Medical profiling and online medicine:

The ethics of ‘personalised healthcare’ in a consumer age

A guide to the report

Table of contents

Introduction 01

Whatis‘personalisedhealthcare’? 02

Ethics 03

Intervention 04

Casestudies Onlinehealthinformation 05 Onlinepersonalhealthrecords 06 Buyingmedicinesonline 08 Telemedicine 09 Personalgeneticprofiling 10 Bodyimaging 11

Conclusions 12

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IntroductionThisguidesummarisestheconclusionsandrecommendationsthatarediscussedinmoredetailintheNuffieldCouncilonBioethics’reportMedical profiling and online medicine: The ethics of ‘personalised healthcare’ in a consumer age(publishedOctober2010).

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Newdevelopmentsinmedicalprofilingandonlinemedicinearepromisedbytheirprovidersasleadingtoaneweraof‘personalisedhealthcare’.Thesedevelopmentsinclude:

•direct-to-consumerbodyimaging(e.g.CTandMRIscans)andpersonalgeneticprofilingasahealthcheck

•theincreaseinwebsitesthatprovidehealthadvice,diagnosis,storageofhealthrecords,andmedicinesforsale.

Thetechnologiesbehindthesedevelopmentsarealreadybeingusedinpositiveways.Forexample,theUK’sNationalHealthService(NHS)usesapprovedgeneticteststodetectraregeneticdisorders.Weexplorethemorecontroversialusesofthesetechnologies,andtheextenttowhichtheyreallydoleadtohealthcarebecomingmorepersonalised.

Notesinsquarebracketsrefertothechaptersinthereport.

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What is ‘personalised healthcare’?Theterm‘personalisation’hasbecomeverywidespread,withmanycompanies,policymakersanddoctorsclaimingthatthisisthefutureofhealthcare.

Wefoundseveralmeaningsfor‘personalisedhealthcare’.Forexample,itcanmeanhealthcarethatistailoredtoaperson’sspecificcharacteristics,orhealthcarewheremoreresponsibilityisgiventoindividualsratherthanmedicalprofessionals[Chapter1].

LinkswithresponsibilisationandconsumerisationSomeofthesetypesofpersonalisedhealthcarecorrespondwithtwokeysocialpressures,called‘responsibilisation’and‘consumerisation’.Thesepressuresarenotjustrelevanttohealthcare,butpresentparticularethicalchallengesforthedevelopmentsbeingconsideredinthisreport.

‘Responsibilisation’

PolicymakersintheUKandelsewhereoftenencouragepeopletotakemoreresponsibilityfortheirownhealth–toleadahealthylifestyleandplayanactiveroleinmanagingtheirhealthcare.Developmentsinmedicalprofilingandonlinemedicinecanprovidenewtoolstoenablepeopletotakemoreresponsibilityfortheirhealth.

‘Consumerisation’

Thereisnothingnewaboutbeingabletoselectandpayforhealthcareintheprivatesector,buttodayevenpublichealthcareservicesareaimingtobecomemoreuserfocused.Aconsumeristapproachtohealthcareandthenewtechnologiesavailablehavebeenseizeduponbyfirmsofferingmedicalprofilingandonlinemedicineservices[Chapter2].

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Ethics Thefollowingfiveethicalvaluesareimportantwhenconsideringdevelopmentsinmedicalprofilingandonlinemedicine:

1Privateinformationshouldbesafeguarded.

2Individualsshouldbeabletopursuetheirowninterestsintheirownway.

3Thestateshouldacttoreduceharm.

4Publicresourcesshouldbeusedfairlyandefficiently.

5Socialsolidarity(sharingrisksandworkingtogethertoprotectthevulnerable)shouldinformpublicpolicy.

ConflictingethicalvaluesTheseethicalvaluesoftenconflictwithoneanother.Allareimportantandnoonevalue‘trumps’another.

Inthefollowingcasestudies,weexaminethebenefitsandharmsineachsituation.Wethenattemptto‘soften’theconflictsbetweentheethicalvaluesbyrespectingeachofthemasmuchaspossibleandmakingrecommendationsthatareevidence-based,proportionateandfeasible[Chapter3].

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Intervention Ifthereisbroadagreementthatanewdevelopmentinmedicalprofilingandonlinemedicineislikelytocausesignificantharm,theninterventionbygovernmentsorotherorganisationsisjustified.

TypesofinterventionCoercivevsnon-coerciveSomeinterventionsinvolveformalstate-specificformsofcoercion,suchaslawsandregulations,whileothersdonot,suchasvoluntarycodesofconductoreducationcampaigns.

SpecificvsgeneralSomeinterventionsarespecifictotheproductorserviceinquestion,whileothersaremoregeneral,forexamplegeneralprofessionalcodesorrulesaboutdataprotection.

ChoosinginterventionsTheinterventionshouldbeproportionatetotheproblem.Lesscoerciveinterventionsshouldbeexploredfirst,unlessthedegreeofharminaparticularcasemeritsamorestringenttypeofintervention.

Moregeneralformsofinterventionareoftenpreferabletomoreservice-orproduct-specificones,particularlywheretechnologyisrapidlychangingandspecificrulescanquicklybecomeoutdated.

Interventionsshouldalsobefeasible.Theremaybetimeswhenmeasurescouldnotrealisticallybeenforced,wouldbeveryexpensiveorcouldhavenegativesideeffects[Chapter4].

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OnlinehealthinformationPeoplehavealwaysbeenabletoaccesshealthinformationinnewspapersandmagazines,buttheinternethasopeneduparangeofnewpossibilitiesforconvenientlyfindingandexchanginginformationonhealth.Thiscanincreasepeople’sinvolvementintheirownhealthandprovidethemwithvaluablesupportfromothers.

However,itisdifficultforpeopletoassesstheaccuracyofinformationtheyaregettingonline,andtheymaynotknowwhohasaccesstoanypersonalinformationtheysubmit.Therearenostrongincentivesforinformationproviderstofollowbestpractice.

Thebestwebsitesarebasedonhighqualityresearch,originatefromanindependentnot-for-profitorganisation,areindependentlyevaluatedandcontinuouslyupdated.

Weconclude…•Allwebsitescontaininghealthinformationshouldcontain

keydetailsabout,forexample,thebasisoftheinformation,theauthors,fundingarrangements,andhowanypersonaldatawillbeused.Websitesshouldseekaccreditationfromrecognisedschemes.

•Governmentsshouldensurethathighqualityhealthinformationisavailableontheinternetanddoctorsshoulddirectpatientstothesesites.

•Doctorsshouldreceivetrainingandadviceoncaringforpatientswhousetheinternettoaccessinformationaboutdiagnosisandtreatment[Chapter5].

Case studies

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OnlinepersonalhealthrecordsBothpublicandprivatehealthcareprovidersarestartingtoofferonlinehealthrecordsservices.

ThroughitsHealthSpacewebsite,theNHScurrentlyintendstoprovideeveryoneinEnglandwithonlineaccesstoasummaryoftheirmedicalrecords,includinginformationabouttheircurrentandpasthealthproblems,medicationandallergies.

Severalcommercialcompanies,mainlyintheUS,provideservicesthatallowpeopletoorganisetheirpersonalhealthinformation,integratehealthrecordsfromdifferentproviders,andsharethemwithotherpeople,includinghealthcareprofessionals.

Theseservicesallowmoreconvenientandpatient-centredcontrolofhealthrecords.However,thereispotentialformisuseofstoredinformation.

Weconclude…•Governmentsshouldsetupaccreditationschemesforonline

healthrecordproviderstoimprovetransparencyandstandardsonhowpersonalinformationisstoredandused.Providersoftheseservicesshouldseekaccreditationfromsuchschemes.

•Duringthesigning-upprocess,onlinehealthrecordprovidersshouldprovidepotentialuserswithinformationaboutdatasecurityandlegalrights.

•ResponsiblebodiesintheEU,suchastheUKInformationCommissioner’sOffice,shouldapplyEuropeanUniondataprotectionlegislationtoonlinehealthrecordsusedbypeopleintheEU[Chapter6].

Case studies continued

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BuyingmedicinesonlineOnlinepharmaciescanallowpeopletobuymedicinesconvenientlyandprivately.GreatBritainhasaregistrationsystemforonlinepharmaciestohelppeopleidentifylegitimatewebsites.

Theinternetcanalsobeusedtobuymedicinesforwhichpeopledonothaveaprescriptionandwhichareillegalintheircountry.Peopledoingthisriskbuyingharmful,fakeorlowqualitymedicinesandcouldmissoutonadviceofferedbydoctorsandpharmacists.Itcouldalsoleadtoanincreaseinantibioticresistancearisingfrommisuseofantibiotics.

Theextentofanyharmcurrentlybeingcausedisnotknownbutthepotentialforharmisgreat.Aswithallonlineservices,theinternationalnatureoftheproblemmakesitadifficultareatoregulate.

Weconclude…•Registrationschemesforonlinepharmacies,suchastheone

inGreatBritain,shouldbemirroredinothercountries.

•Governmentwebsitesshouldprovideinformationabouttherisksofbuyingmedicinesonlineandhowtoidentifyaregisteredonlinepharmacy.

•Doctorsshouldreceivetrainingandadviceonhowtodealwithpatientswhomaybebuyingmedicinesonline.

•Governmentsworldwideshouldsetandenforceregulationsonthesupplyofantibioticsintheircountry[Chapter7].

Case studies continued

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TelemedicineTelemedicinereferstoanyhealthcarethatinvolvescommunicationstechnologyandanelementofdistance.Itincludespatientsanddoctorscommunicatingwitheachotherelectronically,andmedicaldevicesbeingoperatedremotely.

Althoughsometypesofcarewillalwaysneedtobedeliveredinperson,telemedicinehasthepotentialtooffercaretopeopleintheirownhomeandincreaseequitableaccesstohealthcareservices.

Telemedicinecouldhaveaparticularlypositiveimpactindevelopingcountries,forexample,byenablingdoctorstoseekexpertopinionsfromspecialistsindevelopedcountries.Telemedicinemayalsohaveanimpactonthe‘braindrain’effectofdoctorsmovingfromdevelopingcountriestoworkindevelopedcountries.

Therehasbeenlittleresearchontheimpactofdifferenttypesoftelemedicineondoctor-patientrelationshipsoronwhethertheybringcostsavings.

Weconclude…•Publichealthcaresystemsshouldoffertelemedicine

serviceswheretheycanfeasiblyandcost-effectivelyhelptoreduceinequitiesinaccesstohealthcare.Anyimpactsonthedoctor-patientrelationshipshouldbeevaluated.

•Internationalagenciesshouldencouragetelemedicinenetworksindevelopingcountrieswheretheyareshowntobebeneficial,cost-effectiveandsustainable.

•Developedcountriesshouldmonitoranyimpactsofoutsourcingtheirhealthcareservicestodevelopingcountriesviatelemedicine,forexampleonthe‘braindrain’effect[Chapter8].

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PersonalgeneticprofilingSeveralcompanies,mainlyUS-based,nowofferpersonalgeneticprofilingservicesfordiseasesusceptibility.AfteranalysingasampleofDNA(e.g.fromasalivasamplesentinthepost),theyclaimtobeabletotellhealthypeopleabouttheirrisksofdevelopingcommondiseasesinfuture,suchascancer,Parkinson’sdiseaseanddiabetes.TheseservicescancostuptoUS$2000.

Thetestsmightprovidereassuranceorenablepeopletotakepreventativeaction.However,thereareanumberofpotentialdownsides:

•Thetestresultscanbeunreliableanddifficulttointerpret.

•‘Good’resultsmayleadtocomplacencyinlifestyle.

•Learningaboutriskofdiseasecouldbeupsetting,particularlyifnotreatmentsareavailable.

•Thereispotentialformisuseofpersonalgeneticinformation.

•Peoplemayseekunnecessaryfurthertestsoradvicefromtheirdoctor.

Thenumberofpeopleusinggeneticprofilingservicesandwhetherthisiscurrentlyleadingtoanyactualharmisnotknown.

Weconclude…•Regulatorsshouldrequestevidenceforanyclaimsbeingmadeby

companiesabouttheclinicalvalueoftheirtests.

•Governmentwebsitesshouldprovideinformationabouttherisksandbenefitsofpersonalgeneticprofiling,includingtherelevanceforinsurance.

•CompaniesshouldnotknowinglyanalysetheDNAofchildrenunlesscertaincriteriaaremet.

•Doctorsshouldreceivetrainingongivingadvicetopatientsaboutcommercialgeneticprofilingservices.

•Companiesshouldvoluntarilyprovideclearinformationonthelimitationsofgeneticprofilingandwhatwillhappentopeople’sdata[Chapter9].

Case studies continued

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BodyimagingCommercialcompaniesarenowofferingpeoplea‘healthMOT’usingbodyimagingtechnologiessuchasCTandMRIscans.Theyclaimtolookforearlysignsofconditionssuchascancerandheartdisease,andcancostmorethan£1000.

Thetestscanputpeople’smindsatrest,orencouragethemtoseektreatmentandmakelifestylechanges.However,thereareanumberofpotentialdownsides:

•CTscansexposepeopletoradiation,whichcanbeharmful.

•Theresultscanbedifficulttointerpret.

•MRIscansoftenpickup‘abnormalities’whichareactuallyharmless,butwhichcouldleadtounnecessaryanxietyandfurtherinvasivetests.

•Thereispotentialformisuseofpersonalhealthinformation.

Thenumberofpeopleusingdirect-to-consumerbodyimagingservicesandwhetherthisiscurrentlyleadingtoanyactualharmisnotknown.

Weconclude…•Companiesthatsellbodyimagingservicesasahealthcheck

shouldberegulatedtoensuretheyaremeetingstandardsofqualityandsafety.

•Direct-to-consumerwholebodyCTimagingshouldbebanned.Part-bodyCTscansshouldonlytakeplaceifitisinthebestinterestsofthecustomer.

•Governmentwebsitesshouldprovideinformationabouttherisksandbenefitsofcommercialbodyimaging,includingtherelevanceforinsurance.

•Companiesshouldvoluntarilyprovideclearinformationonthelimitationsofdirect-to-consumerbodyimaging,andwhatwillhappentopeople’sdata.

•Doctorsshouldreceivetrainingongivingadvicetopatientsaboutdirect-to-consumerbodyimagingservices[Chapter10].

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Conclusions

PersonalisationAllthedevelopmentsinmedicalprofilingandonlinemedicineconsideredinthereportofferincreased‘personalisation’tosomeextent.Butmanyoftheclaimsformoreindividualiseddiagnosisandtreatmentseemtobeoverstatedandshouldbetreatedwithcautionatthepresenttime.Forexample,commercialgeneticprofilingandbodyimaginghavethepotentialtotailorhealthcaretotheindividual,butthatpotentialhasyettobefullyrealised.

ConsumerisationAllthedevelopmentsconsideredbythereportcanlendthemselvestotheprovisionofhealthcareasaconsumergood.Wethinkchoiceisoftenagoodthing,buttoworkeffectivelyinhealthcareitneedstobeaccompaniedbyproperinformationandadvice.

Wealsoneedtofindwaysofbalancingindividualchoicewiththeprincipleofsocialsolidarity–i.e.thatweshouldsharetheresponsibilitytohelppeopleinneed.

ResponsibilisationThedevelopmentsconsideredinthisreportcanleadtonewobligationsandexpectationsfortheindividualswhousethem.Forexample,onlinepersonalhealthrecordssystemscanplacenewdemandsonindividualstochecktheirrecordsandensuretheirsecurity.

Wethinkresponsibilityforhandlingnewrisksassociatedwiththesedevelopmentsshouldbeplacedinthehandsofthosebestplacedtomanageit.Insomecasesthisisthestate,insomecasesthemedicalprofessional,andinothercasestheindividual.Eachcaseneedstobeconsideredonitsownmerits.

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©NuffieldCouncilonBioethics2010

PublishedOctober2010

SummaryNewdevelopmentsinmedicalprofilingandonlinemedicinearepromisedbytheirprovidersasleadingtoaneweraof‘personalisedhealthcare’.

‘Personalisedhealthcare’canhavedifferentmeanings,includinghealthcarethatistailoredtotheindividualandhealthcarethatgivesmoreresponsibilitytotheindividual.

Anumberofnewdevelopmentsinmedicalprofilingandonlinemedicineareconsideredascasestudies:

•Personalgeneticprofiling

•Direct-to-consumerbodyimaging

•Onlinehealthinformation

•Buyingmedicinesonline

•Onlinepersonalhealthrecords

•Telemedicine

Thebenefitsandharmsofeachareweighedup,alongwiththeethicalvaluesthatcomeintoplay,suchasindividualsbeingabletopursuetheirowninterestsandeffortsbythestatetoreduceharm.Wequestionthedegreeofpersonalisationachievedbythenewdevelopmentsandalsotheirimplicationsfor‘consumerisation’and‘responsibilisation’ofhealthcare.Recommendationsforpolicyandpracticearemadeineachcase.