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  • 7/27/2019 Data Protection and the eLogbook

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    Ann R Coll Surg Engl (Suppl) 2013; 95: 238240

    TRAiNEES fORUM

    We welcome orgnal artcles for

    the Tranees Forum on any suject

    of nterest to surgcal tranees

    (maxmum 1,500 words). We wll

    also consder letters commentng on

    artcles pulshed n the Tranees

    Forum. Please emal sumssons to

    [email protected].

    Mantanng a record of procedures performed s an essental component of surgcal

    practce ut the rsks assocated wth handlng patent data are not always apprecated.

    vesey et al prode clear gudance on the mplcatons that legslaton goernngsenste data hae for tranees. They outlne steps that the nddual can take to make

    sure that they use resources such as the eLogook safely and comply wth wth the

    Data Protecton Act.

    Bjan Moara

    Seres Edtor

    The pan-specaty surgca

    elogbook, mantane by The Roya

    Coege o Surgeons o Enburgh

    (RCSE) on beha o the our roya

    surgca coeges, s now the de

    facto too or a surgca tranees.The coeges ssue new terms an

    contons at about the same tme

    that genera surgca tranees were

    obge to transer to the elogbook

    rom the prevousy manate

    intercoegate Surgca Currcuum

    Programme ogbook. Some o

    the causes wthn the terms an

    contons gave rse to concern,

    an severa tranees contacte the

    Assocaton o Surgeons n Tranng

    (ASiT) to seek clarifcation.

    in ths artcle, we hae undertaken

    to briey review the most pertinent

    legslate ackground and to address the

    concerns that arose. Data goernance

    n medcne s a large, expandng and

    complex ssue and ths monograph s

    necessarly narrow n scope. A Jont

    Surgcal Colleges Data Goernance

    Commttee has recently conened and

    s examnng the ssue, wth road terms

    of reference on ehalf of all fellows and

    memers of the surgcal colleges.

    Backgroun

    The expresson dgtal reoluton s not

    hyperole. Our alty to use computers

    to process and transfer ast quanttes of

    nformaton almost nstantaneously has

    had truly unfathomale consequences.

    indeed, as n many domans, computng

    has led to a paradgm shft n the world

    of medcne; from electronc patent

    records all the way to the affordale

    and rapd sequencng of an nddualsentre genome (somethng that was

    unmagnale 20 years ago). The lst of

    examples s endless. These adances

    have undoubtedly brought great benet,

    ut as wth so many new dscoeres,

    other consequences aound. in medcne,

    two of the man concerns centre on

    data securty and accuracy and the

    implications for patient condentiality

    and safety. These two concerns are at the

    root of the prolem that legslators hae

    to contend wth alancng the rghts of

    the nddual to control access to ther

    personal data aganst the socetal alue

    of so-called g data and the rghts and

    responsltes of those who hold and

    control that data.

    in an attempt to strke ths alance, much

    legslaton has een drafted and enacted

    n the EU and the UK durng the past

    30 years. The most recent and germane

    pece of UK legslaton s the Data

    Protecton Act (DPA) of 1998.

    The data Protecton Act 1998

    Key Defnitions

    > Data subject the identiable

    nddual to whom personal

    data pertan.

    > Data controller any entty

    (nddual or organsaton) that

    determnes how personal data

    are processed.

    > Personal data any data that can

    e lnked to a lng nddual.

    This denition also applies topseudonymsed or lnked-anonymous

    data when the data controller has the

    means to decrypt such data.

    > Senste personal data any

    personal data relatng to race,

    ethncty, poltcal opnon, relgon,

    health, sexual lfe, actual or alleged

    crmnal record.

    Although complex, the DPA n essence

    ensures that personal data s handled

    correctly. it sets out to achee a

    alance etween protectng the rghts

    of the nddual to mantan control of

    ther personal data and the rghts of

    organsatons to use such data legtmately

    wthout undue regulatory strcture.

    It achieves this in two ways: rst, the

    act places certan olgatons upon data

    controllers and, second, t enshrnes

    certan rghts for data sujects (that

    manly relate to data access, qualty

    and use). The whole act s ased upon

    eght prncples:

    1. Personal data shall e processed

    farly and lawfully.

    2. Personal data shall e otaned only

    for lawful purposes.

    data protecton an the elogbookAT Vesey brtsh Heart Foundaton Centre for Cardoascular Research, Unersty of Ednurgh

    JEf ftzger a Royal College of Surgeons of England, Assocaton of Surgeons n Tranng

    A lamb Royal College of Surgeons of Ednurgh

    DOi: 10.1308/147363513X13690603820748

    238

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    THE ROYAL COLLEGE OF SURGEONS OF ENGLAND BUllETiN

    3. Personal data shall be adequate,

    relevant and not excessve.

    4. Personal data shall be accurate and

    up to date.

    5. Personal data shall not be kept

    for longer than s necessary.

    6. Personal data shall be

    processed n accordance wth

    the rghts of data subjects.

    7. Data shall be held and

    processed securely.

    8. Personal data shall not be

    transferred to another countrywthout adequate protecton.

    A key theme s consent. in most

    cases, the consent of the data subject

    should be sought before processng

    personal data. in the case of senstve

    personal data, obtanng explct

    consent s nearly always mandated.

    indvduals or organsatons actng as

    data controllers must be regstered

    as such wth the informaton

    Commissioners Ofce (ICO).

    The dPA an the elogbook

    The eLogbook s a large database

    holdng vast amounts of apparently

    senstve personal data pertanng to

    mllons of people. in order to ensure

    full complance wth the DPA, a number

    of measures were nsttuted ncludng

    the release of the aforementoned

    terms and condtons. it should be

    noted at the outset that the actual

    servers that host the eLogbook

    (and iSCP databases) are housed

    and mantaned by a company wth

    the approprate expertse that has

    a contract wth the colleges and the

    Jont Commttee on Surgcal Tranng.

    Here follow the clauses that gave

    rse to concern, accompaned n each

    case by a bref analyss and answer.

    A lnk to full terms and condtons can be

    found at the end of the artcle.

    Clauses 1.8, 11.1, 12.1 and 12.7

    These clauses relate to the colleges

    and users oblgatons as stakeholders

    n the eLogbook. The colleges,

    as admnstrators of the logbook,

    are clearly dened as data controllers

    as specied by the DPA but it is

    not necessarly clear whether

    users should smlarly regster wth

    the iCO as ndvdual data controllers.

    Two points are relevant. The rst

    relates to the ndvdual users employer.As an NHS employee or ndeed a

    unversty-employed research fellow, an

    ndvdual wll be requred to process

    senstve personal data on a daly bass

    and therefore wll qualfy as a data

    controller. Strctly, n these nstances,

    the employer will have notied the

    iCO and therefore the employee s

    n t heory automatcally covered. if,

    however, any data s prvately collected

    and processed then an ndvdual s not

    covered by the employers notication.

    The second pont relates to whether data

    collected on the logbook actually count

    as personal data. it could be argued

    that they do not as no mmedately

    identiable information elds are

    completed. However, referrng to the

    denition of personal data, if the data

    controller n queston has the means

    to lnk anonymous data back to an

    ndvdual (easly done wth a Communty

    Health index or hosptal number)then such data do ndeed qualfy as

    personal data and a user should notfy

    the iCO. Furthermore, n the case of

    senstve personal data (e all the data

    on the logbook), explct and nformed

    consent should also be obtaned before

    collectng such data. Gven that falure

    to comply wth the oblgatons as set

    out by the DPA consttutes a crmnal

    offence, should all users of the eLogbook

    therefore regster wth the iCO as data

    controllers and obtan explct and

    nformed consent for every patent

    they operate on? is ths realstc?

    The royal surgcal colleges legal team has

    conrmed that those who record or use

    personal data or senstve personal data

    n a self-employed capacty (e outsde

    of ther employment wth the NHS or

    universities) will need to be notied with

    the iCO as data controllers. Gven that

    most tranees wll at some stage assst

    ther consultant traners n the prvate

    sector and that many wll tran wthn

    ndependent sector treatment centres

    (iSTCs) outsde the NHS, regsterng

    wth the nformaton commssoner as

    a data controller should be regarded as

    mandatory. Furthermore, data collected,

    processed and retaned by an ndvdual

    durng a perod of transent employment

    wth a unversty (e as a research

    fellow) may also fall out of the remt of

    the universities ICO notication once

    such employment ends. Ths should be

    regarded as another absolute ndcatonfor individual notication. It should,

    however, be noted that personally

    retanng non-anonymous

    (e lnked-anonymous or pseudonymous)

    personal research data on laptops or

    personal computers s not advsable.

    if strctly necessary, these data

    should be properly encrypted.

    Ganng wrtten, explct consent from

    prvate or iSTC patents for collectng

    logbook data s a must. Although t s thecase that ths s not strctly necessary

    for NHS patents, there s a strong

    deontologcal argument for dong so;

    the standard should apply to all patents.

    Ganng such consent s also consstent

    wth the sprt of the DPA as well as

    General Medcal Councl gudance on

    the matter. A tranee should always

    meet a patent before partcpatng n

    ther surgery. Most consent forms

    now have a eld relating to data

    collecton and audt; a few extrawords about the need to mantan

    a logbook for tranng shouldnt

    represent a signicant burden.

    Clause 6.3

    To the fullest extent permitted by law, we

    shall not be liable, including for any indirect,

    special or consequential loss or economic

    damage (such as without limitation loss of

    bargain, prot, data, reputation, placement,

    position, learning agreement, resultant

    losses or otherwise), and whether in

    contract, tort, or otherwise, arising out of

    the use of the website or the reliance on

    any of the information displayed on it.

    Ths clause lmts the lablty of the

    colleges for user actvtes. There had

    been concern that ths was a way of

    lmtng the colleges lablty n the

    event of data loss (by the webste) and

    the professional difculties for the user

    that would arse as a consequence.

    The royal surgcal colleges legal team

    have gven assurances that ths does

    not relate to data loss but rather the

    qualty of the data on the webste.

    As the colleges are not themselves

    enterng patent data, data are ever-

    changng and there s an ever-present

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    THE ROYAL COLLEGE OF SURGEONS OF ENGLAND BUllETiN

    rsk of llegtmate access, t s evdently

    not possble to track and qualty control

    all of the content all of the tme. The

    colleges therefore cannot reasonably be

    expected to assume lablty for llegal

    or rresponsble use. Such dsclamersare standard practce for webstes.

    Several tranees h ave therefore enqured

    whether keepng a personal backup of

    ther logbook would be advsable.

    The ofcial legal advice is that this is

    not advsable. A meanngful personally

    controlled logbook could clearly not be

    truly anonymous as recordng outcomes

    would become mpossble and the rsk

    to the ndvdual of losng data or t beng

    accessed by a thrd party would not bensubstantal. Furthermore, the company

    to whch the colleges sub-contract

    the physcal runnng of the eLogbook

    and iSCP data has robust securty

    arrangements, sophstcated back-up

    systems and a very clear nformaton

    governance framework n place.

    There are many examples of doctors

    gettng nto serous trouble wth

    respect to data loss, commonly as

    a result of lost laptops or droppedash drives. However, if a trainee

    is notied with the ICO, has adequately

    encrypted the data and has ganed

    consent, mantanng a prvate logbook

    s entrely legal and many may

    opt to do ths n addton to

    mantanng ther eLogbook database.

    Cauton s, of course, advsed.

    A further queston that arose relatng to

    ths clause concerned the lablty of the

    ndvdual user n the event of data beng

    accessed by a thrd party, ether by accdent

    or malcous ntent. The surgcal colleges

    legal team have emphassed that userlablty would only arse f such a breach

    had occurred as a result of the users own

    falure to take reasonable securty steps

    (for example, not dsclosng passwords,

    etc). indvduals would not be lable were

    the colleges or some other entty at fault.

    The team also noted that enforcement

    actions and nes for breaches of the DPA

    are unlkely to arse unless there has been

    substantal damage and dstress caused as a

    result (for example, loss of a large database

    of personal data).

    Clause 12.3

    Special care must be used when

    inputting data in any free elds, including

    for other informationaccordingly.

    Questons arose relatng to whch

    data ths referred to. The formal

    advce s to strctly avod nputtng

    any data that mght lnk the entry

    to an ndvdual (addresses, telephone

    numbers, names). Further clncalor operatve detals are acceptable.

    Notfyng the iCO of status as ata

    controer

    Ths can be done onlne by usng the

    lnks quoted at the end of the artcle.

    There s a self-assessment tool that

    will recommend notication. The New

    Notication icon then needs to be

    selected and nstructons wll follow.

    There is a specic template for junior

    surgeons usng the eLogbook (N955) to

    follow. The annual fee s 35.

    Summary

    The oblgatons placed upon ndvduals

    by the DPA are strct and probably

    not apprecated by many eLogbook

    users. All tranees are strongly advsed

    to notfy the iCO of ther status as

    data controllers.

    Ganng explct, nformed and wrtten

    consent to collect data for the purposes

    of logbook mantenance should now

    be encouraged.

    Mantanng a detaled personal logbook

    of operatons wth outcomes wll

    appeal to many tranees and s an am

    that should be commended. Cauton s

    advsed, however ndvduals should

    ensure that they are notied with the

    iCO, famlar wth the DPA and encrypt

    the data adequately.

    Usefu lnks

    intercoegate elogbook Termsan Contons:

    www.elogbook.org/ste/2903/default.aspx

    How to notfy the informaton

    Commissioners Ofce:

    www.co.gov.uk/for_organsatons/data_

    protection/notication.aspx

    Assococaton of Surgeons webste:

    www.asit.org and @ASiTOfcial on Twitter

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    240

    http://www.elogbook.org/site/2903/default.aspxhttp://www.ico.gov.uk/for_organisations/data_http://www.asit.org/http://www.bris.ac.uk/prospectus/postgraduate/2013http://www.bris.ac.uk/prospectus/postgraduate/2013http://www.asit.org/http://www.ico.gov.uk/for_organisations/data_http://www.elogbook.org/site/2903/default.aspx