RDAHealthDataIGEdwinMorley-Fletcher(co-chair),Lynkeus

RDAmeetsNordicresearchers,14June2017,Göteborg,Sweden

BriefHistory

• BoFs @RDAP6inParisand@RDAP7inTokyo• HealthDataInterestGroupestablished@RDAP8inDenver(September2016) #over100members

• Secondmeetingat@RDAP9withfocusonDataProtection(GDPR)andHealthDataMappinghttps://docs.google.com/spreadsheets/d/1WUGU1McZH3jo5x7g2FCMsvPdF5DKUHKL6AqJWBUamB0/edit#gid=1612672872

• BOFonBlockchain forHealth@RDAP9inBarcelona(April2017),tobeheldagain@RDAP10,inviewofestablishingadedicatedWorkingGroup.

• Quarterlyconfcalls

• Dataaccessandprotection• sharingbestpracticeonpseudonymisation andanonymisation• developingmodelsforconsentthatprotectpatientswhileenablingresearch• providingaforumfordiscussing,explainingandrespondingtodataprotectionregulation• secureopeningupofdatatofacilitateresearch

• Data-basedhealthcareforpersonalised medicine• diseasesignaturesidentification• stratificationofpatientgroups• patient-specificsimulationandprediction

• DataliteracyinHealthcare• providingmaterialsforeducationofhealthcareprofessionalsonuseandmisuseofdata

• Patientdatarepositories/patient-centricdatagatheringsystems• In-silicodrugdevelopmentandclinicaltrials

• representinginterestsofthedata-basedhealthcarecommunitytopolicymakers• identifyinganddiscussingrelatedchallenges,interdisciplinaryresearchneedsandpotentialroadmaps.

• Blockchainapplicationstohealthdata

Userscenarios/focusareas

• Clinicians(tousedatatechnologytoimprovepractice)

• Biomedicalresearchers(usinganalyticaltechniques)• HealthcareDataAnalytics(withdatamining,machinelearning,physiologicalmodellingandimage

processingexpertise)

• HPCanddistributedcomputingexperts• Policy-makersforHealthcare• Healthbioinformaticslegalexperts• Healthcareadministrators- HealthMaintenanceOrgs• Pharmaceuticalindustryresearchersandmanufacturers• Medicalequipmentresearchersandmanufacturers• Insilicomodelling,testingandclinicaltrialexperts• BlockchainApplicationsinHealth

Targetparticipationareas

LookingforwardtoanRDAWGfocusingonBlockchaininHealth?

• TheHD-IGissponsoringtheideaofestablishingaWGfocusingonBlockchaininhealthdatawiththeaimofdebatingindepththepotentialofsuchasystemandwhethertheblockchaincanensurecompliancewithadvanceddataprotectionrequirements(suchasthosedefined,forinstance,bytheEUGeneralDataProtectionRegulation– GDPR),yetmakingithappenseamlesslyandefficiently,atscale.

• Duetoitsscope,thenext(second)preliminaryBoF meetingideallyfostersrelationstoanumberofRDAWGsandIGsthatmaybeabletocontributewiththeirresultsto,orbenefitfrom,theproposedfutureWG’sactivities.

BlockchainHype?

TheEconomist (2015),“Thepromiseoftheblockchain:Thetrustmachine”,October 31st - HealthITCentral– May15th,2017

BlockchainHype?TheEconomist

• TheEconomistwentsofarastostatethat,atfirstsight,“thenotionofsharedpublicledgersmaynotsoundrevolutionaryorsexy.Neitherdiddouble-entrybook-keepingorjoint-stockcompanies.Yet,likethem,theblockchainisanapparentlymundaneprocessthathasthepotentialtotransformhowpeopleandbusinessescooperate.[…]Arealisationthatsystemswithoutcentralisedrecord-keepingcanbejustastrustworthyasthosethathavethemmaybringradicalchange.[…]Aworldwithrecord-keepingmathematicallyimmunetomanipulationwouldhavemanybenefits.”

BlockchainHype?IBM• “Blockchainpromisestoputprivacyandcontrolofdatabackinthehandsofcitizens.Trustandintegritywillbeestablishedwithoutrelianceonthird-partyintermediaries.IBMbelievesblockchainisanextraordinarilyimportantphenomenonwiththepotentialtotransformindustriesandupendbusinessmodels”.

• “Inhealthcare,newresearchisseekingtoapplyblockchain’sdistributedledgeranddecentralizeddatabasesolutionstothecriticalissuesofinteroperability,security,recorduniversality,andmore.Intriguingusesinotherindustriesarebeingextendedtohealthcare,suchasextendingblockchain’ssmartcontractstoprovidernetworkmanagementorconnectingmyriadmedicaldevicesthroughcommon,blockchain-enabledsystemsofinformationrelationships.Whiletechnicalconsensusonadistributedledgerforhealthcarehasyettoemerge,withdebateongoingregardingscalability,security,andregulatorycompliance,blockchaintechnologyandencryptionwill driveinnovationinhealthcareservicesandadministration”

IBMGlobalBusinessServicesPublicSectorTeam(2016),UseofBlockchain inHealth ITandHealth-related Research,proposal submitted onAugust8,2016,totheIdeation Challengelaunched bytheOfficeoftheNationalCoordinatorforHealth InformationTechnologyintheUSA.

BlockchainHype?Deloitte

• HealthcarepainpointsandpotentialblockchainsolutionsweresimilarlyindicatedbyIBMaswellasbyDeloitte,inwhoseWhitePaper,however,theyappearedtobemoreconvenientlysummarisedasshowninthenexttable,takenfrom:

Deloitte(2016),Blockchain:OpportunitiesforHealthCare,WhitePaperdevelopedinresponsetotheDepartmentofHealthandHumanServices’OfficeoftheNationalCoordinatorforHealthInformationTechnology(ONC)ideationchallengeon“TheUseofBlockchaininHealthITandHealth-RelatedResearch”.

BlockchainValuePropositionsforHealthcare

WhoisRonaldCoase?

• RonaldCoase(1910-2013):NobelLaureateforEconomicson1991Morethan50yearsafterhisdisruptiveTheNatureoftheFirm(1937),and30yearsafterTheProblemofSocialCosts(1960).

• ItisnowpossibletoreverseRonaldCoase’sTransactionCosts.

• WhatInternetdidtotransactioncostsregardinginformation,blockchaincandoregardingtrust.

AssumptionsandExpectations

• Publicandprivateinitiatives,bothinEuropeandintheUS,arecurrentlyaddressingthepotentialofapplyingtheblockchainapproachtohealthdata.

• Thisisrelatedtogreatgeneralexpectations(“whatInternetdidtotransactioncostsregardinginformation,blockchaincandoregardingtrust”)andtotheassumptionthatwhatisneededforhealthdataisaDistributedEmpowermentsystem,providingsecureaccessfromanywhereonanydevice.

• Thereistheneedtodevelopnewmechanismsoftrustandofdirect,value-basedrelationshipsbetweenpeople,hospitals,researchcentres,andbusinesses,leadingtoanopenbiomedicalinformationnetworkcentredontheconnectionbetweenorganisationsandtheindividual.

BlockchainLedger

• ADistributedEmpowermentsystemhavingtheBlockchainledgerassecure,non-editablerecord,wherealltransactionsareconfirmedbythenetworkasentriesformingblocksoftransactions,andthewholenetworkmonitorsthelegitimacyofeachtransaction,guaranteeingdistributedcontrol.

SmartContracts

• TheblockchainisexpectedtobebasedonportfoliosofSmartContracts.• SmartContractsaretheexecutablepiecesofcode,storedontheblockchainforfutureexecution.

• Thesebindpeopleandtransactionstospecificactionsandoutcomesandrequirenofurtherdirecthumaninvolvementafterthesmartcontracthasbeenmadeapartofthedistributedledger(whichiswhatmakesthesecontracts"smart"orself-enacting).

HD-IGGOALSwithregardtoPrivacy,Security,andBlockchain

• Profileandclassifysensitivedatabasedontheirinformationalandeconomicvalue• Assessthemostsuitableandrobustde-identification andencryption technologiesneededtosecuredifferenttypesofinformation

• Allowhavingadvancedanalyticsrunningonanonymisedorpseudonymiseddata• EvaluatetheoverallsecurityofMHMDmulti-modulararchitecturebytestingitthroughdedicatedself-hacking simulationsandpublichackingchallenges

• Analyseusers’behaviouralpatternsalongsideethicalandculturalorientations,toidentifyhiddendynamicsintheinteractionsbetweenhumansandcomplexinformationservices

• Improvethedesignofdata-drivenplatforms• Fosterthedevelopmentofaninformationmarketplace,inwhichbothindividualsandclinicalinstitutionswillbeabletoexertcontrolontheirhealthdataandleveragetheirvalue

StrategicallyrelyingontheongoingMyHealthMyData EU-fundedprojectand

onitsFourLeadingHospitals

• Following theexample ofroutinedatainflow bytheOPBGPCDR,andtheinteroperabilitysystemestablished inCardioproofandMD-Paedigree

• Taking into accounttheless restricted dataprocessingallowed bytheGDPRwhen it is aimedat scientific research,andtheproviso that thedataprotection legislation does not apply toduly anonymised data

• Guaranteeing that all health andpersonaldatawill:• Be duly anonymised before been uploaded on MHMD Infostructure• Be processed, should the use of partial anonymisation techniques be indicated for the intended use of data, on the

ground of a Dynamic Consent provided by the data subjects.

• Exploringdifferentopendataimplementationapproaches• Evaluating,totheextentpermittedbynationalandEuropeanregulations,solutionsprovidingsomeconcreteacknowledgmentofdatavalue

Twolayersofdataflow

• A semi-automated data profiling and cleaning engine that:o Ensuresandassessesdataqualityo Guaranteesthemostappropriatede-identificationorencryptionmechanism,accordingtoeachtypeofdataormodality

• A privacy preserving and security layer that combines:o Aprivacypreservingdatapublishingengine(providinganonymisation tools)o Aprivacypreservingcomplexdataflowexecutionengine(i.e.,differentialprivacy,SMPC,homomorphicencryption)

• Thejointgoalis toallow:o Classifyingmedicaldataandcorrespondentsecurityandprivacyprovisionsineachcategoryo Assessingrelevance,sensitivity,riskfortheindividualandpracticalvalueo Selectingthemostappropriatesecurityandprivacypreservingtechniqueineachcase

InstitutionalDataprovidersrequirements

AllMHMDhospitalscommitto:• Acquireaservertohostthelocaldatacatalogueandcontributetoblockchaintransactions• HavetheirresearchdataindexedusingDOIs• IntegratetheserverintheirHealthcareInformationSystem(HIS)(thusallowinglaterproduction)• Consenttobeconsultedonfuturecohortrequests• EnsureVeracity,Validity&Integrityoftheirdata• Onlymakepseudonymousdataavailable• Handletheresponsibilityofpatientidentitymappingwithlocalanonymousdata

IndividualMHMDUserEntitlements(1)

• Aggregatepersonaldatafromdisparatesources:• Socialmediaaccounts,clinicaldatarepositories,personaldrives,wearabledevices,etc.,inasingle,user-ownedaccount(PDA).

• Assigndataaccessrights• Withinanefficientworkflow,basedonstakeholders’permissionsandaddressingsimplequestions:

o Type ofdatarequestedo Intended useo Datathatwillberetainedo Datathatwillbesharedwith3rd partiesandintendeduseo ImplementationoftheRighttobeforgotten.

IndividualMHMDUserEntitlements(2)

• Stayinformedof,andenquiryon,relevantdatatransactionsafteraccesshasbeengranted

• Beabletorevokedataaccessrights,orextendthem• Beabletoreceiverequestsfromstakeholdersfordataaccess

permissions.• Requestsmayalsoincludeincentivesofferedbystakeholdersinexchangefordata

• Definepost-mortemusageordonationofpersonaldata

Blockchain:norecoursetoTrustedThirdParty

• Applying theblockchain approach tohealth dataguarantees secure accessfromanywhere onany device

• TheBlockchainledgeristhesecure,non-editablerecordwhere:o Alltransactionsareconfirmed bythenetworkas entriesforming blocks oftransactionso Thewholenetworkmonitorsthelegitimacyofeachtransaction,guaranteeingadistributedcontrolsystem

• Eachstakeholdercanenactanonymoustransactionsthroughtheledger:o Employing publickey encryption foridentifying owners intheledger,recording onehalf ofthepublickey pairo Only theperson oristitution holdingthecorresponding privatekey candecidewhat happens next totheir data

• Eachstakeholderisequippedwitha‘wallet’containing:o Anencryptedidentifiero His/herDynamicConsento His/herdataaccesspolicyfile

DOISystem:Handle.net

• TheHandleSystemisacomprehensivesystemchosenforassigning,managing,andresolvingpersistentidentifiersfordigitalobjectsandotherresourcesontheInternet

• Theprotocolsenableadistributedcomputersystemtostoreidentifiersofdigitalresourcesandresolvethoseidentifiersintotheinformationnecessarytolocateandaccesstheresources

• Thehandle.net8.1softwareinclude:o aRESTfulJSON-basedHTTPAPIo abrowser-basedadmincliento anextensionframeworkallowingJavaServletappso authenticationusinghandleidentitieswithoutspecificindexesomulti-primaryreplicationo Securityimprovements

AppliedAnalytics:ProbabilisticModelingforstatisticalsimulation

Modelling

Dependency Analysis

Inference

Applied Analytics:DeepReasoner bySiemensMulti-modal patient modelling inMD-Paedigree

Final Conference

Createpatientrepresentationcombininginformationfrommultiplesources

Clinicalinformation

Cardiacfunction

Circulation

StrainsMicrobiome Fatinformation