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HowtheEUAIActisReshapingMedtechinEMEA
Alphasense
Alphasense
What’sInside
1Introduction
3CHAPTER1
ANeedforNewRules
5CHAPTER2
UnderstandingtheAIAct
7CHAPTER3
RiskClassi?cationUndertheAIAct
11CHAPTER4
ExistingRegulationOverlapswiththeAct
15CHAPTER5
StayonTopoftheEvolvingAILandscapewithAlphaSense
17CHAPTER6
LookingForward
Alphasense
Introduction
SincetheCOVID-19pandemicgrippedtheworld,globalmedical
marketshavehadtodramaticallyreinventthemselvestowithstandanumberofunpredictableandvolatileevents.In2020,once
unshakeablesupplychain-ef?ciencystoodatastandstillinthewake
ofworldwidelockdowns.Newgeopoliticalconlictsthataroseafterthepandemic’sinception(e.g.,Russia-Ukrainewar,Israel-
Palestineconlict,etc.)posedthechallengeofprovidinglife-saving
medicalcareinthemidstofwarfare.Likewise,demandforchronic
conditionstreatmentsskyrocketed.Thebottomline:innovationwithin
healthcarewasdesperatelyneeded,astraditionalorexistingmedicalinterventionwasfallingshort.
Cuearti?cialintelligence(AI)andthequick-pacerolloutofgenerative
AI(genAI).Inamatterofmonths,thistechnologyreimaginedhowdrugdiscovery,RD,massivedataanalysis,vaccinedevelopment,
andmuchmorecouldbeconductedmoreef?cientlyandeffectively.ExcitementremainspalpableforgenAIasresearchersandmedtech
developerswieldittoful?lloncetedious,time-consumingprocesses.
However,thisexcitementhasledtosomespeculationaboutwherethistechcouldbetroublesomefortheentireindustry.
ToputparametersaroundtheuseofAIinhealthcareandquash
qualmsofpotentialprejudicialbiasorprivacyrisksassociatedwithit,theEUrecentlyintroducedtheArti?cialIntelligen
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