Health data privacy and confidentiality rights: crisis or redemption?
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www.else ie .p / psp
O iginal
A icle
Heal h
da a
p i acy
and
confiden iali y
igh s:
C isis
o
edemp ion?
Paula
Loba o
de
Fa ia∗,
João
Valen e
Co dei o
Escola
Nacional
de
Saúde
Pública
da
Uni e sidade
NOVA
de
Lisboa
and
CESNOVA
-
Cen o
de
Es udos
de
Sociologia
da
Uni e sidade
No a
de
Lisboa,
Lisboa,
Po ugal
a
i
c
l
e
i
n
o
A icle
his o y:
Recei ed
31
July
2014
Accep ed
15
Oc obe
2014
A ailable
online
22
No embe
2014
Keywo ds:
Righ
o
p i acy
Righ
o
confiden iali y
Heal h
da a
Heal h
da a
p o ec ion
and
secu i y
Pa ien ’s
igh s
Eu opean
da a
p o ec ion
law
a
b
s
a
c
Al hough
widely
analyzed
by
au ho s
and
heo e ically
alued
by
he
public,
he
igh
o
heal h
da a
confiden iali y
seems
o
be
mo e
o
an
academic
figu e
han
a
eal
p o ec ed
igh .
This
happens
due
o
in insic
p oblems
wi h
he
p ac ical
en o cemen
o
some
pa ien ’s
igh s,
bu
is
ge ing
mo e
no o ious
in
con empo a y
socie y.
This
a icle
desc ibes
he
igh s
o
heal h
da a
p i acy
and
confiden iali y
in
hei
classical
con ou s,
ocusing
on
a eas
o
consensus
and
con o e sy
and
analyzing
he
ecen
ans-
o ma ions
in
socie y
ha
a e
causing
a
c isis
in
hese
same
igh s.
We
ag ee
ha
he e
a e
easons
o
belie e
ha
he e
a e
no
no el
legal
ins umen s
in
Heal h
Law
o
edeem
hese
igh s,
excep
o
Eu opean
Da a
P o ec ion
Law.
He e,
we
b iefly
analyze
he
new
Eu opean
da a
p o ec ion
d a
egula ion,
which
in ends
o
b ing
ein o ced
ools
on
his
domain.
We
conclude
ha
he
ju idical
au a
ha
s ill
emb aces
he
igh
o
medical
and
gene ic
da a
confiden iali y
in
Heal h
Law
and
Bioe hics
seems
o
no
longe
ha e
a
p ac ical
sense.
Howe e ,
despi e
his
pe cep ion,
he
essen ial
dimension
o
indi idual
eedom
ela ing
o
pe sonal
in o ma ion
and
o
he
no ion
ha
he
less
is
known
abou
us
he
ee
we
all
a e
is
s ill
e y
ele an
and
so
Heal h
Law
needs
o
dedica e
mo e
a en ion
o
he
ans o ma ions
o
p i acy
and
confiden iali y
in
he
medical
and
gene ic
fields
in
o de
o
main ain
hem
p o ec ed
and
espec ed.
©
2014
Escola
Nacional
de
Saúde
Pública.
Published
by
Else ie
España,
S.L.U.
All
igh s
ese ed.
Di ei o
à
ida
p i ada
e
à
confidencialidade
de
dados
de
saúde:
c ise
ou
edenc¸ão?
Pala as-cha e:
Di ei o
à
ida
p i ada
Di ei o
à
confidencialidade
Dados
de
saúde
e
s
u
m
o
Apesa
de
amplamen e
analisado
pelos
au o es
e
eo icamen e
alo izado
pelo
público,
o
di ei o
à
confidencialidade
dos
dados
de
saúde
pa ece
se
mais
de
uma
figu a
académica
do
que
um
di ei o
ealmen e
p o egido.
Tal
acon ece
de ido
a
alguns
p oblemas
in ínsecos
na
aplicac¸ão
p á ica
de
alguns
dos
di ei os
dos
doen es,
mas
o na-se
cada
ez
mais
no ó io
nas
sociedades
con empo âneas.
∗Co esponding
au ho .
E-mail
add ess:
pa.lob a [email protected]
(P.L.d.
Fa ia).
h p://dx.doi.o g/10.1016/j. psp.2014.10.001
0870-9025/©
2014
Escola
Nacional
de
Saúde
Pública.
Published
by
Else ie
España,
S.L.U.
All
igh s
ese ed.
124
e
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2(2):123–133
P o ec¸ão
e
segu anc¸a
de
dados
de
saúde
Di ei os
dos
doen es
Di ei o
eu opeu
da
p o ec¸ão
de
dados
Es e
a igo
desc e e,
em
p imei o
luga ,
os
di ei os
à
ida
p i ada
e
à
confidencialidade
de
dados
de
saúde
nos
seus
con o nos
clássicos,
mos ando
as
á eas
de
consenso
e
con-
o é sias
em
o no
deles.
Em
segundo
luga ,
analisam-se
as
ecen es
ans o mac¸ões
na
sociedade
que
es ão
a
causa
uma
c ise
nesses
mesmos
di ei os,
sendo
es a
capaz
de
os
ans o ma
ou
mesmo
de
os
elimina
como
di ei os
dos
doen es
e dadei amen e
espei a-
dos.
Nes e
capí ulo,
cons a a-se
que
há
o es
sinais
pa a
ac edi a
que
no
Di ei o
da
Saúde
e
na
Bioé ica
os
di ei os
à
ida
p i ada
e
à
confidencialidade
es ão
a
so e
uma
c ise
e
que
não
se
êm
c iado
quaisque
ins umen os
legais
ino ado es
em
Di ei o
da
Saúde
pa a
os
esga a ,
ao
con á io
do
que
acon ece
no
Di ei o
Eu opeu
de
P o ecc¸ão
de
Dados.
Es a
p emissa
le a
à
e cei a
pa e
do
a igo,
onde
se
analisam
b e emen e
a
p opos a
do
no o
egulamen o
eu opeu
de
p o ec¸ão
de
dados
pessoais,
cada
ez
mais
pe o
de
se
publicado,
o
qual
p e ende
aze
e amen as
e o c¸adas
nes e
domínio.
Conclui-se
que
a
au a
ju ídica
que
ainda
en ol e
os
di ei os
à
confidencialidade
dos
dados
médicos
e
gené icos
em
Di ei o
da
Saúde
e
Bioé ica
não
pa ece
e
já
um
sen ido
p á ico,
sendo
quase
como
p omo e
um
p odu o
com
eno me
po encial
mas
que
não
exis e
no
me cado.
A
única
á ea
que
ainda
se
mo e
na
en e
de
de esa
da
ida
p i ada
e
da
confidencialidade
de
dados
pessoais
na
nossa
sociedade
é
o
di ei o
eu opeu
de
p o ec¸ão
de
dados.
No
en an o,
mesmo
que
es e
ac o
ap esen e
no as
endências
legais
que
podem
ajuda
a
da
aos
di ei os
dos
doen es
à
ida
p i ada
e
à
confidencialidade
dos
seus
dados
um
pouco
mais
de
o c¸a,
pensamos
que,
apesa
das
medidas
eu opeias
ino ado as,
o
Di ei o
da
Saúde
p ecisa
de
se
dedica
mais
a
p oduzi
um
no o
pensamen o
ju ídico
ope acional
pa a
que
os
di ei os
à
ida
p i ada
e
à
confidencialidade
nos
u u os
cená ios
da
Medicina
e
da
Gené ica
con inuem
a
se
espei ados.
©
2014
Escola
Nacional
de
Saúde
Pública.
Publicado
po
Else ie
España,
S.L.U.
Todos
os
di ei os
ese ados.
In oduc ion
“Issues
o
p i acy
ha e
become
en angled
wi h
bioin o -
ma ics
as,
inc easingly;
we
ely
on
echnology
a he
han
on
human
beings
o
esol e
p i acy
issues.”1(p6)
“New
echnologies
uphea e
old
no ms,
and
new
no ms
need
o
be
nego ia ed:
a
p ocess
ha
akes
ime.”2(p125)
P elimina y
no e
Al hough
we
a e
awa e
ha
he
opic
o
his
a icle
is
no
no el,
we
hink
ha
i
s ill
needs
a en ion
as
con inuous
ans o ma ions
in
socie y
a e
cons an ly
b inging
new
ac s
ha
eflec
upon
he
igh s
o
p i acy
and
confiden iali y
as
pa ien ’s
igh s
ei he
in
heal hca e
o
medical
esea ch
se ings.
Ba ing
his
p emise
in
mind,
his
pape
aims
o
discuss
he
classical
concep s
o
he
igh s
o
p i acy
and
confiden iali y
in
heal h
e sus
he
ecen
de elopmen
and
solidifica ion
o
a
pe manen
“ eali y
show”
socie y
which
i ializes
he
disclo-
su e
and
he
dissemina ion
o
pe sonal
da a,
including
heal h
da a.
Mo e
and
mo e
people
adhe e
o
ee
in o ma ion
and
a e
igno an
o
eluc an
o
da a
p o ec ion
p inciples
un il
hey
su e
conside able
consequences.
Ne e heless,
li iga ion
ega ding
he
igh s
o
p i acy
and
confiden iali y
o
heal h
da a
is
a e.
As
some
au ho s
pu
i
“ he
(.
.
.)
issue
o
medical
confiden iali y
has
been
mo e
discussed
han
li iga ed.”3
The e
is
an
ample
Heal h
Law
and
Bioe hics
li e a u e
on
he
impo ance
o
he
igh
o
confiden iali y
o
medical
and
gene ic
da a,
which
is
conside ed
a
undamen al
pa ien
igh
and
is
ensh ined
in
he
Law
o
se e al
coun ies.
This
igh
is
also
one
o
he
main
da a
p o ec ion
igh s.
Impo an ly,
med-
ical
and
gene ic
da a
a e
conside ed
excep ionally
sensi i e
da a
by
cu en
Da a
P o ec ion
Laws,
which
is
a
special
s a us
equi ing
ex a
secu i y
and
confiden iali y
p o ec ion
meas-
u es.
The
eason
o
his
special
s a us
is
ha
medical
and
gene ic
da a
a e
conside ed
o
belong
o
he
“p i a e”
sphe e
o
he
pe son
(da a
subjec ),
as
hey
ela e
o
he
mos
in ima e
pe sonal
a eas.
Hence,
an
unau ho ized
disclosu e
o
his
da a
is
po en ially
mean
o
cause
disc imina ion
and
s igma iza-
ion
in
he
pe sonal,
p o essional
o
social
li e
domains
o
he
da a
subjec .
Concu en ly,
heal h
da a
p i acy
is
also
a
e y
impo an
ool
in
Public
Heal h
policies
(e.g.
o
he
accep ance
and
success
o
name-based
su eillance).4
F om
he
Hippoc a ic
Oa h,
o
he
igh
o
be
o go en
The
du y
o
confiden iali y
is
a
medical
deon ological
pilla
since
he
Hippoc a ic
Oa h,
da ing
back
o
he
5 h
cen u y
BC.
On
he
o he
hand,
he
igh
o
p i acy
is
a
ela i ely
ecen
ju idical
concep .
The
classical
concep ion
o
he
igh
o
p i acy
sp ou s
om
he
no ion
ha
h oughou
li e
e e y
pe son
mo es
wi hin
ju idical
spaces
wi h
a ying
deg ees
o
libe y.5,aSuch
spaces
can
be
b oadly
g ouped
in o
wo
main
aJona han
F anzen
e e s
o
his
ma e
in
page
43
o
his
e y
acu e
essay
on
p i acy,
called
“Impe ial
Bed oom”:
“Wha
eally
unde gi ds
p i acy
is
he
classical
libe al
concep ion
o
pe sonal
au onomy
o
libe y.
In
he
las
ew
decades,
many
judges
and
schola s
ha e
chosen
o
speak
o
a
“zone
o
p i acy”
a he
han
a
“zone
o
libe y”,
bu
his
is
a
shi
in
emphasis,
no
in
subs ance:
no
he
making
o
a
new
doc ine
bu
he
epackaging
o
an
old
one”.
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
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2(2):123–133
125
a eas,
a
public
and
a
p i a e
sphe e.
When
we
mo e
wi hin
ou
public
sphe e
wha e e
we
do,
say
o
choose
can
be
consid-
e ed
public
in o ma ion
in
a
way
ha
no
es ic ions
a e
placed
o
i s
di usion
and
dissemina ion.
In
pa allel,
inside
ou
p i-
a e
sphe e,
special
ca e
mus
be
exe cised
in
o de
o
es ic
access
and
sha ing
o
in o ma ion
so
ha
special
limi s,
which
a e
defined
by
he
indi idual,
a e
no
c ossed
unless
a
e y
significan
public
in e es
is
a
s ake.
The
igh
o
p i acy
is
in
ha
sense
a
“pe sonali y
igh ”6,b oo ed
in
he
need
o
espec
he
au onomy
o
people
and
aimed
a
p o ec ing
hem
om
ha m.7The
concession
o
e e y
human
being
o
an
indi idual
p i a e
space
is
deeply
connec ed
wi h
alues
such
as
ee-
dom
and
sel -de e mina ion.
Ce ainly,
he
bo de s
be ween
public
and
p i a e
sphe es
a y
significan ly
depending
on
his o ical
and
sociological
con ex s,
poli ical
condi ions
and
e en
pe sonal
and
indi idual
ep esen a ions
o
eali y.
I
has
been
mo e
han
120
yea s
since
Samuel
D.
Wa en
and
Louis
D.
B andeis8w o e
“The
Righ
o
P i acy”
an
influen ial
Ha a d
Law
Re iew
a icle
d awing
a en ion
o
he
need
o
p o ec-
ion
agains
he
in asion
o
p i acy.
In
his
a icle,
he
au ho s
defined
he
concep
o
p i acy
p o ec ion
by
adap ing
a
amous
exp ession
o
judge
Thomas
Cooley
( ega ding
o
inju y)
as
“(.
.
.)
an
ins ance
o
he
en o cemen
o
he
mo e
gene al
igh
o
he
indi idual
o
be
le
alone”.8
The
p emoni o y
significance
o
his
a icle
and
he
inc easing
di ficul y
and
necessi y
o
find
he
co ec
measu es
o
p o ec
p i acy
in
an
age
o
as -paced
echnology-d i en
p og ess
a e
well
acknowledged.
In
ac ,
jus
abou
one
hun-
d ed
yea s
a e
Wa en
and
B andeis,
in
a
pe suasi e
1998
New
Yo ke
essay
i led
“Impe ial
Bed oom”,
Jona han
F anzen
depic ed
p i acy
as
“(.
.
.)
espoused
as
he
mos
undamen al
o
igh s,
ma ke ed
as
he
mos
desi able
o
commodi ies,
and
p onounced
dead
wice
a
week”.5In e es ingly,
in
“Impe ial
Bed oom”
F anzen
also
quo ed
Richa d
Powe s’
defini ion
o
he
p i a e
aspec s
o
he
sel
as
“(.
.
.)
ha
pa
o
li e
ha
goes
un egis e ed”.5
These
quo es
eflec
he
p esen
s a e
o
he
igh
o
p i-
acy,
which
was
bo n
ou
o
a
wo ld
ha
had
jus
disco e ed
he
wonde s
and
pe ils
o
he
elephone
o
pho og aphy
and
oday
is
h ea ened
by
ou
echnology-swamped
li es.
We
concede
ha
he
challenges
ha
echnology
poses
o
he
igh
o
p i acy
and
confiden iali y
a e
many
and
ha
socie y
has
e ol ed
in
ways
ha
seem
o
con adic
he
almos
e e ed
impo ance
ha
hese
igh s
once
had.
Howe e ,
such
challenges
do
no
necessa ily
co espond
o
obli ion
o
hese
igh s.
E idence
has
shown
ha
ega ding
heal h
and
gene ic
da a,
he
p o ec ion
o
hese
igh s
is
s ill
a
p io i y
o
pa ien s
and
physicians.7,9,cFu he mo e,
i
is
he
main
conce n
o
he
public
ega ding
he
dona ions
o
hei
own
biological
ma e ial
o
biobanks.10 These
ac s
sugges s
ha
bThis
is
he
ca ego y
o
igh s
in
which
he
Po uguese
Cons i-
u ion
includes
he
igh
o
p i acy
(a icle
26).
See
o
all
Mo ei a
and
Cano ilho,
Cons i uic¸ão
da
República
Po uguesa,
a icles
1◦
o
107◦.
cDespi e
he
educed
numbe
o
cou
ac ions
agains
p o es-
sionals
who
did
no
disclose
gene ic
isk
o
ela i es
o
hei
pa ien s
he e
is
eluc ance
om
physicians
and
gene ic
coun-
selo s
o
b each
confiden iali y.
p i acy
and
confiden iali y
a e
s ill
alued
concep s
by
mos
people
and
he e o e
did
no
lose
all
hei
p ac ical
sense.
Some
o
hese
ac o s,
which
explain
a
diminishing
alue
o
he
igh s
o
p i acy
and
confiden iali y,
we e
gene ally
iden-
ified
by
he
Eu opean
Commission
as
a
basis
o
he
ongoing
e o m
o
da a
p o ec ion
in
he
Eu opean
Union
(EU).11 In
his
a icle
we
highligh
he
e o s
on
new
da a
p o ec ion
mechanisms,
which
ha e
been
de eloped
by
he
Eu opean
Commission
(EC)
and
coined
in
he
d a
o
a
new
da a
p o ec-
ion
egula ion,das
a
good
example
o
confiden iali y
igh s
esilience.11 We
analyze
his
new
legal
u n
in
da a
p o ec ion
in
he
EU
and
make
some
conside a ions
on
i s
ele ance
o
he
confiden iali y
o
pe sonal
heal h
da a.
In
b ie ,
he
new
egula ion
will
gi e
mo e
powe
o
cus ome s
o
online
se -
ices,
de e mine
s onge
sa egua ds
o
EU
ci izens’
da a
ha
ge s
ansmi ed
ab oad,
and
conside ably
inc ease
fines
on
companies
ha
b each
he
law.
Impo an ly,
in
he
egula ion
d a ,
heal h
da a
a e
s ill
conside ed
“pa icula ly
sensi i e
and
ulne able
in
ela ion
o
undamen al
igh s
o
p i acy”
dese ing
“specific
p o ec ion”.11
We
also
examine
he
new
“ igh
o
be
o go en”
which
is
also
enac ed
in
he
al eady
men ioned
egula ion
d a
on
da a
p o ec ion
and
was
ecognized
by
he
Cou
o
Jus ice
o
he
Eu opean
Union
on
May
2014
in
he
Google
Spain
SL,
Google
Inc.
s
Agencia
Espa˜
nola
de
P o ección
de
Da os
case.12
In
b ie ,
his
a icle
aims
mainly
o
summa ize
he
issues
and
ques ions
aised
in
he
heal h
da a
p o ec ion
field,
a he
han
o
p o ide
any
solu ions.
None heless,
bea ing
he
new
Eu opean
Law
de elopmen s
in
mind,
his
a icle
ends
wi h
ou
las
wo d
on
he
s a us
quo
o
p i acy
and
confiden iali y
o
pe sonal
heal h
da a
igh s.
S a e
o
he
a
The
igh s
o
p i acy
and
confiden iali y
The
igh
o
confiden iali y
is
based
on
he
undamen al
igh s
o
p i acy
and
o
“in o ma ional
sel -de e mina ion”,
which
ela e
o
pe sonal
da a
p o ec ion
(da a
p o ec ion
igh s).
Howe e ,
confiden iali y
is
a
di e en
concep
han
p i acy,
and
i
comp ises
mo e
han
da a
p o ec ion
igh s.
Fi s ly,
confiden iali y
wo ks
downs eam
o
p i acy
and
o
confi-
den iali y
o
be
legally
“ igge ed”,
p i acy
mus
ha e
al eady
been
disclosed.13 Fu he mo e,
on
one
hand
he
igh
o
p i-
acy
is
wha
is
called
a
“nega i e”
igh
because
i
claims
non-in e e ence
wi h
in o ma ion
belonging
o
he
p i a e
sphe e.
On
he
o he
hand,
confiden iali y
is
bo h
a
“nega i e”
and
a
“posi i e”
igh
as
i
simila ly
claims
non-in e e ence
o
silence
(e.g.
in
he
o m
o
p o essional
sec ecy)
bu
also
p ac-
ical
p o ec i e
ac ions
(e.g.
secu i y
measu es;
supe ision;
sanc ions
–
see
Fig.
1).
His o ically,
unde s anding
he
eal
meaning
and
he
limi s
o
he
igh
o
confiden iali y
can
be
be e
achie ed
by
aking
dRegula ions
a e
he
s onges
Eu opean
Union
no ma i e
ins umen s
en e ing
in
o ce
in
all
membe
S a es
as
soon
as
hey
a e
published
in
he
O ficial
Jou nal
o
he
Communi ies.
They
di -
e
om
“di ec i es”,
which
need
o
be
ansposed
o
he
membe
S a es
in e nal
legal
o de .
126
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
1
4;3
2(2):123–133
Con iden iali y V. P i acy
P i acy sphe e
Di ec disclosu e (doc o )
P o essional
sec ecy
Secu i y
measu es
Supe ision
sanc ions
Indi ec disclosu e (biobank)
Medical-gene ic
in o ma ion Sec e in o ma ion
Con iden iali y
Fig.
1
–
Confiden iali y
e sus
p i acy
o
heal h
da a.
a
look
a
he
1988
English
o
law
case
A o ney
Gene al
.
The
Obse e
L d.14 This
case
co e ed
he
publica ion
in
se e al
B i ish
newspape s
o
exce p s
om
he
con o e sial
book
Spyca che ,
w i en
by
o me
MI5
coun e in elligence
o fice
Pe e
W igh .
The
book,
a
he
ime
al eady
published
in
he
USA
and
Aus alia
bu
no
in
England,
con ained
de ails
abou
W igh ’s
ac i i y
in
MI5,
which
cons i u ed
a
iola ion
o
an
Ac
o
he
Pa liamen
o
he
Uni ed
Kingdom
–
he
O ficial
Sec e s
Ac
1991
–
p o ec ing
s a e
sec e s
and
o ficial
in o ma ion.
In
his
a gumen
in
he
House
o
Lo ds,
Lo d
Go
o
Chie eley
iden ified
a
i al
dimension
o
he
igh
o
confiden iali y
–
he
du y
o
confidence.
Acco ding
o
Lo d
Go
o
Chie eley,
his
du y
“(.
.
.)
a ises
when
confiden ial
in o ma ion
comes
o
he
knowledge
o
a
pe son
( he
confidan ),
wi h
he
e ec
ha
(.
.
.)
he
should
be
p ecluded
om
disclosing
he
in o ma ion
o
o he s”.14 The e o e,
he
concludes
“(.
.
.)
he e
is
such
a
public
in e es
in
he
main enance
o
confidences,
ha
he
law
will
p o ide
emedies
o
hei
p o ec ion”.11 Impo an ly,
A o ney
Gene al
.
The
Obse e
L d.
also
pe mi ed
o
iden i y
he
limi s
o
he
igh
o
confiden iali y.
Fi s ,
he
igh
o
confiden iali y
only
applies
o
confiden ial
in o ma ion
and
no
o
in o ma ion
ha
has
al eady
en e ed
he
public
domain
(in o ma ion
o
which
he e
is
gene al
access).
Second,
he
igh
o
confiden iali y
does
no
apply
o
i ial
in o ma ion.
Thi d,
and
pe haps
mos
significan ly,
he
public
in e es
o
confidence
p o ec ion
mus
be
balanced
in
he
ace
o
o he
public
in e es s.
In
his
ega d,
Lo d
Go
o
Chie eley
decla ed
ha
“(.
.
.)
i
is
his
limi ing
p inciple
which
may
equi e
a
cou
o
ca y
ou
a
balancing
ope a ion,
weighing
he
public
in e es
in
main aining
confidence
agains
a
coun e ailing
public
in e es
a o ing
disclosu e”.14
As
A o ney
Gene al
.
The
Obse e
L d.
so
well
illus a es,
he
mos
con o e sial
pa
o
he
igh /du y
o
confiden ial-
i y
is
he
zone
whe e
his
igh
has
o
be
balanced
wi h
o he
conflic ing
public
in e es s.
In
ac ,
his
zone
o
conflic
has
been
he
subjec
o
in ense
s udy
in
he
fields
o
Heal h
Law
and
E hics
mainly
in
he
domain
o
HIV
in ec ion
(p obably
he
mos
con o e sial)
and,
pa icula ly,
in
he
ela ed
en-
sion
be ween
he
du y
o
p o essional/medical
sec ecy
and
he
du y
o
disclose
pe sonal
heal h
in o ma ion
o
he
pu poses
o
p o ec ing
a
hi d
pa y’s
heal h
o
li e.
Impo an ly,
ecen
ad ances
in
genomics
and
he
possibili y
o
define
someone’s
u u e
isk
o
de eloping
a
disease
by
analyzing
he edi a y
gene ic
in o ma ion
eeds
in o
he
same
discussion
and
illus-
a es
ha
his
deba e
is
e y
much
ali e
in
ou
ime.15
Unde s anding
he
ension
be ween
he
igh
o/du y
o
confiden iali y
and
public
in e es
mus
also
be
in o med
by
a
close
look
a
di e en
defini ions
o
he
la e .
Public
in e -
es
is
an
open
and
e e
e ol ing
concep .
Many
would
a gue
ha
no
ma e
he
ex en
o
which
he
concep
e ol es
and
ans o ms,
public
in e es
should
ne e
be
allowed
o
be
con used
wi h
cu iosi y
o
oyeu ism
and
ha
exagge a ed
b oadening
o
some
defini ions
o
public
in e es
would,
ul i-
ma ely,
end
up
emp ying
he
no ion
o
p i a e
in o ma ion,
u ning
i
in o
i ia,
and
de ea ing
he
pu pose
o
ecogniz-
ing
a
igh
o
confiden iali y
wi h
balanced
limi s.
On
he
o he
hand,
o he s
a gue
ha
we
a e
mo ing
owa ds
a
b oad
no ion
o
public
in e es
ha
would,
mos
o
he
imes,
a o
disclosu e
o
in o ma ion.
Acco ding
o
his
no ion
he
al e -
na i e
public
in e es
ela ed
o
p o ec ing
confidence
looks
inc easingly
mo e
like
a
p i a e
in e es .
No
ma e
which
side
we
ake
on
his
a gumen ,
i
is
impo an
o
balance
public
in e es
wi h
confiden iali y
and
iden i y
and
discuss
ele an
ac o s
leading
o
a
possible
ading
o
ansmu a ion
o
he
la e .
The
igh s
o
p i acy
and
confiden iali y
a e
nowadays
en angled
wi h
he
igh
o
he
p o ec ion
o
pe sonal
da a,
which
is
es ablished
by
A icle
8
o
he
Cha e
o
Fundamen al
Righ s
o
he
EU,16 A icle
16
o
he
T ea y
on
he
Func ioning
o
he
Eu opean
Union
(TFEU),17 and
in
A icle
8
o
he
Eu opean
Con en ion
o
Human
Righ s
(ECHR).18 As
unde lined
in
2010
by
he
Cou
o
Jus ice
o
he
EU
in
he
joined
cases
Volke
und
Ma kus
Schecke
GbR
and
Ha mu
Ei e
Land
Hessen,19 he
igh
o
he
p o ec ion
o
pe sonal
da a
is
no
an
absolu e
igh ,
bu
mus
be
conside ed
in
ela ion
o
i s
unc ion
in
socie y.
Da a
p o ec ion
is
closely
linked
o
he
espec
o
p i a e
and
amily
li e
p o ec ed
by
A icle
7
o
he
Cha e .16 This
is
eflec ed
by
A icle
1(1)
o
Di ec i e
95/46/EC20 which
p o ides
ha
Mem-
be
S a es
shall
p o ec
undamen al
igh s
and
eedoms
o
na u al
pe sons
and
in
pa icula
hei
igh
o
p i acy
wi h
espec
o
he
p ocessing
o
pe sonal
da a.
Wha e e
happens
in
he
da a
p o ec ion
law
field
will
a ec
emendously
he
igh s
o
p i acy
and
confiden iali y
in
he
heal h
law
domain.
This
is
why
he
ongoing
e o m
in
Eu opean
da a
p o ec ion
legal
ins umen s
is
so
impo an
o
discuss
he e.
In
a
2012
documen
p eceding
he
d a
o
he
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
1
4;3
2(2):123–133
127
new
EU
egula ion,
wi h
he
sugges i e
i le
o
Sa egua ding
P i-
acy
in
a
Connec ed
Wo ld
–
A
Eu opean
Da a
P o ec ion
F amewo k
o
he
21s
Cen u y,21 he
Eu opean
Commission
undoub edly
shows
ha
he
p o ec ion
o
p i acy
and
confiden iali y
igh s
is
he
co e
o
da a
p o ec ion
law.
This
documen
iden ifies
as
he
majo
challenge
o
oday’s
da a
p o ec ion,
he
new
ways
o
sha ing
in o ma ion,
h ough
social
ne wo ks
and
emo e
s o age
o
la ge
amoun s
o
da a,
which
“ha e
become
pa
o
li e
o
many
o
Eu ope’s
250
million
in e ne
use s”.21
Ne e heless,
i
s esses
e y
clea ly
ha
“in
his
new
digi-
al
en i onmen ,
indi iduals
ha e
he
igh
o
enjoy
e ec i e
con ol
o e
hei
pe sonal
in o ma ion”.21
In
a
way,
we
hink
ha ,
a
p esen ,
da a
p o ec ion
law
is
he
“p ac ical”
o
“ easible”
pa
o
he
de ense
o
he
igh s
o
p i acy
and
confiden iali y
o
heal h
in o ma ion.
This
is
pa icula ly
so
as
nowadays,
he
compliance
wi h
hese
igh s
essen ially
depends
almos
o ally
on
he
exis ence
o
e y
objec i e
secu i y
measu es
in
heal hca e
in o ma ion
ech-
nologies
(IT).
Fo
ins ance,
he
concep
o
“p i acy
by
design”
b ough
up
by
he
EU
da a
p o ec ion
e o m
and
also
included
in
he
d a
o
he
new
egula ion,11,ei
adop ed
in
heal hca e
uni s
could
be
he
key
o
p e en
b eaches
o
confiden iali y
“ om
sc a ch”.
Howe e ,
he
cos s
and
echnical
implica ions
o
hese
measu es
may
be
dissuasi e,
pa icula ly
i
sanc-
ions
o
no
complying
wi h
da a
p o ec ion
measu es
a e
no
s ong
enough
o
i
con ol
by
he
compe en
au ho i ies
is
inexis en .
Nowadays,
pe sonal
heal h
da a
a e
s o ed
and
accessed
in
di e en
sys ems,
some imes
independen ly
o
sec ecy
du ies.
In
o he
cases,
such
da a
can
e en
be
s o ed
in
he
Cloud,
al hough
his
p ac ice
is
conside ed
o
be
inad isable
by
da a
p o ec ion
commissione s.
Hence,
i
is
ob ious
ha
in
o de
o
p o ec
he
igh
o
confiden iali y
in
con empo a y
soci-
e ies
and
heal hca e
uni s,
in o ma ion
echnology
sys ems
mus
p o ide
he
app op ia e
mechanisms
o
a oid
illegi i-
ma e
b eaches
o
pa ien ’s
da a.
A
e y
impo an
co olla y
o
his
is
ha
confiden iali y
became
expensi e
o
p o ec
and,
as
such,
i
may
come
o
be
mo e
o
a
“luxu y”
o
heal h
manage-
men
han
a
basic
necessi y.
This
endency
may
e en
be
mo e
acu e
o
he
heal h
ca e
sys ems
in
an
in e ed
demog aphic
py amid
wo ld.
Consensual
and
de ying
ideas
The
in e connec ed
igh s
o
p i acy
and
confiden iali y
ega ding
medical
and
gene ic
in o ma ion
ha e
been
amply
discussed
in
he
Bioe hics
and
Heal h
Law
fields
and
ha e
been
he
objec
o
consensual
and
de ying
ideas.
In
he
fi s
g oup,
i
is
indispu able
ha
as
a
cen ena y
medical
du y,
he
du y
o
medical
sec ecy
is
s ill
key
o
he
medical
business.
Wi hou
he
pe cep ion
ha
physicians
a e
bound
by
a
du y
o
medical
sec ecy,
ce ainly
mos
pa ien s
would
no
disclose
some
o
hei
in ima e
clinical
his o y.
Fu he mo e,
i
is
impo an
o
highligh
he
consensual
no ion
ha
he
igh
o
confiden ial-
i y
in
heal h
wo ks
no
only
o
p ese e
a
significan
elemen
o
us ,
which
is
o
i al
impo ance
in
mos
in e ac ions
in
eSee
sec ion
2
on
Da a
Secu i y,
a icle
30/3
(secu i y
o
p ocessing)
o
he
egula ion
d a .
he
heal hca e
con ex ,
bu
also
o
p e en
s igma iza ion
and
de end
agains
disc imina ion.
The e o e,
confiden iali y
p o-
ec ion
measu es
a e
aluable
public
heal h
allies,
no
only
in
he
his o y
o
epidemics
as
al eady
men ioned
abo e4bu
also
in
ela i ely
new
a eas,
such
as
public
heal h
genomics
(e.g.
wi hou
us
in
he
confiden iali y
o
biobanks
o
esea ch
pu poses,
people
a e
no
willing
o
dona e
hei
DNA10).
Howe e ,
ele an
as
hey
may
be,
he
adi ional
con-
cep s
o
p i acy
and
confiden iali y
ha e
been
significan ly
defied.
The
fi s
no ewo hy
example
is
ha
o
he
amous
1982
New
England
Jou nal
o
Medicine
a icle
by
Ma k
Siegle ,22
which
denounced
he
excessi e
numbe
o
people
accessing
medical
eco ds
in
hospi als,
leading
o
he
cha ac e iza-
ion
o
confiden iali y
in
medicine
as
a
“dec epi
concep ”.22
Twen y
yea s
a e ,
an
ex ensi e
li e a u e
e iew
by
Pamela
Sanka
and
colleagues
illus a ed
a
gene al
unawa eness
o
misunde s anding
o
he
e hical
and
legal
igh
o
medi-
cal
confiden iali y
by
pa ien s,
which
p omp ed
he
au ho s
o
label
he
concep
as
bo h
“o e
and
unde es ima ed”.23
No ably,
widesp ead
con usion
(and
in
some
cases
igno ance)
abou
confiden iali y
and
i s
ele ance
in
he
biomedical
a ena
is
hough
o
be
influenced
by
he
inexis ence
o
a
clea ,
p ecise
and
ha monized
defini ion
o
wha
cons i u es
“confiden ial
da a”.
This
imp ecision
has
led
some
au ho s
o
po ay
con-
fiden iali y
as
a
“Tou
o
Babel”.24
In
addi ion
o
he
a o emen ioned
issues
on
a
lack
o
clea
defini ions
o
“confiden ial
da a”
and
p i acy
bound-
a ies,
ecen
ends
in
he
con ex
o
gene ics
( o
example
in
he
con ex
o
biobanking)
p o ide
no el
challenges
o
heal h
p i acy.
The
ad ancemen
o
echnology
and
i s
impac
in
molecula
biology
esea ch
also
b ough
agi a ion
and
s ess
o
he
concep s
o
p i acy
and
confiden iali y.
In
summa y,
can
hese
concep s
su i e
in
he
o m
o
a
du y
o
gene ic
confiden iali y
and
gene ic
p i acy
igh s?
Le
us
look
a
he
example
o
biobanking.
In
biobanks
he e
is
no
“p i ileged”
ela ionship3be ween
he
scien is s
on
one
side
and
he
esea ch
pa icipan s
on
he
o he ,
con a ily
o
wha
hap-
pens
in
he
pa ien -physician
biomedical
ela ionship.
This
con as
necessa ily
begs
he
need
o
a
edefini ion
o
he
legal
basis
in
which
pe sonal
in o ma ion
is
sha ed
and
p o ec ed
in
biobanks.
In
ace
o
hese
new
challenges,
he
necessa y
depa u e
om
classical
no ions
is
some imes
so
significan
ha
some
au ho s
conside
ha
concep s
canno
bend
ha
a
wi hou
being
i epa ably
b oken
and
he e o e
wonde
whe he
confiden iali y
is
now
bu
an
obsole e
concep .25
To
close
his
b ie
p esen a ion
o
de ying
ideas
on
heal h
and
gene ic
da a
p i acy
and
confiden iali y
we
should
men ion
he
issue
o
anonymiza ion
o
human
biological
ma e ials
(HBMs).
In
eali y,
biobanking
ac i i ies
pose
p i-
acy
and
confiden iali y
obs acles
ha
a
fi s
glance
seem
o
be
su passed
i
he
concep
o
confiden iali y
is
edefined
and
econfigu ed,
mo ing
on
om
a
us -based
model
o
in o -
ma ion
sec ecy,
owa ds
an
anonymized-da a
model.26 The
p e- equisi e
would
be
ha
anonymiza ion
would
become
a
co e
equi emen
o
build
a
biobank.
Howe e ,
anonymiza ion
o
HBMs
poses
se e al
ques ions,
which
endange
his
appa -
en
solu ion.
Quo ing
Ma iachia a
Tallacchini”27 he
a ionale
behind
his
model
is
based
on
he
assump ion
ha
he
de-iden ifica ion
o
he
human
biological
ma e ials
(HBMs)
cancel
hei
“subjec i e
aceabili y”,
i.e.
he
cha ac e is ics
128
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
1
4;3
2(2):123–133
ha
ende
hem
e-iden ifiable,
and
ha
his
is
“ he
ech-
nical
fil e
which
gua an ees
da a
confiden iali y”
(by
using
di e en
me hods
o
enc yp ing
he
sensi i e
in o ma ion).27
None heless,
he
same
au ho
in e es ingly
sugges s
ha
he e
a e
a eas
o
doub
in
he
alidi y
o
his
“gua an ee”.
Fi s ly,
by
s a ing
ha
“ he
exp ession
‘anonymiza ion
o
da a’
o en
conceals
si ua ions
in
which,
in
ac ,
he
possibili y
o
eiden i ying
da a
s ill
exis s,
and,
he e o e,
in
which
anonymi y
is
nei he
eal
no
comple e”
(.
.
.).
Secondly,
and
pe haps
mo e
c i ically,
by
conside ing
anonymi y
as
“ he
he o ical
s a egy
o
denying
he
exis ence
o
any
subjec i e
in e es
in
HBMs
and,
consequen ly,
o
a fi ming
hei
ee
a ailabili y
o
hose
who
may
make
in e es ing
use
o
hem:
he
bio ech
indus y”.27
In
summa y,
he
a o emen ioned
consensual
and
de ying
ideas
clea ly
illus a e
how
he
field
o
heal h
and
gene ic
da a
p i acy
and
confiden iali y
igh s
is
a
e y
complex
legal
g ound,
which
claims
o
mo e
dedica ed
a en ion
om
aca-
demics
in
he
field
o
Heal h
Law.
Fac o s
ha
a e
ans o ming
heal h
da a
p i acy
and
confiden iali y
The
p og essi e
e osion
o
ou
own
p i a e
sphe es2is
now
con ibu ing
o
he
g ow h
and
expansion
o
a
global
pub-
lic
sphe e
we
all
sha e.
P i acy
concessions
can
be
obse ed
e e ywhe e
and
ha e
mul iple
causes
and
aims.
Secu i y,
o
example,
is
he
p ominen
cause
o
disclosu e
o
p i a e
da a.
Following
he
9/11
e o is
a acks
in
he
Uni ed
S a es
o
Ame ica,
p i acy
concessions
based
on
secu i y
easons
we e
g ea ly
expanded.28 Concomi an ly,
in usions
in
ou
p i a e
sphe es
such
as
ai po
sc eening,
collec ion
o
fin-
ge p in s
and
pho og aphs
and
ex ensi e
ideo
su eillance
a e
now
widely
accep ed
and
pe cei ed
as
no mal
p ac ice.
Rema kably,
people
a e
no
only
ole a ing
p i acy
conces-
sions
o
sha ed
pu poses
such
as
common
secu i y
bu
also
inc easingly
op ing
o
gi e
away
p i acy
o
indi idual
gains,
such
as
ame,
money
and
ecogni ion.
TV
shows
and
social
phenomena
whe e
people
linge
on
o he ’s
mos
in ima e
momen s
such
as
p ecise
fi s -hand
accoun s
o
deeply
au-
ma ic
expe iences
(including
heal h- ela ed
condi ions)
ha e
gained
significan
no o ie y.
The
case
o
Jade
Goody,
a
27
yea -
old
B i ish
Big
B o he
pa icipan
is
an
ex eme
example
o
exposu e
o
e minal
illness
in
he
media.
Goody
aised
a ound
£1
m
om
media
deals
signed
since
she
was
old
she
had
e -
minal
ce ical
cance .
He
main
eason
o
sign
hese
con ac s
o
a
li e
co e age
o
he
final
days
was
o
lea e
he
money
o
he
child en.
In
Po ugal,
e y
ecen ly,
Manuel
Fo jaz,
a
well-known
and
cha isma ic
academic
amously
sha ed
w i ings
and
pho os
on
social
media
abou
he
p og ession
o
his
cance ,
including
See
newspape
a icles
“Jade
Goody
o
wed
and
die
‘in
he
pub-
lic
eye’
The
eali y
TV
s a
will
sell
media
igh s
o
aise
money
o
he
child en”
(The
Obse e ,
Sunday
15
Feb ua y
2009)
A ailable
a :
h p://www. hegua dian.com/ heobse e /2009/ eb/15/jade-goody-
cance )
and
“Jade
Goody
se
o
make
£1
m
om
media
deals”
( he-
gua dian.com,
Wednesday
18
Feb ua y
2009
12.33,
a ailable
a :
h p://www. hegua dian.com/media/2009/ eb/18/jade-goody-
wedding-deals).
chemo he apy
sessions,
i s
seconda y
e ec s
and
consequen
su e ing.
Du ing
his
pe iod
he
pa icipa ed
in
a
weekly
TV
show
and
spoke
egula ly
and
openly
in
public
abou
his
disease.
He
died
a
ew
days
a e
publishing
a
book
abou
his
sha ed
expe ience
as
a
cance
pa ien .29 These
si ua-
ions
illus a e
he
possible
ans o ma ion
o
he
na u e
o
heal h
da a
om
a
pa adigm
o
sec ecy
made
o
a
ce -
ain
“emba assmen ”,3in o
a
possible
u u e
pa adigm
o
openness.
O e all,
heal h
da a
a e
becoming
socially
accep -
able
in o ma ion
and
i s
sel -disclosu e
is
becoming
i ial.
Howe e ,
his
endency
ce ainly
does
no
sui
e e yone
as
di -
e en
people
ha e
e y
di e en
no ions
o
wha
hey
wan
o
keep
p i a e.
S ill,
he
pa adigm
may
be
changing,
and
i
would
be
a
leas
doub ul
i
someone
who
sha ed
his
o
he
heal h
condi ion
on
social
media
could
subsequen ly
y
o
sue
hose
who
decided
o
sha e
ha
in o ma ion
ou side
he
ci cle
wi hin
which
ha
in o ma ion
was
o iginally
sha ed.
Hence,
in
a
wo ld
whe e
heal h
in o ma ion
oo
becomes
widely
sha ed
on
social
ne wo ks,
socie y
can
ela i ize
he
igh s
o
medical
and
gene ic
p i acy
and
confiden iali y,
which
may
ul ima ely
pe ade
law
and
jus ice.
T i ializa ion
o
he
sha ing
o
o me ly
conside ed
“sen-
si i e
da a”
is
also
becoming
mo e
acu e
due
o
he
almos
impossible
ask
ha
is
equi ed
o
da a
p o ec ion
au ho i-
ies
o
con ol
he
mul i ude
o
heal h
da a,
which
is
cu en ly
being
collec ed.
On
he
o he
hand,
building
sys ems
ha
secu e
confiden iali y
is
some imes
conside ed
a
luxu y,
which
is
neglec ed
by
heal h
adminis a o s,
pa icula ly
in
coun ies
whe e
financial
c ises
ha e
led
o
aus e i y
meas-
u es
(e.g.
Po ugal).
In
he
case
o
Po ugal,
he
absence
o
sys ema ic
supe ision
and
sanc ions
by
da a
p o ec ion
au ho i ies,
which
s uggle
wi h
lack
o
means,
oge he
wi h
he
almos
inexis en
li iga ion
in
his
domain,
esul
in
andom
p i acy
o
confiden iali y
p o ec ion
conce ns
in
heal hca e
uni s.
As
a
consequence,
anecdo al
e idence
indi-
ca es
ha
i
is
possible
o
adminis a i e
s a
o
access
pa ien s’
medical
his o ies,
in
iola ion
o
na ional
law.
Unsu -
p isingly,
in
coun ies
whe e
social
wel a e
is
jeopa dized,
pa ien s
p io i ize
access
o
ca e
o e
any
o he
igh s
and
a e
less
p one
o
complain
o
cases
in ol ing
a
iola ion
o
p i acy
and
confiden iali y
igh s.
Gene ic
p i acy
and
confiden iali y
No ably,
his
e osion
o
heal h
da a
p i acy
and
confiden ial-
i y
finds
pa allel
in
mo e
specific
phenomena
in
he
a eas
o
gene ics
and
genomics.
He e
again,
p i acy
concessions
a e
mo i a ed
by
public
and
p i a e
in e es
alike.
As
we
know,
he
Human
Genome
P ojec
(HGP)
and
he
ad en
o
genomics
ha e
highligh ed
(o
a
leas
p omised)
he
impo -
ance
o
gene ic
da a
in
figh ing
disease
and
imp o ing
heal h
ou comes.
Fo
example,
di e en
Public
Heal h
fields,
such
as
in ec ious
and
ch onic
disease,
occupa ional
heal h
and
en i onmen al
heal h
can
ad an age
om
he
p og ess
o
genomics
and
he
sha ing
o
gene ic
da a,
leading
o
wha
has
been
desc ibed
by
some
au ho s
as
“Gene ic
in o ma ion
o
all”
synd ome.30 This
subjec
and
he
ela ed
issue
o
pe son-
alized
medicine
(whe e
he apy
is
specifically
designed
o
an
indi idual
based
on
his/he s
gene ic
p ofile)
ha e
deep
p i acy
and
confiden iali y
implica ions.
Fi s
and
o emos ,
we
mus
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
1
4;3
2(2):123–133
129
conside
whe he
ou
gene ic
in o ma ion
can
con ibu e
o
significan
conclusions
abou
ou
isks
o
de eloping
u u e
diseases.
I
ha
is
es ablished,
a
leas
a
a
easonable
le el,
gene ic
da a
need
o
be
conside ed
as
p i a e
as
any
o he
heal h
da a.
Ne e heless,
i
is
clea
ha
i
someone
ca ies
a
gene ic
al e a ion
ha
has
been
associa ed
wi h
a
significan
and
ele a ed
isk
o
de eloping
a
disease
in
he
u u e,
ha
in o ma ion
could
be
use ul
o
amily
membe s
who
migh
sha e
ha
same
al e a ion.
Despi e
he
ac
ha
di e en
s ud-
ies
show
ha
he
o e whelming
majo i y
o
pa ien s
choose
o
pass
in o ma ion
o
gene ic
isk
and
gene ic
disease
o
am-
ily
membe s,
in
some
cases
sha ing
in o ma ion
collides
bo h
wi h
he
pa ien s’
will
and
he
igh
o
amily
membe s
no
o
know.31,32 Hence,
in
ponde ing
whe he
o
no
o
sha e
gene ic
da a
wi h
amily
membe s,
he
p obabili y
ha
he
disease
will
de elop
and
he
magni ude
o
he
ha m
should
ha
disease
indeed
de elop
mus
be
balanced
and
weigh ed
agains
he
cos s
(indi idual
and
public)
o
b eaching
confi-
den iali y
du ies.13 Hence,
clea ly,
he
ad ances
in
gene ics
and
genomics
pose
significan
challenges
o
p i acy
and
con-
fiden iali y
oo.
Finally,
a
supplemen a y
no e
o
men ion
ha ,
in
line
wi h
he
a o emen ioned
secu i y
conce ns
and
he e o e
pe haps
unsu p isingly,
in
some
cases
i
is
al eady
accep ed
o
gi e
away
gene ic
p i acy
o
jus ice
easons.
Fo
example,
he
UK
Na ional
DNA
da abase
al eady
includes
DNA
p ofiles
o
mo e
han
3
million
indi iduals,
co e ing
mo e
han
6%
o
he
pop-
ula ion
and
aising
p i acy
and
confiden iali y
issues
amongs
o he
innume ous
bioe hics
and
human
igh s
ques ions.33–35
The
opic
o
gene ic
p i acy
and
biobanks
o
o ensic
pu -
poses,
howe e ,
will
no
be
deba ed
he e
as
i
goes
beyond
he
scope
o
his
a icle.
The
Eu opean
Da a
P o ec ion
Law
e o m:
he
edemp ion
o
heal h
da a
p i acy
and
confiden iali y
igh s?
P elimina y
no e
In
he
p e ious
sec ions
we
iden ified
easons
o
belie e
ha
he
igh s
o
heal h
da a
p i acy
and
confiden iali y
–
once
so
che ished
in
Heal h
Law
–
a e
su e ing
a
c isis.
This
c i-
sis
is
caused
no
only
by
gene al
socie al
phenomena
bu
also
by
specific
ac o s
ela ed
o
he
fields
o
heal hca e
and
genomics.
We
also
men ioned
ha
we
conside
da a
p o ec ion
law
as
he
“p ac ical”
o
“ easible”
pa
o
he
de ense
o
he
igh s
o
p i acy
and
confiden iali y
o
heal h
in o ma ion
as,
cu en ly,
he
compliance
wi h
hese
igh s
essen ially
depends
on
secu i y
measu es
and
in o ma ion
echnology
(IT).
Hence,
we
ag ee
ha
wha e e
happens
in
he
da a
p o ec ion
law
field
will
ha e
a
significan
impac
in
he
igh s
o
p i acy
and
confiden iali y
in
he
heal h
law
domain.
Conside ing
ha
Eu opean
Da a
P o ec ion
Law
has
been
ecen ly
subjec
o
a
conside able
e o m,
including
a
new
Eu opean
egula ion
d a ,
i
is
e y
impo an
o
ana-
lyze
i
he e,
al hough
no
in
de ail,
as
his
does
no
fi
exac ly
he
scope
o
his
a icle,
which
is
o ien ed
o
Heal h
Law
and
Bioe hics
and
no
o
Da a
P o ec ion
Law
issues,
which
o he
au ho s
ha e
discussed
elsewhe e.36,37
The
EU
e o m
o
he
da a
p o ec ion
legal
amewo k
“Rapid
echnological
de elopmen s
ha e
b ough
new
chal-
lenges
o
he
p o ec ion
o
pe sonal
da a.
The
scale
o
da a
sha ing
and
collec ing
has
inc eased
d ama ically.
Technol-
ogy
allows
bo h
p i a e
companies
and
public
au ho i ies
o
make
use
o
pe sonal
da a
on
an
unp eceden ed
scale
in
o de
o
pu sue
hei
ac i i ies.
Indi iduals
inc easingly
make
pe sonal
in o ma ion
a ailable
publicly
and
globally.
Technology
has
ans o med
bo h
he
economy
and
social
li e.”11(p1)
In
2012,
he
Eu opean
Commission
(EC)
p oposed
a
key
e o m
o
he
EU
legal
amewo k,
which
led
o
he
d a
o
a
new
Eu opean
egula ion
on
he
p o ec ion
o
pe sonal
da a.
This
egula ion
in ends
o
s eng hen
indi idual
igh s
and
ackle
he
challenges
o
globaliza ion
and
new
echnolo-
gies
(mainly
on-line)
by
adap ing
he
gene al
p inciples
which
we e
conside ed
o
emain
alid
o
hese
challenges
while
main aining
he
echnological
neu ali y
o
he
legal
ame-
wo k.
When
i
comes
in o
o ce,
which
has
become
mo e
likely
o
happen
a e
he
majo i y
o
he
Eu opean
Pa liamen
app o ed
i s
d a
(Ma ch
2014),
he
new
Regula ion
(hence-
o wa d
ci ed
as
“ he
Regula ion”)
will
immedia ely
become
he
new
gene al
legal
amewo k
o
da a
p o ec ion
in
all
membe
S a es
o
he
EU,
abolishing
he
long
ime
uling
o
Di ec i e
95/46/CE.20 The
pa hway
o
his
e o m
was
based
in
se e al
documen s
om
di e en
en i ies,
some
o
which
included
inno a i e
mechanisms
o
p o ec
pe sonal
da a
agains
he
challenges
i
endu es
a
p esen
ime.38 This
pa h-
way
also
included
a
Eu oba ome e
2011
su ey39 on
he
a i udes
owa ds
da a
p o ec ion,
which
showed
in e es -
ing
esul s
and
e ealed
ha
he
majo i y
o
Eu opeans
eel
obliged
o
a e
willing
o
gi e
up
hei
p i acy
and
confiden-
iali y
almos
on
a
daily
basis.
Resul s
o
he
Eu oba ome e
2011
su ey
showed
ha
58%
o
Eu opeans
eel
ha
he e
is
no
al e na i e
o he
han
o
disclose
pe sonal
in o ma-
ion
i
hey
wan
o
ob ain
p oduc s
o
se ices;
79%
o
social
ne wo king
and
sha ing
si e
use s
we e
likely
o
dis-
close
hei
name;
51%
hei
pho o
and
47%
hei
na ionali y.
Online
shoppe s
ypically
ga e
hei
names
(90%),
home
add esses
(89%),
and
mobile
phone
numbe s
(46%).
Only
a
hi d
o
Eu opeans
we e
awa e
o
a
na ional
public
au ho -
i y
esponsible
o
p o ec ing
hei
pe sonal
da a
igh s
(33%)
and
jus
o e
a
qua e
o
social
ne wo k
use s
(26%)
and
e en
ewe
online
shoppe s
(18%)
el
in
comple e
con ol
o
hei
da a.39 Impo an ly,
hese
numbe s
jus
confi med
wha
he
Eu opean
ins i u ions
al eady
suspec ed.
In
2010,
in
a
Communica ion
o
he
Eu opean
Pa liamen ,
he
Council,
he
Eu opean
Economic
and
Social
Commi ee
and
he
Com-
mi ee
o
he
Regions,
i led
“A
comp ehensi e
app oach
on
pe sonal
da a
p o ec ion
in
he
Eu opean
Union”,40 he
Com-
mission
concluded
ha
he
EU
needed
“a
mo e
comp ehensi e
and
cohe en
policy
on
he
undamen al
igh
o
pe sonal
da a
p o ec ion”.40
130
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
1
4;3
2(2):123–133
The
new
gene al
ules
in
he
Regula ion
ha
can
ha e
impac
in
he
p o ec ion
o
heal h
da a
The
new
EU
s a egy
in ends
o
“pu
indi iduals
in
con ol
o
hei
own
da a”11 and
a
new
app oach
o
wha
is
conside ed
“nomina i e
da a”
is
adop ed
in
he
Regula ion.
Fo
ins ance,
he
ac s
o
being
obse ed
and
being
aced
become
p i acy
h ea s,
e en
wi hou
knowing
he
name
o
he
obse ed
o
aced
pe son.36 A icle
4/2
o
he
Regula ion
de e mines
ha
pe sonal
da a
“means
any
in o ma ion
ela ing
o
a
da a
sub-
jec ”.
Da a
subjec
is
defined
as
“an
iden ified
na u al
pe son
o
a
na u al
pe son
who
can
be
iden ified,
di ec ly
o
indi ec ly,
by
means
easonably
likely
o
be
used
by
he
con olle
o
by
any
o he
na u al
o
legal
pe son,
in
pa icula
by
e e ence
o
an
iden ifica ion
numbe ,
loca ion
da a,
online
iden ifie
o
o
one
o
mo e
ac o s
specific
o
he
physical,
physiological,
gene ic,
men al,
economic,
cul u al
o
social
iden i y
o
ha
pe son”
(A icle
2/1).
A
significan
imp o emen
is
he
p inciple
o
anspa ency
in oduced
by
A icle
5
(P inciples
ela ing
o
pe sonal
da a
p ocessing),
which
s ipula es
ha
pe sonal
da a
mus
be
“p ocessed
law ully,
ai ly
and
in
a
anspa en
manne
in
ela ion
o
he
da a
subjec ”
(A icle
5/a).
Two
o he
inno a ions
in
e ms
o
da a
con ol
igh s
a e
he
igh
o
po abili y
and
he
igh
o
be
o go en.
A icle
18/1
o
he
Regula ion
de e mines
ha
da a
subjec s
ha e
he
igh
o
ob ain
a
copy
o
hei
pe sonal
da a
om
he
con olle ,
in
a
“s uc u ed
and
commonly
used
o ma
which
is
com-
monly
used
and
allows
o
u he
use
by
he
da a
subjec ”.
In
A icle
18/2
i
is
g an ed
o
he
da a
subjec
he
“ igh
o
ans-
mi
pe sonal
da a
and
any
o he
in o ma ion
p o ided
by
he
da a
subjec
and
e ained
by
an
au oma ed
p ocessing
sys em,
in o
ano he
one,
in
an
elec onic
o ma
which
is
commonly
used,
wi hou
hind ance
om
he
con olle
om
whom
he
pe sonal
da a
a e
wi hd awn”.
As
some
au ho s
pu
i ,
da a
po abili y
is
he e o e
he
igh
o
“ ake
pe sonal
da a
and
lea e”.36 Impo an ly,
he
“ igh
o
be
o go en”
(and
o
e a-
su e)
is
also
a
new
op ion
in
he
Regula ion
and
has
ecen ly
been
confi med
by
he
Cou
o
Jus ice
o
he
Eu opean
Union
(A icle
17)12:
“Any
pe son
should
ha e
he
igh
o
ha e
pe sonal
da a
conce ning
hem
ec ified
and
a
‘ igh
o
be
o go en’
whe e
he
e en ion
o
such
da a
is
no
in
compliance
wi h
his
Regula ion.
In
pa icula ,
da a
subjec s
should
ha e
he
igh
ha
hei
pe sonal
da a
a e
e ased
and
no
longe
p ocessed,
whe e
he
da a
a e
no
longe
necessa y
in
ela-
ion
o
he
pu poses
o
which
he
da a
a e
collec ed
o
o he wise
p ocessed,
whe e
da a
subjec s
ha e
wi hd awn
hei
consen
o
p ocessing
o
whe e
hey
objec
o
he
p ocessing
o
pe sonal
da a
conce ning
hem
o
whe e
he
p ocessing
o
hei
pe sonal
da a
o he wise
does
no
com-
ply
wi h
his
Regula ion.
This
igh
is
pa icula ly
ele an ,
when
he
da a
subjec
has
gi en
hei
consen
as
a
child,
when
no
being
ully
awa e
o
he
isks
in ol ed
by
he
p ocessing,
and
la e
wan s
o
emo e
such
pe sonal
da a
especially
on
he
In e ne .
Howe e ,
he
u he
e en ion
o
he
da a
should
be
allowed
whe e
i
is
necessa y
o
his o i-
cal,
s a is ical
and
scien ific
esea ch
pu poses,
o
easons
o
public
in e es
in
he
a ea
o
public
heal h,
o
exe cising
he
igh
o
eedom
o
exp ession,
when
equi ed
by
law
o
whe e
he e
is
a
eason
o
es ic
he
p ocessing
o
he
da a
ins ead
o
e asing
hem.”11
In
his
espec ,
we
ag ee
wi h
Cos a
and
Poulle 36 when
hese
au ho s
a fi m
ha
he
e ec i eness
o
he
igh
o
be
o -
go en
elies
on
a
echno-legal
app oach,
as
echnical
solu ions
ha e
o
be
adop ed
o
ensu e
he
e asu e
and
blocking
o
da a
on
he
In e ne .
This
ac
is
ela ed
o
ano he
inno a i e
ule
o
he
Regula ion,
he
in oduc ion
o
a
“p i acy-by-design”
obliga ion.
“P i acy-by-design”
is
es ablished
in
A icle
23
o
he
Regu-
la ion
(Da a
p o ec ion
by
design
and
by
de aul )
gi ing
da a
con olle s
he
du y
o
“Ha ing
ega d
o
he
s a e
o
he
a
and
he
cos
o
implemen a ion
(.
.
.)
bo h
a
he
ime
o
he
de e mina ion
o
he
means
o
p ocessing
and
a
he
ime
o
he
p ocessing
i sel ,
implemen
app op ia e
echnical
and
o ganiza ional
measu es
and
p ocedu es
in
such
a
way
ha
he
p ocessing
will
mee
he
equi emen s
o
his
Regula ion
and
ensu e
he
p o ec ion
o
he
igh s
o
he
da a
subjec ”
(A icle
23/1).
The
Eu opean
Commission
is
he
ins i u ion
empowe ed
o
speci y
da a
p o ec ion
by
design
equi emen s
“applicable
ac oss
sec o s,
p oduc s
and
se ices”
(A icle
23/3).
Ve y
impo an
o
he
u u e
o
pe sonal
da a
p o ec ion
in
gene al
and
in
he
field
o
heal h
and
gene ic
da a
p i acy
and
confiden iali y
igh s,
in
pa icula ,
is
he
new
app oach
ound
in
he
Regula ion
in
wha
e e s
o
Responsibili y
and
Lia-
bili y.
Di e en ly
om
he
Di ec i e
95/46/CE,
he
Regula ion
is
e y
much
conce ned
abou
esponsibili y,
and
clea ly
s a es
ha
he
con olle s
o
da a
a e
esponsible
o
implemen
da a
secu i y
equi emen s
(A icle
23).
Impo an ly,
he
Regula ion
de e mines
a
“p inciple
o
accoun abili y”
and
desc ibes
in
de ail
he
obliga ion
o
he
con olle
o
comply
wi h
he
Reg-
ula ion
and
o
demons a e
his
compliance,
including
by
way
o
adop ion
o
in e nal
policies
and
mechanisms
o
ensu -
ing
such
compliance.11 This
is
a
e y
impo an
s ep
ahead
in
he
gene al
p o ec ion
o
pe sonal
da a,
which
can
ha e
a
huge
impac
on
heal h
da a
con olle s
and
p ocesso s
(A i-
cle
22
on
he
esponsibili y
o
he
con olle ).
Fu he mo e,
in
e ms
o
liabili y,
he
Regula ion
p esen s
wo
conside able
modifica ions
o
he
Di ec i e.
I
makes
p ocesso s
( hose
who
p ocess
da a
on
behal
o
con olle s)
liable
o
damages
and
when
hese
a e
mul iple
i
es ablishes
a
“join
liabili y”
a oid-
ing
he
necessi y
o
iden i y
he
one
a
aul
(A icles
23
and
24).
The
Regula ion
also
imposes
on
con olle s
and
p ocesso s
he
du y
o
coope a e
wi h
he
supe iso y
au ho i y
(A icle
29).
In
b ie ,
wi h
all
hese
new
da a
p o ec ion
en o cemen
mechanisms
he
Regula ion
seems
o
b ing
he
possibili y
o
a
new
e a
o
p i acy
and
confiden iali y
igh s
and
implic-
i ly
o
heal h
and
gene ic
da a
p o ec ion.
Ne e heless,
in
specific
e ms
he
only
inno a ion
in
he
Regula ion
which
a ge s
heal h
da a
is
A icle
84,
inse ed
in
Chap e
IX
(P o-
isions
ela ing
o
specific
da a
p ocessing)
on
“Obliga ions
o
sec ecy”.
In
his
disposi ion
i
is
s a ed
ha
wi hin
he
limi s
o
he
Regula ion,
Membe
S a es
may
adop
specific
ules
(which
ha e
o
be
no ified
o
he
Eu opean
Commis-
sion)
o
se
ou
he
in es iga i e
powe s
by
he
supe iso y
au ho i ies
“in
ela ion
o
con olle s
o
p ocesso s
ha
a e
e
p
o
s
a
ú
d
e
p
ú
b
l
i
c
a
.
2
0
1
4;3
2(2):123–133
131
subjec s
unde
na ional
law
o
ules
es ablished
by
na ional
compe en
bodies
o
an
obliga ion
o
p o essional
sec ecy
o
o he
equi alen
obliga ions
o
sec ecy,
whe e
his
is
necessa y
and
p opo iona e
o
econcile
he
igh
o
he
p o-
ec ion
o
pe sonal
da a
wi h
he
obliga ion
o
sec ecy”.41,g
Fo
he
emaining,
he
Regula ion
main ains
he
concep
ha
“heal h
ela ed
da a”
and
“gene ic
da a”
mus
be
con-
side ed
as
“sensi i e
da a”,
and
as
such
equi e
mo e
da a
p o ec ion
sa egua ds.
A icle
9
o
he
Regula ion11 se s
ou
he
gene al
p ohibi ion
o
p ocessing
special
ca ego ies
o
pe sonal
da a,
including
“da a
conce ning
heal h”
and
he
excep ions
om
his
gene al
ule,
building
on
A icle
8
o
he
Di ec i e
95/46/EC.20 S angely,
a icle
81
o
he
Regula ion
which
defines
he
p ocessing
o
heal h
da a
does
no
include
gene ic
da a.
The
Regula ion
defines
bo h
“gene ic
da a”
and
“da a
conce ning
heal h”
(A icle
4)
bu
i
is
ob ious
ha
his
sec o
was
no
a
majo
conce n
in
he
EU
da a
p o ec ion
e o m.
O e all,
some
o
he
new
ins umen s
p oposed
o
a
enewed
amewo k
o
da a
p o ec ion
in
Eu ope
can
gi e
a
p ac ical
sense
o
he
igh s
o
p i acy
and
confiden ial-
i y
in
heal hca e
and
gene ic
se ings,
ans o ming
hem
om
he o ical
figu es
in o
eal
obliga ions
o
he
coun e -
pa s
(heal h
and
gene ic
da a
con olle s
and
p ocesso s).
Fo
ins ance,
he
obliga ion
o
build
“p i acy
by
design”
o
he
p ocessing
o
heal h
da a
o
biobanks
will
be
key
o
heal h
in o ma ion
sys ems’
manage s.
Fo
example,
in
Po ugal,
a
comp ehensi e
and
o ficial
Heal h
Da a
Pla o m42 has
been
launched
wi hou
uly
in o ming
he
public
abou
heal h
p i acy
and
confiden iali y
issues.
Fu he mo e,
he e
is
no
men ion
in
he
Pla o m
websi e
o
he
igh s
o
he
people
who
will
be
pu ing
he e
hei
medical
da a
lacuna,
which
would
ha e
been
impossible
yea s
ago.
Mo eo e ,
he
Na ional
Da a
P o ec ion
Commission
is
no
e e enced
in
he
po al
as
ha ing
gi en
i s
au ho iza ion
o
ea men
o
medical
da a
a
such
an
ex ension.
We
hink
ha
when
in
o ce,
he
new
ules
om
he
EU
Regula ion
will
ha e
a
posi i e
impac
on
he
p i-
acy
and
confiden iali y
o
pa ien s’
da a,
which
u gen ly
need
edemp ion
in
Po ugal.
Las
wo d
“Bu
someone
will
always
ha e
o
speak
o
p i acy,
because
i
doesn’
na u ally
ise
o
he
op
o
mos
con-
side a ion
se s,
whe he
in
go e nmen
o
in
he
p i a e
sec o .”2(p126)
gThis
impo ance
gi en
o
sec ecy
was
also
s essed
on
he
Mad id
Resolu ion,
signed
by
he
Da a
P o ec ion
and
P i acy
Com-
missione s
in
2009
whe e
on
opic
13
da a
ela ing
o
heal h
o
sex
li e
is
conside ed
“sensi i e
da a”.
In
he
same
documen ,
opic
21
e e s
o
a
“du y
o
confiden iali y”
which
s a es
ha
“The
espon-
sible
pe son
and
hose
in ol ed
a
any
s age
o
he
p ocessing
shall
main ain
he
confiden iali y
o
pe sonal
da a.
This
obliga ion
shall
emain
e en
a e
he
ending
o
he
ela ionship
wi h
he
da a
subjec
o ,
when
app op ia e,
wi h
he
esponsible
pe son.”
“You
ha e
ze o
p i acy
anyway.
Ge
o e
i .”
This
amous
1999
quo e
in
Wi edhby
Sco
McNealy,27 was
mo e
han
an
epiphany
as
i
becomes
mo e
and
mo e
accu a e
as
ime
goes
by.
Ce ainly,
oday
p i acy
is
a
defied
and
pe haps
e en
com-
p essed
concep .
None heless,
e en
hose
willingly
sha ing
hei
a eas
o
eclusion
ake
o ense
when
seeing
o he s
in uding
hose
same
a eas
wi hou
hei
consen .
Fu -
he mo e,
expe iencing
pe nicious
e ec s
ela ed
o
p i acy
exposu e
can
cons i u e
dis u bing
inciden s,
which
a ely
lead
o
decisions
o
main aining
minu e
a eas
o
pe sonal
e ea .
The e o e,
despi e
i s
ansmu a ions
and
me amo -
phosis,
p i acy
is
s ill
pa
o
ou
ha dwi ing
as
agen s
endowed
wi h
ee
will.
Hence,
ans o med,
nuanced
and
sel -a fi med
concep s
o
p i acy
s ill
pe se e e
in
hese
highly
demanding
ci cums ances.
In
a
way,
he
ac s
a e
no
sui ing
any
da a
p o ec ion
igh s,
bu
he
new
EU
egula ion
seems
o
wan
o
p o ec
hese
igh s
agains
all
odds,
ein en ing
da a
p o ec ion
in
a
mix
o
a
legal- echnological
app oach.
Ne e heless,
we
mus
no
be
naï e,
and
i
is
impo an
o
no ice
ha
he
a io
o
he
EU
conce ns
is
no
linked
o
a
human
igh s
based
philosophy
o
de ense,
bu
mainly
o
economic
mo i es.
The
undamen-
al
goal
o
he
new
EU
ins umen s
on
da a
p o ec ion
is
he
“building
o
us
in
he
online
en i onmen ”
which
is
“key
o
economic
de elopmen
as
lack
o
us
makes
consume s
hes-
i a e
o
buy
online
and
adop
new
se ices”.11 No el
policies
on
da a
p o ec ion
in
Eu ope
aim
o
a oid
he
isks
ha
ea
o
an
uncon olled
sha ing
o
da a
may
slow
down
he
de elopmen
o
inno a i e
uses
o
new
echnologies.
I
is
men ioned
in
he
explana o y
memo andum
o
he
Regula ion11 ha
“hea y
c i icism
has
been
exp essed
ega ding
he
cu en
agmen-
a ion
o
pe sonal
da a
p o ec ion
in
he
Union,
in
pa icula
by
economic
s akeholde s
who
asked
o
inc eased
legal
ce -
ain y
and
ha moniza ion
o
he
ules
on
he
p o ec ion
o
pe sonal
da a”.
Also,
he
complexi y
o
he
ules
on
in e na-
ional
ans e s
o
pe sonal
da a
is
conside ed
as
cons i u ing
a
“subs an ial
impedimen
o
hei
ope a ions
as
hey
egula ly
need
o
ans e
pe sonal
da a
om
he
EU
o
o he
pa s
o
he
wo ld”.11 Ne e heless,
e en
when
economic
mo i a ions
a e
d i ing
e o m,
undamen al
human
igh s
o
p i acy
and
da a
p o ec ion
and
confiden iali y
may
benefi
om
he
new
EU
Regula ion.
In
eali y,
e en
i
he
e osion
o
he
igh s
o
p i acy
and
confiden iali y
in
he
heal h
ca e
and
biobanking
fields
becomes
clea e ,
he
public
and
heal h
p o essionals
s ill
demand
a
leas
a
pe cep ion
o
he
obse a ion
o
hese
igh s.
The
ac s
hough
seem
o
e eal
an
uns oppable
ading
o
he
on ie s
o
p i a e
li e,
especially
in
he
heal hca e
domain.
Clea ly,
many
changes
occu ed
du ing
he
100
yea s
ha
media ed
be ween
“The
Righ
o
P i acy”
and
“Impe ial
Bed oom”.
The
bi h
o
he
po able
snapsho
pho og aphy
came a
and
la e
o
he
ideo
camco de ,
he
mobile
phone
indus y,
he
mass
use
o
compu e s
and
he
dawn
o
he
in e ne
a e
good
examples
o
echnology-p opelled
social
hWi ed
is
a
amed
magazine
on
scien ific
inno a ions
and
hei
impac
in
socie y,
also
known
o
ea u ing
edi o ials
om
indus y
leade s.