealthinformation–Quality,well-coordinatedcare•ProvidersWant:–Todeliverquality,well-coordinatedcare–Maximalquantityandquality(i.e.,utility)ofdata–Protectionagainstliability–Minimaladministrativeburdenandcost•PayersWant:–Maximalpatientandproviderparticipation–Minimalburdenandcost–Accesstodata•ExchangesWant:–Maximalpatientandproviderparticipation–Maximalflexibilitytosustaintheexchange–Minimaladministrative/operationalburden–MaximalabilitytoprovidevaluetoparticipantsPrimaryResearch•Phoneandemailcorrespondence–HITsystemdevelopers(bothfor-andnot-for-profit)–Statehealthagencies–State-basedHITprogrammanagers–LegalconsultationsSecondaryResearch•Scholarlymedicaljournals,e.g.,JAMA,NEJM•Scholarlylegaljournals,e.g.,NYULawReview,JournalofLaw,Medicine&Ethics•Non-profitpublications,e.g.,RAND,Markle•Governmentpublications•Congressionaltestimony•HITindustrypublicationsObservations•Smallnumberofoperationalexchanges(withpublically-articulatedconsentpolicies)toevaluate•Diversityacrossexchangespreventsgeneralizationsaboutwhatdoes/doesnotwork•Themoreinformationincluded(bothvolumeandtype)inanexchange,thegreaterthebenefits(topatients,providers,clinicalcare,publichealthandresearch)•Architectureofexchangehasimplicationsforthefeasibility/desirabilityofcertainconsentoptionsRecommendations•Oneconsentmodelmaynotfitallcircumstances;guidanceisneededforcontextualassessments•Helpfulstepscouldinclude:–Supportingcollaborationacrossexchanges–Compensatorymeasurestopromoteadoption/lessenshort-termcostbarriers–Developmentofbetterevidencebasetodeterminerelativeeffectivenessandimpactofdifferentmodels–Coordinationofbroaderpolicydiscussionsregardingconsumerprotectionenvironmentrelativetoconsent–SystematicprovisionofinformationandtoolstostateHIEgrantees