WaveStone：2024年数字医疗雷达 Digital Healt Radar 2024

DigitalHealth

Radar2024

Summary

1.DigitalHealth

Radar

OpeningInsights

StartupLonglist

2.Insights

OurShortlist

MarketInsights

AViewtotheFuture

3

5

6

7

11

3.SelectCase

Studies

CharcoNeurotech

Avegen

TaraCares

4.Appendix

Methodology

Glossaryand

References

12

13

14

15

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DigitalHealthRadar

DigitalHealthRadar2024

OpeningInsights

SinceCOVID,weandourclientshave

observedadiscerniblechangeinhow

healthcareisdeliveredtopatientsglobally.Digitalhealthisseenasatransformational

partofthischangeinhealthcareprovision.Thisisevidencedbyrenewedimpetusinthestartupspacewithinvestmentreaching$3billionin2021.Ourfirstinterviewee,LucyJung,founderandCEOofCharcoNeurotech,notedthistrend,highlightingtheriseinhealthcare-

focusedproductdevelopmentandtechnology.

However,thesituationisnotentirelypositive.In2023investmentdeclinedto$1.1billion,

indicatingthatothereconomicand

geopoliticaldevelopmentsmaybeleading

tovolatility.Factorssuchastheemergenceofopen-accessGenAI,thewarinUkraine,thePalestine-Israelconflict,issuesintheGulfofAden,risinggasprices,andgeneralinflationmayallplayapart.

Pharma’sresponsetodigitalhealthhasbeenmixed.WhilstBiogencloseditsdigitalarm,EliLillyandCompanyreleaseditsowndigital

healthsolution:LillyDirectTMandAstraZenecahastakentheplungetospinoutitsdigital

healthdevelopmentarmintoEvinova,

leadingtomixedsignalsacrosstheboard.UtilisingstartupstosuperchargeinnovationcouldbeawaytobridgethegapforthosecautionaryPharmacompanieswishingtoexpand.

“Whenwestartedin2019,thereweren’tmanypeopleintheproductdevelopmentandtechareathatwerelookingintohealthcare.Therewaslotsofresearch

conceptsbutnotmanycompaniesorsupportinthisspace.I’mexcitedtoseetheimportanceofthisrisingovertheyears.”

LucyJungCo-founder&CEO,CharcoNeurotech

3

DigitalHealthRadar

“Thegeneraltrendistowardspartnership,towardspartneringwithstartups

likeourselvesbecausewecanprovidethedevelopmentcapability,wecanprovidetheplatform.Theydon'tneedtodoallthat.Theydon'tneedtohiresoftwareengineers.TheyneedprojectmanagersorprojectownerswhichisaneasierroletofillinPharma.”

JamieCampbellAssociateDirectorofCommercialPartnerships,Avegen

Inour2023WhitePaper

‘Competingthrough

CustomerValue

’wediscussedhow

partneringbetweenstartupsandpharmacanallowcompaniestogeneratevalueforpatientsandcustomersataquickerpace.ThisviewissomethingJamieCampbell,

AssociateDirectoratAvegen,pointsout,

describingtheefficienciesthatcancomewithemployingexternalexpertise.Digital

healthsolutionscanalsohelptoremove

someofthecostfromproviders,freeingupinvestmenttootherpartsofthehealthcaresystemandenhancingvalueforcustomers.Lookingtothestartupscenemaythereforehelptodiscernthefutureofthisdynamic

space.

Whilstthedigitalhealthstartupmarket

withintheUSiswelldeveloped,withseveralexamplesofunicorns(suchas23andMeasof2015orTempusasof2018),themarket

withinEuropehasnotbeenasfruitful.Thereareseveralpotentialreasonsforstagnation.Theseincludetheuniversalhealthcare

modelscommonlyutilisedinEurope,whichcanmakeprofitabilitymorechallengingandconsequentlylessappealingtoinvestors.

Additionally,Europe'sfragmentednature

resultsinnumeroussmallermarkets,

collectivelytotaling500millionpotential

users,asopposedtoasinglemarketof350millionpotentialusersintheUS.

TherearesomeverygoodexampleswithinEuropeofcompaniesdevelopingbeyondasinglemarket,companies,suchasOwlstoneMedical,havebecomeprofitableand

successfulacrossmultiplemarkets,bridgingthegaptotheUSandglobally.Consideringthesegreenshoots,wehaveanalysedthe

Europeanstartupmarketandhighlightedthekeydevelopments,trendsandexamplesofcompaniesthatweareeagertowatchthathaveinnovativesolutionsorthataremakingwavesinthemarket.Youcanfindoutmore

aboutourmethodology

here

.

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DigitalHealthRadar

TheDigitalHealthRadar

StartupLonglist2024

Ourlonglistillustratesourinterpretationofthe

dimensionsofthedigitalhealthstartupspace.Displayedaretheuniqueandinnovativeofferingsthathavethe

potentialtotransformpatientcare.

Animportantpointtonoteisthat

telemedicineandmHealthpropositionsareconspicuousbytheirexclusionfromthe

Radar.Thenumberofthesehave

skyrocketedfollowingCOVIDandcontinuestogrow;in2020,250newdigitalhealthappswereaddedtotheappstoreperday1.Duetothescaleofthissector,wehavetherefore

limitedtheirappearanceinourRadartoa

fewspecial-caseexampleswebelievetobetrulyinnovative.ThisincludesMika,anAI-

poweredcompanionforcancerpatientsandcaregivers,BeneTalk,ahabitbuildingapp

forstammeringthatanalysesspeechandprovidesrealtimefeedback.

w5

Insights

OurShortlist

Ourshortlistdepictswhatwebelievetobethepotentialfutureleadersindigitalhealthinnovations.

Ourinterpretationofmarketinsights

Overall,weseefourkeytrendsacrossthestartupmarket:

1.Providinginformationtopatientsandinvestorsfuelssuccess

2.Gatheringinformationandpatientinsightsimproveprospects

3.Companiesaddressingmultipletouchpointsacrossthepatientjourneyshowgreatpotential

4.Thereisagrowingrequirementforevidence-ledDTxandhealthcaresolutions

6

Insights

MarketInsights

1.Providinginformationtopatientsandinvestorsfuelssuccess

Onecriticalobservationwe

gainedfromcyclingthrough574companies,wasthat

thismarketisvast.Tofloatto

thetop,startupsarebenefitingfromusingvalidatedresearchto

differentiatethemselvesand

increasecredibility.There

arenumerousexamplesofthisthroughoutourlonglist.One-waystartupsaredoingthisisbyfocusingon

informationprovisionto

drivepatienteducation,

adherenceanddrivevalueandsuccess.Whathas

becomeofincreasing

importancetopatient

providersandusersisthattheinformationprovidedisaccurateandever

increasinglyactionable.

Acrosstheboard,theresultsareconsistent-evidence-

basedapproachesarekeyforpatientengagement.Thisincludespatientstudies

acrossconditionsand

therapyareas,including

asthma,diabetes3and

hypertension4.Likewise,

studiessuchasTinschertetal.2019showtheimportanceofevidence-based

informationingaining

patienttrustinAIchatbots.

Whilstyoumaybeabletoprovideinformationto

patients,whatcanyoudowiththatinformation?

Wesawasaturationof

digitalappsthatfocusedonbringingpatientstodoctors;however,reducingthe

impactonhealthcare

systemsbypreventative

measuresisincredibly

important,especiallyifwewishtoachievesustainablehealthcaresystems.

Itisthereforeessentialwe

looktoeducation,basedonpeerreviewedinformation,tosupportpatientsin

everythingfromtreatmentchoicetobehavioural

support.Thisisagapseen

by

TaraCares

whoturned

individualizedresearchintomeaningfulinsightsto

informhormonehealthy

ageingforsubscribersofitsMIMOSAplatform.FounderandCEOJyotiSharmaspoketousabouttheimportanceofcenteringscienceintheconversationaroundage-

relatedhealth

Thecompanylooksto

enableitsuserstogaina

bettercontroloftheirbodiesholistically,whichbrings

agencyandinevitablycanreduceimpactonthe

individual,employers,andhealthcaresystems.Healthy

ageingandbetter

understandingofourbodiesandthechangesthattheygothroughasweprogressthroughlifeisofincreasingimportancetopatients(andconsumers).

However,withgreater

evidenceoftencomes

greaterregulatoryoversight.Tocombatsomecompaniesarebeginningtheir

propositionsby

recommendinginformation,slowlybuildingthegreaterscrutinyneededforbuildingamedicaldeviceordigitaltherapeutic.Thismethod

hastheaddedbenefitof

enablingtrustbuildingandcredibilityinthespace.

“Wearelevellingupthescienceforhealthyageing.BypersonalizingsciencebasedonindividualdifferencesforhormonalshiftsandtransitionincludingMenopauseweareshapingthefutureoffemaleworkforgenerationsto

comeanddeliveringahealth-orientedemployee-employercaremodel

JyotiSharmaFounderandCEO,TaraCares

w7

Insights

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2.Gatheringinformationandpatientinsights

improvesprospects

Ofcourse,thereisadualitytothisinformation.Asmorepatientsbegintousedigitalhealthsolutions,more

informationbasedon

consumptionbecomes

availabletothecompaniesthemselves.LucyJungof

CharcoNeurotech

spoketousaboutsomeofthe

benefitsshefoundfrom

leaningintothisopenand

curiousapproachtopatientstoprovidepivotalinsightsforitsCUE1wearable.Lucy

reflectedonaconversationshe’dhadwithacommitteememberandfriendwhowaslivingwithParkinson’s.He

pointedouttoherthe

difficultiesinconveyingthecompleteanddiverse

strugglesofthediseaseby

lookingpurelyatclinical

data.Oneday,hehad

visitedLondonforadoctor’sappointment.Whilstseatedherealisedhehadbecomeunabletogetup,leftgoingincirclesonthetubeand

unabletomove.He’daskedher:“ifIwasn’tabletomakeonestepthatday,howcanyoumeasurethat?”Those

wordsstuckwithLucyandhaveshapedCharco

Neurotech’sapproachtoitspatients;utiliseclinicaltrialswhilststayingcloseand

curiouswiththepeopletheyaretryingtohelp.

Onahumanlevelthese

insightsareessentialto

rememberthepurposeandimpactofthesedigital

healthsolutionsandprovide

directionforopportunitiesfordevelopment,potentialrisksorareasfordiversification.

Likewise,addingmeaningtoyourdatacancreatebuyinforinvestorsandconsumersalike.

“We'renotlookingtooneanswer.We're

lookingforlotsof

answers…It’snotjustclinicalmeasures

thatareimportant–remembertothink

aboutthepeople”

LucyJungCo-founder&CEO,CharcoNeurotech

Insights

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3.Companiesaddressingmultipletouchpoints

acrossthepatientjourneyshowgreatpotential

Wheninvestigatingtheperformanceofourlonglistwebegantoseeatrendwithnumerousofferings

reachingfunding,developmentorclinical

milestoneswhenaddressingmultipletouchpointsacrossthepatientjourney.Forexample,wehave

seencompaniessuchasIkerian,withitsRetinAI

platform,supportingclinicalresearchflowsaswellasAIenabledeyediagnosticsanddecisionsupportreachingfundingandpartnershipmilestones.

Wevalueconnectionwith

peopleusingorwaitingtouse

thedevice.Oncetheloopisbroken,innovationsuffers.”

LucyJungCo-founder&CEO,CharcoNeurotech

4.Thereisagrowingrequirementforevidence-ledDTxandhealthcaresolutions

NeedforValidation

TheEuropeanmedicalspaceisarguablyoneofthemostevidence-ledindustriesinthe

world,highlyvettedandhighlyregulated.Itappearsthedigitalhealthspaceiscatchinguptotheestablishedstandardsofthis

industryanditspharmacompanieswhich

holdthewealthandinfluencetosupportnewstartupsuccess.ProducingourRadar,the

shifttowardsinvestmentintechnologies

evidencingtheirclinicalvaluewasapparent;perhapshelpingtheseofferingstostandout

againsttheplethoraofunvalidated

telehealthsolutionsthathavefloodedthemarketinrecentyears.

WhereHCPsandpayersarethecustomer,

clinicalevidenceorpublicationprovides

validationinamarketthatvaluesrobust

scientificapproach.

Avegen

Associate

DirectorofCommercialPartnerships,JamieCampbell,detailedtheneedforevidencetosupportitscloud-hosted,DigitalClinical

Workflows.ThecompanyrecentlyreceivedthegoldawardfromHSJforclinical

partnershipsasitsKlickofferingreducedwaitingtimesfrom6to3monthsand

decreasingmissedappointmentsby41%.6

CurrentChallenges

However,whilstthedemandforevidence

backedhealthcaresolutionsprevails,the

levelofevidencerequiredfordigitalhealthtechnologieswithineachofthesesegments

variesgreatly.Ambiguitywithinthe

requirementsdefinedbyregulatorybodiesremainsachallengeandorganizationsarestartingtopre-emptmorerobustregulatorypositionsinthisarea,leadingtoanincreaseinclinicalvalidationfordigitalhealth

technologies.Eventhosedigitalhealth

technologiesthatarenotregulatedas

medicaldevicesarestartingtocollectdatatoevidenceeffectivenessandbackup

claims.TherecentAIactfromtheEUfurtherimpactshere,theadditionofdataprivacyandusageregulationsforAImakeitmorecomplextogetthedataandinsightneededtoprovidemaximumvaluefornewsolutionsandenablevalidation.

Finally,tothepointaroundregulation,

ensuringcybersecurityhasbeenthoroughlybakedintoanydigitalsolutionthatcontainsdataremainsparamountforfutureor

ongoingsuccess.Anexampleofthisis

RetinAI,anAI-poweredeyediagnosticdatamanagementplatformusedtosupport

clinicalresearchworkflows.Nowboasting20processedclinicalstudies,over40peer

reviewedpublicationstodateanda2023CEMarkingCertificateforDiscoveryasaclassIIadevice.7

Insights

FindingtheSolution

However,whilstourRadarexemplifiesthestandoutsinthemarketcapitalizingon

evidence-ledsolutions,itappearsmanyhavefallenbehind.A2022studyestimatesonly20%ofhealthtechcompanieshavegoodclinicalevidenceandregulatory

filings.8

Ironically,theanswertomanyofthese

hurdlesmightlieinsomehealthtech

companiesfeaturedonourlist.Forexample,TrialBeeisacomprehensiverecruitment,

pre-screeningandconsentsolution

designedtodrivetrialefficienciesthroughscalable,real-worlddataandreal-timeanalytics.9

AnothergreatexampleisuMotif,apatient

engagementplatformforclinicalandpost-marketresearch.Itscasestudieshave

shownbothanincreaseincomplianceandareductionofstudytimelinesby30%,

demonstratingtheexpertiseandfinancial

benefitsofitsservices.10SanoGeneticsalso

offerpatientsearch,screeningand

engagementservicesinwhattheycall‘a

completecircle’platformthatutilisesDNAanalysistosuggestclinicaltrialstoviablecandidates.11Theseofferingsmaythereforehelptogeneraterobustevidencewith

greatereaseandspeed

“Oneplacemanydigitalhealthcompaniesfalldownisthattheydon’tcollectanyclinicalevidence.Webelieveit’sreallyimportanttobackupourclaimswithevidenceandoutcomes.”

JamieCampbellAssociateDirectorofCommercialPartnerships,Avegen

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Insights

AViewtotheFuture

Regulatorsmustalsocatchuptothese

changes.AsLucyJungstates,regulators

must,andareadaptingtotheevolveddigitalcarepathway.Anexampleofthiscanbe

seeninGermanywiththeintroductionof

DiGAin2019.ThisinitiativeincludesaFast

Trackprocessforstreamliningformal

approvalsandlistingsofdigitalhealthcareapplications,enablingfastermarketentry.

DiGAissymptomaticofthedemandand

competitionfacedinthisspacewithstartupsneedingtoofferinnovativeandeffective

solutionstomeettheDiGAdirectory

criteria.12

ChangescanbeseenintherestofEuropetoo,withtheEuropeanHealthDataSpace(EHDS)proposingnewregulationsthat

mandatedatasharinginthehealthcarespace,implyinggreateraccesstohealthdata.

Alongsidethesenewtechnologiescomesaneedforcompaniestoadapttheirinternalgovernance,ensuringcompliancewithnewdirectivessuchastheAILiabilityDirective

(AILD)andthepreviouslymentionedAIAct.

Startupsandpharmaalikemustprepareforthechallengesofassessingandelevatingriskmanagement,traceabilityand

cybersecutiry.13

“Technology'sonething,regulations

andtrialsarestilltraditional

pathwaysofpharmacological

process(phase1/2/3)whendigitalcareisaquitedifferentpathway.Ifeelpositivethatregulatorsare

realisingthisandadaptingand

pushingoutregulations.Thisisa

challengingareabutit’samazingtoseepeoplearemoreinterestedandfoundersaregettinginvolved.I’m

hopeful.There’salottodoandwe

needtocollaborateacrossindustries”

LucyJungCo-founder&CEO,CharcoNeurotech

Withdynamismandnewplayersalwayscomingtothe

market,thedigitalhealthstartuplandscapeinEurope

remainsofcriticalinteresttohealthcaresystemsand

pharma.Welookforwardtoseeinghowthestartupmarketadaptsandchangesinthecomingmonthsandyearsandtolearnwhatnewdevelopmentsourshortlistcompanieshaveinstore.

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CaseStudies

SelectCaseStudies

CharcoNeurotech

Mission

Lucytellsus:mypersonalgoalis"bringingbacksmilestopeoplewithParkinson’s".It'sthedevice,theservice.It'sthetotalthat

makesabigdifference.We'renotadevicecompany,we'reacompanythatcaresforpeople.Wewanttohelpotherpeoplewithmovementdisordersandneurological

conditions.

CEO

LucyJung

Website

HQ

UK

Category

Wearable/DigitalTherapeutic

TherapyArea

Parkinson’swithafocusonstiffness,slownessandgait

Funding

Seedfunded.LastinvestmentNovember16th,2021,of£7.4m

Tech

TheCUE1isanon-invasive,wearable,

medicaldeviceforpeoplewithParkinson’s,toimprovemovementandqualityoflife

Purpose

Theprincipleofferingofthecompanystems

from19thcenturyFrenchneurologist

ProfessorJean-MartinCharcotwhofoundhispatients’symptomsdramaticallyimprovedwhentheytravelledtohimbycarriage.Itwassoonsurmisedthevibrationsofthecarriagerideseemedtooffertherapeuticbenefit.In

modernday,thisideahassincebeen

researchedwithstudiesfindingvibration

stimulationtoresultinimprovementinstiffness,slownessandgaitamongothersymptoms.

Testing

Pilottestshaveseenparticipantswith

Parkinson’simprovetheirMDS-UPDRSscoresbyanaverageof9.3points,3timesthelevelconsideredclinicallysignificant.100%of

participantsreportedthattheywouldwanttousethedeviceagain.Continuingtostudy–3,200peoplecurrentlyusingthedevice

andbeingstudiedforthey’reusingandthesymptomcategory.

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CaseStudies

Avegen

CEO

Dr.NayanKalnad

Website

HQ

UK

Category

PatientSupport

TherapyArea

Longtermconditions

Funding

PrivatelyfundedwithintentionforseriesAfunding

Tech

Customizabledigitalhealthplatform

Purpose

ClinicianNayanKalnadandNeerajApte

createdAvegenin2015followinga

successfulandeducationalexperiencein

Pharmaandtechwiththemissionofmakingtheworldahealthierplace.Avegenisdrivenbypatientinsightsandcutting-edge

research

Testing

Avegenhasconductedmultiplestudiesonitsappstoensureitsclaimsarebackedup

withevidence.Thisincludesapublished

studyforHeartHealthfindinga51%reductionin6-monthreadmissionsanda30%increaseinclinicalcapability.ItsrandomisedclinicaltrialforitsTogetherforHerappfounda90%increaseinhealthliteracyanda142%

increaseindietarydiversity.Italsotracked1.9millioninstalls,positioningtheappinIndia’sTop3forparentingatthetimeofthestudy.

w13

CaseStudies

TaraCares

Mission

Levellingupthescienceforhealthyageing

Tech

ResponsibleAI-baseddigitalsupporttoolandeducation

Purpose

Equippingeveryhumantomastertheir

uniquehealthyageingjourneywith

personalisedresearchandhealthinsights

(withmenopausenavigationasaninitialuse

case)bytacklingmisinformation,

misdiagnosis,andmismanagement.

Integratingacademicresearch,clinicalexcellenceandcomputationalscience.

Product

MIMOSA,themodularplatformdevelopedby

TaraCares,isrevolutionizingtheway

corporatesaddressmenopause.Withits

evidence-led,science-backedapproach,MIMOSAofferscontinualaccesstoresearch,andscientificevidencetailoredfortheuser.

Fromtracing29hormonalhealth

determinantstopreparingformedicalappointments,theplatformprovidesa

comprehensivesolutionforwomen

navigatingmenopause.Morethanjustatool,MIMOSArepresentsashiftinmindset.It

encouragesorganizationstomovebeyondsuperficialmenopausepoliciesandinvestinscience-backed,actionablestrategies.Byunderstandingtheirmenopause

demographicandindividualpainpoints,

companiescancreateamoreinclusive,

supportiveworkenvironment.Indoingso,

theynotonlyretainvaluabletalentbutalsofosteracultureofunderstandingand

empathy.MIMOSAlookstoavoidthetrapsofsymptomtrackingandhormonetestingto

provideholisticsupportandinformation.Inarevolutionaryground-breakingmovethe

companyhasreleased,MIMI(MenopauseInformationandManagementInterface)

afterayear-longBetatestingwithcliniciansfromtheUS,UKandIndia.Availablefor

CEO

JyotiSharma

Website

mymimosa.uk

HQ

UK

Category

PatientEmpowerment(B2B

SaaS,HRTechforMenopauseHealthliteracyandintegratedemployeewellbeing)

TherapyArea

Healthyageingandhormonalshifts

Funding

Privatelyfunded

premiumsubscribersofMIMOSAplatform,

MIMIistheworld'sfirstResponsibleAIco-

pilot.Leveragingcutting-edgeresponsibleAIandadeepunderstandingofhumanhealth,MIMIaimstobecomeanindispensabletoolforwomenandfemaleindividualsofallagesseekingtooptimisetheirhormonalwellbeingandhealthspan,frompubertytopost-

menopause.MIMOSAisavailablein20+countriesonAndroidandiOSthroughemployerpaidsubscriptionmodel.

w14

Appendix

Methodology

ThiseditionoftheDigitalHealthRadaris

basedondataobservedoverthepastyear.WeanalysedbothOpen-SourceIntelligence(OSINT)andconductedqualitativeinterviewstoproducethisRadar,incorporatingourownopinionsandsubjectmatterexpertise.

Depictedare84longlistedinnovative,

Europeanstartupswehaveattemptedtosegmentintotheprimaryfunctiontheirsolutionsappeartooffer.

However,weknowtherearemanymoredigitalhealthinnovatorsintheEuropean

ecosystemthatweneedtohearfrom.Ifyouareinterestedinbeinginvolvedinthenextedition,pleasegetintouch[link].

Inoursearchwereviewed33funds,

researched574companies,longlisted88,

shortlisted16andinterviewed3ofthemost

excitingmarketinnovatorsintheEuropeanDigitalHealthspace(inouropinionof

course).Theirofferingsrangedfromdigitaltherapeuticstowearablesandutilised

techniquesrangingfromAR,VRthroughtoAIandbeyond.

OurSelectionCriteria:

•BasedinEuropebutcouldhaveoperationsinotherpartsoftheworld

•Itsbusinessmodelcentersaroundinnovationsinthedigitalhealthspace

•Definedasastartup

w15

Appendix

GlossaryandReferences

Glossary

DiGAreferstoDigitale

GesundheitsanwendungeninGermanor

digitalhealthcareapplications.Theseare

applicationsformallyapprovedandlistedin

theDiGAdirectory,followingtheregulationsoutlinedintheDigitalHealthcareAct

(Digitale-Versorgung-Gesetz,DVG).

DigitalTherapeutics(DTx)ultimately

enhancespatientoutcomesthrough

combiningtechnologyandmedical

expertise.Regardingtreatmentplanningandmanagement,DTxisenhancedby

leveragingtechnologyforpersonalised

suggestionsandrecommendations,goingbeyondprocessessuchasautomationorsymptomtracking.ItincludesHCP

interactions,recommendations,

interpretationofresultsandtargeted

interventionsthatutilizeexpertise.Withmonitoring,thisisautomated,involvingpatientinteractionsandtargetingand

communicatingdirectlyorindirectlywiththeHCP,forexampleviareports.

mHealthreferstomobilehealth,ageneraltermfortheuseofmobilephonesandotherwirelesstechnologyinmedicalcare.

mHealthhasanarrayofusesincludingeducationofpreventativehealthcare

services,diseasesurveillance,treatmentsupport,epidemic