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1、11U.S.FOODANDDRUGADMINISTRATION234FOSTERINGDIGITALHEALTHINNOVATION:5DEVELOPINGTHESOFTWAREPRECERTIFICATIONPROGRAM6PUBLICWORKSHOP78Day1910Tuesday,January30,2018118:43a.m.121314NationalInstitutesofHealth(NIH)Campus159000RockvillePike16RuthL.KirschsteinAuditorium17NatcherCo
2、nferenceCenter,Bldg.4518Bethesda,MD2089219202122Reportedby:CaseySmith121APPEARANCES23FDALEADERSHIP:4JEFFREYSHUREN,CenterDirector5CenterforDevicesandRadiologicalHealth6BAKULPATEL,AssociateCenterDirector7CenterforDevicesandRadiologicalHealth89PANELONE:10DANELLEMILLER,Vice
3、PresidentofGlobalRegulatory11Policy&Intelligence12RocheDiagnostics13HOWARDLOOK,CEO&Founder14Tidepool15YONGJINLEE,SeniorVicePresident16SamsungElectronics17DIANEJOHNSON,DigitalHealthPolicyLead18Johnson&Johnson19LARRYCARRIER,HeadofGlobalRegulatoryAffairs20VerilyLifeScience
4、s21ALEXBISIGNANO,CEO22Phosphorus231APPEARANCES(Continued)23ADAMPELLEGRINI,GeneralManager4FitbitHealthSolutions5DAVIDARMOR,VPofQuality&RegulatoryAffairs6PearTherapeutics7JENNNEWBERGER,SeniorLegalCounsel8Apple910PANELTWO:11LINDARICCI,HealthScientitst12OfficeofDeviceEvalua
5、tion13JOHNMURRAY,ExpertRegulatoryReviewScientist14OfficeoftheCenterDirector15MARTINHO,AssociateDirectorforQuantitative16Innovation17OfficeoftheSurveillance&Biometrics18MARISACRUZ,SeniorMedicalOfficer19OfficeoftheCenterDirector20ADAMBERGER,Ph.D.,PersonalizedMedicineStaff
6、21OfficeofInVitroDiagnosticsandRadiological22Health341APPEARANCES(Continued)23CATHYBAHR,DigitalHealthExpertAdvisor4OfficeoftheCenterDirector5ESTHERBLEICHER,SeniorPolicyAdvisor6OfficeoftheCenterDirector7FRANCISCO(CISCO)VICENTY,ProgramManager8OfficeoftheSurveillance&Biome
7、trics910PANELTHREE:11CARATENENBAUM,SeniorAdvisor12OfficeoftheCenterDirector13KATHLEENBLAKE,MD,MPH,VicePresidentofHealthcare14Quality15AmericanMedicalAssociation16ADAMBROWN17HeadofDiabetesTechnology&DigitalHealth,18CloseConcerns19SeniorEditor,diatribe.org20DR.ANDREWAUERB
8、ACH,ProfessorofMedicine21UCSFCenterforDigitalInnovation22451APPEARANCES(Continued)23DR.NAOMIARONSON,ExecutiveD
