2024欧盟人工智能法案对欧洲中东和非洲地区医疗科技领域的影响分析报告 How the EU AI Act is Reshaping Medtech in EMEA.docx

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