ethics concerning electronic medical data

8/16/2019 Ethics Concerning Electronic Medical Data

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A study to defne the international guidelines o ethics concerning electronic medical data

Mohammed Jawad, [1] Elsa Butrous, [2] Benjamin Faber, [3] ChandniGupta, [] Christopher !a""art, [#] $atel [%]

Cite as& Jawad, M', Butrous, E', Faber, B', Chandni, G', !a""art, C', $atel, (', )*stud+ to dene the international "uidelines o- ethi.s .on.ernin" ele.troni.medi.al data/, European Journal -or 0aw and e.hnolo"+, ol' 3, o' 1, 2412

1. ABSTRACT

here has been a "lobal in.rease in the use o- in-ormation s+stems, with a"rowin" amount o- ele.troni. data bein" .olle.ted, stored, pro.essed,manipulated, trans-erred and distributed 5these bein" the -our domains o-usa"e6' Medi.al data is no e7.eption, with the e7plosion o- Ele.troni. !ealth

8e.ords 5E!86 and health.are data minin" bein" 9e+ e7amples' (u.h a.ti:itiesha:e .reated an arra+ o- ethi.al dilemmas .on.ernin" the use o- Ele.troni.Medi.al ;ata 5EM;6' * preliminar+ literature re:iew re:ealed a la.9 o- uni:ersal,international and .on.lusi:e set o- ethi.al "uidelines pertainin" to these domainso- EM;' he -ollowin" literature re:iew helps ll this :oid b+ .reatin" su.h a set o- ethi.al "uidelines'

2. INTRO!CTIONMoore/s 0aw -ore.asted that .omputer power will double rou"hl+ e:er+ 12


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here are a multitude o- ethi.al prin.iples that .an help shape morall+ reasonedand lo"i.al ar"uments with re"ard to EM; usa"e' here-ore, this stud+/s ethi.aldis.ussion reuired an appre.iation o- .lassi.al ethi.al prin.iples and an in


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)igure 1 ine


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t -ollows that -or a data subje.t to .onsent to the .olle.tion o- their medi.al data,the+ must be able to -ull+ understand what the+ are .onsentin" to' here-ore, it isimportant that the data subje.t has the ri"ht to reuest -urther in-ormation abouthow their data mi"ht be used' he data .olle.tor should be suH.ientl+ open andwillin" to e7plain to a data subje.t, the de"ree o- data use'

*. Su,5ects hae the right to re4uest inormation +ertaining to the

sco+e o use o their electronic medical data.

6. ata collectors hae an ethical res+onsi,ility to ensure the ma3imum

easi,le trans+arency.

0oshin identies a list o- parties whi.h .an la+ potential .laim to data in.ludin"the .reator, .onsumer, .ompiler, -under and pur.hasers' [23] *lthou"h ea.h hasa ri"ht to .laim ownership, ownership does not ne.essaril+ pla.e responsibilit+ on

them' he spe.ied le:el o- se.urit+ laid out when .olle.tin" data should bemaintained when mana"in" the data' t is there-ore the data .olle.tor/sresponsibilit+ to ma9e sure the+ .olle.t the data under these .onditions'

7. Those that collect the electronic medical data are ethically

accounta,le or the data and to the +ersons on -hich it is ,ased.

Clearl+, as health .are pra.ti.es be.ome more ali"ned with data stora"e, a.ertain de"ree o- .onsent will be .riti.al -or re.ei:in" optimal .are' * subje.tshould be able to re-use .olle.tion o- their EM; as it has been determined that

obtainin" .onsent is ethi.all+ sensiti:e' ne inter:iewee dis.ussed theimportan.e o- ensurin" that these patients who do re-use .onsent aresubseuentl+ not treated in a biased nature' !owe:er, these subje.ts must alsounderstand the possible disad:anta"eous .onseuen.es'

8. Su,5ects should not ,e additionally disadantaged i they decline

electronic medical data collection and should ,e ade4uately inormed o

the +ossi,le conse4uences o this.

'2 (8*GE

*s E!8/s be.ome .ommonpla.e, it seems reasonable -or subje.ts to allow theirin-ormation to be stored ele.troni.all+, espe.iall+ to ensure .ontinuit+ o- .are' nthe medi.al pro-ession, this stora"e usuall+ o..urs under implied .onsent'Furthermore, i- subje.ts ha:e .onsented to data .olle.tion, then b+ impli.ation,the+ ha:e .onsented to its stora"e'

;uration o- stora"e is another important :ariable o- .onsent' t is ethi.all+appropriate to .lari-+ how lon" data should be stored& -or e7ample whether a

subje.ts/ E!8 is bein" stored -or li-e'

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1. ata storage should occur -ith res+ect to a++ro+riate consent rom

the su,5ect -hich should include the duration +eriod o storage.

t is ar"ued that onl+ EM; that is ne.essar+ -or the purpose o- use should bestored' [2] [2#] [2%] his is based on the ethi.al reasonin" that one should onl+

store data that dire.tl+ inuen.es the "reater "ood'

2. Ater electronic medical data is collected only the releant amount

or the +ur+ose should ,e stored.

he -ollowin" "uideline is justied b+ the ar"ument that i- a part+ .olle.ts thedata, onl+ the+ .an dire.tl+ .ontrol the data so the+ must be held a..ountable -orits stora"e'

". The +arty -ho collected and stored the electronic medical data

should ,e held accounta,le or the sae storage o that data.

rust is an )ethi.al imperati:e/ and it should be "uarded b+ prote.tin" pri:a.+'ne inter:iewee put -orward pri:a.+ as one o- the -our 9e+ ethi.al prin.iples inmedi.ine be.ause it not onl+ maintains trust but upholds autonom+' [2>] $ri:a.+is a.hie:ed throu"h maintainin" adeuate se.urit+' t is important that these.urit+ o- data should not pre:ent timel+ a..ess to data otherwise it ma+

jeopardise the purpose o- storin" it 5i'e' allowin" a..ess to an E!8 in anemer"en.+6'

*. $lectronic medical data should hae an a++ro+riate degree o

security to saeguard su,5ect +riacy -hilst allo-ing a++ro+riate ease

o access.

(e.urit+ is desi"ned to pre:ent unauthorised a..ess' here-ore, ethi.all+ storeddata should onl+ "rant a..ess to those people with a le"itimate purpose' [2=][2@]

6. Only those +arties -ith an authorised mandate or the use o the

stored $# should ,e granted access.

'3 $8CE((G *; M*$K0*

n-ormed .onsent is .ru.ial within ethi.al pro.essin" and manipulation o- EM;' *subje.t should pro:ide .onsent -or the manipulation and pro.essin" o- their ownEM; su.h as in data minin"' he prin.iple o- openness helps one understand that.onsent should be "i:en b+ the subje.ts e:er+ time the data is pro.essed -or anew purpose' [34] he deC;E .ase 5where the biomedi.al .ompan+ was"ranted permission to a..ess the e7istin" medi.al re.ords database o- all.elandi. people and .reate a "eneti. database6 re:ealed .on.erns -or ne"le.tin"

the prin.iple o- autonom+ b+ brea.hin" pri:a.+ and .onsent'[31]

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* -urther issue reuirin" dis.ussion is the lin9in" o- non


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anon+mised leadin" to unreliable andor biased data, and so the+ ar"ue that the+should be able to use and manipulate data that has not been anon+mised to the-ullest e7tent e:en i- the+ do not ha:e .onsent' [33] hose a..ountable -or dataha:e a moral obli"ation to ensure that mista9es are a:oided, and this stud+ hasalso noted that onl+ those a..ountable should .arr+ out these .he.9s in order toa:oid pri:a.+ brea.hes' his ualit+ assuran.e .an be a.hie:ed throu"h auditsand re:iews'

*. #ani+ulators and +rocessors o electronic medical data should hae

an ethical res+onsi,ility to ensure accuracy and relia,ility o electronic

medical data ia regular audits and reie-s.

*.ts and laws are alread+ in pla.e to prote.t indi:iduals -rom se.urit+ and pri:a.+brea.hes' !owe:er, the ethi.al impli.ations o- noti-+in" a subje.t are .onsidered-urther in this stud+' he or"anisation responsible -or su.h a brea.h ma+ -ear

ne"ati:e publi.it+ or nan.ial reper.ussions, but the maintenan.e o- a subje.t/srespe.t and di"nit+ is more ethi.all+ :aluable' here-ore, the manipulatorresponsible has a moral obli"ation to rebuild the trust o- the subje.t -ollowin" abrea.h'

6. In the eent o a data ,reach mani+ulators and +rocessors should

hae an ethical duty to inorm the su,5ect -hose data security and

+riacy has ,een com+romised.

Considerin" both Guideline and #, i- a brea.h is dete.ted, it -ollows on that an

in:esti"ation into the .auses must be .arried out in order to reassure the subje.tand rebuild their trust -or the manipulation and pro.essin" o- EM;'

7. In the eent o a data ,reach mani+ulators and +rocessors should

hae an o,ligation to ensure that they are a,le to conduct a su/ciently

e3tensie reie- and audit to identiy the cause o a data ,reach.

*s pre:iousl+ mentioned in Guideline 1, .onsent should be obtained -or thea..ess to identiable EM;' ut o- .ourtes+, .onsent -or anon+mised data shouldalso be obtained but there is a "eneral .onsensus that it .an be manipulated and

distributed without .onsent, espe.iall+ -or a utilitarian purpose' !owe:er, thereare :arious de"rees o- anon+mised data and thus manipulatin" and pro.essin"without .onsent is a mineeld' deall+, pri:a.+ should be maintained throu"h de<identi.ation but the stud+ also appre.iates that unreliable, unhelp-ul andina..urate in-ormation .ould result -rom de


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' 8*(FE8 *; ;(8BK

he trans-er and distribution o- EM; internationall+ or between or"anisations,

institutions or indi:iduals raises ethi.al dilemmas' he reuirement to "ainin-ormed .onsent is on.e a"ain .riti.al'

he e7ample o- data trans-er and distribution -rom the 3 se.ure networ9 to theunse.ure internet reuires ethi.al .onsideration' For instan.e, there is a need toin-orm subje.ts o- su.h trans-ers and to "ain in-ormed .onsent, espe.iall+ i- datais o- an identiable nature' !owe:er, the ar"ument a"ainst this is the potentialhindran.e to health.are resear.h and ser:i.es i- in-ormed .onsent was reuireddurin" trans-er, or that there would be -easibilit+ issues asso.iated with "ainin".onsent' ne inter:iewee re-used to a..ept that -easibilit+ diH.ulties are an

e7.use -or not "ainin" .onsent, but in an emer"en.+, in-ormed .onsent must bewai:ed i- this is in the patient/s best interests' *n o:erar.hin" .ompromise .ouldbe to a..ept that the trans-er and distribution o- unidentiable data is a..eptablewithout .onsent, 5as an+ potential se.urit+ brea.hes are hi"hl+ unli9el+ to resultin subje.t identi.ation6'

* related ar"ument is that .onsent should alwa+s be obtained -or identiabledata' his stan.e is supported b+ E$((, a leadin" or"aniLation in the eld o-medi.al data trans-er, who ha:e stated a need to "ain .onsent -or internationaltrans-ers, espe.iall+ when EM; is identiable' [3]

1. Ade4uate consent or a +ur+ose should ,e o,tained -heneer

identifa,le electronic medical data is transerred and distri,uted.

2. Consent should not ,e re4uired or the ethical transer and

distri,ution o de0identifed electronic medical data.

". hen electronic medical data is transerred and distri,uted across

,orders or an unsecured net-or; inormed consent should ,e o,tained

or this transer and distri,ution.

he ambi"uous relationship between ownership and a..ountabilit+ is apparent'ne .an .on.lude that the owner o- the EM; has responsibilit+ o:er the data set,whi.h mirrors the raditional 8ule ar"ument where the ph+si.ian should alsoassume a..ountabilit+' *lternati:el+, one .ould ar"ue the data subje.t shouldmaintain ownership o- EM;, as it is in-ormation about them& a :iew whi.h twointer:iewees also a"reed with' *n ethi.al .on.lusion arose that re"ardless o-ownership, the part+ that trans-ers EM; should alwa+s maintain responsibilit+o:er it, rather than the owner o- the data' his stan.e is supported b+ the $$E;*"uidelines' [3#] !owe:er, the .onstantl+ de:elopin" worldwide web and posediH.ulties in maintainin" a..ountabilit+ o:er ele.troni. data 5as it .an betrans-erred and distributed so ui.9l+6' * -urther rele:ant :iew is that re"ardless

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o- standardisation and rules, there are alwa+s e7.eptions in the owner] ne option.ould be to set a minimum standard o- se.urit+ that must be met durin" EM;trans-er and distribution' !owe:er, this is a potentiall+ unethi.al a.tion, not tomention hi"hl+ un-easible when .onsiderin" the "lobal :ariation in se.urit+measures' here-ore, a .omparati:e approa.h to se.urit+ seems to be the mostethi.all+ a..eptable and -easible "uideline, as it also ensures .onsisten.+ with

8awls/ "eneralit+ prin.iple' [3=]

8. ata transer reci+ients should +roide e4ual or greater leels o

security than the electronic medical data sender.

he appropriate le:el o- en.r+ption is a -urther reuirement durin" data trans-erand distribution, as it helps uphold the underl+in" ethi.al ri"ht -or all indi:idualsto e7pe.t a le:el o- pri:a.+' * dis.ussion o- en.r+ption and pri:a.+ .annot o..urwithout in.orporatin" the .losel+ related topi. o- de


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maintained& it also pro:ides resear.hers with si"ni.ant room -or resear.h anddata usa"e whi.h "oes some wa+ to partiall+ a.hie:in" utilitarian benets' his isas lon" as de


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[3] Benjamin Faber is a -ourth +ear medi.al student at mperial Colle"e 0ondon,inter.alatin" with a B(. in Medi.al (.ien.es with Mana"ement at mperial Colle"eBusiness (.hool

[] Chandi Gupta is a third +ear medi.al student at in"Os Colle"e 0ondon,

inter.alatin" with a B(. in Medi.al (.ien.es with Mana"ement at mperial Colle"eBusiness (.hool

[#] Christopher !a""art is a -ourth +ear medi.al student at mperial Colle"e0ondon, inter.alatin" with a B(. in Medi.al (.ien.es with Mana"ement atmperial Colle"e Business (.hool

[%] (a"ar $atel is a -ourth +ear medi.al student at mperial Colle"e 0ondon,inter.alatin" with a B(. in Mana"ement in Medi.al (.ien.es with Mana"ement atmperial Colle"e Business (.hool

[>] Moore, G' Crammin" more .omponents onto inte"rated .ir.uits' Ele.troni.s1@%#I3=5=6& 11'

[=] (a-ran, C', Bloomrosen, M', !ammond, E', 0ab9o?, (', Mar9elI1 516& 1


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[1] lu"e, E'

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[1=] *nnas, G' J' Medi.al pri:a.+ and medi.al resear.h < jud"in" the new -ederalre"ulations' "e+ England Journal of Medicine 2442I3%536& 21%

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[2>] Mommens, $' Ethi.al ssues o- health.are in the in-ormation so.iet+' .ealthInformatics Journal 1@@@I#56I 233

[31] !lodan, ' /or Sale# Iceland0s 1enetic .istory ' [nline] *:ailable-rom& http&www'a.tionbios.ien.e'or""enomi.hlodan'html [*..essed on 2nd Ma+2414]

[32] Custers, B' he 8is9s o- Epidemiolo"i.al ;ata Minin"' n& Chadwi.9, 8',ntrona, 0';', Marturano, *' 5eds'6, $ro.eedin"s o- the /ourth International$onference on $omputer Ethics ( Philosophical En2uiry 5CE$E 24416, K'0an.aster Kni:ersit+I 2441'p' %14

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[3>] (ur"enor, ' he pri.e o- data sharin"' "et+or3 Security 244%I244%5146& =<14'

[3=] *ros9ar, M' *natom+ o- an Ethi.al ;ilemma& he heor+' !he American Journal of "ursing 1@=4I=456& %#=

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