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ArtificialIntelligence

inMedtech:NavigatingChangeandOpportunity

November2025

Foreword

ForewordfromElizabethOrr,ManagingEditor,PolicyandRegulation,MedtechInsight:

Artificialintelligenceisn’tjustreshaping

thefuture–it’ssculptingthepresent.From

classroomstoconcerthalls,AIischanginghowwelearn,work,andcreate.Andthemedtech

industryisnoexception.TheUSFDAhas

alreadyclearedmorethan1,200AI-enableddevices,withcountlessconsumer-focused

“wellness”productsjustbeyonditsreach.

Thepaceisdizzying,andmissingabeatcouldmeanfallingbehindforgood.Thiscollectionofin-depth,forward-lookingarticlesfromMedtechInsighthelpsyoumakesenseofitall.Inside,

you’llfindexpertreportingandanalysison:

?AIdealmaking:$9.2bninmedtechAImergersandacquisitionswereannouncedinthefirst

halfof2025–triplethe2024total.

?Wherethenextwaveisheaded:Apreviewofthepatient-focuseddealsanalystsexpecttoseeinthecomingmonthsandyears.

?Thehumanfactor:Johnson&Johnson

MedtechresearchrevealingwhatcliniciansandpatientsreallythinkaboutAI’sroleinhealthcare.

?Regulationandreality:HowCalifornia’s

toughpatientprivacylawsareshaping

nationalandinternationalconversationsonhealthcareAI.

You’llalsogetexclusivepreviewsoftwo

subscriber-onlydeepdives–oneanalyzing

stakeholderfeedbackontheFDA’slatestAIguidance,andanotherexploringhowtohelppatientsembraceAI-drivencare.

SubscribetodayforfullaccesstothesefeaturesandongoingcoverageofAI,digitalhealth,andothertechnologiesreshapingmedtech.

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Contents

IndustryExpertsExpectAI-DrivenMedtechM&AToContinueIn202504

J&JSurvey:ClinicianBurnoutAndAgingPopulationsDriveDemandForAI

AndRoboticsInFutureHealthCare07

GuidanceFeedbackHighlightsOutstandingQuestionsInAIDevelopment

10

NavigatingAICompliance:InsightsfromCalifornia’sLatestAdvisories

11

BurdenIsTooHeavyForMedtechsToGoItAloneOnComplexMedtechAIProjects

14

AIInHealthDelivery:PatientsMostConfidentWhenHCPsAreInCharge

18

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IndustryExpertsExpectAI-DrivenMedtechM&AToContinueIn2025

MarionWebb

ExecutiveSummaryAI-drivenmedtechM&Aslowedslightlyinvolumebuttripled

invalueinearly2025,withbuyersfocusingonAI-drivendiagnostics,surgicaltechandanalytics.Industryexpertsexpectcontinuedhigh-valuedealsasfirmsdefendmarketshareandpursueworkflow-enhancingAI.

KeyTakeaways

?Q12025medtechM&Afellfrom62to57deals,butdealvaluejumpedfrom$2.7bnto$9.2bn,reflectingfocusonmatureassets.

?AI-poweredsurgical,diagnosticanddata-drivenplatformsremaintop

acquisitiontargets.

WhenitcomestoM&Aactivityinmedtech,

buyers’appetitehasbeenonAI-powered

diagnostics,surgicalsolutionsanddata

analytics,atrendthatindustryinsidersexpectwillcontinuefortherestof2025.

AlthoughthenumberofM&Adealsdipped

slightlyinthefirstquarterfrom62to57,

thecombinedvaluesurgedfrom$2.7bnto

$9.2bn.Thisshiftreflectsastrongeremphasis

onmaturecompanieswithdeeperproduct

pipelinesorcommercialtraction,wroteMorrisonFoersterassociateattorneyDustinMcKenzie

andpartnerShaiKalanskyinarecentblogpost.

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IndustryExpertsExpectAI-DrivenMedtechM&AToContinueIn2025

SurgicalTechnologies

OneofthelargesttransactionswasStryker’s$4.9bnacquisitionofInariMedical,expandingStryker’sportfoliointhecardiovascular

andperipheralmarkets.Inari’sproprietary

thrombectomydevicesgeneratereal-time

proceduralandoutcomesdata,whichalign

withStryker’spushtointegrateprocedural

intelligence,clinicalanalyticsandAI-assistedtechnologiesintoitssurgicalplatforms.

Sincethedealwasannounced,Inarihas

launcheditssecond-generationInThrill

ThrombectomySystemforclotremovaland

beganrecruitingpatientsforitsInariVISIONRegistry,whichwillcollectpost-marketdata.

Othernotabledealsinthesurgicalspace

includeBostonScientific’s$900macquisitionofBoltMedicaland,withit,itsintravascular

lithotripsylaser-basedplatformfortreating

coronaryandperipheralarterydisease.In

August,ZimmerBiometannounceda$177m

dealtobuyMonogramTechnologiestobolsteritsorthopedicsroboticsplatform.

Thesectoralsosawlargescaletransactionsoutsideofsurgery.

AmongtherecentnotableM&Adealsare

WatersCorp.,s$17.5bnbuyoutofBecton

Dickinson’sLifeSciencesbusiness,Alcon’s

$1.5bnpurchaseofSTAARSurgical,HistoSonics’$2.25bnmanagement-ledmajoritystake

acquisitionbyasyndicateofprivateandpublicinvestors,andZimVie’s$730macquisitionofanArchimedaffiliate.

DefensiveBuyingStrategies

For2025,BryanHughes,managingdirector

atinvestmentbankingfirmP&MCorporate

Finance,expectsM&AactivitytostayfocusedonAI-enabledtechnologiesthatstreamline

surgicalworkflowsfrompreoperativeplanning

andprocedureoptimizationtopostoperativeoutcome.

HealsoanticipatesthatthosemedtechswithaparticularportfolioofdeviceswillbelookingtoacquireAI-enabledtechnologiestohelpprovidedoctorsandpatientswithamore“holistic

solution.”

“Typically,thosecompaniesdon’thavethe

resourcesinternally”tocreateandimplementtheirownholisticsolutionstodrivebetter

outcomes,hesaid.

Notallactivitywillbegrowth-driven.

DeepakSahu,managingdirectoratconsultingfirmTrinityLifeSciences,predictsthatmany

dealsfortheremainderoftheyearwillbe

defensiveasmedtechsbraceforfinancial

pressuresonhealthsystems.Factorssuchas

policyshiftsandnewregulations,hesaid,will

driveupcommercialinsurancepremiums,whichwillleadmorepeopletodelaycare.

“So,whenthathappens,youareseeingthe

stockofmedicaldeviceseitherremaining

flat,singlelow-digitgrowthorcompanieswill

seetheirsharepricecrashing,”Sahusaid.In

response,heexpectsthatmedtechswilllook

toacquireAI-basedtoolsthatcanhelpthem

differentiatethemselvestodefendtheirmarketposition.

Challenges

DespitebillionsofdollarsflowingintoAI,adoptionhurdlesremain.

MostFDA-clearedAI-enabledmedicaldevicesareconcentratedinradiologyandpathologytoenhanceimagequality,speedupworkflowor

improvediagnosticaccuracy.

“That’swhyGEandPhilipsandothercompanieslikethathavebeenleadersinthatspace,”

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IndustryExpertsExpectAI-DrivenMedtechM&AToContinueIn2025

Hughessaid,notingthatfromaregulatory

perspective,thereisnowmoreconvergenceon“howfarthe[USFoodandDrugAdministration]isallowingcompaniestopushthings.”

Also,“TheFDA,asmuchasitissayingtheir

reviewersarenowusingAItodoalltheirreviewsandeverythingelse,itisslowmoving,veryslowmoving,”Hughessaid.HealsopointedoutthatthemanychangesattheUSDepartmentof

HealthandHumanServicesoverthelastnineto12monthsalsodonotsupporta“l(fā)evelof

increasedapprovalswithintheFDA.”

InEurope,regulatorydistractionfromthe

MedicalDeviceRegulation(MDR)rollouthasbeguntoease,whichwillallowmedtechs

tofocusoninnovationagain,hesaid.Still,

reimbursementchallengesremainaheadwindforAI-enableddevices,Sahucautioned.

Withmedtechcompaniesexpectedtoinvest

upwardof$10bnannuallyintoAIby2025,

theindustryappearstobesetforfewerbut

higher-valuedealsasfirmsdoubledownon

technologiesthatcanprotectandexpandtheirmarketpositions.

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J&JSurvey:ClinicianBurnoutAnd

AgingPopulationsDriveDemandForAIAndRoboticsInFutureHealthCare

AGlobalPulseCheckFindsOptimismInAI,RoboticsAndData-DrivenSolutionsForAgingCare.

ShubhamSingh

ExecutiveSummaryAccordingtoasurveyofhealthcareprofessionalsbyJ&J,over

45%ofsurveyedrespondentsreportedexperiencingsymptomsofburnout,includingemotionalexhaustionandreducedsenseofpersonalaccomplishment.Thisaffectsnotjustclinicians,butalsothequalityandsafetyofcaretheydeliver.Mostclinicians(72%)saythatdataandtechnologycouldsignificantlyhelp

alleviatethisburden.

KeyTakeaways

?98%ofhealthcareproviderssaymedicaltechnologieswillbeessentialforearlydiseasedetection.

?Burnoutaffectsnearlyhalfofhealthcareworkers;72%ofthembelievetechnologycanhelp.

?94%ofcliniciansandnearly75%ofadultpatientssupportintegratingAIintocare.

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J&JSurvey:ClinicianBurnoutAndAgingPopulationsDriveDemandForAIAndRoboticsInFutureHealthCare

Ashealthcaresystemsworldwidebraceforthedemandsofanagingpopulationand

increasinglycomplexcareneeds,aglobal

surveycommissionedbyJohnson&Johnsonrevealsstrongoptimismaroundtheroleof

medicaltechnologyandartificialintelligence(AI)inreshapingthefutureofcare.

Theglobalsurvey,conductedacross11

countries,includedresponsesfromover

11,000adultsandnearly1,000healthcare

professionals.Itfoundthat89%ofsurveyedadultsand97%ofhealthcareprofessionalsconsideraddressingthehealthcareneedsofolderpopulationsanurgentissue.

Thelionshareofclinicians(98%)saidthattechinnovationwillbecriticalindetectingdiseaseatearlierstages,asentimentthatwassharedbymanysurveyedadultpatients(72%)who

expressedconfidencethatemergingtools,

particularlyroboticsandAI,willenhancecareforolderadults.

“Astheagingpopulationcontinuestogrow,

healthcaresystemsaroundtheworldface

increasingpressuretoprovidehigh-qualitycareforindividualswithcomplexneeds,”saidPeterSchulam,M.D.,Ph.D.,chiefscientificofficer,

Johnson&JohnsonMedTech.“WiththepowerofAI,datascienceandadvancedtechnology

we’remakingenormousstridesatJohnson&

Johnsontoprovidehealthcarepractitioners

withtheinnovativesolutionstheyneedto

improvepersonalizedpatientcareandreduceburnout.Theresultsfromsurveyslikethese

reinforcethatweareontherightpath,and

weareexcitedtocontinuedrivinginnovation

forwardforfuturegenerationsofpatientsandhealthcareprofessionals.”Withnearlythree

quartersofadultsexpressingexcitement

aboutAI’sgrowingroleinmedicineand94%ofclinicianscallingforitsintegration,technologyisnolongerseenasasupplementtocarebut

asanecessarypartnerinaddressingthetwinpressuresofrisingpatientloadsandworkforceburnout.

AgingPopulationsAndBurnout:TwoSidesOfTheSameCrisis

However,thesurveyalsopointedtochallenges.Aslifeexpectancyincreasesandpopulations

growolder,healthcaresystemsmustmanageahighervolumeofage-relatedconditionssuchasjointdeterioration,heartdisease,andneurodegenerativedisorders,withanever-shrinkingclinicalworkforce.

Burnoutamongphysicians,particularlythose

involvedindirectpatientcare,hasescalatedinrecentyears.Over45%ofclinicianssurveyed

reportexperiencingsymptomsofburnout,

includingemotionalexhaustionandreduced

senseofpersonalaccomplishment.Thisaffectsnotjustclinicianspersonally,butthequalityandsafetyofcaretheydeliver.Mostclinicians(72%)saythatdataandtechnologycouldsignificantlyhelpalleviatethisburden.

TrustInInnovation:FromAIToRobotics

Nearlyallclinicians(94%)advocateforthe

integrationofAIinclinicalworkflows.Among

thegeneraladultpopulation,closetothree

quartersexpressexcitementabouttheroleofAIinhealthcare.

Accordingtothesurvey,98%ofcliniciansagreethatmedicaltechnologycanhelpidentify

diseaseatearlierstages,aninsightthatcouldhelppivothealthcaresystemsfromreactivetopreventivecare.Meanwhile,90%believe

thatroboticswillimprovepatientoutcomes,particularlyinsurgicalandorthopedic

specialties.

“Theseinnovationsnotonlyenhancethe

qualityofcarebutalsoallowustoaddresstheuniquechallengesthatcomewithanaging

population,”saidKevinPerry,anorthopedic

surgeonatMayoClinic.“Integratingtechnologyintoourdailypracticehelpsreduceburnoutbyimprovingefficiencyandallowingustofocusonwhattrulymatters–patientcare.”

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J&JSurvey:ClinicianBurnoutAndAgingPopulationsDriveDemandForAIAndRoboticsInFutureHealthCare

“Asanorthopedicsurgeon,integrating

technologyintomypracticeiscrucialfor

deliveringhigh-quality,personalizedcare,”KevinPerrytoldMedtechInsight.“IrelyontheVELYSRobotic-AssistedSolutionforkneeandhip

replacements,whichenablesmetooperatewithgreaterprecision.Ithelpstailoreachproceduretoapatient’suniqueanatomy,improving

implantalignmentandplacement.Asaresult,patientsoftenexperiencebettersurgical

outcomesandfasterrecoveries.Infact,Inowuseroboticsexclusivelyforallkneesurgeries.”

“Withtherisingdemandfororthopedic

procedures–drivenbybothanaging

populationandyoungerpatientsneeding

jointreplacements–robotictechnologyalso

helpsmeimproveefficiencyandmanagea

highercaseload,”headded.“Thisisespecially

importantasmorepeopleseekaccesstotheselife-changingsurgeries.IstronglybelieveAIandroboticswillplayadefiningroleinthefutureofhealthcare.Whilewe,restillintheearlystagesofincorporatingthesetechnologiesintoeverydaypractice,educatinghealthcareprofessionalsontheirpotentialisessentialtorealizingtheirfull

benefitforpatients.”

PublicReadinessForData-DrivenHealthcare

Anessentialpieceofthepuzzleisthepublic’swillingnesstoengagewithtech-enabled

systems.Overthree-quartersofadultsgloballysaytheyarecomfortablesharingpersonal

healthdatatoenablemorepersonalizedtreatmentplans.

Foragingpatients,whooftenmanagemultipleconditionssimultaneously,dataintegration

offersthepossibilityofmorecoordinated,

tailoredcare.ItalsoopenspathwaysforearlierdetectionofdiseaseslikeAlzheimer’s,which

dependonsubtlesignalsthatcanbelostintraditionalcaremodels.

TrainingTheNextGeneration,Sustainably

Beyonddirectcare,technologyisalsobeing

viewedasalong-termsolutiontoworkforce

training.Amongsurveyedclinicians,94%

expressedthattheywouldfeelmoreoptimisticaboutthefutureofhealthcareiftechnologiescouldhelpstreamlinemedicalandsurgical

training.

Advancementsinsimulation,real-timedata

feedback,anddecision-supportAIarealreadybeingpilotedinvariousmarkets,butthe

appetiteforwiderimplementationisclearly

growing.Thisisparticularlyrelevantascountriesconfrontshortagesinkeyspecialtieslike

geriatrics,primarycare,andsurgery.

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GuidanceFeedbackHighlightsOutstandingQuestionsInAI

Development

ElizabethOrr

ExecutiveSummaryManyofthehundred-pluscommenterstotheFDA’sdraft

guidanceonAIinmedicalproductregulationsaidthe

documentwasagoodstartbutneededadditionalclarityandmoreconcreteexamples.Stakeholdersrecommendedthe

inclusionofcasestudies,metrics,andclearerguidelinesto

enhancetheutilityoftheguidance,whichisseenasavitalstepforAIintegrationinhealthcare.

AdditionalguidancefromtheUSFoodand

DrugAdministrationisneededtounlockthe

fullpotentialofartificialintelligenceinthe

developmentandregulationofdrugsandothermedicalproducts,stakeholderstoldtheagencyincommentstoaJanuarydraftguidance.

Morethan100stakeholdersrespondedto

“ConsiderationsfortheUseofArtificial

IntelligencetoSupportRegulatoryDecision-

MakingforDrugandBiologicalProducts”beforethecommentperiodclosedearlierthismonth.

Thedocumentprovidesarisk-basedassessment

KeyTakeaways

?StakeholdersurgetheFDAtoprovide

clearerguidelines,casestudies,and

riskmetricstoenhancetheutilityofitsdraftguidanceonAIinmedicalproductregulation.

?Transparency,lifecyclemanagement,

andstandardizedreferencedatasetsarecriticalareasneedingfurtherclarificationtoensureeffectiveAIintegrationin

healthcare.

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NavigatingAICompliance:

InsightsfromCalifornia’sLatestAdvisories

ElizabethOrr

ExecutiveSummaryRecentlegaladvisoriesonAIfromCaliforniaAttorneyGeneral

RobBontacouldpointtoaforthcomingenforcementcrackdownonfirmsthatfailtoprotectpatientdataorallowAItechnologiestomakemedicaldecisions.However,companiescanstayclearbyrememberingtoplaybytherulesofthehealthcaresector,

ratherthanthemorefreewheelingapproachoftech.

KeyTakeaways

?Companiesindigitalhealthmust

prioritizecompliancewithstricthealthcareregulations,includingpatient

dataconsentandcorporatepracticeofmedicinelaws,overgeneraltechindustryrules.

?State-specificAIregulations,likeCalifornia’s,mayincrease

administrativeburdensandchallengeinnovation,especiallyforsmallerfirmsandstart-ups.

CaliforniaisnotonlythelargeststateintheUSbypopulation;it’salsothefifthlargesteconomyintheworld.Assuch,Californiastateregulationsrapidlymakethemselvesfeltelsewhere.And

recentlegaladvisoriesonartificialintelligencefromstateAttorneyGeneralRobBontamaybenoexception.

On13January,Bontaissuedtwoadvisories:oneongenerallegalconcernsaroundAI

andanotherfocusedonthehealthcare

sector.Inadditiontotheapplicationof

longstandingconsumerprotection,privacyandantidiscriminationlawstoAI,theadvisoriesalsodiscussnewAI-specificstatelawsthatcame

intoeffecton1January.

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NavigatingAICompliance:InsightsfromCalifornia’sLatestAdvisories

SB1120,acrucialnewlawforthedevicesector,mandatesthatlicensedphysicianssuperviseAItoolsusedinhealthcareservicesandinsuranceclaims.Additionally,Californiaphysician

licensinglawstatesthat“onlyhumanphysicians(andothermedicalprofessionals)arelicensed

topracticemedicineinCalifornia”andthatrolecannotbedelegatedtoAIorotherdigitaltools.

Althoughthespecificcontentoftheseadvisoriesraisedfewconcernsinthemedicaldevice

sector,tradegroupsandotherswarnthatstate-specificlawscouldincreasetheadministrativeburdenfordevicefirms,slowinnovation,and

ultimatelyhurtpatients.

Inparticular,AdvaMedhastoldstate

governmentsthatregulationofhealthcare

AIshouldremainwiththeUSFoodandDrugAdministration,whichalreadyhasproceduresinplaceforevaluatingAIbothpre-andpost-market.

“Unlikemanyotherindustries,theuseofAI

inmedicaltechnologyisalreadysubjectto

strictregulationbytheFDA,whichincludes

rigorousreviewandassessmentofmitigationsagainstunwantedbias,”thetradegroupsaidincommentsfiledwiththeCaliforniastate

assembly.AdvaMedhasalsofiledsimilar

commentsinVirginia,Connecticut,Texasandelsewhere.

AIregulationsareonstatedocketsnationwide.Atleast45statesproposedAI-related

legislationin2024,and31passedthem,

saidLaurenRoth,aformerFDAassociate

commissionerforpolicywhorecentlybecameapartneratlawfirmKing&Spalding.Many

ofthesebillsspecificallyaddressdataprivacy,patientsafety,orotherhealthcare-related

topics.

Shesaidthatwhileshesympathizedwith

concernsaboutexcessiveorconflicting

regulationsbeingdevelopedonastate-by-state

basis,notallareascoveredbystatelawfallwithintheFDA’sremit.

“WhattheFDAislookingatiswhethermedicaldevicesgenerally,includingAI-enableddevices,aresafeandeffectivefortheirintendeduse,

andsothatparticularregulatorymandate

doesn’treallymapontowhattheCalifornia

AGisdescribinginthelegaladvisories,”she

said.“Thoseadvisoriesareaboutthepanoply

ofstatelaws,liketheunfaircompetitionlaw,

thecivilrights-relatedlawsandsomeofthe

newstatutesthatwerepassedrecentlybythe

CalifornialegislatureandwentintoeffectatthebeginningofJanuary.”

ThinkHealthCare,NotTechnology

Holland&KnightpartnerJohnVaughan,

meanwhile,toldMedtechInsightthatthe

advisoriesseemtoindicatethatBardaplanstostrictlyenforcelegallimitstotheuseofAI.

Thismeansthatdevelopersofdigitalhealth

technologiesdistributedinCalifornianeedto

makesuretheirregulatoryteamsattemptto

complywithhealthcareregulations,ratherthanonlythosegoverningtechnologies.

“Therearetrapsfortheunwaryinusinga

technologyproductforhealthcareapplicationswithoutunderstandingexactlywhichlaws

governthatconduct,assumingthattheproductitselfissomehownotsubjecttotheselaws,”

Vaughansaid.

“Ifit’spatientdataandyoudon’thave

appropriateconsenttouseit…you’relikelytobeoutofcompliancewithanumberofdifferentCalifornialaws.

JOHNVAUGHAN

Asanexample,hepointedtotheCaliforniaGeneticPrivacyInformationAct,whichhasstricterrulesgoverningconsentforAIuseof

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NavigatingAICompliance:InsightsfromCalifornia’sLatestAdvisories

patientdatathanthefederalHealthInsurancePortabilityandAccountabilityAct(HIPAA).

“Whenamanufacturerreceivesadataset,theyshouldfirstconsiderwhetherthatdataistheirs,”heexplained.“So,ifit’spatientdataandyou

don’thaveappropriateconsenttouseit…you’relikelytobeoutofcompliancewithanumberofdifferentCalifornialaws.”

Manufacturersalsoneedtoconsiderwhat

Vaughancalls“consentflow,”orthewaypatientconsentismonitoredthroughouttheuseofa

dataset.Forexample,apatientmightconsenttotheuseofAItohelpdiagnosewhethera

lesioniscancerousornot,withoutconsidering

whethertheirrecordswillthenbeusedtohelp

traintheAImodel.Intech,Vaughansaid,the

temptationistouseany“interestingdata”a

developercomesacross.Butinhealthcare,thepatientneedstobeabletowithdrawconsentforuseofthedataatanypoint.

“Makesurethatfromthetimeapatientgives

consentforherdatatobeuseduntiltheproductisfinishedthatthereisawaytotracethat

consent,becausethatisareallyeffectivewayformanufacturerstolimittheirlegalrisk,”hesaid.

DevelopersofhealthcareAImayalsobe

challengedbyCalifornialawsaroundthe

corporatepracticeofmedicine,whichrequire

medicaldecisionstobemadebyaphysician

ratherthanbyabusiness.Thelawsareintendedtohelpensuremedicaldecision-makingis

focusedonthepatient,ratherthanonprofits.

Whatthatmeans,Vaughansaid,isthatanyAI

tools,specificallytrainedtoreducehealthcarespending,mightbeseenasviolatingthelaw,

especiallyiftheyleadtosubparpatientcare,inwhathecalledanexampleofanoldlawbeingappliedtoanewtechnology.

“Thecorporatepracticeofmedicinelaw,whichisdesignedtomakesurethatdoctorsaren’t

makingdecisionsthatbenefitthecorporationinsteadofthepatient,andnowthey’re

applyingthattoasystemthatmakesdecisionsandlearnsonitsown,”hesaid.“That’snot

acceptableinthestateofCaliforniarightnow.”

Noneofthesourceswespoketowereaware

ofspecificFDA-clearedproductsthatreturna

diagnosisandtreatmentplanwithoutphysicianoversight.ButastheagencyhasclearedalmostathousanddevicesthatuseAIormachine

learning,it’sdifficulttonaildownthespecificsofeveryproductavailable.

VaughanexpectssmallandmidsizecompaniestofacethelargestchallengesincomplyingwithCalifornialaw,simplybecausetheymaynotbeawareofthevariedfacetsofthehealthcare

regulatorylandscape.Start-ups,hesaid,mightconceiveofatechsolutiontoahealthcare

problemwithoutthinkingthroughissuesarounddataprivacyorotherregulations.

“Folksreallyneedtobecarefulaboutnot

makingthecategoryerrorthatthey’reworkingintechnologywhentheconductinvolveshealthcare,”hesaid.“Becauseiftheconductinvolveshealthcare,ifitinvolveshelpingpatients,if

you’reusinghealthcaredatasets,you’reinthehealthcarebusiness,andthehealthcarelawsapplytoyou.You’renolongerjustatec