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Bahls et al. J Transl Med (2020) 18:394

RESEARCH

Designingand pilotinga genericresearch

architectureand work?owsto unlockGerman primarycaredatafor secondaryuse

Thomas

Bahls 1* ,JohannesPung 2 ,Stephanie

Heinemann

3 ,Johannes

Hauswaldt

3 ,Iris

Demmer

3 Arne

Blumentritt

4 ,Henriette Rau 4 ,Johannes

Drepper

5 ,Philipp

Wieder

6 ,Roland Groh 6 ,Eva

Hummers

3 and Falk

Schlegelmilch

3

Abstract

Background:

Methods:

Results:

fulfiltheRADARtaskswereevaluated - forexample,re-usingBDTinterfacefordataexchangeandTrustedThird responders.

Conclusion:

licence,visit http://creat iveco

OpenAccessJournal of

Translational Medicine*Correspondence:thomas.bahls@uni-greifswald.de 1

Institutefor

CommunityMedicine,SectionEpidemiologyof

HealthCare

and 2,

Greifswald

17475,Germany

Page2of10Bahls et al. J Transl Med (2020) 18:394

Background

dataobtainedfromotherresearchsources - forexam alsotakenintoaccount. comprehensivenationalregistry[ 1 ,2],theUnitedKing since1987[ 3 ],andSwedenbuiltanationwidequality 4 ofmarketanalysisinQ1/2018)[ 5 ]butalsohardlysup lungsdatentransfer-Schnittstelle,BDT)[ 6 ],whichinmost

2001-2003[

7 ].Withinthisstudy,FDsreceivedanexport siteintheFD'spracticeandsentbackbypost - thus,

MedViPproject[

8 ].InMedViP,thedatatransferpath and(d)deliveryinperson[ 9 ].BasedontheBDTdata published[ 10 14 ].Also,BDTisabasicbuildingblockof dor[ 15 ].?eBeoNetRegistry-Databaseusesencrypted

PrivateNetwork(VPN)connection.

data.

Methods

(2)adesignphase,and(3)apilot.

Phase1:analysingprerequisitesand requirements

TMFstaff(TMF - Technology,Methods,andInfrastruc

withthesameparticipantgroups - theso-calledRADAR projectteam - andwereconductedusingtheformats

Keywords:

Page3of10Bahlsffet al. J Transl Med (2020) 18:394 implementation. sitesandrequirements.

Phase2:designingarchitectureand work?ows

1wascontinuedbutre-focussed.

15 19 vascularResearch(DZHK),wereconsidered. pletetheRADARtasksof (a)

ExportingdatafromPMS,

(b)

Recordingandcheckingapatient'sconsentfor

RADARproject,

(c)

Storingpatient'sidentifyingdata(IDAT)and

dataandpseudonym, (d)

PseudonymisingtheEHRdatasubsetforwhicha

RADARconsentexists,and

(e)

Transferringthepseudonymiseddataintothe

RADARresearchdatabaseforlaterdatause

TMF. cation[ 20 ],alreadyusedinseveralcurrentprojects. calandpracticemanagementperspectiveatthe ?eresultofthisprojectphasewasanarchitec (workflow)fordatacaptureandstorage.

Phase3:implementing,testingand piloting

Basedontheresultsofphase1and2,theRADAR

theRADARarchitectureandworkflows - extendedbya processes. ?eimplementationofthetechnicalRADARcompo alityandfeasibilitybarriers - first,withinatestenvi- practiceasreal-worldscenario.

RADARresearchdatabase.

theRADARresearchdatabase. Page4of10Bahls et al. J Transl Med (2020) 18:394

Results

Phase1:analysingprerequisitesand requirements

thefollowingTable 1.?eliststartswithFD-associated frameworkconditions[ 21

RADARprojectteam(no.12-13).

Phase2:designingarchitectureand work?ows

earlierBeoNetprojectinasimilarFPsetting[ 15 ].?e Table 1 Listof prerequisitesand requirements(referredto in thefollowing textas "REQ")

REQNo.Prerequisite/Requirement

avoidedwhereverpossible project project 8 and 9 internet accessavailabilityofthepractices 10

TheRADARdataexportshoulddealwithlocal

practice-internal networkavailability operationsmodel process setupthat(b)complieswithGDPRrequirements quentanalysis Page5of10Bahlsffet al. J Transl Med (2020) 18:394 bere-used. 16

REQ#1).

calsituations[ 22
]withmedicaltreatmentofpatientsand

However,bothGNCandDZHKsharethesamearchi

aTTP[ 17 ]isusedtomanageIDATwhiletheresearch operationintheRADARproject: (a)

FDpracticeindigitalformatincludingtheBDT

RADARprojectpartnerA;REQ#7,#3,#2).

(b)

RADARsoftwaremodulethatsupportsitemised

B;REQ#8,#14,#11).

(c)

TTPwithsoftwaremodulesandinterfacestoi)

communicateandstoreIDATofpatients,whopar uniquepseudonymsforeachRADARpatient,and nyms(providedbytheTrusted?irdPartyofthe partnerC;REQ#8,#11). (d)

RADARsoftwaremodulethatpseudonymisesthe

EHRdatasubsetforwhichaRADARconsentexists

RADARprojectpartnerB;REQ#8,#14).

(e)

RADARresearchdatabasewithdataimportand

jectpartnerD;REQ#17). ?eRADARprojectleadisattheDepartmentofGen tionconcept(REQ#15).Figure 1showstheorganisation perspective).

Figure 2illustratestheworkflowfordatacapture,

draftedbytheTMF(REQ#15). Page6of10Bahls et al. J Transl Med (2020) 18:394

Data Storage

PracticeManagement

System(PMS)

RADARSoftware

TTP Dispatcher

Pseudonymized

Medical Data

Identifying

Data

Pseudonyms

Informed

Consents

Department of General Practice

A B

Dept. ofMedical Informatics

Electronic Health

Record(EHR)

RADARProject

Coordination

C D E

Search andRetrieval

ofResearch DataRADAR Project

Data Protection

Concept

Fig. 1 RADAR

Software

PMS C D A IDAT,

MDATMDAT,

Temp-PSN

1 5 67

Temp-PSN

9 B

Data Storage

Research DB

TTP

Physician/

Study NursePatient

Consent

3 2 IDAT,

ICModules

4

BDT&IC

IDAT,

ICModules

8

IDAT,MDATMDAT,Temp-PSN

10 11

Temp-PSNPSN

12MDAT,PSNResearchDB

Fig. 2 Page7of10Bahlsffet al. J Transl Med (2020) 18:394 storedasstructuredresearchdata. ascsvdatafile.

Phase3:implementing,testingand piloting

oftheRADARsoftwarewasimplemented.?eimple 16 ,17, 22
23

Datastoragewasimplementedbydefiningadata

base.?eMDATfileisdeletedafterwards.

PilotingtheRADARapproachwasalsoconducted

MDAT,pseudonymisedandsavedintheRADARdata

withintheresearchdatabase. Page8of10Bahls et al. J Transl Med (2020) 18:394 datacapturinginaFP(REQ#2,#5,#9,#10).[ 24
cessfullywithintheresearchdatabase. intheRADARresearchdatabase.

Discussion

theoutdatedformatwere (a) exportmechanism(e.g.,paymentofone-timeor thatthevendorhastobeaskedfor)and. (b) non-compliancetotheBDTspecification,i.e. consideredwhencodingtheBDTparseraspartof Table 2quotesdbs_dbs26.pdfusesText_32

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