数字健康中国篇（英）-26正式版-WN8

CHAMBERSGLOBALPRACTICEGUIDES

DigitalHealthcare2024

Definitivegloballawguidesoffering

comparativeanalysisfromtop-ranked

lawyers

China:Law&Practice

AlanZhou,CharleneHuang,

JennyChenandStephanieWang

GlobalLawOffice

CHINA

LawandPractice

Contributedby:

AlanZhou,CharleneHuang,JennyChenandStephanieWangGlobalLawOffice

Contents

1.DigitalHealthcareOverviewp.6

1.1DigitalHealthcare,DigitalMedicineandDigitalTherapeuticsp.6

1.2RegulatoryDefinitionp.6

1.3NewTechnologiesp.6

1.4EmergingLegalIssuesp.6

2.HealthcareRegulatoryEnvironmentp.72.1HealthcareRegulatoryAgenciesp.72.2RecentRegulatoryDevelopmentsp.7

2.3RegulatoryEnforcementp.9

3.Non-healthcareRegulatoryAgenciesp.10

3.1Non-healthcareRegulatoryAgencies,RegulatoryConcernsandNewHealthcareTechnologiesp.10

4.PreventativeHealthcarep.10

4.1PreventativeVersusDiagnosticHealthcarep.10

4.2IncreasedPreventativeHealthcarep.11

4.3RegulatedPersonalHealthDataandUnregulatedFitnessandWellnessInformationp.11

4.4RegulatoryDevelopmentsp.11

4.5ChallengesCreatedbytheRoleofNon-healthcareCompaniesp.11

5.Wearables,ImplantableandDigestiblesHealthcareTechnologiesp.125.1InternetofMedicalThingsandConnectedDeviceEnvironmentp.12

5.2LegalImplicationsp.12

5.3CybersecurityandDataProtectionp.12

5.4ProposedRegulatoryDevelopmentsp.12

6.SoftwareasaMedicalDevicep.13

6.1Categories,RisksandRegulationsSurroundingSoftwareasaMedicalDeviceTechnologiesp.13

7.Telehealthp.14

7.1RoleofTelehealthinHealthcarep.14

7.2RegulatoryEnvironmentp.15

7.3PaymentandReimbursementp.15

8.InternetofMedicalThingsp.15

8.1DevelopmentsandRegulatoryandTechnologyIssuesPertainingtotheInternetofMedicalThingsp.15

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9.5GNetworksp.16

9.1TheImpactof5GNetworksonDigitalHealthcarep.16

10.DataUseandDataSharingp.17

10.1TheLegalRelationshipBetweenDigitalHealthcareandPersonalHealthInformationp.17

11.AIandMachineLearningp.19

11.1TheUtilisationofAIandMachineLearninginDigitalHealthcarep.19

11.2AIandMachineLearningDataUnderPrivacyRegulationsp.20

12.HealthcareCompaniesp.20

12.1LegalIssuesFacingHealthcareCompaniesp.20

13.UpgradingITInfrastructurep.2113.1ITUpgradesforDigitalHealthcarep.21

13.2DataManagementandRegulatoryImpactp.21

14.IntellectualPropertyp.2214.1ScopeofProtectionp.22

14.2AdvantagesandDisadvantagesofProtectionsp.23

14.3LicensingStructuresp.23

14.4ResearchinAcademicInstitutionsp.24

14.5ContractsandCollaborativeDevelopmentsp.24

15.Liabilityp.25

15.1PatientCarep.25

15.2Commercialp.25

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Contributedby:AlanZhou,CharleneHuang,JennyChenandStephanieWang,GlobalLawOffice

GlobalLawOfficewasoneofthefirstlawfirms

inthePeople’sRepublicofChina(PRC),with

morethan600lawyerspractisinginitsBeijing,

Shanghai,ShenzhenandChengduoffices.

Itslifesciencesandhealthcare(L&H)group,

alsoknownasChinaLifeSciences&Health-

careLaw(CLHL),isoneoftheleadingpractice

groupsinChina,asitprovides“one-stop”legal

servicesforeverysectoroftheL&Hindustry,

includingR&D,clinicalresearchorganisations,

pharmaceuticals,biotechnology,medicalde-

vices,supplyproducersanddistributors,hos-

pitalsandotherhealthcareproviders,andin-

vestmentfunds.GLOregularlyadvisesclients

onchallengingL&Hlegalissuessuchasregu-

latorycompliance,structuringtransactionsand

contractualarrangements,realisationofpipe-

lineandgeographicexpansions,capital-raising

andproject-financing,M&A,reorganisations,IP

protection,licensinganddistributionarrange-

ments,settlementofdisputesinvolvingadverse

effectsinclinicaltrialsandmedicaltreatment.

Thefirmhascloselinkstoindustrialassocia-

tionsandmakesrecommendationsonindustry

codesofconductandcompliancemanagement

standards.

Authors

AlanZhouistheheadoflife

sciencesandhealthcare(L&H)

practiceofGlobalLawOffice

andtheheadofChinaLife

Sciences&HealthcareLaw

(CLHL).Hehasbeenrecognised

asapioneerinprovidingoutstandinglegal

consultingservicesintheL&Hpractice.Alan

hasroutinelyrepresentedmultinational

corporations,well-knownChinesestate-owned

andprivateenterprises,andprivateequity/

venturecapitalfundsintheL&Harea.Hehas

beenengagedbylocalauthoritiesand

industrialassociationstoadviseonlegislation

andindustrialstandardsintheL&Hindustry,

areasofwhichincludee-healthcare,medical

insurancereform,medicalrepresentative

administration,andothercomplianceissues.

Hehaswonnumerousawardsandhasbeen

recognisedbypeersforhisexpertise,andis

widelypublishedbothinChinaand

internationally.

CharleneHuangisapartner

basedinGlobalLawOffice’s

Shanghaioffice,within-depth

experienceinM&Aandcross-

borderlicencedeals,especially

inthesectorofhealthcareand

lifesciences.Shehasledprojectsinvolving

outboundandinboundinvestment,acquisition

ofstate-ownedandprivateequity/assets,

pipelineconsolidationorrestructuringof

MNCs,andvariouslicenceorcollaboration

dealsinthepharmaceutical,medicaldevice

andmedicalservicessectors.Sheregularly

providessupportandadviceonprojects

concerningcelltherapy,genetherapy,digital

healthcare,medicalAI,etc.Charlenealsohas

in-depthexperienceadvisingmultinational

companiesingeneralcorporate,cybersecurity,

anddatamanagement.

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JennyChenisapartnerin

GlobalLawOfficebasedin

Shanghai,anattorneyatlawin

thePRCandCaliforniaUS,a

certifiedfraudexaminerofUS

ACFE,acertifiedpublic

accountant(non-practising).Shefocusesher

practiceoncompliance,government

investigation,internalinvestigationanddata

security.Jennyiswellversedinconducting

investigationsinconnectionwithanti-

corruption(USFCPAandUKBriberyAct),

financialfrauds,occupationalembezzlement,

self-dealingandtradesecrets.Jennyhas

extensiveexperienceincybersecurityanddata

compliance.Shehashandledmultiplelarge-

scaleprojectsine-discovery,cross-border

dataprotectionandsecurity,andsensitive

informationreview.

StephanieWangisanof

counselinGlobalLawOffice

basedinShanghai.Shehas

beenactivelyinvolvedin

advisingmultinational

pharmaceuticalandmed-tech

companiesontheircorporategovernance,

dailyoperations,andcompliance.Stephanie

hasextensiveknowledgeandexperienceinthe

lifesciencesandhealthcareindustry,and

routinelyadvisesclientsonavarietyof

commercialagreementsrelatingtoR&D,

licensing,marketingauthorisationsandthe

manufacturing,distributionandpromotionof

medicalproducts.Shehasalsoworkedwith

notableprivateequityinstitutionson

investmentinvariouspharmaceutical

enterprises.

GlobalLawOffice

35th&36thFloorShanghaiOneICC

No.999MiddleHuaiHaiRoad

XuhuiDistrictShanghai200031

China

Tel:+862123108200

Fax:+862123108299

Email:Alanzhou@

Web:

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1.DigitalHealthcareOverview

1.1DigitalHealthcare,DigitalMedicine

andDigitalTherapeutics

Digitalhealthcare,digitalmedicineanddigital

therapeuticsarenotlegaltermsdefinedinPeo-

ple’sRepublicofChina(PRC)lawsandregula-

tions,butarefrequentlyreferredtoincommer-

cialcontextsandindustrypolicies.

Digitalhealthcareusuallyreferstohealthcare

technologiesdevelopedbasedoninformation

technologiesusedbyandforthepublicingen-

eral,including:

serviceorproductinthefieldsofdigitalhealth-

careanddigitalmedicinefallwithinthecategory

ofpharmaceuticalsormedicaldevices,orbe

usedforthediagnosisandtreatmentofhuman

diseases,administrativeregulationswouldcor-

respondinglyapply.

1.3NewTechnologies

Giventhebroadapplicationscopeofkeytech-

nologiesandthefactthatdigitalhealthcare

anddigitalmedicinearesometimesusedinter-

changeablyinpractice,itissometimesdifficult

toaccuratelydistinguishbetweenthetwofields.

•healthcaremanagement;

•diseaseawareness;

•telemedicine;

•onlinesaleofpharmaceuticalproducts;and

•otherhealthcare-relatedactivitiesconducted

throughdigitalplatforms.

Digitalmedicineusuallyreferstotheapplica-

tionofinformationtechnologyintheprocessof

diagnosisandtreatment,whichcanonlybeper-

formedbyqualifiedmedicalinstitutions.

Fordigitalhealthcare,keytechnologiesmay

include:

•bigdatathatcanbeusedinpublichealth

monitoring;

•healthcarecostcontrol;and

•theinternetofthingsandrelatedsensor

technology,globalpositioningsystem(GPS)

technology,blockchaintechnology,cloud

computingand5Gtechnologythatenables

smarthomeandeldercare,hospitalmanage-

ment,telemedicine,etc.

Digitaltherapeuticsusuallyreferstothesoft-

ware-basedproductsthatareusedforthera-

peuticinterventions,eitherasmonotherapyor

incombinationwithotherconventionalmedical

therapies.Suchproductsusuallyfallwithinthe

categoryofmedicaldevices,andthereforeare

subjecttoregulatoryadministrationtoensure

theirsafetyandefficacy.

Fordigitalmedicine,keytechnologiesmay

includeartificialintelligence(AI)andmachine

learningusedforassisteddiagnosisandtreat-

ment,medicalimaging,etc.

1.4EmergingLegalIssues

Keyemerginglegalissuesindigitalhealthmay

includethefollowing.

1.2RegulatoryDefinition

Aspreviouslystated,digitalhealthcare,digital

medicineanddigitaltherapeuticsarenotlegal

termsdefinedinPRClawsandregulations,but

arefrequentlyreferredtoincommercialcontexts

andindustrypolicies.Nevertheless,shouldany

RegulatoryFramework

Digitalhealthcareactivities,basedondifferent

scenarios,aregovernedby:

•PRCphysicianpractisinglawsandtelemedi-

cine-relatedregulations;

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•PRCdrugadministrativelawsandregulations

inrelationtoonlinesaleofpharmaceutical

products;

•PRCadvertisinglaws;

•PRClawsandregulationsoncybersecurity

anddataprotection;and

•PRClaws,regulationsandindustrystand-

ardsontelecommunicationsandinformation

technology.

However,aunifiedandsystematiclaworregula-

tiontospecificallygovernthedigitalhealthcare

industryisstillunderdevelopment.

CybersecurityandDataProtection

Asdigitalhealthinvolvesalargeamountofper-

sonaldata,especiallythatofasensitivenature,

thedesignandimplementationoflife-cyclepro-

tectionofsuchdataneedstobecarefullycon-

sidered,underthecybersecurityandprivacy

protectionlawsandregulations–particularly

theregulationsofthePRCPersonalInformation

ProtectionLaw(PIPL),whichcameintoeffecton

1November2021.

Liability

AsAItechnologiesaremorefrequentlyusedin

diagnosisandtreatmentbyhealthcareinstitu-

tions,incircumstanceswherepersonaldamages

arecausedtopatientsduetotheapplicationof

suchtechnologies,whichpartyshouldassume

responsibilityneedstobefurtheranalysed.

2.HealthcareRegulatory

Environment

2.1HealthcareRegulatoryAgencies

Theauthoritiesinvolvedintheregulationofdigi-

talhealthcaretechnologiesmainlyincludethe

following,atanationallevel,andtheirsubordi-

natebranchesasapplicable.

TheNationalMedicalProducts

Administration(NMPA)

TheNMPAregulatesdrugs,medicaldevices

andcosmeticsinChina,andisresponsiblefor

theirsafety,supervision,andmanagement,from

registrationandmanufacturingtopost-market

riskmanagement.Technologiesanddevices,

includingsoftwarethatfallswithinthecategory

ofpharmaceuticalsormedicaldevices,arealso

subjecttoregulationandsupervisionbythe

NMPAanditssubordinatebranches.

TheNationalHealthCommission(NHC)

TheNHCprimarilyformulatesandenforces

nationalhealthpoliciesandregulationsper-

tainingtohealthcareinstitutions,healthcare

services,andhealthcareprofessionals(HCPs).

Internet-baseddiagnosisandtreatment(includ-

inginternethospitals)andremoteconsultations

betweenhealthcareinstitutionsandpatientsare

bothsupervisedbytheNHC.

Theclinicalapplicationofmedicaltechnolo-

giesforthepurposeofdiagnosisandtreatment

(includingAI-assisteddiagnosisandtreatment)

byhealthcareinstitutionsandprofessionalsis

alsounderthesupervisionoftheNHC.

TheNationalHealthcareSecurity

Administration(NHSA)

TheNHSAisprimarilyresponsibleforimple-

mentingpoliciesrelatedtobasicmedicalinsur-

ance(BMI),suchasreimbursement,pricingand

theprocurementofdrugs,medicalconsumables

andhealthcareservices.

2.2RecentRegulatoryDevelopments

RegulatoryDevelopmentsonTelemedicine

“InternetPlusHealthcare”–ie,healthcarein

combinationwithapplicationoftheinternet–is

nowakeynationalstrategyinChina.Toregulate

diagnosisandtreatmentprovidedremotely–ie,

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teleconsultationbyHCPsorinternet-baseddiag-

nosis–inJuly2018theNHCandtheNational

AdministrationofTraditionalChineseMedicine

(NATCM)issued:

•theAdministrativeMeasuresforInternet-

basedDiagnosis(forTrialImplementation)

(the“IDM”);

•theAdministrativeMeasuresforInternetHos-

pitals(forTrialImplementation)(the“Internet

HospitalMeasures”);and

•theGoodPracticesforTelemedicineServices

(forTrialImplementation)(the“RulesonTel-

emedicine”).

Furthermore,theNHCandtheNATCMreleased

theRulesfortheRegulationofInternet-based

Diagnosis(forTrialImplementation).

Thesemeasuresclarifyhowtechnicalsupport

oninternet-baseddiagnosisandtreatment

shouldbeconductedandsetforththeregula-

toryrequirementsthereof.

Inaddition,thegrowthofinternet-baseddiagno-

sisalsoboostedthedemandforinternetsales

ofmedicine.TheProvisionsforSupervisionand

AdministrationofOnlineDrugSalesandtheCir-

cularonRegulatingtheDisplayofOnlineSales

InformationofPrescriptionDrugsenactedin

recentyearsstipulatedthat,exceptformedicinal

productssubjecttospecialadministration,inter-

netsalesofbothover-the-counterdrugsand

prescriptiondrugsareallowed.Nevertheless,it

iscrucialforthird-partyplatformsandenterpris-

esengaginginonlinedrugsalestocomplywith

relevantrequirementsfordisplayinformationon

theonlinesalesofprescriptiondrugs.

RegulatoryDevelopmentsonElectronic

MedicalInsurance

InAugust2019,theNHSAissuedthe“Inter-

netPlus”MedicalServicePricesandMedical

InsurancePaymentPolicyandlaunchedthe

electronicmedicalinsurancesystem,which

regulatespricesandinsurancepoliciestoallow

forinternet-basedhealthcareservicestobe

coveredbyChina’smedicalinsurancesystem.

Implementationpolicieswerefurtherissuedin

2020andlocalenforcementruleshavebeen

graduallyissuedbylocalauthoritiessince2021.

RegulatoryDevelopmentsonAI-Assisted

DiagnosisandTreatment

InFebruary2017,theNHCissuedupdated

administrationregulationsonbothAI-assisted

diagnosistechnologyandAI-assistedtreatment

technology,togetherwiththeapplicablequality

controlcriteriaforclinicalapplication,reflect-

ingthemostrecentregulatorypositionofthe

NHCtoencourage,whilestrictlyregulating,the

developmentandcybersecurityapplicationof

AI-assisteddiagnosisandtreatmentforsafety

considerations.

In2019,theNMPAissuedtheKeyConsidera-

tionsforReviewofMedicalDeviceSoftware

UsingDeepLearningTechnologyforAssisted

Decision-Making,layingoutitsconcernsforreg-

istrationreviewoftherelevantmedicaldevice

software,includingsoftwaredevelopment,soft-

wareupdatesandrelatedtechnicalconsidera-

tions.In2021and2022respectively,theNMPA

issuedtheGuidingPrinciplesfortheClassifica-

tionandDefinitionofAIMedicalDevices,and

theGuidingPrinciplesforRegistrationReview

ofAIMedicalDevices,thelatterlayingoutthe

applicationrequirementsandtechnicalreview

standardofAImedicaldevices.In2022,the

NMPAissuedaseriesofindustrystandards

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relatedtothequalityrequirementsandevalua-

tionofAImedicaldevices.

RegulatoryDevelopmentsonDataProtection

InJuly2018,theNHCissuedtheAdministra-

tiveMeasuresontheStandards,Securityand

ServicesregardingNationalHealthcareBig

Data(the“MeasuresonHealthcareBigData”),

announcingthedirectionofregulatingtheuse

andapplicationofthehealthcare-relateddata

fromacomplianceperspective,andimplement-

ingindustry-specificdataprotectionrequire-

ments.InDecember2020,arecommended

nationalstandard,theInformationSecurityTech-

nology–GuideforHealthcareDataSecuritywas

releasedtoprovidecomprehensiveguidelinesin

protectinghealthcaredata,particularlyconsider-

ingtherapiddevelopmentofdigitalhealthcare.

Additionally,inApril2021,theNHSAissuedthe

GuidingOpinionsonStrengtheningNetwork

SecurityandDataProtection,whichrequires

theestablishmentofamoresolidfoundationfor

networksecurityanddataprotectionmecha-

nismsindigitalmedicalinsuranceanddigital

healthcare.

Fromageneralperspective,followingtwo

importantdataprotectionlawswhichtookeffect

in2021,thePIPLandthePRCDataSecurity

Law,aseriesofmeasuresandguideshavebeen

promulgatedsince2022regardingdetailedreg-

ulationsondataprotection,securityassessment

measuresandtheexecutionofstandardcon-

tractsforcross-borderdatatransfer.

withitsPRCestablishedorcontrolledentities

areonlypermittedtouseChineseHGRupon

filing/approvedbytheHGRauthorityandare

prohibitedfromcollection,storage,andcross-

bordertransferoftheHGR.

2.3RegulatoryEnforcement

Currently,thekeyareasofregulatoryenforce-

mentindigitalhealthcareincludecybersecurity,

personaldataprotection,andinternet-based

diagnosisandtreatment(includinginternethos-

pitals).

Intermsofcybersecurity,theimplementation

oftheMulti-LevelProtectionScheme(MLPS),

whichisacompulsorylegalobligationunder

thePRCCybersecurityLawandrelevantregu-

lations,isnowbecominganenforcementfocus

formostindustriesinvolvingsensitiveinforma-

tion–particularlyhealthcare.

TheMLPSiscomposedofaseriesoftechnical

andorganisationalstandardsandrequirements

thatneedtobefulfilledbyallnetworkoperators

inChina.Asthedevelopmentandoperationof

digitalhealthcareheavilyreliesonnetworksand

ITinfrastructure,itiscriticalfordigitalhealthcare

providerstoenforceandcompletetheMLPS

gradingprocess.PursuanttotheIDMandthe

InternetHospitalMeasures,healthcareinstitu-

tionsprovidinginternet-baseddiagnosisser-

vicesandinternethospitalsshallbegradedand

protectedasGradeIIIundertheMLPSregime.

FailuretocompletetheMLPSwouldleadto

administrativepenaltiesincludingwarningsand

finesissuedbythePublicSecurityBureau(PSB).

Especially,humangeneticresourcessamples

anddata(HGR)areprimarilygovernedbythe

BiosecurityLaw,theAdministrativeRegula-

tiononHumanGeneticResources(the“HGR

Regulation”),alongwithitsimplementationrules

newlyissuedin2023.Notably,foreignparties

Intermsofpersonaldataprotection,relevant

dataprotectionauthoritiessuchastheCyber-

spaceAdministrationofChina(CAC),theMin-

istryforIndustryandInformationTechnology

(MIIT)andthePSBhavebeenactivelyenforcing

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personaldataprotectionrequirementsacross

industries,includinghealthcare.Industrysuper-

visionauthoritiessuchastheNHCandthe

NHSAarealsoinvolvedinthoseenforcement

actionsonhealthcareinstitutions.

•recordingfilingandapprovalofInternetCon-

tentProviders(ICPs);and

•formulatingpoliciesandstandardsondata

security,etc.

3.Non-healthcareRegulatory

Agencies

3.1Non-healthcareRegulatory

Agencies,RegulatoryConcernsandNew

HealthcareTechnologies

TheCyberspaceAdministrationofChina

TheCACisresponsiblefortheoverallplanning

andco-ordinationofnetworksecurityandrel-

evantsupervisionandadministration.Interms

ofdigitalhealthcare,theCAC’sinvolvementmay

includeregulatingthecollectionandutilisation

ofpersonalinformation,cross-bordertransferof

healthcaredata,andthecybersecurityreviewof

internethospitals,etc.

Intermsofdigitalhealthcare,theMIIT’sinvolve-

mentmayincluderegulatingrelatedtechnol-

ogydevelopment,suchasthedevelopmentof

andsecurityrequirementsforAItechnology.In

addition,theMIITactivelyleadspersonaldata

protectioncampaignsonmobileapplications,

includingappsusedinthehealthcareindustry.

NationalDataBureau

ItisnoteworthythattheNationalDataBureau

(NDB)wasofficiallyinauguratedon23October

2023toco-ordinatetheimprovementofdata

infrastructuresystems–includingthedevelop-

ment,utilisationandinteractionofdataresourc-

es,andpushingforwardthebuildingofdigital

China.Therefore,itisexpectedthattheNDBwill

playcertainroleindataprotectionenforcement

regardingdigitalhealthcare.

ThePublicSecurityBureau

Intermsofcybersecurity,thePSBismainly

responsibleforenforcingtheMLPSandinves-

tigatingcybercrimes.Withrespecttodigital

healthcare,thePSB’sinvolvementincludes:

•recordfilingandinspectionsrelatedto

MLPSsofhealthcareinstitutions(including

internethospitals);and

•investigatingcrimes,suchastheinfringement

ofpersonaldataandillegalaccesstoinfor-

mationsystems.

MinistryforIndustryandInformation

Technology

TheMIITisresponsiblefor:

•regulatingtheinformationtechnologyand

communicationsindustry;

4.PreventativeHealthcare

4.1PreventativeVersusDiagnostic

Healthcare

Preventativecareisnotalegaltermdefinedin

PRClawsandregulationsandcanbeinterpreted

broadly.Inpractice,ifapreventativecarecon-

cernsgeneralhealthcareconsulting,eldercare,

nursery,massage,fitnessorwellness,without

makingjudgementaboutdiseasesorgivingtar-

getedrecommendationstowardsspecifichealth

issuesorconditions,itmaynotfallwithinthe

definitionofdiagnosisandtreatmentandthus

willnotbesubjecttospecialregulation.Onthe

otherhand,ifapreventativecarefallswithinthe

areaofdiagnosisortreatmentactivities(eg,dis-

easescreeningorvaccination),itcanonlybe

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performedbyaqualifieddoctorinamedical

institution.

UtilisationofAIandMachineLearninginDigital

Healthcare.

4.2IncreasedPreventativeHealthcare

Nationalpoliceshaveheightenedtheawareness

aroundpreventativecarebyenhancingdisease

preventionandcontrolsystems.Thesepolicies

emphasisetheinterconnectednessofdisease

preventionandtreatment,callingforrelevant

authoritiestoenhancehealthpromotionand

preventativehealthcareservicesformaternity,

infants,students,occupationalgroups,and

theelderly.Thegovernmentpoliciesalsofocus

onimprovingservices,suchaseldercare,and

supportingtherevitalisationanddevelopmentof

traditionalChinesemedicine(TCM),whichwill

encourageawarenessofpreventativecare.

Socialtrendsalsorevealtheincreasedneedfor

preventativecare.Ontheonehand,withtherap-

iddevelopmentofthenationaleconomyandthe

expansionofthemiddleclass,moreconsum-

ershavebeguntopursueabetterqualityoflife

andarewillingtopayforpreventativecare.On

theotherhand,theoutbreakofCOVID-19and

thestressoftheageingpopulationwithlimited

socialendowmentinsurancehasalsocontrib-

utedtopublichealthawareness.

4.3RegulatedPersonalHealthData

andUnregulatedFitnessandWellness

Information

UnderPRClaw,thereisnoclearseparationof

personalhealthdataandfitnessandwellness

information.Ifcertainfitnessandwellnessinfor-

mationfallswithinthescopeofpersonalinfor-

mation,informationonHGRorhealthcarebig

data,itwillberegulatedaccordingly.Thelegal

considerationscanbereviewedin10.1The

LegalRelationshipBetweenDigitalHealthcare

andPersonalHealthInformationand11.1The

4.4RegulatoryDevelopments

Currently,therearenodetailedregulations

focusingonpreventativehealthcare.However,

nationalpolicieshavebeenaddressingthistop-

ic.Forexample:

•preventativehealthcarefortheelderlyhas

beenrepeatedlyemphasisedonnational

policies,eg,the14thFive-YearPlanforthe

NationalDevelopmentofUndertakingsonthe

ElderlyandfortheElderlyServiceSystem,

theGuidingOpinionsonFurtherPromot-

ingtheDevelopmentofIntegratedMedical

andNursingCareandtheNoticeonFurther

StrengtheningtheConstructionofGeriatric

DepartmentinTCMHospitals;

•introducingthefamilydoctorinthepub-

lichealthservices(includingpreventative

healthcare)isexplicitlyfacilitatedintheGuid-

ingOpinionsonPromotingtheHigh-Quality

DevelopmentofFamilyDoctorContracting

ServicesissuedinMarch2022.

TheGuidelinestoPromotetheHigh-quality

DevelopmentofDiseasePreventionandCon-

trolissuedbytheGeneralOfficeofStateCouncil

inDecember2023setsthegoaltobuildupa

diseasepreventionandcontrolsystemby2030.

4.5ChallengesCreatedbytheRoleof

Non-healthcareCompanies

Thehealthcareindustryisrelativelystrictlyregu-

latedinChina.Whenanon-healthcarecompany

entersthemarketbyintroducingnewtechnolo-

giesandtheapplicationofexistingtechnologies

tohealthcare,itmustevaluate:

•whetherthedeviceusingsuchtechnologies

willbedeemedasamedicaldevice;and

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•whethertheapplicationofsuchtechnolo-

gieswillbedeemedasprovisionofmedical

services.

thepatientmayalsoclaimforproductliability

againstthemanufacturer.

Ineithercase,entrantsintotherelevantmarket

mustfirstobtainalicence.

5.Wearables,Implantable

andDigestiblesHe