blockchain for health data and its potential use in health it and

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BlockchainForHealthDataandItsPotentialUseinHealthITandHealthCareRelatedResearch

LaureA.Linn MarthaB.Koo,M.D.

laure.linn@yahoo.com m.koo2@me.comI.IntroductionItisaveryexcitingtimeforhealthcareandinformationtechnology(IT).Duetoimprovementsingeneticresearchandtheadvancementofprecisionmedicine,healthcareiswitnessinganinnovativeapproachtodiseasepreventionandtreatmentthatincorporatesanindividualpatient’sgeneticmakeup,lifestyleandenvironment.Simultaneously,ITadvancementhasproducedlargedatabasesofhealthinformation,providedtoolstotrackhealthdataandengagedindividualsmoreintheirownhealthcare.CombiningtheseadvancementsinhealthcareandinformationtechnologywouldfostertransformativechangeinthefieldofhealthIT.TheAmericanRecoveryandReinvestmentActrequiredallpublicandprivatehealthcareproviderstoadoptelectronicmedicalrecords(EMR)byJanuary1,2014,inordertomaintaintheirexistingMedicaidandMedicarereimbursementlevels.ThisEMRmandatespurredsignificantgrowthintheavailabilityandutilizationofEMRs.However,thevastmajorityofthesesystemsdonothavethecapacitytosharetheirhealthdata.BlockchaintechnologyhasthepotentialtoaddresstheinteroperabilitychallengescurrentlypresentinhealthITsystemsandtobethetechnicalstandardthatenablesindividuals,healthcareproviders,healthcareentitiesandmedicalresearcherstosecurelyshareelectronichealthdata.Inthispaperwedescribeablockchainbasedaccess-controlmanagertohealthrecordsthatwouldadvancetheindustryinteroperabilitychallengesexpressedintheOfficeoftheNationalCoordinatorforHealthInformationTechnology’s(ONC)SharedNationwideInteroperabilityRoadmap.InteroperabilityisalsoacriticalcomponentanyinfrastructuresupportingPatientCenteredOutcomesResearch(PCOR)andthePrecisionMedicineInitiative(PMI).AnationalhealthITinfrastructurebasedonblockchainhasfar-reachingpotentialtopromotethedevelopmentofprecisionmedicine,advancemedicalresearchandinvitepatientstobemoreaccountablefortheirhealth.

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II.UnderlyingFundamentalsofBlockchainTechnologyBlockchainisapeer-to-peer(P2P)distributedledgertechnologyforanewgenerationoftransactionalapplicationsthatestablishestransparencyandtrust.BlockchainistheunderlyingfabricforBitcoinandisadesignpatternconsistingofthreemaincomponents:adistributednetwork,asharedledgeranddigitaltransactions.a.DistributedNetworkBlockchainisadecentralizedP2Parchitecturewithnodesconsistingofnetworkparticipants.Eachmemberinthenetworkstoresanidenticalcopyoftheblockchainandcontributestothecollectiveprocessofvalidatingandcertifyingdigitaltransactionsforthenetwork.b.SharedLedgerMembersinthedistributednetworkrecorddigitaltransactionsintoasharedledger.Toaddtransactions,membersinthenetworkrunalgorithmstoevaluateandverifytheproposedtransaction.Ifamajorityofthemembersinthenetworkagreethatthetransactionisvalid,thenewtransactionisaddedtothesharedledger.Changestothesharedledgerarereflectedinallcopiesoftheblockchaininminutesor,insomecases,seconds.Afteratransactionisaddeditisimmutableandcannotbechangedorremoved.Sinceallmembersinthenetworkhaveacompletecopyoftheblockchainnosinglememberhasthepowertotamperoralterdata.

c.DigitalTransactionsAnytypeofinformationordigitalassetcanbestoredinablockchain,andthenetworkimplementingtheblockchaindefinesthetypeofinformationcontainedinthetransaction.Informationisencryptedanddigitallysignedtoguaranteeauthenticityandaccuracy.Transactionsarestructuredintoblocksandeachblockcontainsacryptographichashtothepriorblockintheblockchain.Blocksareaddedinalinear,chronologicalorder.

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III.ProposalOurproposalinvolvestheuseofapublicblockchainasanaccess-controlmanagertohealthrecordsthatarestoredoffblockchain.Therearecurrentlynoopenstandardsorimplementationsofblockchainthatutilizethisapproachbutresearchsupportsthefeasibilityoftheproposedsolution.Bitcoinhasalreadydemonstratedthattrusted,auditablecomputingispossibleusingadistributednetworkaccompaniedbyasharedledger.Additionally,thetechnologiesfordatastorage,securityandencryptionexistandareinusetoday.ThispaperborrowsheavilyfromtheMassachusettsInstituteofTechnology’spublishedresearchonusingapublicblockchaintomanageandcontrolaccesstopersonaldata.IV.BitcoinandPrivateBlockchainLimitationsforHealthCareApplicationBitcoinisbasedonopen-sourcecryptographicprotocolsandhasproventobeaverysafeplatformforcrypto-currencyexchange.WhiletheidentitiesbehindsomeBitcointransactionsremainunknown,theplatformprovidestransparencyasanyonecanaccesstheblockchainandseebalancesandtransactionsforanyBitcoinaddress.LackofdataprivacyandtheabsenceofrobustsecuritymaketheBitcoinpublicblockchainunsuitableforahealthblockchainthatrequiresprivacyandcontrolled,auditableaccess.Additionally,theBitcoinstandardforblocksizeandmaximumnumberoftransactionspersecondpresentscalabilityconcernsforlarge-scaleandwidelyusedblockchainapplications.Privateandconsortiumledblockchainswouldaddresstheprivacy,securityandscalabilityconcerns.However,theseblockchainswouldposedifferentchallengesastheyruntheriskofnotbeingvendorneutralanddonotuseopenstandards.V.ABlockchainModelForHealthCareAnyblockchainforhealthcarewouldneedtobepublicandwouldalsoneedtoincludetechnologicalsolutionsforthreekeyelements:scalability,accesssecurityanddataprivacy.

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a.ScalabilityAdistributedblockchainthatcontainshealthrecords,documentsorimageswouldhavedatastorageimplicationsanddatathroughputlimitations.IfmodeledaftertheBitcoinblockchain,everymemberinthedistributednetworkofthehealthcareblockchainwouldhaveacopyofeveryhealthrecordforeveryindividualintheU.S.andthiswouldnotbepracticalfromadatastorageperspective.Becausehealthdataisdynamicandexpansive,replicatingallheathrecordstoeverymemberinthenetworkwouldbebandwidthintensive,wastefulonnetworkresourcesandposedatathroughputconcerns.Forhealthcaretorealizebenefitsfromblockchain,theblockchainwouldneedtofunctionasanaccess-controlmanagerforhealthrecordsanddata.Theinformationcontainedinourproposedhealthblockchainwouldbeanindex,alistofalltheuser’shealthrecordsandhealthdata.Theindexissimilartoacardcataloginalibrary.Thecardcatalogcontainsmetadataaboutthebookandalocationwherethebookcanbefound.Thehealthblockchainwouldworkthesameway.Transactionsintheblockswouldcontainauser’suniqueidentifier,anencryptedlinkedtothehealthrecordandatimestampforwhenthetransactionwascreated.Toimprovedataaccessefficiency,thetransactionwouldcontainthetypeofdatacontainedinthehealthrecordandanyothermetadatathatwouldfacilitatefrequentlyusedqueries(themetadatacouldbeaddedastags).Thehealthblockchainwouldcontainacompleteindexedhistoryofallmedicaldata,includingformalmedicalrecordsaswellashealthdatafrommobileapplicationsandwearablesensors,andwouldfollowanindividualuserthroughouthislife.Allmedicaldatawouldbestoredoffblockchaininadatarepositorycalledadatalake.Datalakesarehighlyscalableandcanstoreawidevarietyofdata,fromimagestodocumentstokey-valuestores.Datalakeswouldbevaluabletoolsforhealthresearchandwouldbeusedforavarietyofanalysisincludingminingforfactorsthatimpactoutcomes,determiningoptimaltreatmentoptionsbasedongeneticmarkersandidentifyingelementsthatinfluencepreventativemedicine.Datalakessupportinteractivequeries,textmining,textanalyticsandmachinelearning.Allinformationstoredinthedatalakewouldbeencryptedanddigitallysignedtoensureprivacyandauthenticityoftheinformation.

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Whenahealthcareprovidercreatesamedicalrecord(prescription,labtest,pathologyresult,MRI)adigitalsignaturewouldbecreatedtoverifyauthenticityofthedocumentorimage.Thehealthdatawouldbeencryptedandsenttothedatalakeforstorage.Everytimeinformationissavedtothedatalakeapointertothehealthrecordisregisteredintheblockchainalongwiththeuser’suniqueidentifier.Thepatientisnotifiedthathealthdatawasaddedtohisblockchain.Inthesamefashionapatientwouldbeabletoaddhealthdatawithdigitalsignaturesandencryptionfrommobileapplicationsandwearablesensors.

b.AccessSecurityandDataPrivacyTheuserwouldhavefullaccesstohisdataandcontroloverhowhisdatawouldbeshared.Theuserwouldassignasetofaccesspermissionsanddesignatewhocanqueryandwritedatatohisblockchain.Amobiledashboardapplicationwouldallowtheusertoseewhohaspermissiontoaccesshisblockchain.Theuserwouldalsobeabletoviewanauditlogofwhoaccessedhisblockchain,includingwhenandwhatdatawasaccessed.Thesamedashboardwouldallowtheusertogiveandrevokeaccesspermissionstoanyindividualwhohasauniqueidentifier.Accesscontrolpermissionswouldbeflexibleandwouldhandlemorethan“all-or-nothing”permissions.Theuserwouldsetupspecific,detailedtransactionsaboutwhohasaccess,theallottedtimeframeforaccessandtheparticulartypesofdatathatcanbeaccessed.Atanygiventimetheusermayalterthesetofpermissions.Accesscontrolpolicieswouldalsobesecurelystoredonablockchainandonlytheuserwouldbeallowedtochangethem.Thisprovidesanenvironmentoftransparencyandallowstheusertomakealldecisionsaboutwhatdataiscollectedandhowthedatacanbeshared.Afterahealthcareproviderisgrantedaccesstoauser’shealthinformation,hequeriestheblockchainfortheuser’sdataandutilizesthedigitalsignaturetoauthenticatethedata.Thehealthcareprovidercouldutilizeacustomizedbest-of-breedapplicationtoanalyzethehealthdata.

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Identityauthenticationwouldfollowthebestpracticesestablishedbyfinancialinstitutionsandregulators.Ideally,biometricidentitysystemswouldbeutilizedastheyofferenhancedsecurityoverpasswordandtoken(smartcard)basedmethodsforidentityauthentication.Giventhismodel,theuserhassingularcontroloverhisdataandthepowertograntaccesstospecifichealthcareprovidersand/orhealthcareentitiesforcommunicationandcollaborationindiseasetreatmentandprevention.Thedecentralizednatureoftheblockchaincombinedwithdigitallysignedtransactionsensurethatanadversarycannotposeastheuserorcorruptthenetworkasthatwouldimplytheadversaryforgedadigitalsignatureorgainedcontroloverthemajorityofthenetwork’sresources.Similarly,anadversarywouldnotbeabletolearnanythingfromthesharedpublicledgerasonlyhashedpointersandencryptedinformationwouldbecontainedwithinthetransactions.VI.TechnicalAdvantagesofaHealthCareBlockchainBlockchaintechnologyoffersmanyadvantagesforhealthcareIT.Blockchainisbasedonopen-sourcesoftware,commodityhardware,andOpenAPI’s.Thesecomponentsfacilitatefasterandeasierinteroperabilitybetweensystemsandcanefficientlyscaletohandlelargervolumesofdataandmoreblockchainusers.Thearchitecturehasbuilt-infaulttoleranceanddisasterrecovery,andthedataencryptionandcryptographytechnologiesarewidelyusedandacceptedasindustrystandards.Thehealthblockchainwouldbedevelopedasopen-sourcesoftware.Open-sourcesoftwareispeer-reviewedsoftwaredevelopedbyskillfulexperts.Itisreliableandrobustunderfast-

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changingconditionsthatcannotbematchedbyclosed,proprietarysoftware.Open-sourcesolutionsalsodriveinnovationsintheapplicationsmarket.Healthprovidersandindividualswouldbenefitfromthewiderangeofapplicationchoicesandcouldselectoptionsthatmatchedtheirspecificrequirementsandneeds.Blockchainwouldrunonwidelyusedandreliablecommodityhardware.Commodityhardwareprovidesthegreatestamountofusefulcomputationatlowcost.Thehardwareisbasedonopenstandardsandmanufacturedbymultiplevendors.Itisthemostcosteffectiveandefficientarchitectureforhealthandgenomicresearch.Excessblockchainhardwarecapacitycouldbesharedwithhealthresearchersandfacilitatefasterdiscoveryofnewdrugsandtreatments.BlockchaintechnologyalsoaddressestheinteroperabilitychallengeswithinthehealthITecosystem.HealthITsystemswoulduseOpenAPI’stointegrateandexchangedatawiththehealthblockchain.OpenAPI’sarebasedonindustrybestpractices.Theyareeasytoworkwithandwouldeliminatetheneedfordevelopmentofcomplexpoint-to-pointdataintegrationsbetweenthedifferentsystems.Blockchainwouldallowpatients,thehealthcarecommunityandresearcherstoaccessoneshareddatasourcetoobtaintimely,accurateandcomprehensivepatienthealthdata.Blockchaindatastructurescombinedwithdatalakescansupportawidevarietyofhealthdatasourcesincludingdatafrompatients’mobileapplications,wearablesensors,EMR’s,documentsandimages.Thedatastructuresareflexible,extendableandwouldbeabletoaccommodatetheunforeseendatathatwillbeavailableinthefuture.Datafromcheapmobiledevicesandwearablesensorsisgrowingatanexponentialrate.Distributedarchitecturesbasedoncommodityhardwareprovidecostefficienthighscalability.Asmorehealthdataisaddedtotheblockchaincostefficientcommodityhardwarecanbeeasilyaddedtohandletheincreasedload.Anotheradvantageofblockchainsdistributedarchitectureisbuilt-infaulttoleranceanddisasterrecovery.Dataisdistributedacrossmanyserversinmanydifferentlocations.Thereisnosinglepointoffailureanditisunlikelyadisasterwouldimpactalllocationsatthesametime.Blockchainworkswithstandardalgorithmsandprotocolsforcryptographyanddataencryption.Thesetechnologieshavebeenheavilyanalyzedandacceptedassecureandarewidelyusedacrossallindustriesandmanygovernmentagencies.VII.HealthCareAdvantagesofHealthCareBlockchainBlockchaintechnologyoffersmanyadvantagestomedicalresearchers,healthcareproviders,caregiversandindividuals.Creationofasinglestoragelocationforallhealthdata,trackingpersonalizeddatainreal-timeandthesecuritytosetdataaccesspermissionsatagranularlevelwouldserveresearchaswellaspersonalizedmedicine.

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Healthresearchersrequirebroadandcomprehensivedatasetsinordertoadvancetheunderstandingofdisease,acceleratebiomedicaldiscovery,fasttrackthedevelopmentofdrugsanddesigncustomizedindividualtreatmentplansbasedonpatientgenetics,lifecycleandenvironment.TheshareddataenvironmentprovidedbyBlockchainwoulddeliverabroaddiversedatasetbyincludingpatientsfromdifferentethnicandsocio-economicbackgroundsandfromvariousgeographicalenvironments.Asblockchaincollectshealthdataacrossapatient’slifetime,itoffersdataidealforlongitudinalstudies.Ahealthcareblockchainwouldexpandtheacquisitionofhealthdatatoincludedatafrompopulationsofpeoplewhoarecurrentlyunder-servedbythemedicalcommunityorwhodonottypicallyparticipateinresearch.TheshareddataenvironmentprovidedbyBlockchainmakesiteasiertoengage“hard-to-reach”populationsanddevelopresultsmorerepresentativeofthegeneralpublic.Blockchaindatastructureswouldworkwellforgatheringdatafromwearablesensorsandmobileapplicationsand,thus,wouldcontributesignificantinformationontherisksversusbenefitsoftreatmentsaswellaspatientreportedoutcomes.Furthermore,combininghealthdatafrommobileapplicationsandwearablesensorswithdatafromtraditionalEMR’sandgenomicswilloffermedicalresearchersincreasedcapabilitiestoclassifyindividualsintosubpopulationsthatrespondwelltoaspecifictreatmentorwhoaremoresusceptibletoaparticulardisease.Daily,personalizedhealthdatawilllikelyengageapatientmoreinhisownhealthcareandimprovepatientcompliance.Moreover,theabilityforphysicianstoobtainmorefrequentdata(i.e.,dailybloodpressuresorbloodsugarlevelsversusonlywhenapatientappearsforanappointment)wouldimproveindividualizedcarewithspecializedtreatmentplansbasedonoutcomes/treatmentefficacy.Blockchainwouldensurecontinuousavailabilityandaccesstoreal-timedata.Real-timeaccesstodatawouldimproveclinicalcarecoordinationandimproveclinicalcareinemergencymedicalsituations.Real-timedatawouldalsoallowresearchersandpublichealthresourcestorapidlydetect,isolateanddrivechangeforenvironmentalconditionsthatimpactpublichealth.Forexample,epidemicscouldbedetectedearlierandcontained.Thereal-timeavailabilityofmobileapplicationandwearablesensordatafromtheblockchainwouldfacilitatecontinuous,24hour-a-daymonitoringofhighriskpatientsanddrivetheinnovationof“smart”applicationsthatwouldnotifycaregiversandhealthprovidersifapatientreachedacriticalthresholdforaction.Careteamscouldreachouttothepatientandcoordinatetreatmentoptionsforearlyintervention.Ahealthcareblockchainwouldlikelypromotethedevelopmentofanewbreedof“smart”applicationsforhealthprovidersthatwouldminethelatestmedicalresearchanddeveloppersonalizedtreatmentpaths.Thehealthproviderandpatientwouldhaveaccesstothesameinformationandwouldbeabletoengageinacollaborative,educateddiscussionaboutthebest-casetreatmentoptionsbasedonresearchratherthanintuition.

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VIII.ConclusionThemostefficientandeffectiveapproachforadvancingONC’sinteroperabilityobjectiveswouldbetoestablishanationaltechnologyinfrastructureforhealthITbasedonopenstandards.OpenAPI’sbasedonindustrybestpracticesarevitalandessentialtoaddressinginteroperability.However,openAPI’sareessentialbutnotsufficient.Ashareddistributedinfrastructurethatprovidesacomprehensiveviewofanindividual’shealthdataacrossalifetimeisanequallyessentialcomponentofinteroperablehealthITsystems.Blockchaintechnologyaddressesinteroperabilitychallenges,isbasedonopenstandards,providesashareddistributedviewofhealthdataandwillachievewidespreadacceptanceanddeploymentthroughoutallindustries.Utilizationoftheproposedhealthblockchaindescribedinthispaperhasthepotentialtoengagemillionsofindividuals,healthcareproviders,healthcareentitiesandmedicalresearcherstosharevastamountsofgenetic,diet,lifestyle,environmentalandhealthdatawithguaranteedsecurityandprivacyprotection.Theacquisition,storageandsharingofthisdatawouldlayascientificfoundationfortheadvancementofmedicalresearchandprecisionmedicine,helpidentifyanddevelopnewwaystotreatandpreventdiseaseandtestwhetherornotmobiledevicesengageindividualsmoreintheirhealthcareforimprovedhealthanddiseaseprevention.BlockchaintechnologydefinitelyhasaplaceinthehealthITecosystem,andtheONCshouldstronglyconsiderbasingtheirinteroperabilitystrategyonblockchainandusingblockchaintopromotetheadvancementofprecisionmedicine.

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