《數(shù)字健康》中國(guó)篇CHAMBERS GLOBAL PRACTICE GUIDES Digital Healthcare 2024

CHAMBERSGLOBALPRACTICEGUIDES

Digital

Healthcare2024

Definitivegloballawguidesofferingcomparativeanalysisfromtop-rankedlawyers

China:Law&Practice

AlanZhou,CharleneHuang,

JennyChenandStephanieWangGlobalLawOffice

CHINA

LawandPractice

Contributedby:

AlanZhou,CharleneHuang,JennyChenandStephanieWang

GlobalLawOffice

Contents

1.DigitalHealthcareOverviewp.6

1.1DigitalHealthcare,DigitalMedicineandDigitalTherapeuticsp.6

1.2RegulatoryDefinitionp.6

1.3NewTechnologiesp.6

1.4EmergingLegalIssuesp.6

2.HealthcareRegulatoryEnvironmentp.7

2.1HealthcareRegulatoryAgenciesp.7

2.2RecentRegulatoryDevelopmentsp.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.12

5.1InternetofMedicalThingsandConnectedDeviceEnvironmentp.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.21

13.1ITUpgradesforDigitalHealthcarep.21

13.2DataManagementandRegulatoryImpactp.21

14.IntellectualPropertyp.22

14.1ScopeofProtectionp.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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GlobalLawOfficewasoneofthefirstlawfirmsvestmentfunds.GLOregularlyadvisesclients

inthePeople’sRepublicofChina(PRC),withonchallengingL&Hlegalissuessuchasregu-

morethan600lawyerspractisinginitsBeijing,latorycompliance,structuringtransactionsand

Shanghai,ShenzhenandChengduoffices.contractualarrangements,realisationofpipe-

Itslifesciencesandhealthcare(L&H)group,lineandgeographicexpansions,capital-raising

alsoknownasChinaLifeSciences&Health-andproject-financing,M&A,reorganisations,IP

careLaw(CLHL),isoneoftheleadingpracticeprotection,licensinganddistributionarrange-

groupsinChina,asitprovides“one-stop”legalments,settlementofdisputesinvolvingadverse

servicesforeverysectoroftheL&Hindustry,effectsinclinicaltrialsandmedicaltreatment.

includingR&D,clinicalresearchorganisations,Thefirmhascloselinkstoindustrialassocia-

pharmaceuticals,biotechnology,medicalde-tionsandmakesrecommendationsonindustry

vices,supplyproducersanddistributors,hos-codesofconductandcompliancemanagement

pitalsandotherhealthcareproviders,andin-standards.

Authors

AlanZhouistheheadoflife

sciencesandhealthcare(L&H)practiceofGlobalLawOfficeandtheheadofChinaLife

Sciences&HealthcareLaw

(CLHL).Hehasbeenrecognised

asapioneerinprovidingoutstandinglegal

consultingservicesintheL&Hpractice.Alanhasroutinelyrepresentedmultinational

corporations,well-knownChinesestate-ownedandprivateenterprises,andprivateequity/

venturecapitalfundsintheL&Harea.Hehas

beenengagedbylocalauthoritiesand

industrialassociationstoadviseonlegislationandindustrialstandardsintheL&Hindustry,areasofwhichincludee-healthcare,medicalinsurancereform,medicalrepresentative

administration,andothercomplianceissues.Hehaswonnumerousawardsandhasbeenrecognisedbypeersforhisexpertise,andis

widelypublishedbothinChinaandinternationally.

CharleneHuangisapartner

basedinGlobalLawOffice’s

Shanghaioffice,within-depthexperienceinM&Aandcross-borderlicencedeals,especially

inthesectorofhealthcareand

lifesciences.Shehasledprojectsinvolving

outboundandinboundinvestment,acquisitionofstate-ownedandprivateequity/assets,

pipelineconsolidationorrestructuringof

MNCs,andvariouslicenceorcollaboration

dealsinthepharmaceutical,medicaldevice

andmedicalservicessectors.Sheregularly

providessupportandadviceonprojects

concerningcelltherapy,genetherapy,digital

healthcare,medicalAI,etc.Charlenealsohasin-depthexperienceadvisingmultinational

companiesingeneralcorporate,cybersecurity,anddatamanagement.

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JennyChenisapartnerin

GlobalLawOfficebasedin

Shanghai,anattorneyatlawinthePRCandCaliforniaUS,a

certifiedfraudexaminerofUS

ACFE,acertifiedpublic

accountant(non-practising).Shefocusesher

practiceoncompliance,government

investigation,internalinvestigationanddata

security.Jennyiswellversedinconducting

investigationsinconnectionwithanti-

corruption(USFCPAandUKBriberyAct),

financialfrauds,occupationalembezzlement,self-dealingandtradesecrets.Jennyhas

extensiveexperienceincybersecurityanddatacompliance.Shehashandledmultiplelarge-

scaleprojectsine-discovery,cross-borderdataprotectionandsecurity,andsensitiveinformationreview.

StephanieWangisanof

counselinGlobalLawOfficebasedinShanghai.Shehasbeenactivelyinvolvedin

advisingmultinational

pharmaceuticalandmed-tech

companiesontheircorporategovernance,

dailyoperations,andcompliance.Stephanie

hasextensiveknowledgeandexperienceinthe

lifesciencesandhealthcareindustry,and

routinelyadvisesclientsonavarietyof

commercialagreementsrelatingtoR&D,

licensing,marketingauthorisationsandthemanufacturing,distributionandpromotionofmedicalproducts.Shehasalsoworkedwith

notableprivateequityinstitutionsoninvestmentinvariouspharmaceuticalenterprises.

GlobalLawOffice

35th&36thFloorShanghaiOneICC

No.999MiddleHuaiHaiRoadXuhuiDistrict

Shanghai200031China

Tel:+862123108200Fax:+862123108299

Email:Alanzhou@Web:

環(huán)球律師事務(wù)所GOBALLAWOFFICE

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1.DigitalHealthcareOverview

1.1DigitalHealthcare,DigitalMedicineandDigitalTherapeutics

Digitalhealthcare,digitalmedicineanddigital

therapeuticsarenotlegaltermsdefinedinPeo-ple’sRepublicofChina(PRC)lawsandregula-tions,butarefrequentlyreferredtoincommer-cialcontextsandindustrypolicies.

Digitalhealthcareusuallyreferstohealthcaretechnologiesdevelopedbasedoninformationtechnologiesusedbyandforthepublicingen-eral,including:

?healthcaremanagement;

?diseaseawareness;

?telemedicine;

?onlinesaleofpharmaceuticalproducts;and

?otherhealthcare-relatedactivitiesconductedthroughdigitalplatforms.

Digitalmedicineusuallyreferstotheapplica-tionofinformationtechnologyintheprocessofdiagnosisandtreatment,whichcanonlybeper-formedbyqualifiedmedicalinstitutions.

Digitaltherapeuticsusuallyreferstothesoft-ware-basedproductsthatareusedforthera-peuticinterventions,eitherasmonotherapyorincombinationwithotherconventionalmedicaltherapies.Suchproductsusuallyfallwithinthecategoryofmedicaldevices,andthereforearesubjecttoregulatoryadministrationtoensuretheirsafetyandefficacy.

1.2RegulatoryDefinition

Aspreviouslystated,digitalhealthcare,digitalmedicineanddigitaltherapeuticsarenotlegaltermsdefinedinPRClawsandregulations,butarefrequentlyreferredtoincommercialcontextsandindustrypolicies.Nevertheless,shouldany

serviceorproductinthefieldsofdigitalhealth-careanddigitalmedicinefallwithinthecategoryofpharmaceuticalsormedicaldevices,orbeusedforthediagnosisandtreatmentofhumandiseases,administrativeregulationswouldcor-respondinglyapply.

1.3NewTechnologies

Giventhebroadapplicationscopeofkeytech-nologiesandthefactthatdigitalhealthcareanddigitalmedicinearesometimesusedinter-changeablyinpractice,itissometimesdifficulttoaccuratelydistinguishbetweenthetwofields.

Fordigitalhealthcare,keytechnologiesmayinclude:

?bigdatathatcanbeusedinpublichealthmonitoring;

?healthcarecostcontrol;and

?theinternetofthingsandrelatedsensor

technology,globalpositioningsystem(GPS)technology,blockchaintechnology,cloud

computingand5Gtechnologythatenables

smarthomeandeldercare,hospitalmanage-ment,telemedicine,etc.

Fordigitalmedicine,keytechnologiesmayincludeartificialintelligence(AI)andmachinelearningusedforassisteddiagnosisandtreat-ment,medicalimaging,etc.

1.4EmergingLegalIssues

Keyemerginglegalissuesindigitalhealthmayincludethefollowing.

RegulatoryFramework

Digitalhealthcareactivities,basedondifferentscenarios,aregovernedby:

?PRCphysicianpractisinglawsandtelemedi-cine-relatedregulations;

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?PRCdrugadministrativelawsandregulationsinrelationtoonlinesaleofpharmaceutical

products;

?PRCadvertisinglaws;

?PRClawsandregulationsoncybersecurityanddataprotection;and

?PRClaws,regulationsandindustrystand-

ardsontelecommunicationsandinformationtechnology.

However,aunifiedandsystematiclaworregula-tiontospecificallygovernthedigitalhealthcareindustryisstillunderdevelopment.

CybersecurityandDataProtection

Asdigitalhealthinvolvesalargeamountofper-sonaldata,especiallythatofasensitivenature,thedesignandimplementationoflife-cyclepro-tectionofsuchdataneedstobecarefullycon-sidered,underthecybersecurityandprivacyprotectionlawsandregulations–particularlytheregulationsofthePRCPersonalInformationProtectionLaw(PIPL),whichcameintoeffecton1November2021.

Liability

AsAItechnologiesaremorefrequentlyusedindiagnosisandtreatmentbyhealthcareinstitu-tions,incircumstanceswherepersonaldamagesarecausedtopatientsduetotheapplicationofsuchtechnologies,whichpartyshouldassumeresponsibilityneedstobefurtheranalysed.

2.HealthcareRegulatoryEnvironment

2.1HealthcareRegulatoryAgencies

Theauthoritiesinvolvedintheregulationofdigi-talhealthcaretechnologiesmainlyincludethefollowing,atanationallevel,andtheirsubordi-natebranchesasapplicable.

TheNationalMedicalProductsAdministration(NMPA)

TheNMPAregulatesdrugs,medicaldevicesandcosmeticsinChina,andisresponsiblefortheirsafety,supervision,andmanagement,fromregistrationandmanufacturingtopost-marketriskmanagement.Technologiesanddevices,includingsoftwarethatfallswithinthecategoryofpharmaceuticalsormedicaldevices,arealsosubjecttoregulationandsupervisionbytheNMPAanditssubordinatebranches.

TheNationalHealthCommission(NHC)

TheNHCprimarilyformulatesandenforcesnationalhealthpoliciesandregulationsper-tainingtohealthcareinstitutions,healthcareservices,andhealthcareprofessionals(HCPs).Internet-baseddiagnosisandtreatment(includ-inginternethospitals)andremoteconsultationsbetweenhealthcareinstitutionsandpatientsarebothsupervisedbytheNHC.

Theclinicalapplicationofmedicaltechnolo-giesforthepurposeofdiagnosisandtreatment(includingAI-assisteddiagnosisandtreatment)byhealthcareinstitutionsandprofessionalsisalsounderthesupervisionoftheNHC.

TheNationalHealthcareSecurityAdministration(NHSA)

TheNHSAisprimarilyresponsibleforimple-mentingpoliciesrelatedtobasicmedicalinsur-ance(BMI),suchasreimbursement,pricingandtheprocurementofdrugs,medicalconsumablesandhealthcareservices.

2.2RecentRegulatoryDevelopments

RegulatoryDevelopmentsonTelemedicine

“InternetPlusHealthcare”–ie,healthcareincombinationwithapplicationoftheinternet–isnowakeynationalstrategyinChina.Toregulatediagnosisandtreatmentprovidedremotely–ie,

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teleconsultationbyHCPsorinternet-baseddiag-nosis–inJuly2018theNHCandtheNationalAdministrationofTraditionalChineseMedicine(NATCM)issued:

?theAdministrativeMeasuresforInternet-basedDiagnosis(forTrialImplementation)(the“IDM”);

?theAdministrativeMeasuresforInternetHos-pitals(forTrialImplementation)(the“InternetHospitalMeasures”);and

?theGoodPracticesforTelemedicineServices(forTrialImplementation)(the“RulesonTel-

emedicine”).

Furthermore,theNHCandtheNATCMreleasedtheRulesfortheRegulationofInternet-basedDiagnosis(forTrialImplementation).

Thesemeasuresclarifyhowtechnicalsupportoninternet-baseddiagnosisandtreatmentshouldbeconductedandsetforththeregula-toryrequirementsthereof.

Inaddition,thegrowthofinternet-baseddiagno-sisalsoboostedthedemandforinternetsalesofmedicine.TheProvisionsforSupervisionandAdministrationofOnlineDrugSalesandtheCir-cularonRegulatingtheDisplayofOnlineSalesInformationofPrescriptionDrugsenactedinrecentyearsstipulatedthat,exceptformedicinalproductssubjecttospecialadministration,inter-netsalesofbothover-the-counterdrugsandprescriptiondrugsareallowed.Nevertheless,itiscrucialforthird-partyplatformsandenterpris-esengaginginonlinedrugsalestocomplywithrelevantrequirementsfordisplayinformationontheonlinesalesofprescriptiondrugs.

RegulatoryDevelopmentsonElectronicMedicalInsurance

InAugust2019,theNHSAissuedthe“Inter-netPlus”MedicalServicePricesandMedicalInsurancePaymentPolicyandlaunchedtheelectronicmedicalinsurancesystem,whichregulatespricesandinsurancepoliciestoallowforinternet-basedhealthcareservicestobecoveredbyChina’smedicalinsurancesystem.Implementationpolicieswerefurtherissuedin2020andlocalenforcementruleshavebeengraduallyissuedbylocalauthoritiessince2021.

RegulatoryDevelopmentsonAI-AssistedDiagnosisandTreatment

InFebruary2017,theNHCissuedupdatedadministrationregulationsonbothAI-assisteddiagnosistechnologyandAI-assistedtreatmenttechnology,togetherwiththeapplicablequalitycontrolcriteriaforclinicalapplication,reflect-ingthemostrecentregulatorypositionoftheNHCtoencourage,whilestrictlyregulating,thedevelopmentandcybersecurityapplicationofAI-assisteddiagnosisandtreatmentforsafetyconsiderations.

In2019,theNMPAissuedtheKeyConsidera-tionsforReviewofMedicalDeviceSoftwareUsingDeepLearningTechnologyforAssistedDecision-Making,layingoutitsconcernsforreg-istrationreviewoftherelevantmedicaldevicesoftware,includingsoftwaredevelopment,soft-wareupdatesandrelatedtechnicalconsidera-tions.In2021and2022respectively,theNMPAissuedtheGuidingPrinciplesfortheClassifica-tionandDefinitionofAIMedicalDevices,andtheGuidingPrinciplesforRegistrationReviewofAIMedicalDevices,thelatterlayingouttheapplicationrequirementsandtechnicalreviewstandardofAImedicaldevices.In2022,theNMPAissuedaseriesofindustrystandards

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relatedtothequalityrequirementsandevalua-tionofAImedicaldevices.

RegulatoryDevelopmentsonDataProtection

InJuly2018,theNHCissuedtheAdministra-tiveMeasuresontheStandards,SecurityandServicesregardingNationalHealthcareBigData(the“MeasuresonHealthcareBigData”),announcingthedirectionofregulatingtheuseandapplicationofthehealthcare-relateddatafromacomplianceperspective,andimplement-ingindustry-specificdataprotectionrequire-ments.InDecember2020,arecommendednationalstandard,theInformationSecurityTech-nology–GuideforHealthcareDataSecuritywasreleasedtoprovidecomprehensiveguidelinesinprotectinghealthcaredata,particularlyconsider-ingtherapiddevelopmentofdigitalhealthcare.

Additionally,inApril2021,theNHSAissuedtheGuidingOpinionsonStrengtheningNetworkSecurityandDataProtection,whichrequirestheestablishmentofamoresolidfoundationfornetworksecurityanddataprotectionmecha-nismsindigitalmedicalinsuranceanddigitalhealthcare.

Fromageneralperspective,followingtwoimportantdataprotectionlawswhichtookeffectin2021,thePIPLandthePRCDataSecurityLaw,aseriesofmeasuresandguideshavebeenpromulgatedsince2022regardingdetailedreg-ulationsondataprotection,securityassessmentmeasuresandtheexecutionofstandardcon-tractsforcross-borderdatatransfer.

Especially,humangeneticresourcessamplesanddata(HGR)areprimarilygovernedbytheBiosecurityLaw,theAdministrativeRegula-tiononHumanGeneticResources(the“HGRRegulation”),alongwithitsimplementationrulesnewlyissuedin2023.Notably,foreignparties

withitsPRCestablishedorcontrolledentitiesareonlypermittedtouseChineseHGRuponfiling/approvedbytheHGRauthorityandareprohibitedfromcollection,storage,andcross-bordertransferoftheHGR.

2.3RegulatoryEnforcement

Currently,thekeyareasofregulatoryenforce-mentindigitalhealthcareincludecybersecurity,personaldataprotection,andinternet-baseddiagnosisandtreatment(includinginternethos-pitals).

Intermsofcybersecurity,theimplementationoftheMulti-LevelProtectionScheme(MLPS),whichisacompulsorylegalobligationunderthePRCCybersecurityLawandrelevantregu-lations,isnowbecominganenforcementfocusformostindustriesinvolvingsensitiveinforma-tion–particularlyhealthcare.

TheMLPSiscomposedofaseriesoftechnicalandorganisationalstandardsandrequirementsthatneedtobefulfilledbyallnetworkoperatorsinChina.AsthedevelopmentandoperationofdigitalhealthcareheavilyreliesonnetworksandITinfrastructure,itiscriticalfordigitalhealthcareproviderstoenforceandcompletetheMLPSgradingprocess.PursuanttotheIDMandtheInternetHospitalMeasures,healthcareinstitu-tionsprovidinginternet-baseddiagnosisser-vicesandinternethospitalsshallbegradedandprotectedasGradeIIIundertheMLPSregime.FailuretocompletetheMLPSwouldleadtoadministrativepenaltiesincludingwarningsandfinesissuedbythePublicSecurityBureau(PSB).

Intermsofpersonaldataprotection,relevantdataprotectionauthoritiessuchastheCyber-spaceAdministrationofChina(CAC),theMin-istryforIndustryandInformationTechnology(MIIT)andthePSBhavebeenactivelyenforcing

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personaldataprotectionrequirementsacrossindustries,includinghealthcare.Industrysuper-visionauthoritiessuchastheNHCandtheNHSAarealsoinvolvedinthoseenforcementactionsonhealthcareinstitutions.

3.Non-healthcareRegulatoryAgencies

3.1Non-healthcareRegulatory

Agencies,RegulatoryConcernsandNewHealthcareTechnologies

TheCyberspaceAdministrationofChina

TheCACisresponsiblefortheoverallplanningandco-ordinationofnetworksecurityandrel-evantsupervisionandadministration.Intermsofdigitalhealthcare,theCAC’sinvolvementmayincluderegulatingthecollectionandutilisationofpersonalinformation,cross-bordertransferofhealthcaredata,andthecybersecurityreviewofinternethospitals,etc.

ThePublicSecurityBureau

Intermsofcybersecurity,thePSBismainlyresponsibleforenforcingtheMLPSandinves-tigatingcybercrimes.Withrespecttodigitalhealthcare,thePSB’sinvolvementincludes:

?recordfilingandinspectionsrelatedto

MLPSsofhealthcareinstitutions(includinginternethospitals);and

?investigatingcrimes,suchastheinfringementofpersonaldataandillegalaccesstoinfor-

mationsystems.

MinistryforIndustryandInformationTechnology

TheMIITisresponsiblefor:

?regulatingtheinformationtechnologyandcommunicationsindustry;

?recordingfilingandapprovalofInternetCon-tentProviders(ICPs);and

?formulatingpoliciesandstandardsondatasecurity,etc.

Intermsofdigitalhealthcare,theMIIT’sinvolve-mentmayincluderegulatingrelatedtechnol-ogydevelopment,suchasthedevelopmentofandsecurityrequirementsforAItechnology.Inaddition,theMIITactivelyleadspersonaldataprotectioncampaignsonmobileapplications,includingappsusedinthehealthcareindustry.

NationalDataBureau

ItisnoteworthythattheNationalDataBureau(NDB)wasofficiallyinauguratedon23October2023toco-ordinatetheimprovementofdatainfrastructuresystems–includingthedevelop-ment,utilisationandinteractionofdataresourc-es,andpushingforwardthebuildingofdigitalChina.Therefore,itisexpectedthattheNDBwillplaycertainroleindataprotectionenforcementregardingdigitalhealthcare.

4.PreventativeHealthcare

4.1PreventativeVersusDiagnosticHealthcare

PreventativecareisnotalegaltermdefinedinPRClawsandregulationsandcanbeinterpretedbroadly.Inpractice,ifapreventativecarecon-cernsgeneralhealthcareconsulting,eldercare,nursery,massage,fitnessorwellness,withoutmakingjudgementaboutdiseasesorgivingtar-getedrecommendationstowardsspecifichealthissuesorconditions,itmaynotfallwithinthedefinitionofdiagnosisandtreatmentandthuswillnotbesubjecttospecialregulation.Ontheotherhand,ifapreventativecarefallswithintheareaofdiagnosisortreatmentactivities(eg,dis-easescreeningorvaccination),itcanonlybe

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performedbyaqualifieddoctorinamedicalinstitution.

4.2IncreasedPreventativeHealthcare

Nationalpoliceshaveheightenedtheawarenessaroundpreventativecarebyenhancingdiseasepreventionandcontrolsystems.Thesepoliciesemphasisetheinterconnectednessofdiseasepreventionandtreatment,callingforrelevantauthoritiestoenhancehealthpromotionandpreventativehealthcareservicesformaternity,infants,students,occupationalgroups,andtheelderly.Thegovernmentpoliciesalsofocusonimprovingservices,suchaseldercare,andsupportingtherevitalisationanddevelopmentoftraditionalChinesemedicine(TCM),whichwillencourageawarenessofpreventativecare.

Socialtrendsalsorevealtheincreasedneedforpreventativecare.Ontheonehand,withtherap-iddevelopmentofthenationaleconomyandtheexpansionofthemiddleclass,moreconsum-ershavebeguntopursueabetterqualityoflifeandarewillingtopayforpreventativecare.Ontheotherhand,theoutbreakofCOVID-19andthestressoftheageingpopulationwithlimitedsocialendowmentinsurancehasalsocontrib-utedtopublichealthawareness.

4.3RegulatedPersonalHealthData

andUnregulatedFitnessandWellnessInformation

UnderPRClaw,thereisnoclearseparationofpersonalhealthdataandfitnessandwellnessinformation.Ifcertainfitnessandwellnessinfor-mationfallswithinthescopeofpersonalinfor-mation,informationonHGRorhealthcarebigdata,itwillberegulatedaccordingly.Thelegalconsiderationscanbereviewedin10.1TheLegalRelationshipBetweenDigitalHealthcareandPersonalHealthInformationand11.1The

UtilisationofAIandMachineLearninginDigitalHealthcare.

4.4RegulatoryDevelopments

Currently,therearenodetailedregulationsfocusingonpreventativehealthcare.However,nationalpolicieshavebeenaddressingthistop-ic.Forexample:

?preventativehealthcarefortheelderlyhas

beenrepeatedlyemphasisedonnational

policies,eg,the14thFive-YearPlanforthe

NationalDevelopmentofUndertakingsontheElderlyandfortheElderlyServiceSystem,

theGuidingOpinionsonFurtherPromot-

ingtheDevelopmentofIntegratedMedicalandNursingCareandtheNoticeonFurtherStrengtheningtheConstructionofGeriatricDepartmentinTCMHospitals;

?introducingthefamilydoctorinthepub-

lichealthservices(includingpreventative

healthcare)isexplicitlyfacilitatedintheGuid-ingOpinionsonPromotingtheHigh-QualityDevelopmentofFamilyDoctorContracting

ServicesissuedinMarch2022.

TheGuidelinestoPromotetheHigh-qualityDevelopmentofDiseasePreventionandCon-trolissuedbytheGeneralOfficeofStateCouncilinDecember2023setsthegoaltobuildupadiseasepreve