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1、C1anbcskiiitItCHAMBERSG1OBA1PRACTICEGUIDESDigita1Hea1thcare2023Definitiveg1oba11awguidesofferingcomparativeana1ysisfromtop-ranked1awyersChina:1aw&PracticeA1anZhou,Char1eneHuang,JennyChenandSy1viaDongG1oba11awOfficeCHINA1awandPracticeContributedby:A1anZhou1Char1eneHuang,JennyChenandSy1viaDongG1oba11a
2、wOfficeContents1. Digita1Hea1thcareOverviewp.61.1 Digita1Hea1thcare,Digita1MedicineandDigita1Therapeuticsp.61.2 Regu1atoryDefinitionp.61.3 NewTechno1ogiesp.61.4 Emerging1ega1Issuesp.61.5 ImpactofCOVID-19p.72. Hea1thcareRegu1atoryEnvironmentp.72.1 Hea1thcareRegu1atoryAgenciesp.72.2 RecentRegu1atoryDe
3、ve1opmentsp.82.3 Regu1atoryEnforcementp.93. Non-hea1thcareRegu1atoryAgenciesp.103.1 Non-hea1tcareRegu1atoryAgencies,Regu1atoryCOnCemSandNewHea1thcareTechno1ogiesp.104. PreventativeHea1thcarep.104.1 PreventativeVersusDiagnosticHea1thcarep.104.2 IncreasedPreventativeHea1thcarep.114.3 Regu1atedPersona1
4、Hea1thDataandUnregu1atedFitnessandWe11nessInformationp.114.4 Regu1atoryDeve1opmentsp.114.5 Cha11engesCreatedbytheRo1eofNon-hea1thcareCompaniesp.125. Wearab1es,Imp1antab1eandDigestib1esHea1thcareTechno1ogiesp.125.1 InternetofMedica1ThingsandConnectedDeviceEnvironmentp.125.2 1ega1Imp1icationsp.125.3 C
5、ybersecurityandDataProtectionp.125.4 ProposedRegu1atoryDeve1opmentsp.136. SoftwareasaMedica1Devicep.136.1 Categories,RisksandRegu1ationsSurroundingSoftwareasaMedica1DeviceTechno1ogiesp.137. Te1ehea1thp.147.1 Ro1eofTe1ehea1thinHea1thcarep.147.2 ReguIatoryEnvironmentp.157.3 PaymentandReimbursementp.15
6、CHINACONTENTS8. InternetofMedica1Thingsp.168.1 Deve1opmentsandRegu1atoryandTechno1ogyIssuesPertainingtotheInternetofMedica1Thingsp.169. 5GNetworksp.179.1 TheImpactof5GNetworksonDigita1Hea1thcarep.1710. DataUseandDataSharingp.1710.1 The1ega1Re1ationshipBetweenDigita1Hea1thcareandPersona1Hea1thInforma
7、tionp.1711. A1andMachine1earningp.1911.1 TheUti1isationofA1andMachine1earninginDigita1Hea1thcarep.1911.2 A1andMachine1earningDataUnderPrivacyRegu1ationsp.2012. Hea1thcareCompaniesp.2012.1 1ega1IssuesFacingHea1thcareCompaniesp.2013. UpgradingITInfrastructurep.2113.1 ITUpgradesforDigita1Hea1thcarep.21
8、13.2 DataManagementandRegu1atoryImpactp.2114. Inte11ectua1Propertyp.2214.1 ScopeofProtectionp.2214.2 AdvantagesandDisadvantagesofProtectionsp.2314.3 1icensingStructuresp.2314.4 ResearchinAcademicInstitutionsp.2414.5 ContractsandCo11aborativeDeve1opmentsp.2415. 1iabi1ityp.2515.1 PatientCarep.2515.2 C
9、ommercia1p.25Contributedby:A1anZhou,Char1eneHuang,JennyChenandSy1viaDong,G1oba11awOfficeG1oba11awOfficewasoneofthefirst1awfirmsinthePeop1e,sRepub1icofChina(PRC),withmorethan6001awyerspractisinginitsBeijing,Shanghai,ShenzhenandChengduoffices.Its1ifesciencesandhea1thcare(1&H)practicegroup,a1soknownasC
10、hina1ifeSciences&Hea1thcare1aw(C1H1)5isoneofthe1eadingadvisersinChina,havingprovided,one-stop,1ega1servicesforeverysectorofthe1&Hindustry,inc1udingR&D,c1inica1researchorganisations,pharmaceutica1s,biotechno1ogy,medica1devices,supp1yproducersanddistributors,hospita1sandotherhea1thcareprovidersandinve
11、stmentfunds.G1Oadvisesc1ientsoncha11enging1&H1ega1issuessuchasregu1atorycomp1iance,structuringtransactionsandcontractua1arrangements,rea1isationofpipe1ineandgeographicexpansions,capita1-raisingandproject-financing,M&A,reorganisations,IPprotection,1icensinganddistributionarrangements,sett1ementofdisp
12、utesinvo1vingadverseeffectsinc1inica1tria1sandmedica1treatment.Thefirmhasc1ose1inkstoindustria1associationsandmakesrecommendationsonindustrycodesofconductandcomp1iancemanagementstandards.AuthorsA1anZhouistheheadof1ifesciencesandhea1thcare(1&H)practiceofG1oba11awOfficeandtheheadofChina1ifeSciences&He
13、a1thcare1aw(C1H1).Hehasbeenrecognisedasapioneerinprovidingoutstanding1ega1consu1tingservicesinthe1&Hpractice.A1anhasroutine1yrepresentedmu1tinationa1corporations,we11-knownChinesestate-ownedandprivateenterprises,andprivateequity/venturecapita1fundsinthe1&Harea.Hehasbeenengagedby1oca1authoritiesandin
14、dustria1associationstoadviseon1egis1ationandindustria1standardsinthe1&Hindustry,areasofwhichinc1udee-hea1thcare,medica1insurancereform,medica1representativeadministration,andothercomp1ianceissues.Hehaswonnumerousawardsandhasbeenrecognisedbypeersforhisexpertise,andiswide1ypub1ishedbothinChinaandinter
15、nationa11y.Char1eneHuangisapartnerbasedinG1oba11awOffice,sShanghaioffice,within-depthexperienceinM&Aandcross-border1icencedea1s,especia11yinthesectorofhea1thcareand1ifesciences.Shehas1edprojectsinvo1vingoutboundandinboundinvestment,acquisitionofstate-ownedandprivateequity/assets,pipe1ineconso1idatio
16、norrestructuringofMNCs,andvarious1icenceorco11aborationdea1sinthepharmaceutica1,medica1deviceandmedica1servicessectors.Sheregu1ar1yprovidessupportandadviceonprojectsconcerningce11therapy,genetherapy,digita1hea1thcare,medica1A11etc.Char1enea1sohasin-depthexperienceadvisingmu1tinationa1companiesingenera1corporate,cybersecurit
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