医疗卫生信息化环境下患者许可获取方案-美国

CONSUMERCONSENTOPTIONSFORELECTRONICHEALTHINFORMATIONEXCHANGE:

POLICYCONSIDERATIONSANDANALYSISPREPAREDBY:MelissaM.Goldstein,JD AlisonL.Rein,MSAssociateResearchProfessor DirectorDepartmentofHealthPolicy AcademyHealthSchoolofPublicHealthandHealthServicesWithResearchAssistanceFrom:PenelopeP.HughesJulieK.Lappas,JDScottA.WeinsteinBenjaminWilliamsThispaperisintendedto:Helpidentifyissuesandchallengesassociatedwith5coreconsentmodelsforelectronichealthinformationexchangeProvidebasicdefinitionsfortheconsumerconsentdiscussion,andpointoutsometimesdivergentstakeholderperspectivesExploretheconsentmodelsofasmallsetofelectronicexchangeefforts,andlearnmoreabouttheirrationaleConsiderandanalyzesomepossibleconsequencesassociatedwithdifferentconsentapproaches

ThispaperisNOTintendedto:RepresentacomprehensiveanalysisoftheelectronichealthinformationexchangelandscapeRepresentacomprehensivereviewofexistingconsentmodelsasappliedinactiveelectronicexchangeeffortsBedirectiveorsuggest“ananswer〞WhatiscoveredDefinitionof5coreconsentmodelsGranularityandconsentSelectU.S.andInternationalexamplesofexchangeAnalysisandimpactofconsentmodelsEthicalconsiderationsProcess,logisticalandtechnicalconsiderationsLegalframeworkStakeholderperspectives5BasicConsentModelsNoConsentOpt-outOpt-outwithexceptionsOpt-inOpt-inwithrestrictionsGranularityObservations ByDataType:Fewexamples,butmanyexchangescurrentlyhavelimiteddataavailable(e.g.,labtestsonly);manyexchangesexcludesourcesofpotentially-sensitiveinformationByProvider:Someexamplesofsequesteringdatafromspecifiedproviderorganizations;fewerbyindividualproviderByTimeRange:

Rare,butevidencedinsomespecificusecases(e.g.,emergencysituations)ByPurpose:

Mostonlyexchangeinformationfortreatmentpurposes;someforpublichealthresearchandsurveillanceSecondaryResearchScholarlymedicaljournals,e.g.,JAMA,NEJMScholarlylegaljournals,e.g.,NYULawReview,JournalofLaw,Medicine&EthicsNon-profitpublications,e.g.,RAND,MarkleGovernmentpublicationsCongressionaltestimonyHITindustrypublicationsObservationsSmallnumberofoperationalexchanges(withpublically-articulatedconsentpolicies)toevaluateDiversityacrossexchangespreventsgeneralizationsaboutwhatdoes/doesnotworkThemoreinformationincluded(bothvolumeandtype)inanexchange,thegreaterthebenefits(topatients,providers,clinicalcare,publichealthandresearch)Architectureofexchangehasimplicationsforthefeasibility/desirabilityofcertainconsentoptionsRecommendationsOneconsentmodelmaynotfitallcircumstances;guidanceisneededforcontextualassessmentsHelpfulstepscouldinclude:SupportingcollaborationacrossexchangesCompensatorymeasurestopromoteadoption/lessenshort-termcostbarriersDevelopmentofbetterevidencebasetodeterminerelativeeffectivenessandimpactofdifferentmodelsCoordin