ACaseStudyforBlockchaininHealthcare:“MedRec”prototypeforelectronichealthrecordsandmedicalresearchdataWhitePaperArielEkblaw*,AsaphAzaria*,JohnD.Halamka,MD?,AndrewLippman**MITMediaLab,?BethIsraelDeaconessMedicalCenterAugust2016Note:Theabstractandfirstthreesectionsofthiswhitepaperaredrawnfromapeer-reviewed,formallyacceptedpaper,presentlybeingpreparedforpublicationwithIEEEthroughtheirOpen&BigDataConference,August22-24,2016.MedRec:UsingBlockchainforMedicalDataAccessandPermissionManagementIEEEOriginalAuthors:AsaphAzaria,ArielEkblaw,ThiagoVieira,AndrewLippmanThismaterialisadaptedandincludedherewithpermissionoftheIEEE,includingpermissionforpublicationbytheONCBlockchainChallengeifselected.AbstractAlong-standingfocusoncompliancehastraditionallyconstraineddevelopmentoffundamentaldesignchangesforElectronicHealthRecords(EHRs).Wenowfaceacriticalneedforsuchinnovation,aspersonalizationanddatasciencepromptpatientstoengageinthedetailsoftheirhealthcareandrestoreagencyovertheirmedicaldata.Inthispaper,weproposeMedRec:anovel,decentralizedrecordmanagementsystemtohandleEHRs,usingblockchaintechnology.Oursystemgivespatientsacomprehensive,immutablelogandeasyaccesstotheirmedicalinformationacrossprovidersandtreatmentsites.Leveraginguniqueblockchainproperties,MedRecmanagesauthentication,confidentiality,accountabilityanddatasharing—crucialconsiderationswhenhandlingsensitiveinformation.Amodulardesignintegrateswithproviders'existing,localdatastoragesolutions,facilitatinginteroperabilityandmakingoursystemconvenientandadaptable.Weincentivizemedicalstakeholders(researchers,publichealthauthorities,etc.)toparticipateinthenetworkasblockchain“miners”.Thisprovidesthemwithaccesstoaggregate,anonymizeddataasminingrewards,inreturnforsustainingandsecuringthenetworkviaProofofWork.MedRecthusenablestheemergenceofdataeconomics,supplyingbigdatatoempowerresearcherswhileengagingpatientsandprovidersinthechoicetoreleasemetadata.Thepurposeofthispaperistoexpose,inpreparationforfieldtests,aworkingprototypethroughwhichweanalyzeanddiscussourapproachandthepotentialforblockchaininhealthITandresearch.1.IntroductionEHRswereneverdesignedtomanagemulti-institutional,lifetimemedicalrecords.Patientsleavedatascatteredacrossvariousorganizationsaslifeeventstakethemawayfromoneprovider'sdatasiloandintoanother.Indoingsotheyloseeasyaccesstopastdata,astheprovider,notthepatient,generallyretainsprimarystewardship(eitherthroughexplicitlegalmeansinover21states,orthroughdefaultarrangementsintheprocessofprovidingcare)[1].ThroughtheHIPAAPrivacyRule,providerscantakeupto60daystorespond(notnecessarilytocomply)toarequestforupdatingorremovingarecordthatwaserroneouslyadded[2].Beyondthetimedelay,recordmaintenancecanprovequitechallengingtoinitiateaspatientsarerarelyencouragedandseldomenabledtoreviewtheirfullrecord[1],[2].Patientsthusinteractwithrecordsinafracturedmannerthatreflectsthenatureofhowtheserecordsaremanaged.Interoperabilitychallengesbetweendifferentproviderandhospitalsystemsposeadditionalbarrierstoeffectivedatasharing.Thislackofcoordinateddatamanagementandexchangemeanshealthrecordsarefragmented,ratherthancohesive[3].Patientsandprovidersmayfacesignificanthurdlesininitiatingdataretrievalandsharingduetoeconomicincentivesthatencourage“healthinformationblocking.”ArecentONCreportdetailsseveralexamplesonthistopic,namelyhealthITdevelopersinterferingwiththeflowofdatabychargingexorbitantpricesfordataexchangeinterfaces[4].Whendesigningnewsystemstoovercomethesebarriers,wemustprioritizepatientagency.Patientsbenefitfromaholistic,transparentpictureoftheirmedicalhistory[3].Thisprovescrucialinestablishingtrustandcontinuedparticipationinthemedicalsystem,aspatientsthatdoubttheconfidentialityoftheirrecordsmayabstainfromfull,honestdisclosuresorevenavoidtreatment.Intheageofonlinebankingandsocialmedia,patientsareincreasinglywilling,ableanddesirousofmanagingtheirdataonthewebandonthego[3].However,proposedsystemsmustalsorecognizethatnotallproviderrecordscanorshouldbemadeavailabletopatients.providerpsychotherapynotes,orphysicianintellectualproperty),andshouldremainflexibleregardingsuchrecord-onboardingexceptions[5],[6].Medicalrecordsalsoprovecriticalforresearch.TheONC'sreportemphasizesthatbiomedicalandpublichealthresearchers“requiretheabilitytoanalyzeinformationfrommanysourcesinordertoidentifypublichealthrisks,developnewtreatmentsandcures,andenableprecisionmedicine”[4].Thoughsomedatatricklesthroughtoresearchersfromclinicalstudies,surveysandteachinghospitals,wenoteagrowinginterestamongpatients,careprovidersandregulatorybodiestoresponsiblysharemoredata,andthusenablebettercareforothers[7],[4].Inthiswork,weexploreablockchainstructureappliedtoEHRs.WebuildonthisdistributedledgerprotocoloriginallyassociatedwithBitcoin[8].Theblockchainusespublickeycryptographytocreateanappend-only,immutable,timestampedchainofcontent.Copiesoftheblockchainaredistributedoneachparticipatingnodeinthenetwork.TheProofofWorkalgorithmusedtosecurethecontentfromtamperingdependsona“trustless”model,whereindividualnodesmustcompetetosolvecomputationally