艾昆緯-將QARA定位為全球化中的市場準入職能 Positioning QARA as a Market Access Function in Globalization 2024

IQVIA

TECHNOLOGIES

ExecutiveSummary

PositioningQARAasaMarketAccessFunctioninGlobalization

EUAIAct’sGlobalRegulatoryImplicationsforMedicalDevices&QARA’sFuture

MIKEKING,SeniorDirector,Product&Strategy,IQVIA

ALEXDENOON,Partner,andHeadofLifeSciencesandRegulatoryTeam,BristowsLLP

SARAFAIRFIELD,AssociateDirector,RegulatoryAffiars,AbbVieIRINAERENBURG,CEO,AVAVA,Inc.

DANIELDEFRANCO,DirectorofQualityinMedicalDeviceManufacturing,BoydBiomedical,Inc.

CHRISTOPHERESCOBEDOHART,Partner,Co-Chair,PrivacyandDataSecurityGroup,FoleyHoagLLPLORIELLIS,HeadofInsights,BioSpace(Moderator)

Tableofcontents

Keytakeaways1

Overview1

Context1

TheEUAIActisinfluencingwhatproductsdeveloperschoosetodevelop1

TheEUAIActcreatesincreasedriskandburdenforsmallercompanies2

QARAprofessionalsneedtoprioritizeglobalizationasthetechnological2

regulatorylandscapeevolves

LoperBrightandCornerPostrulingscreateuncertaintythroughoutthe3

lifesciencesindustryintheUnitedStates

Companiesmustgetfamiliarwithcybersecurityactionplans4

Conclusion4

Abouttheauthor5

Keytakeaways

?TheEUAIActisinfluencingwhatproductsdeveloperschoosetodevelop.

?TheEUAIActcreatesincreasedriskandburdenforsmallercompanies.

?QARAprofessionalsneedtoprioritizeglobalizationasthetechnologicalregulatorylandscapeevolves.

?LoperBrightandCornerPostSupremeCourtrulingscreateuncertaintythroughoutthelifesciences

industryintheUnitedSates.

?Companiesmustgetfamiliarwithcybersecurityactionplans.

Overview

Withinthelastfewyears,AIhasmaderemarkable

stridesinthelifesciencesindustry.Asquicklyasthesestridesaremade,challengesarebecomingapparent.Asaresult,regulatorybodiesaredevelopingand

revisingregulationstoencompassnewrisksastheyarediscovered.Integratingqualityassuranceand

regulatoryaffairs(QARA)professionalsandteamsearlyoninmedicaldevicedevelopmentprocessesisimperativetonavigateaconstantlychanging

globalregulatoryenvironmentwhilesimultaneouslyaddressingincreasedcybersecurityrisks.

Context

AsregulationsandjudicialdecisionssuchastheEUAI

Act,LoperBrightandCornerStonecontinuetounfurl,

QARA’sroleisevolvingatarapidpace.Asaresult,

QARAdepartmentsmustnotonlybeintegratedwitheachotherbutintotheproductdevelopmentprocessattheearlieststages.Thisdiscussionfocusedon

challengeswithintheindustrythatQARAindividualsmustbepreparedtofacetocompeteinthefuture.

TheEUAIActisinfluencingwhatproductsdeveloperschoosetodevelop

Whilewell-intentioned,theEUAIActisgoingtobe

extremelychallengingformedtechandmedicaldevicedevelopers,atleastduringtheinitialdeployment

stages.Consequently,alargenumberofcompaniesfocusedondevelopingAIproductsarelookingtoleadwithdevelopmentoutsideofEurope.

“IfyoufallwithinthescopeoftheEUAIAct,thereisalotofterror

andalotofreluctancetodevelopinEurope.”

—AlexDennon,PartnerandHeadofLifeSciencesandRegulatoryTeam,BristowsLLP

Hehighlighted,however,thatalargenumberofAIdeploymentsforQARAsystemsandteamsdonotfallunderthescopeofEUAIAct.

Medicaldevicesmayoftenfallintothehigh-risk

categoryoftheEUAIAct.Fromapracticalperspective,ChrisChristopherEscobedoHart,partnerandco-

chairoftheprivacyanddatasecuritygroupatFoleyHoagLLP,stressedthatthepracticalrequirementsoftheEUAIAct“suchastransparencyrequirements,explainability,requirements,riskassessment

requirements,andthelikearegoingtocreatereal

burdensonorganizationsintermsoftheirgovernanceofthedataandworkingsofAIsystems.”

ThisisespeciallytroublingbecauseofthefearthattheEUAIActwillbeadoptedasdefactogovernancebeyondtheEU,aswehaveseenwiththeBrussels

effect.Beingtheworld’slargestsinglemarket,therulesdesignatedbytheEUareoftenadoptedbyothercountries.

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WhiletheUnitedStatesandEUhaveagreedto

collaborateinevaluatingAI,thereislittleconcernthattheUnitedStateswilladopttheEUAIActgovernancelargelyduetoprogressiveattitudethecountry

maintainstowardinnovation.Thatbeingstated,

thepanelistsdidnotethattheU.S.,aswithother

countries,willbefollowingtheprogressionoftheEUAIAct,evaluatingwhatworksandwhatdoesnotItis

expectedthattheUSwillhaveitsownsetofregulations.

TheEUAIActcreates

increasedriskandburdenforsmallercompanies

WhiletheEUAIActiscomplexforallmedicaldevice,invitro-diagnosticsandpharmacompanies,the

regulatoryenvironmentisparticularlydifficultfor

smallercompanies.IrinaErenburg,CEOofAVAVA,

Inc.,explainedtheconcernsshefacesassheleadshercompanythroughthenuancesofthelegislation.

Sheemphasizedthatthesequestionsneedtobeaddressedrapidlyenoughtoavoidparalyzinganorganizationfromriskaversion.

“Themajorityofmedtechcompaniesareactuallybuildingthemedical

sideofproducts,thisiswherethereexpertiseis.

Thereisanenormouslegalburden,there’sadatamanagementburden,andthere’satechburdensothe

questionsbecomewhoisresponsible

andwhentointroducerisk

managementintooperations.”—IrinaErenburg,CEO,AVAVA,Inc.

hurdleforsmallercompaniestotakeonthemselves.“Iftheyareatechormedtechcompanydevelopingsoftwareasamedicaldevice(SaMD)orsoftware

inamedicaldevice(SiMD)ordevelopingSaMDor

SiMDintegratedwithAI,thehurdlesquadruple,

consequentlymakingitevenharderforcompaniestogettheirproductstomarket.”

Subsequently,companieshavetomakehardchoices

outofpracticality.Denoonnotedthatthecurrent

trendisforcompaniestopartnerwithsomeone

who’salreadygottechnologyplatforms.Thedanger

here,however,isthat“theyhopeandpraythatthe

platformisgoodenough,ratherthanbeinggenuinelyverticallyintegrated,whichisrare,”Dennonsaid.“Theconsensusisthatcompaniesarebuyingmoreriskthanyouthoughtyouwereevenfiveyearsago.”

QARAprofessionalsneed

toprioritizeglobalizationasthetechnologicalregulatorylandscapeevolves

WhileEuropeandtheUnitedStatesmakeupthe

largesthealthcareandeconomicmarkets,focusingonthosetwomarketsalonewillnotleadcompaniestoglobalsuccess.Innovationrequiresglobal

infrastructure,whichcanbeproblematicforsmallercompaniesthatdependondifferentstakeholders.

Additionally,regulationsareoftenvagueandevolveasregulatorsworktoaddresstechnologicaladvances.

MikeKing,directorofproductandstrategyatIQVIA,advisedthatcompaniesproceedwithcaution.

“Whenreviewingtestingrequirements,languageisimportant.Asanexample,ifyougotoBrazil,thereis

BrazilianPortuguese,whichisdifferentfromPortugalPortuguese.”

KingfurtherexplainedthattheQARAroleneedstoevolveastechnologyandtheworkforcedo.

SarahFairfield,associatedirectorofregulatoryaffairsatAbbVie,addedthatadheringtoelectronicmedicaldevicereporting(eMDR)guidelinesisalreadyahuge

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“Ifyoulookattheupcoming

generationsofprofessionals,they’repoweredbyAItechnologies.

It’ssomethingthat’snaturally

embeddedintherisinggenerationswhohavegrownupnowwith

touchscreentechnologyformostoftheirconsciouslife.”

—MikeKing,SeniorDirector,Product&Strategy,IQVIA

AIempowersQARAprofessionalstolookbeyondhomeandtraditionalmarkets,butKingemphasizedthatweneedtoempowerthemwithenoughexperienceandeducationtolearntoasktherightquestionsaround

globalmarketizationandaroundrisk.

LoperBrightandCornerPostrulingscreateuncertaintythroughoutthelifesciencesindustryintheUnitedStates

AddingtoregulatorycomplicationsforQARA

professionalskeepingupwithglobalchangesaretworecentSupremeCourtdecisions:theLoperBrightrulingthatonJune28,2024,overturnedthelongstanding

doctrineknownasChevrondeferenceandtheCornerPostrulingannouncedonJuly1,2024.

UntiltheLoperBrightruling,courtsupheldChevron

deference,whichmadeitdifficulttooverturnagencyregulationsiftheywerechallengedjudicially.Courtswoulddefertoagencyinterpretationsofambiguousstatutorylanguage.TheLoperBrightrulingdeclaredthatlegaldeferenceisunconstitutionalandputstheinterpretationofstatutesintothehandsofthecourts.AsfortheCornerPostruling,itessentiallyremoves

thestatuteoflimitationsduringwhichacompany

canchallengeanagencyregulation.Previouslysetatsixyearsafteraregulationwascreated,CornerPost

changesthestatuteoflimitationstosixyearsafteracompanyisinjuredbyaregulation.

“Whatthatmeansisthatagencyinterpretations

ofstatutesasagencyregulationsthatdependon

interpretationsofstatutesarereallyupintheair,”Hartexplained.“They’reupforgrabsbecausecourtscan

nowfreelyoverturnagencydecisionmaking,”althoughhestatedthatthisdoesnotapplytoallsituations.

Withoutastatuteoflimitations,parentcompanies

cantheoreticallycreatenewcompaniessimplyforthepurposesofchallenginganagencyrule.

Asaconsequence,whathasbeensettledlawaboutagencyrulesnolongerapplies.Goingforward,

agenciesarelikelytobemorethoughtfulandcarefulaboutbringingrulesforcommentandnoticeprior

tofinalizingbecausetheycanbeeasilychallenged.Concerningtheregulatorychanges,Erenburgstated,“It’screatedsuchamorassinanenvironmentof

emergingtechnologythathonestlymostpeoplestilldon’tknowwhatisgoingtobeandhowit’sgoingtogetregulated.Soinsteadofjusthavingthestandardregulations,youhavealegalmorassthat’sbeing

createdbyoverturningstandardsthathavebeeninplaceforthatmanyyears,whichcreatesonemorelayerofriskasaleadertomakejudgmentcalls.It’sacompleteriskmanagementprocessatthispoint.”

Fromasmallercompanyperspective,DanielDeFranco,directorofqualityinmedicaldevicemanufacturingatBoydBiomedicalInc.,highlightedthatanychangeinfederalregulations“bringsalevelofattentiontous

thatwearenowforcedtobringinconsultants.We’renowforcedtogooutsideagencyandtopartnerwith

othercompaniestoensurethatwhatwe’redoingis

spotonbecausewejustweliveinaneraofworldthatwecan’toperateatthatlevel.”Heemphasizedthat

theneedforsmallercompaniestopartnerisgreat

becausehisqualityteamhasadifferentfocus,whichisverifyingtheendproductisgoingtothecustomerinthewayintended.“Wedon’thavethespecialiststocomeinandlookat,youknow,softwarevalidationandintegrationofAI.”

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Companiesmustget

familiarwithcybersecurityactionplans

Cybersecurityhasbeenonthemindsofeveryoneintheindustry—itgoeshandinhandastechnologyevolves.Asthisdiscussionwastakingplace,

companieswerestillrecoveringfromtheCrowdStrikeincident.Whileitwasnotanattack,theincidentitselfhighlightedhowvulnerablecompaniesare.

Duringthediscussion,Kinghighlightedthedangersoftheincidenttothelifesciencesandhealthcare

industries.“ThesoftwarewasdeemedlowriskbutnoneofuscouldgetintoourmachinesonFriday,”

heexplained.

TheseconddangerKingnotedisfarmorenefarious.“Atleastweknewithappened,”hesaidofthe

CrowdStrikeincident,incontrasttoapotential

cybersecurityattack.“Ifyou’vegotimagingsoftwareandyouareusingAIaspartofimagingsoftware

designedtohelpyoufindstagesofcancerthathasbeencompromisedwithoutyourknowledge,thereisthepotentialthatpeoplewillpassawayfrom

undiagnosedormisdiagnosedcancers.”

Dennonsuggestedthat“QARAprofessionalsget

familiarwiththeterminology,thestepsthatcanbe

taken,understandwhatstandardsapply,findan

ISOstandard,andtryandmarrythatupwithyour

insurance.”Cybersecurityisoneareawherecompanies

cannotcutcorners.However,Hartcautionedthat

thisisnotaseasyasonewouldthink.“Thereisan

increasingmultiplicityofregulatorycybersecurity

tools,butthey’renotnecessarilygoinginthesame

directionsoifyou’refollowinganindustrystandard,whichindustrystandardandwhythatoneinparticularbecomeimportantquestions.”

Erenburgexplainedthechallengesforcybersecurityinsuranceforsmallcompaniesarebecoming

increasinglyproblematic.“Theassessmentofthepoliciesisanightmarealone.Whattheydo[and]do

notcoverisactuallyaverychallengingpartofthe

analysis.”Tosomeextent,companiesmustdependonexperts,whichmayshiftrisktosomebodyelse.

Fairfieldstate