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DIGITALHEALTHFUNCTIONALITYINITIATIVESTOFOSTERINNOVATIONINOPHTHALMICDEVICES
RONALDSCHUCHARDCENTERFORDEVICESANDRADIOLOGICALHEALTH
OFFICEOFDEVICEEVALUATION
2
TypesofDigitalHealthDevices
Softwareas aMedicaldevice“SaMD”
Softwarein aMedicaldevice
in
as
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• Manyophthalmicdevicesrelyheavilyondigitaltechnology• AIsoftwarediagnostics(CADx)andadvancedanalytics(CADe)
areemergingrapidlyinhealthcare• Greaterconnectivity(interoperability)ofdeviceshasleadto
new/greaterrisks• Softwaredevelopmentpracticesareevolvingrapidly• Changestodigitaltechnology
aremorefrequent(includingaftermarketclearance/approval)
3
RapidlyEvolvingLandscape
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TheRapidlyEvolvingNatureofDigitalHealthisSparkingaParadigmShift
CurrentRegulatoryParadigm
Premarkettimelinesuitedforhardware basedproducts
Software developmenttimelines,softwaredevelopmentpractices+rapiditerations
Deterministicrisks,knownresponsibilities,physicalproducts
Evolvingissues:cybersecurity;distributedresponsibilities,non-physicalproducts
Potentialforsignificantly differentcontentwithinsubmissions
Stableprogramexperience:~3,500510(k)submissions/2200pre-submissions
DigitalHealthParadigmShift
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• Telemedicine(e.g.,teleophthalmology)systems– TelemedicinehealthcareispartofthepracticeofmedicineandnotregulatedbyFDA
– TelemedicineislikelytohaveMedicalDeviceDataSystems(MDDS)functionalitywhichtransfers,stores,ordisplaysmedicaldevicedatawithoutcontrollingoralteringthefunctionsorparametersofamedicaldevice
– 21st CenturyCuresremovedMDDSfunctionalityfromthedefinitionofamedicaldevice;Section3060(a)(o)(1)(D)–“productsfortransferring,storing,convertingformats,ordisplayingclinicallaboratorytestorotherdevicedataandresults,findingsbyahealthcareprofessionalwithrespecttosuchdataandresults,generalinformationaboutsuchfindings,andgeneralbackgroundinformationaboutsuchlaboratorytestorotherdevice,unlesssuchfunctionisintendedtointerpretoranalyzeclinicallaboratorytestorotherdevicedata,results,andfinding”
TelemedicineinOphthalmicHealthCare
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• Telemedicinesystems(continued)–MedicalDevicesusedinTelemedicineareregulatedbyFDA(someofthemareDigitalHealthDevices)–OphthalmicCameras– AtHomeVisionTesters(e.g.,VisualAcuity&Amsler Grid)
– TelemedicineandDigitalHealthDevicescanbeClassIorClassII510(k)exemptdevices– Perimeterswithdatabases– Group1LightSourceOphthalmicCamerasvrs Group2LightSourceOphthalmicCameras
TelemedicineinOphthalmicHealthCare
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21stCenturyCuresAct– CodifiesFDAPoliciesAmendedthedefinitionof“device”intheFood,DrugandCosmeticActtoexclude certainsoftwarefunctionsintended...
FDAPoliciesaffected/codified
AdministrativeFunctionality
(B)formaintainingorencouragingahealthylifestyle;
(C)toserveasaelectronicpatientrecords;
(D) fortransferring,storing,convertingformats,ordisplayingclinicallaboratorytestorotherdevicedataandresultsandcertainotherrelatedinformation;
(E) toproviderecommendationstohealthcareprofessionalsforclinicaldecisions,wheretheusercanindependentlyreviewthebasisoftherecommendation.
(A)foradministrativesupport;
FDAPolicyforLowriskgeneralwellnessproducts
HealthManagementfunctionality
PolicyforClinicalDecisionSupportSoftwareincludedin
HealthManagementfunctionality
MedicalDeviceDataSystem(MDDS)
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ClinicalDecisionsSupport– DraftGuidance
• DraftGuidance(12/17)thatidentifiesthetypesofclinicaldecisionsupport(CDS)softwarefunctionalitiesthat:– Donotmeetthedefinitionofadeviceasamendedby
the21st CenturyCuresAct– MaymeetthedefinitionofadevicebutforwhichFDA
doesnotintendtoenforcecompliancewithapplicablerequirementsoftheFD&CAct,including,butnotlimitedto,premarketclearanceandpremarketapprovalrequirements
– TheFDAintendstofocusitsregulatoryoversighton
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AdministrativeFunctionality*
HealthManagementFunctionality*
MedicalDeviceFunctionality*
NoAdditionalRegulatoryOversight
PrimarilyFDAOversight
PrimaryFocusofProposedHealthITFramework
• Healthinformationmanagement;
• Datacaptureandencounterdocumentation;
• Electronicaccesstoclinicalresults;
• Mostclinicaldecisionsupport;• Medicationmanagement;• Electroniccommunication(e.g.provider-patient,provider-provider,etc.);
• Providerorderentry;• Knowledgemanagement;• PatientIDandmatching.
• Admissions;• Billingandclaimsprocessing;• Practiceandinventorymanagement;
• Scheduling;• Generalpurposecommunications;
• Analysisofhistoricalclaimsdata;
• Determinationofhealthbenefiteligibility;
• Reportingcommunicablediseases;
• Reportingonquality.
• Computeraideddetectionsoftware;
• Remotedisplayornotificationofreal-timealarmsfrombedsidemonitors;
• RefractiveSurgerytreatmentplanningsoftware;
• HighIOPdetection.
*Examplesprovidedarenotintendedtobeanexhaustivelistoffunctionalities.
FDASIACategoriesofHealthIT
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HealthManagementFunctionality1• Clinicianordersets• Clinicianhealthrecordsaccess• Drugdosingcalculations;• Drugformularyguidelines;• Remindersforpreventativecare;• Accesstotreatmentguidelines;• Calculationofpredictionrules.
MedicalDeviceFunctionality2• Computeraideddetection(CADe)• Computeraideddiagnostic(CADx)• Refractiontreatmentplanning• Roboticsurgicalplanningandcontrol• Electrophysiologyanalyticalsoftware.
Toolsintendedtoenhance,inform,andinfluencehealthcaredecisions.
1 Ifaproductwithhealthmanagementfunctionalitymeetsthestatutorydefinitionofamedicaldevice,FDAdoesnotintendtofocusitsoversightonit.
2 CDSthathavemedicaldevicefunctionalityandpresenthigherriskswarrantFDA’scontinuedfocusandoversight.
FDASIAHealthITClinicalDecision Support
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HealthInformationTechnology(IT)• FederalAgencieswithuniqueresponsibilitiesintheHealthInformationTechnology:– FoodandDrugAdministration(FDA)– OfficeoftheNationalCoordinatorforHealthIT(ONC)– FederalCommunicationsCommission(FCC)
• FoodandDrugAdministrationSafetyInnovationAct(FDASIA)of2012– FDAtoworkwithFCCandONCtoproposeastrategyandmakerecommendationsonanappropriate,risk-basedregulatoryframeworkforhealthITthatpromotesinnovation,protectspatientsafety,andavoidsunnecessaryandduplicativeregulation
• FDASIAHealthITReport– ReleasedbyFDA,FCCandONCon4/3/2014– Outlinesrisk-basedstrategyandrecommendations
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FocusingonHigherRiskFunctionality
HigherRiskFunctionality
Intendtoassurepatientsafetywhileencouragingadvancesininnovativetechnologyandproductlife-cycle
• DeNovo• 510(k)• PMA
LowerRiskFunctionality
Maynotalwaysenforceregulatoryrequirements
Lowerrisksarenotlikelytoexceedthelimitsofexemption(§886.9)
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• PremarketAssessments:– Whatarethekeyfunctionsofthedevice?– Whataretheaspectsofthedevicethatarevulnerable?– Howarethekeyfunctionsimpactedbyavulnerability?– Whatprotectionsareinplace?
• MethodsofMitigatingRisks:– Safeguardsbuiltintothesoftware/hardware– Methodstolimittheintendedusers– Labellingprovidedforpatientuse– Trainingmodulesandtutorials
RiskAssessmentiskey
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GeneralWellness– BigPicture
• FinalguidancepublishedonJuly29,2016• TheFDAencouragesthedevelopmentofgeneralwellness
productssuchasfitnesstrackers,whichcanempowerindividualstotakeamoreactiveroleinmanagingtheirhealth.
• TheFDA’sFinalGuidanceonGeneralWellnesstakesahands-offapproachtotheregulationoflowriskgeneralwellnessproductsthatonlypromoteahealthylifestyleorthatpromoteawell-knownassociationbetweenahealthylifestyleandacertaindiseaseorcondition.
• TheFDAwillcontinuetofocusitsoversightonproductsthatareinvasive,implantedorposegreaterriskstopatients,eveniftheyareintendedforgeneralwellnesspurposes.
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MedicalDeviceData
Systems
Softwareasa
MedicalDevice
Wireless-
Cybersecurity
AdvancedAnalytics
Interoperability
MobileMedical
Applications
Cloud-Fog/Edge
ArtificialIntelligence
Implementconsistentregulatorystrategiesandpoliciesforophthalmicdigitalhealthtechnologies
Opthalmic DigitalHealthAreas
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MedicalMobileApps(MMA)
• FinalGuidanceissuedFeb9,2015• Focusesonlyontraditionallyregulatedfunctionality
• Providesuserswithsamelevelofassuranceofpatientsafety
• IdentifiesmobileapptypesthatFDAdoesnotintendtoenforcerequirements
• Clarifieswhatisnotadevice–(OutsideofFDA’sJurisdiction)
Mobileappsnotconsidered
“medicaldevices”
MMA
Lowerriskmobileappsthat
meetdevicedefinition
MobileMedicalApps
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MMA’sIntendedUse
Theintendeduseofamobileappdetermineswhetheritmeetsthedefinitionofadevice.Asstatedin21CFR801.4,intendedusemaybeshownbylabelingclaims,advertisingmaterials,ororalorwrittenstatementsbymanufacturersortheirrepresentatives
Ingeneral,ifamobileappisintendedforuseinperformingamedicaldevicefunction(i.e.fordiagnosisofdiseaseorotherconditions,orthecure,mitigation,treatment,orpreventionofdisease)itisamedicaldevice,regardless ofthemobileplatformonwhichitisrun
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MMAOphthalmicExamples• DiseaseProgression– AidsinDiagnosis/Therapy
– MMAVisualAcuityandAmsler Grid/HOQ– MMAEyeMovementMonitor/HLLGWN– Mobiledevicecameras– TabletVisualFunctionAssessment
• TherapyMMAs– DichopticTreatmentofAmblyopia;Red/Green
GlassesorVirtualRealityGlasses– Wayfindingandobjectdetection/localizationas
assistivetechnologydevicesforvisuallyimpaired
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ConvergedFrameworkandPrinciplesforSaMD
Categorization Based on definition statement
SaMDdefinitionstatement:• CriticalityofContext• Significanceofrecommendation
2
31
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SaMD OphthalmicExamples
• DiagnosticSaMD– CADx forDiabeticRetinopathy
• OphthalmicImageManagementSystems- 892.205– PictureArchivingandCommunicationsSystem(PACS)/NFJ
• SaMD:ClinicalEvaluationGuidance– 12/17– ThisguidanceadoptstheinternationallyconvergedprinciplesagreeduponbytheIMDRF;https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf
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MachineLearning– DeepLearningSaMD
• AdvancedAnalytics:Adeviceorproductthatcanidentify,analyze,andusebigdataandlargecomplexdatasetsfromavarietyofsources.Theproductextractsnewandrelevantinformationorpatternstouseformedicalpurposesusingmachinelearningordeeplearning.
• ArtificialIntelligence:Adeviceorproductthatcanimitateintelligentbehaviorormimicshumanlearningandreasoning.Artificialintelligenceutilizesmachinelearning,neuralnetworks(deeplearning),andnaturallanguageprocessing.Sometermsusedtodescribeartificialintelligenceincludecomputer-aideddetection/diagnosis,statisticallearningorsmartalgorithms.
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MedicalDeviceInteroperabilityistheabilityoftwoormoreproducts ,technologiesorsystemstosafelyandeffectivelyexchangeanduseinformationthathasbeentransferredbetweendevices
9/2017FDAGuidance“DesignConsiderationsandPremarketSubmissionRecommendationsforInteroperableMedicalDevices
Interoperability
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InteroperabilityStandards
Canbeusedfordifferentlevelsofinteroperability
August2013– FDARecognized14standardsforinteroperability• Nomenclature• Medicaldevicecommunications• System/Softwarelifecycleprocess
• .
24
Wireless
2013FinalGuidanceonAddressingRFWirelessTechnologyinMedicalDevices
• Selection/performanceofwirelesstechnology• QualityofService• WirelessCoexistence• WirelessDataIntegrity/Security• EMC• Labeling
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MedicalDeviceCybersecurity
October2014GuidanceContentofPremarketSubmissionsforManagementofCybersecurity
inMedicalDevices
• Philosophyofriskanalysisandmanagement• Considerappropriatesecuritycontrolssuch
as:o Limitaccesstotrustedusersonlyo Ensuretrustedcontento Usefailsafeandrecoveryfeatures
• Considerenvironmentofuse,typeandprobabilityoftheriskstowhichproductisexposed,andprobableriskstopatientsfromasecuritybreach
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12/2016– Postmarket ManagementofCybersecurityinMedicalDevicesGuidance
Cybersecurityriskmanagementprogramsshouldinclude:• Monitoringcybersecurityinformationsourcesforidentificationanddetectionofcybersecurityvulnerabilities
• Understanding,assessinganddetectingpresenceandimpactofavulnerability
• Establishingandcommunicatingprocessesforvulnerabilityintakeandhandling
• Clearlydefiningessentialclinicalperformancetodevelopmitigationsthatprotect,respondandrecoverfromthecybersecurityrisk
• Adoptingacoordinatedvulnerabilitydisclosurepolicyandpractice
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Cybersecurity
• Thehealthcareandpublichealth(HPH)sectorrepresentsasignificantandlargeattacksurface– Intrusionsandbreachesoccurthroughweaknessesinthesystemarchitecture
• Connectedmedicaldevices,likeallothercomputersystems,arevulnerabletothreats
• Whenmedicaldevicevulnerabilitiesarenotaddressedandremediated,theycanserveasaccesspointsforentryintohospital/healthcarefacilitynetworks– Mayleadtocompromiseofdataconfidentiality,integrity,andavailability
– Mayserveasasafetyissue
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FDA’sRolesinMedicalDeviceCybersecurity
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OngoingReviewofGuidanceDocuments
• Guidancedocumentsthatwilllikelybeupdated– GeneralWellness:PolicyforLowRiskDevices– MobileMedicalApplications– Off-The-ShelfSoftwareUseinMedicalDevices– MedicalDeviceDataSystems,MedicalImageStorageDevices,andMedicalImageTransferDevices
• Guidancedocumentthatwilllikelybewithdrawn– GuidancefortheSubmissionofPremarketNotificationsforMedicalImageManagementDevices
30
FDAPre-Cert:AReimaginedApproach
Clinical TrialsOutcomes research
CommercialDistribution&Real-WorldUse
e.g.lower-risksoftware,certainmodifications
Real World Data
Collection
BasedonSaMDRisk+Pre-Certlevel
StreamlinedPremarketReview
FDAPre-Certlevel
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ConcepttoProgram:AnIterativeApproach
OrganizationalExcellence StreamlinedReview RealworldDataCollection
PublicmeetingJanuary2018
Programproofofconcept– Late2018
PilotStartSept2017
AreasofFocusDuringConceptDevelopment
32
Conclusions
• OphthalmicDigitalHealthwillleadtomanynewinnovativedevicesthatwillprovidediagnosticandtherapeutichealthcare
• CDRHintendstofostertheRightCurefortheRightPatientattheRightTimethroughinnovativedigitalhealthproducts
• CDRHiscommittedtoevolvingRegulatoryParadigmsfordigitalhealthproductsinaflexibleprocess
• Continuedeffortsareneededtoevolveregulatorysciencefordigitalhealthfunctionality
• ThankyouforyourinterestinDigitalHealth