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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.
|1
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
2|PositioningQARAasaMarketAccessFunctioninGlobalization
“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.”
|3
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
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