Digital Healthcare 2022

Definitivegloballawguidesofferingcomparativeanalysisfromtop-rankedlawyers DigitalHealthcare2022 China:Law&Practice AlanZhou,CharleneHuang,JennyChenandSylviaDongGlobalLawOffice practiceguides.chambers.com LawandPractice Contributedby: AlanZhou,CharleneHuang,JennyChenandSylviaDong GlobalLawOfficeseep.23 CHINA CONTENTS 1.DigitalHealthcareOverviewp.4 1.1DigitalHealthcare,DigitalMedicineandDigitalTherapeuticsp.4 1.2RegulatoryDefinitionp.4 1.3NewTechnologiesp.4 1.4EmergingLegalIssuesp.4 1.5ImpactofCOVID-19p.5 2.HealthcareRegulatoryEnvironmentp.5 2.1HealthcareRegulatoryAgenciesp.5 2.2RecentRegulatoryDevelopmentsp.6 2.3RegulatoryEnforcementp.7 3.Non-healthcareRegulatoryAgenciesp.8 3.1Non-healthcareRegulatoryAgencies,RegulatoryConcernsandNewHealthcare Technologiesp.8 4.PreventativeHealthcarep.8 4.1PreventativeVersusDiagnosticHealthcarep.8 4.2IncreasedPreventativeHealthcarep.8 4.3RegulatedPersonalHealthDataand UnregulatedFitnessandWellnessInformationp.9 4.4RegulatoryDevelopmentsp.9 4.5ChallengesCreatedbytheRoleofNon- healthcareCompaniesp.9 5.Wearables,ImplantableandDigestiblesHealthcareTechnologiesp.9 5.1InternetofMedicalThingsandConnected DeviceEnvironmentp.9 5.2LegalImplicationsp.10 5.3CybersecurityandDataProtectionp.10 5.4ProposedRegulatoryDevelopmentsp.10 6.SoftwareasaMedicalDevicep.10 6.1Categories,RisksandRegulationsSurroundingSoftwareasaMedicalDevice Technologiesp.10 7.Telehealthp.11 7.1RoleofTelehealthinHealthcarep.11 7.2RegulatoryEnvironmentp.12 7.3PaymentandReimbursementp.13 8.InternetofMedicalThingsp.13 8.1DevelopmentsandRegulatoryandTechnologyIssuesPertainingtotheInternetof MedicalThingsp.13 9.5GNetworksp.14 9.1TheImpactof5GNetworksonDigital Healthcarep.14 10.DataUseandDataSharingp.14 10.1TheLegalRelationshipBetweenDigital HealthcareandPersonalHealthInformationp.14 11.AIandMachineLearningp.16 11.1TheUtilisationofAIandMachineLearningin DigitalHealthcarep.16 11.2AIandMachineLearningDataUnderPrivacyRegulationsp.17 12.HealthcareCompaniesp.18 12.1LegalIssuesFacingHealthcareCompaniesp.18 13.UpgradingITInfrastructurep.18 13.1ITUpgradesforDigitalHealthcarep.18 13.2DataManagementandRegulatoryImpactp.18 CHINACONTENTS 14.IntellectualPropertyp.19 14.1ScopeofProtectionp.19 14.2AdvantagesandDisadvantagesofProtectionsp.20 14.3LicensingStructuresp.20 14.4ResearchinAcademicInstitutionsp.21 14.5ContractsandCollaborativeDevelopmentsp.21 15.Liabilityp.22 15.1PatientCarep.22 15.2Commercialp.22 16.HotTopicsandTrendsontheHorizonp.22 16.1HotTopicsThatMayImpactDigitalHealthcare intheFuturep.22 1.DIGITALHEALTHCAREOVERVIEW 1.1DigitalHealthcare,DigitalMedicineandDigitalTherapeutics Digitalhealthcare,digitalmedicineanddigitaltherapeuticsarenotlegaltermsdefinedinPeo-ple’sRepublicofChina(PRC)lawsandregula-tionsbutarefrequentlyreferredtoincommercialcontextsandindustrypolicies. Digitalhealthcareusuallyreferstohealthcaretechnologiesdevelopedbasedoninformationtechnologiesusedbyandforthepublicingen-eral,includinghealthcaremanagement,diseaseawareness,telemedicine,onlinesaleofpharma-ceuticalproductsandotherhealthcare-relatedactivitiesconductedthroughdigitalplatforms. Digitalmedicineusuallyreferstotheapplica-tionofinformationtechnologyintheprocessofdiagnosisandtreatment,whichcanonlybeper-formedbyqualifiedmedicalinstitutions. Digitaltherapeuticsusuallyreferstothesoft-ware-basedproductsthatareusedforthera-peuticinterventions,eitherasmonotherapyorincombinationwithotherconventionalmedicaltherapies.Suchproductsusuallyfallintothecategoryofmedicaldevices,andthereforearesubjecttoregulatoryadministrationtoensuretheirsafetyandefficacy. 1.2RegulatoryDefinition Digitalhealthcare,digitalmedicineanddigitaltherapeuticsarenotlegaltermsdefinedinPRClawsandregulationsbutarefrequentlyreferredtoincommercialcontextsandindustrypolicies.Nevertheless,shouldanyserviceorproductinthefieldsofdigitalhealthcareanddigitalmedi-cinefallintothecategoryofpharmaceuticals,medicaldevices,orbeusedforthediagnosisandtreatmentofhumandiseases,administrativeregulationscorrespondinglyapply. 1.3NewTechnologies Giventhebroadapplicationscopeofkeytech-nologiesandthefactthatdigitalhealthcareanddigitalmedicinearesometimesusedinter-changeablyinpractice,itwouldbedifficulttoaccuratelydistinguishbetweenthetwofields. Generallyspeaking,fordigitalhealthcare,keytechnologiesmayincludebigdatathatcanbeusedinpublichealthmonitoring,healthcarecostcontrol,andinternetofthingsandrelatedsen-sortechnology,globalpositioningsystem(GPS)technologyand5Gtechnologythatenablessmarthomeandeldercare,hospitalmanage-ment,telemedicine,etc. Fordigitalmedicine,keytechnologiesmayincludeartificialintelligence(AI)andmachinelearningthatarebeingusedforassisteddiag-nosisandtreatment,medicalimaging,etc. 1.4EmergingLegalIssues Thekeyemerginglegalissuesindigitalhealthmayincludethefollowing. RegulatoryFramework Digitalhealthcareactivities,basedondifferentscenarios,aregovernedby: •PRCphysicianpractisinglawsandtelemedi-cine-relatedregulations; •PRCdrugadministrativelawsandregulationsinrelationto