区块链在医疗保健领域的研究案例用于医疗记录及医学数据研究的MedRec原型.docx
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区块链在医疗保健领域的研究案例用于医疗记录及医学数据研究的MedRec原型.docx
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区块链在医疗保健领域的研究案例用于医疗记录及医学数据研究的MedRec原型
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区块链在医疗保健领域的研究案例用于医疗记录及医学数据研究的MedRec原型
ACaseStudyforBlockchaininHealthcare:
“MedRec”prototypeforelectronichealthrecordsandmedicalresearchdata
WhitePaper
ArielEkblaw*,AsaphAzaria*,JohnD.Halamka,MD?
AndrewLippman*
*MITMediaLab,?
BethIsraelDeaconessMedicalCenter
August2016
Note:
Theabstractandfirstthreesectionsofthiswhitepaperaredrawnfromapeer-reviewed,formally
acceptedpaper,presentlybeingpreparedforpublicationwithIEEEthroughtheirOpen&BigData
Conference,August22-24,2016.
MedRec:
UsingBlockchainforMedicalDataAccessandPermissionManagement
IEEEOriginalAuthors:
AsaphAzaria,ArielEkblaw,ThiagoVieira,AndrewLippman
ThismaterialisadaptedandincludedherewithpermissionoftheIEEE,includingpermissionfor
publicationbytheONCBlockchainChallengeifselected.
Abstract
Along-standingfocusoncompliancehastraditionallyconstraineddevelopmentoffundamentaldesign
changesforElectronicHealthRecords(EHRs).Wenowfaceacriticalneedforsuchinnovation,as
personalizationanddatasciencepromptpatientstoengageinthedetailsoftheirhealthcareandrestore
agencyovertheirmedicaldata.Inthispaper,weproposeMedRec:
anovel,decentralizedrecord
managementsystemtohandleEHRs,usingblockchaintechnology.Oursystemgivespatientsa
comprehensive,immutablelogandeasyaccesstotheirmedicalinformationacrossprovidersand
treatmentsites.Leveraginguniqueblockchainproperties,MedRecmanagesauthentication,
confidentiality,accountabilityanddatasharing—crucialconsiderationswhenhandlingsensitive
information.Amodulardesignintegrateswithproviders'existing,localdatastoragesolutions,facilitating
interoperabilityandmakingoursystemconvenientandadaptable.Weincentivizemedicalstakeholders
(researchers,publichealthauthorities,etc.)toparticipateinthenetworkasblockchain“miners”.This
providesthemwithaccesstoaggregate,anonymizeddataasminingrewards,inreturnforsustainingand
securingthenetworkviaProofofWork.MedRecthusenablestheemergenceofdataeconomics,
supplyingbigdatatoempowerresearcherswhileengagingpatientsandprovidersinthechoicetorelease
metadata.Thepurposeofthispaperistoexpose,inpreparationforfieldtests,aworkingprototypethrough
whichweanalyzeanddiscussourapproachandthepotentialforblockchaininhealthITandresearch.
1.Introduction
EHRswereneverdesignedtomanagemulti-institutional,lifetimemedicalrecords.Patientsleave
datascatteredacrossvariousorganizationsaslifeeventstakethemawayfromoneprovider'sdatasiloand
intoanother.Indoingsotheyloseeasyaccesstopastdata,astheprovider,notthepatient,generally
retainsprimarystewardship(eitherthroughexplicitlegalmeansinover21states,orthroughdefault
arrangementsintheprocessofprovidingcare)[1].ThroughtheHIPAAPrivacyRule,providerscantake
upto60daystorespond(notnecessarilytocomply)toarequestforupdatingorremovingarecordthat
waserroneouslyadded[2].Beyondthetimedelay,recordmaintenancecanprovequitechallengingto
initiateaspatientsarerarelyencouragedandseldomenabledtoreviewtheirfullrecord[1],[2].Patients
thusinteractwithrecordsinafracturedmannerthatreflectsthenatureofhowtheserecordsaremanaged.
Interoperabilitychallengesbetweendifferentproviderandhospitalsystemsposeadditional
barrierstoeffectivedatasharing.Thislackofcoordinateddatamanagementandexchangemeanshealth
recordsarefragmented,ratherthancohesive[3].Patientsandprovidersmayfacesignificanthurdlesin
initiatingdataretrievalandsharingduetoeconomicincentivesthatencourage“healthinformation
blocking.”ArecentONCreportdetailsseveralexamplesonthistopic,namelyhealthITdevelopers
interferingwiththeflowofdatabychargingexorbitantpricesfordataexchangeinterfaces[4].
Whendesigningnewsystemstoovercomethesebarriers,wemustprioritizepatientagency.
Patientsbenefitfromaholistic,transparentpictureoftheirmedicalhistory[3].Thisprovescrucialin
establishingtrustandcontinuedparticipationinthemedicalsystem,aspatientsthatdoubtthe
confidentialityoftheirrecordsmayabstainfromfull,honestdisclosuresorevenavoidtreatment.Inthe
ageofonlinebankingandsocialmedia,patientsareincreasinglywilling,ableanddesirousofmanaging
theirdataonthewebandonthego[3].However,proposedsystemsmustalsorecognizethatnotall
providerrecordscanorshouldbemadeavailabletopatients.providerpsychotherapynotes,or
physicianintellectualproperty),andshouldremainflexibleregardingsuchrecord-onboardingexceptions
[5],[6].
Medicalrecordsalsoprovecriticalforresearch.TheONC'sreportemphasizesthatbiomedicaland
publichealthresearchers“requiretheabilitytoanalyzeinformationfrommanysourcesinordertoidentify
publichealthrisks,developnewtreatmentsandcures,andenableprecisionmedicine”[4].Thoughsome
datatricklesthroughtoresearchersfromclinicalstudies,surveysandteachinghospitals,wenotea
growinginterestamongpatients,careprovidersandregulatorybodiestoresponsiblysharemoredata,
andthusenablebettercareforothers[7],[4].
Inthiswork,weexploreablockchainstructureappliedtoEHRs.Webuildonthisdistributed
ledgerprotocoloriginallyassociatedwithBitcoin[8].Theblockchainusespublickeycryptographyto
createanappend-only,immutable,timestampedchainofcontent.Copiesoftheblockchainaredistributed
oneachparticipatingnodeinthenetwork.TheProofofWorkalgorithmusedtosecurethecontentfrom
tamperingdependsona“trustless”model,whereindividualnodesmustcompetetosolve
computationally-intensive“puzzles”(hashingexercises)beforethenextblockofcontentcanbeappended
tothechain.Theseworkernodesareknownas“miners,”andtheworkrequiredofminerstoappendblocks
ensuresthatitisdifficulttorewritehistoryontheblockchain.
OurMedRecblockchainimplementationaddressesthefourmajorissueshighlightedabove:
fragmented,slowaccesstomedicaldata;systeminteroperability;patientagency;improveddataquality
andquantityformedicalresearch.WebuildontheworkofZyskindetal.[9]toassemblereferencesto
dataandencodetheseashashedpointersontoablockchainledger.Wethenorganizethesereferencesto
explicitlycreateanaccessiblebreadcrumbtrailformedicalhistory,withoutstoringrawmedicaldataon
theblockchain.Oursystemsupplementsthesepointerswithon-chainpermissioninganddataintegrity
logic,empoweringindividualswithrecordauthenticity,auditabilityanddatasharing.Webuildrobust,
modularAPIstointegratewithexistingproviderdatabasesforinteroperability.Anoveldata-mining
schemeisproposedtosustaintheMedRecnetworkandbringopen,bigdatatomedicalresearchers.We
presentMedRecnotasthepanaceaformedicalrecordmanagement,butasaforayintothisspaceto
demonstrateinnovativeEHRsolutionswithblockchaintechnology.
2.SystemImplementation
Overview
ForMedRec,theblockcontentrepresentsdataownershipandviewershippermissionssharedby
membersofaprivate,peer-to-peernetwork.Blockchaintechnologysupportstheuseof“smartcontracts,”
whichallowustoautomateandtrackcertainstatetransitions(suchasachangeinviewershiprights,or
thebirthofanewrecordinthesystem).ViasmartcontractsonanEthereumblockchain[10],welog
patient-providerrelationshipsthatassociateamedicalrecordwithviewingpermissionsanddataretrieval
instructions(essentiallydatapointers)forexecutiononexternaldatabases.Weincludeontheblockchain
acryptographichashoftherecordtoensureagainsttampering,thusguaranteeingdataintegrity.Providers
canaddanewrecordassociatedwithaparticularpatient,andpatientscanauthorizesharingofrecords
betweenproviders.Inbothcases,thepartyreceivingnewinformationreceivesanautomatednotification
andcanverifytheproposedrecordbeforeacceptingorrejectingthedata.Thiskeepsparticipantsinformed
andengagedintheevolutionoftheirrecords.
MedRecprioritizesusabilitybyalsoofferingadesignatedcontractwhichaggregatesreferencesto
allofauser'spatient-providerrelationships,thusprovidingasinglepointofreferencetocheckforany
updatestomedicalhistory.Wehandleidentityconfirmationviapublickeycryptographyandemploya
DNS-likeimplementationthatmapsanalreadyexistingandwidelyacceptedformofID.name,or
socialsecuritynumber)totheperson'sEthereumaddress.Asyncingalgorithmhandlesdataexchange
“off-chain”betweenapatientdatabaseandaproviderdatabase,afterreferencingtheblockchainto
confirmpermissionsviaourdatabaseauthenticationserver.
Inthefollowingsectionswepresentthedesignprinciplesofourdistributedsystemandits
implementation.
BlockchainBackground
Originallydesignedforkeepingafinancialledger,theblockchainparadigmcanbeextendedto
provideageneralizedframeworkforimplementingdecentralizedcomputeresources[10].Eachcompute
resourcecanbethoughtofasasingletonstate-machinethatcantransitionbetweenstatesvia
cryptographically-securedtransactions.Whengeneratinganewstate-machine,thenodesencodelogic
whichdefinesvalidstatetransitionsanduploaditontotheblockchain.Fromthereon,theblocksjournal
aseriesofvalidtransactionsthat,whenincrementallyexecutedwiththestatefromthepreviousblock,
morphthestat
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- 关 键 词:
- 区块 医疗保健 领域 研究 案例 用于 医疗 记录 医学 数据 MedRec 原型