Læknablaðið - 15.06.1999, Page 61

LÆKNABLAÐIÐ 1999; 85
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patients are prone to withhold
information. This is also apt
to have serious consequences
(see Breach of patient/physi-
cian trust below).
2) Breach of patient/phy-
sician trust
Physicians will be forced to
hand over entrusted informa-
tion. The transfer of medical
records to third parties will
undermine the confidence
between patients and physi-
cians and have at least two
serious consequences. First,
patients worried about the pri-
vacy of sensitive medical in-
formation may withhold in-
formation from the physician,
increasing the risk of tnisdia-
gnosis and inadequate or inap-
propriate treatment. Second,
if there is erosion of trust the
information is likely to be-
come unreliable and scientific
conclusions reached from
such data will consequently
be of inferior quality.
Not only are physicians
forced to hand over informa-
tion to third parties but physi-
cians in public institutions
will have no veto power re-
garding the transfer of infor-
mation into the database.
Politically appointed boards
of directors will be em-
powered to negotiate all trans-
fers of information, without
any review by independent
ethics committees.
3) The necessity of inde-
pendent review mechanisms
The Act has changed and
weakened the role of the Ice-
landic National Bioethics
Committee formed according
to the Act on Patients' Rights.
The role of the National
Bioethics Committee has
been reduced from being an
independent scrutinizer of all
research protocols to one of
accepting lists of queries and
querors to the proposed
Health Sector Database.
According to rules set by
the Ministry (Art. 12) the Act
calls for a special interdisci-
plinary ethics review commit-
tee to replace functions pre-
viously performed by the
National Bioethics Commit-
tee. Composed of representa-
tives appointed by the Minis-
try of Health, members of
parliament have indicated that
representatives of the licensee
will sit in this committee to
protect its interest.
4) Abuse of patient con-
sent
The HSD "presumes" that
the data is not personally
identifiable. The Act proposes
to protect individual privacy
by a one-way coding function
- coding that can not be traced
using a decoding key. This
logic is used to circumvent the
necessity of obtaining infor-
med consent of the individual.
In order to be able to update
the database all institutions
must, however, use the same
coding function and the same
function must also be used for
the entire life of the database.
Therefore, a key exists: the
function itself is a key. By
feeding the National Registry
(which contains the names
and personal identifying num-
bers of 275.000 Icelanders)
through the one-way function,
a look-up table of names and
pseudonyms can be formed.
Hence, any person can be
identified.
This violates the guidelines
of the European Data Protec-
tion Act, set by the European
Parliament and Council,
which explicitly state that in-
formed consent for participa-
tion of human subjects in
gathering and storing infor-
mation is mandatory, as well
as being an essential precon-
dition to processing the data.
All individuals (alive, de-
ceased, unborn) will be inclu-
ded in the database unless
they opt out before June 17th,
1999. If individuals opt out
after this date they are only
able to stop the transfer of
future data, previously en-
tered data cannot be erased
and thus these individuals
may be subjects of research
against their expressed ins-
tructions. Relatives of the de-
ceased have no say in protec-
ting the rights of their de-
ceased family members and
all information on them wil!
be included.
5) Disregarding of estab-
lished scientific standards
According to Article 6
access of scientists working at
collaborating health institu-
tions is negotiable but not
legally binding. Access by
scientists outside these insti-
tutions is only possible if the
scientist collaborates with the
institution or negotiates di-
rectly with the licensee. Thus
the licensee gets to "pick and
choose" who will get access to
the database.
The Icelandic Medical As-
sociation strongly believes
that monopolizing informa-
tion and access to research
subjects is not only harmful to
scientific progress but also
encroaches on the freedom of
research.
6) Medical records as a
commodity.
The Act gives a single com-
pany, the licensee, an exclu-