NishithDesai-印度的远程医疗-医学实践的未来 Telemedicine in India The Future of Medical Practice 2024

MUMBAISILICONVALLEYBENGALURUSINGAPORENEWDELHINEWYORKGIFTCITY

Research

TelemedicineinIndia

TheFutureofMedicalPractice

August2024

©NishithDesaiAssociates2024

Research

TelemedicineinIndia

TheFutureofMedicalPractice

August2024

DMSCode:30666.1

©NishithDesaiAssociates2024

Rankedasthe‘MostInnovativeIndianLawFirm’intheprestigiousFTInnovativeLawyersAsiaPacificAwardsformultipleyears.Alsorankedamongstthe‘MostInnovativeAsiaPacificLawFirm’intheseeliteFinancialTimesInnovationrankings.

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Aegermartet

回woruDX

BUSINESSTODAY

equalipi

©NishithDesaiAssociates2024

TelemedicineinIndia—TheFutureofMedicalPractice

Disclaimer

ThisreportisacopyrightofNishithDesaiAssociates.Noreadershouldactonthebasisofanystatementcontainedhereinwithoutseekingprofessionaladvice.Theauthorsandthefirmexpresslydisclaimallandanyliabilitytoanypersonwhohasreadthisreport,orotherwise,inrespectofanything,andofconsequencesofanythingdone,oromittedtobedonebyanysuchpersoninrelianceuponthecontentsofthisreport.

Contact

Foranyhelporassistancepleaseemailusonconcierge@orvisitusat.

Acknowledgements

TanyaKukade

tanya.kukade@

VarshaRajesh

varsha.rajesh@

EshikaPhadke

Eshika.phadke@

Dr.MilindAntani

Milind.antani@

©NishithDesaiAssociates2024Provideduponrequestonly

Contents

Introduction

BusinessModels

A.ConsultationoverTelemedicinePlatformB.ConsultationoveraMessagingPlatformC.PhysiciantoPhysicianconsultations

D.Cross-BorderConsultations

RegulatoryFrameworkGoverningTelemedicine

A.NationalMedicalCommissionAct,2019(“NMCACT”)

B.TelemedicinePracticeGuidelines(“TPG”)IssuedundertheMCICode

C.DrugsandCosmeticsAct,1940(“D&CAct”)andDrugsRules,1945(‘DrugsRules”)

D.TheInformationTechnologyAct,2000(“ITAct”),theInformationTechnology(ReasonableSecurityPracticesandProceduresandSensitivePersonalDataorinformation)Rules,2011(togetherthe

“DataProtectionRules”)andtheInformationTechnology(IntermediariesGuidelines)Rules,2011(“IntermediariesRules”)

E.GovernmentPoliciesRegulatingHealthData

F.TelecomCommercialCommunicationCustomerPreferenceRegulations,2018(“TCCPRegulations”)

TelemedicinePracticeGuidelines

A.ProvidesLegalRecognitiontothePracticeofTelemedicine

B.SpecificallyExcludesNon-TeleconsultationAspectsofTelemedicine

C.TypesofTelemedicineConsultation

D.SituationswhereTelemedicineisPermitted

E.IdentificationofPatientandRMPPriortoConsultationF.ConsultationtoMinors

G.PatientConsent

H.PrescribingMedicines

I.LiabilityofTelemedicinePlatforms

TelemedicineGoingForward

A.LimitedApplicability

B.PatientConsentandDataPrivacy

C.ProtectiontoMinors

D.RestrictionsonPrescribingMedicines

E.LackofIntegrationofRecords—LackofSufficientDataforCareContinuityF.CreatingServiceAwareness

ConclusionAnnexureA

ListofMedicines

AnnexureB

SamplePrescriptionFormat

1

3

6

10

19

24

25

27

©NishithDesaiAssociates2024Provideduponrequestonly

TelemedicineinIndia—TheFutureofMedicalPractice

Introduction

Introduction

Telemedicineistheuseofinformationandcommunicationtechnologiestoimprovepatientoutcomesbyincreasingaccesstohealthcareandmedicalinformation.Itisconsideredtobethetoolofremotediagnosisandtreatmentofpatientsbytheuseoftechnology.TheIndianGovernmenthasadoptedthedefinitionoftelemedicineprovidedbytheWorldHealthOrganization(“WHO”),asfollows.

“Thedeliveryofhealthcareservices,wheredistanceisacriticalfactor,byallhealthcareprofessionalsusing

informationandcommunicationtechnologiesfortheexchangeofvalidinformationfordiagnosis,treatment

andpreventionofdiseaseandinjuries,researchandevaluation,andforthecontinuingeducationofhealth

careproviders,allintheinterestsofadvancingthehealthofindividualsandtheircommunities”

IntheIndiancontext,telemedicinehasthepotentialtoincreaseaccesstoqualityhealthcareforallIndians,giventhatIndiasuffersfromalowdoctortopatientratiowithonlyonedoctorforevery1,445Indians.1Thishamperstheequitabledistributionofhealthcareserviceswhichhasremainedtobeamajorgoalinpublichealthmanagementforyears.Thedisparityisevenmorepronouncedintheruralareasasmanydoctorsprefertopracticeinthecities.AccordingtoastudyconductedbytheWHO,59.2%ofallhealthworkersarelocatedinurbanareas,where27.8%ofthepopulationresides,and40.8%ofallhealthworkerswereinruralareas,where72.2%ofthepopulationresides.2Telemedicinecanhelpsmoothenovertheseinequalitiesbyenablingdoctorsinurbanareastoconsulttheruralpopulation,includingprovidingspecializedcareasnecessary.

TheCOVID-19pandemicservedasafillipforthelegitimisationanddevelopmentoftelemedicineinIndia.TheTelemedicinePracticeGuidelines,whichwerereleasedin2020,broughtaboutclarityonthelegalstatusoftelemedicineinIndia.TheIndiangovernmenthassinceactivelyincorporatetelemedicineintothepublichealthdeliverysystemthroughtheeSanjeevaniprogrammes.

Inthispaper,wehaveoutlinedthelegalandregulatoryframeworkregulatingtelemedicineandprovidedourinputsonhowweseethisspaceevolving.ThepaperfocusesexclusivelyonthepracticeoftelemedicinebyallopathicpractitionersanddoesnotdealwiththeregulationsapplicabletopractitionersoftraditionalmedicinesuchasAyurveda,Homoeopathy,UnaniandSiddhaformsofmedicine.Wehopethispaperservesasaprimerforexistingstakeholdersinthetelemedicinespace(suchaspatients,HCPs,telemedicineplatformsandinvestors)aswellasthosewhoaretestingthewaters.

1Availableat:

https://health.economictimes./news/industry/doctor-patient-ratio-in-india-less-than-who-prescribed-orm-of

-11000-govt/72135237,(LastaccessedonJanuary28,2023).

2Availableat:

/hrh/resources/16058health_workforce_India.pdf

,(LastaccessedonJanuary28,2023).

©NishithDesaiAssociates2024Provideduponrequestonly1

TelemedicineinIndia—TheFutureofMedicalPractice

Introduction

ImportantComponentsoftheProcessofTelemedicine

a.Patient:TheindividualwhorequiresTele-consultation.

b.PrimaryDoctor:TheregisteredmedicalpractitionerwhohasphysicalaccesstothePatient.ThePrimaryDoctorwillbeavailableattheTCC(definedbelow).

c.Specialist:TheregisteredmedicalpractitionerwhoprovidesmedicalconsultationtothePatientfromoveradistance.ASpecialistislocatedatTelemedicineSpecialtyCentre.

d.TelemedicineSystem:Thesystem/technologycreatedinordertostore,transmitandcontrolalltheinformation/dataofthepatient[(e.g.theElectronicMedicalRecord(“EMR”)fromthePatienttotheSpecialist,viaTCCandTSC(definedbelow)].

e.TelemedicineConsultancyCentre(“TCC”):Themedicalfacilitywherethepatientispresent.TheTCCwillbeequippedwithbasictechnologyrequiredforexchangeofmedicalinformationandmedicalconsultation.

f.TelemedicineSpecialtyCentre(“TSC”):ThemedicalfacilitywheretheSpecialistispresent.LiketheTelemedicineConsultancyCentre,thisfacilitywillbeequippedwithbasictechnologyrequiredforexchangeofmedicalinformationandmedicalconsultation.ThespecialistwillprovideTele-consultancyfromtheTSC.

g.Tele-consultation:Thedeliveryofhealthcareservicesusinginformationandcommunicationtechnologyoveradistance.

©NishithDesaiAssociates2024Provideduponrequestonly2

TelemedicineinIndia—TheFutureofMedicalPractice

BusinessModels

Thefollowingbusinessmodelsareprevalentinthetelemedicinesector.

A.ConsultationoverTelemedicinePlatform

Manytelemedicineplatformshavebeenlaunchedinthepastfewyears.Theseplatformsareusuallysetupintheformofwebsiteormobileapplications.TheplatformconnectspatientswithHCPswhereconsultationtakesplaceoveranapp-integratedmessagingorcallingservice.TheplatformmayeitherprovidepatientswithalistofdoctorsavailableontheplatformandletthepatientchoosetheHCPwithwhomtoconsultordirectlyconnectthepatientwiththespecificHCP.Attheendoftheconsultation,theHCPmaysendaprescriptiononlineoverthetelemedicineplatformonthebasisofwhichthepatientmaypurchasetherequiredmedicines.Alternatively,theHCPmayalsoaskthepatienttogetcertaintestsdonetobeabletoproperlydiagnosetheunderlyingmedicalcondition.

HCPRegistersontheTelemedicinePlatform

HCPprovidesa

prescriptiontothe

patientonlineororderstestsandafollow-up

consultation

Patient

RegistersontheTelemedicine

Platform

Consultationtakesplace

overtext/video/audio

Patientprocures

medicinesonthebasisoftheprescriptionorundergoesthetests

prescribed

>

>

Chart1:ConsultationOveraTelemedicinePlatform

B.ConsultationoveraMessagingPlatform

PatientsandHCPsoftenconsultinformallyovergeneralmessagingplatforms.Themessagingappsaredistinctfromtelemedicineplatformsastheyarenotspecificallygearedtowardsprovidingmedicalconsultationorthecollectionorprocessingofhealthinformation.

©NishithDesaiAssociates2024Provideduponrequestonly3

BusinessModels

TheconsultationmaybeinitiatedbyapatientbyreachingouttotheHCPandmaytakeplaceovertextmessaging,callorvideofacilitiesprovidedbythemessagingapp.Attheendoftheconsultation,theHCPmaysendaprescriptiononlineoverthemessagingapponthebasisofwhichthepatientmaypurchasetherequiredmedicines.Alternatively,theHCPmayalsoaskthepatienttogetcertaintestsdonetobeabletoproperlydiagnosetheunderlyingmedicalcondition.

>

Patientinitiates

aconsultationoverthemessagingapp

>

Consultationtakes

placeovertext/

video/audio

>

HCPprovides

aprescriptionto

thepatientonline

ororderstests

andafollow-up

consultation.

Patientprocures

medicineson

thebasisofthe

prescriptionor

undergoesthetests

prescribed.

Chart2:ConsultationOveraMessagingPlatform

C.PhysiciantoPhysicianconsultations

Asthenamesuggests,theseconsultationstakeplacebetweentwophysicianswhenonephysician(treatingphysician/referringphysician)consultsaspecialistregardingapatientunderthecareofthetreatingphysician.Theseconsultationstypicallytakeplaceinformallywherethetreatingphysiciandisclosespatientinformationtothespecialisttoobtainthespecialist’sinputsonthediagnosisorthecourseoftreatment.Thespecialisttypicallydoesnotinteractwiththepatientthemselvesandanyadviceprovidedbythespecialistisconveyedtothepatientbythetreatingphysician.

<

>

Treatingphysician

consultswithspecialist

onthepatient’scase

<

Thetreatingphysicianconveys

theadviceprovidedbythe

specialisttothepatient

Thespecialistprovidestheir

professionalopiniononthe

diagnosis/courseoftreatment

Thetreatingphysician

signsoffontheadvice

providedbythespecialist

Consultationbetween

patientandtreating

physiciantakesplace

Patientapproachestreatingphysician

<

<

>

>

>

>

Chart3:PhysiciantoPhysicianConsultations

©NishithDesaiAssociates2024Provideduponrequestonly4

TelemedicineinIndia—TheFutureofMedicalPractice

BusinessModels

D.Cross-BorderConsultations

Cross-borderconsultationsareasub-setofphysician-to-physicianconsultations.Cross-borderconsultationsmaytakeplaceintwoways:

a.AphysicianlicensedtopracticeinIndiareviewsmedicalinformationofapatientlocatedabroadbasedonareferralmadebyaforeignphysician.Inthiscase,theforeignphysicianisthereferring/treatingphysicianwhiletheIndianphysicianisthespecialist.Thespecialistprovidesmedicaladvicetoeithertothepatientdirectly(dependingonwhetherthelawsinthepatient’scountrypermitthis)orprovidestheirprofessionalopiniontothetreatingphysicianwhoultimatelysignsoffonthepatient’streatmentplan.

b.AphysicianlicensedtopracticeinIndiaconsultsaforeignphysicianonaspecificcase.Inthiscase,theIndianphysicianisthereferring/treatingphysicianandtheforeignphysicianisthespecialist.Theforeignphysicianreviewsthemedicalinformationprovidedandrecommendsacourseofaction.TheIndianphysicianultimatelysignsoffonthiscourseofactionasthetreatingphysician.

©NishithDesaiAssociates2024Provideduponrequestonly5

RegulatoryFrameworkGoverningTelemedicine

ThefollowingRegulationsregulatethepracticeoftelemedicineinIndia.

A.NationalMedicalCommissionAct,2019(“NMCACT”)

TheMinistryofHealthandFamilyWelfare(“HealthMinistry”)notifiedtheNMCActinSeptember2020astheprimarylegislationtoregulatemedicaleducationandthemedicalprofessioninIndia.TheNMCActprovidesthatonlythosepersonswhohavearecognizeddegreeinmedicineandareregisteredwithastatemedicalcouncilhavetherighttopracticemedicineinIndia.

TheNMCActreplacedtheIndianMedicalCouncilAct,1956(“IMCAct”)whichregulatedthemedicalprofessionpriortoSeptember2020.TheNMCActcontainstransitionprovisionsstatingthatrulesandregulationspublishedundertheIMCActcontinuetoremaininforceandoperatetillnewstandardsorrequirementsarespecifiedundertheNMCAct.1

TherulesandregulationsaredeemedtohavebeenissuedundertherelevantprovisionsoftheNMCActitself.2OnesuchregulationframedundertheIMCActistheIndianMedicalCouncil(ProfessionalConduct,EtiquetteandEthics)Regulations,2002(“MCICode”)whichlaysdownprofessionalandethicalstandardstobefollowedbydoctorsintheirinteractionwithpatients,pharmaceuticalcompaniesandwithintheprofession.TheMCICodecontinuestoremaininforceandwillbedeemedtohavebeenissuedundertheNMCActunlessaseparateregulationonmedicalethicsisissuedundertheNMCAct.

InAugust2023,theNMCissuedtheRegisteredMedicalPractitioner(ProfessionalConduct)Regulations,2023(“NMCCode”)insupersessionoftheMCICode.TheNMCCodealsoincludedthe‘GuidelinesforPracticeofTelemedicineinIndia’,whichwouldreplacethe2020versionoftheTelemedicinePracticeGuidelines.However,theNMCCodewassubsequentlyputinabeyanceand,pendingitsre-notification,theMCICodeprevails.

B.TelemedicinePracticeGuidelines(“TPG”)IssuedundertheMCICode

TheBoardofGovernorsinstitutedbytheCentralGovernmentforregulatingmedicaleducationandthemedicalprofessioninIndia(insupersessionoftheMedicalCouncilofIndia),issuedtheTelemedicinePracticeGuidelinesinpartnershipwiththeNITIAayog.TheseguidelineshavebeenmadepartoftheMCICodeandarethereforebindingonmedicalpractitionerspracticingallopathicmedicine.TheguidelineswillremainbindingandbedeemedtohavebeenissuedundertheNMCActunlessanewsetofrulesonthissubjectisissuedundertheNMCAct.

1Section61(2)ofNMCAct.

2ProvisotoSection61(2)ofNMCAct.

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TelemedicineinIndia—TheFutureofMedicalPractice

RegulatoryFrameworkGoverningTelemedicine

TheTelemedicinePracticeGuidelinesenablemedicalpractitionerstopracticetelemedicineinanypartofthecountry,provideguidanceonthenatureofcarethatmaybeprovidedandthemannerofprovidingsuchcare.Forinstance,itprovidesguidanceonwhichmodeofcommunication(audio/video/text)touseforwhichtypesofconsultation(emergency/non-emergency/medicalpractitionertomedicalpractitioner).TheTPGalsocategorizesmedicinesinListO,ListA,ListBandProhibitedListandspecifywhichmedicinescanbeprescribedinspecificsituations(coveredindetailinSectionIVsub-heading8).

TheDraftRMPRegulationscontainGuidelinesforPracticeofTelemedicine(“ProposedGuidelines”)inIndiawhichwillreplacetheexistingTPG.ThefeaturesoftheProposedGuidelinesarediscussedbelow.

C.DrugsandCosmeticsAct,1940(“D&CAct”)andDrugsRules,1945(‘Drugs

Rules”)

TheD&CActandDrugsRulesregulatethemanufacture,sale,importanddistributionofdrugsinIndia.Inmanyforeignjurisdictions,thereisacleardistinctionbetweenadrugthatmustbesoldunderthe

supervisionofaregisteredpharmacistontheproductionofavalidprescription(signedbyaregisteredmedicalpractitioner)andthosethatcanbesoldbygeneralretailersover-the-counter(“OTC”).OTCdrugshaveadifferentmeaninginthecontextofIndianlaws.TheD&CActrequiresthatalldrugsmustbesoldunderalicense.TheDrugsRulesclearlylaydownwhichdrugscanbesoldonlyontheproductionofaprescriptionissuedbyaregistereddoctor,whichimpliesthatthereisadistinctionbetweenprescriptionandnon-prescrip-tiondrugs.DrugswhichcanbesoldonlyonprescriptionarestatedinSchedulesH,H1,andXoftheDrugsRules.

TheD&CActstatesthatnopersoncansellanydrugwithoutalicenseissuedbythelicensingauthority.However,itprovidesforcertaindrugs,namelythosefallingunderScheduleKoftheDrugsRules,tobesoldbypersonswhodonothavesuchalicense.Hence,OTCdrugsintheIndiancontextwouldmeanonlythosedrugsthatarespecifiedunderscheduleK.Thesebroadlyincludedrugsnotintendedformedicaluse,quinineandotherantimalarialdrugs,magnesiumsulphate,substancesintendedtobeusedfordestructionofverminorinsectsthatcausediseaseinhumansoranimalsandhouseholdremedies,amongothers.InMay2022,adraftamendmenttotheDrugsRuleswasreleasedforpublicconsultationwhichspecifiedsixteendrugsthatmaybesoldwithoutaprescription.Thedrugsincludeantifungals(clotrimazole),antisepticanddisin-fectant(povidoneiodine),mouthwash(chlorhexidine),analgesic(diclofenac),antipyretics(paracetamol),laxatives(lactulose),anti-dandruffshampoo(ketoconazole),nasaldecongestants(sodiumchloride)andantihistamine(diphenhydramine).3TheDrugsRulesalsostatethatprescriptiondrugscanonlybedispensedontheproductionofaprescriptionwhichisinaccordancewiththeprovisionsoftherules.Foraprescription4tobeconsideredvalidundertheDrugsRules,itmustbeinwriting,signedanddatedbythedoctorissuingtheprescription.Theprescriptionmustalsostatethenameandaddressofthepersonforwhosetreatmentitisgivenandalsothequantitytobesupplied.5

3Availableat:

https://egazette.nic.in/WriteReadData/2022/236010.pdf

.

4Rule65(10(a)oftheDrugsRules.

5Rule65(10)(b),(c)oftheDrugsRules.

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TelemedicineinIndia—TheFutureofMedicalPractice

RegulatoryFrameworkGoverningTelemedicine

D.TheInformationTechnologyAct,2000(“ITAct”),theInformationTechnology

(ReasonableSecurityPracticesandProceduresandSensitivePersonalDataorinformation)Rules,2011(togetherthe“DataProtectionRules”)andtheInformationTechnology(IntermediariesGuidelines)Rules,2011(“IntermediariesRules”)

Telemedicineinvolvesaconstantexchangeofinformationbetweenthepatientandtheserviceprovider.Atpresent,thepatient’spersonalinformation,suchasmedicalhistoryandphysiologicalconditions,areconsideredSensitivePersonalDataorInformation6(“SPDI”)undertheDataProtectionRules.Whenabodycorporate6collects,stores,transfersorprocessessuchinformation,certainrequirementsundertheDataProtectionRulesaretriggered.

ThedataprotectionframeworkisintheprocessoftransformationgiventhattheDigitalPersonalDataProtectionAct,2023(“DPDPA”)waspassedbythelegislatureinAugust2023andisproposedtobebroughtintoforceinaphasedmannedfollowedbythespecificrulesforthepurposeofimplementationoftheDPDPA.OncetheprovisionsundertheDPDPAarebroughtinforce,itwillreplacetheInformationTechnology

(Reasonablesecuritypracticesandproceduresandsensitivepersonaldataorinformation)Rules,2011.OurdetailedanalysisoftheDPDPAisaccessiblehere.

Broadly,theDPDPAprovidesspecificcompliancerequirementstobeundertakenbyanyentityprocessingdigitalpersonaldatapertainingtoanindividual.ConsentisoneofthemajorrequirementsundertheDPDPA.Beforeadoctororaninstitutiondoesanythingwithapatient’sdata,theyarerequiredbylawtoobtaintherecipient’sconsentinwritinguponprovidinganoticeincompliancewiththeconditionsprescribedundertheDPDPAinthisregard.7TherulesarelikelytoprovidefurtherclarityontheformandmannerofobtainingsuchconsentincompliancewiththeDPDPA.

Further,ifabodycorporateiscollecting,storingandprocessingpersonaldataonbehalfofanotherentitythenitmayavailthesafeharbourprovisionprovidedunderSection79oftheITAct.Inordertoavailthis,itmustfollowtheextensiverequirementsprovidedforundertheInformationTechnology(IntermediaryGuidelinesandDigitalMediaEthicsCode)Rules,2021(“IntermediariesRules”).Theserequirementsincludehavingagrievanceredressalmechanism,8displayingprivacypolicyandusageofpersonaldata,9removalofunethical10andobsceneinformation,11monthlycompliancereport,12implementreasonablesecuritypractices13etc.

6Section43AoftheITActdefines“bodycorporate”tomeananycompanyandincludesafirm,soleproprietorshiporotherassociationofindividualsengagedincommercialorprofessionalactivities.

7Section5and6ofDPDPA.

8Rule3(2),IntermediariesRules.

9Rule3(1)(a),IntermediariesRules.

10Rule3(1)(d),IntermediariesRules.

11Rule3(2)(b),IntermediariesRules.

12Rule3(1)(d),IntermediariesRules.

13Rule3(1)(i),IntermediariesRules.

©NishithDesaiAssociates2024Provideduponrequestonly8

RegulatoryFrameworkGoverningTelemedicine

E.GovernmentPoliciesRegulatingHealthData

TheIndianGovernmentiscurrentlyintheprocessofestablishinganationalhealthsystemwiththeultimateaimofstoringthemedicalrecordsofeveryIndianelectronically.TheprocesscommencedwiththereleaseoftheNationalHealthPolicy,2017whichidentifiedtheattainmentofuniversalhealthcareandtheestablish-mentofaNationalDigitalHealthEcosystem(“NDHE”)asoneofitsgoals.Subsequently,theNITIAayog(theIndianGovernment’sthinktank)andtheHealthMinistryhavereleasedvariouspoliciestowardssettinguptheNDHE.

ThesepoliciesincludetheNationalHealthStackandtheNationalDigitalHealthBlueprintReportwhichlaydownthebasicinfrastructureandframeworkfortheNDHE.OnAugust15,2020,theIndianGovernmentlaunchedtheNationalDigitalHealthMission(“NDHM”)–amajordigitalhealthinitiativewhichaimstoprovideaHealthIDtoeverypersoninthecountry.14TheNDHMwasinitiatedasapilotprojectinsixunionterritories.Recently,theNDHMhasbeenrevampedasAyushmanBharathDigitalMission(“ABDM”)andisnowoperationalacrosstheCountry.

TheestablishmentoftheABDMinfrastructureiscurrentlyintheearlystagesofdevelopment.Oncefullyoperational,HCPsprovidingteleconsultationwouldhavetheoptionofaccessingtheirpatient’selectronicdatawithease.Itshouldbenoted,however,thatbothHCPsandtelemedicineplatformsmayberequiredtoundertakecertaincompliancestoensurethattheyhandlepatientdataincompliancewiththepoliciesframedundertheNDHE.

PursuanttothistheHealthMinistryalsoreleasedtheHealthDataManagementPolicy(“HDMPolicy”)whichcoversthedataprotectionandprivacyaspectofthehealthdata,whichentitiesparticipatingintheABDMmustcomplywith.Itoutlinestherightsandobligationsofallstakeholdersinvolvedinthecollectionandprocessingofdigitalhealthdatai.e.patients,HCPs,clinicalestablishments,pharmaceuticalcompanies,insuranceprovidersetc.

F.TelecomCommercialCommunicationCustomerPreferenceRegulations,2018

(“TCCPRegulations”)

TelemedicineplatformsmayberequiredtosendSMStopatientsandusersontheplatform.Sendingun