EGE Report: Implants in the Human Body

[Allen L. Barker]

[This text version of the European Group on Ethics' report "Ethical
Aspects of ICT Implants in the Human Body" was converted (without
footnotes) from the html version in the Google cache at
http://www.google.com/search?q=cache:u5Zs3--4gUIJ:europa.eu.int/comm/european_group_ethics/docs/avis20en.pdf+&hl=en.
The original PDF file is at
http://europa.eu.int/comm/european_group_ethics/docs/avis20en.pdf.

The use of implanted devices (and other, related technologies) in
human beings raises fundamental ethical and moral questions which are
*finally* beginning to be openly discussed and taken seriously. To
their credit, the authors of this EGE report have for the most part
done a very good job of covering and explaining the issues. They are
not afraid to use the term "human dignity" or to insist on informed
consent.

The report's recommendations with regard to the use of information
and communication technology (ICT) implants for surveillance purposes
are as follows:

[...]

6.4. ICT IMPLANTS FOR NON-MEDICAL PURPOSES

The wide range of potential non-medical applications of ICT
implants also demands informed consent, respect for privacy,
etc. Some of these applications are analysed in the following
sections. The EGE makes the general point that non-medical
applications of ICT implants are a potential threat to human
dignity and democratic society. Therefore, such applications
should respect in all circumstances the principles of informed
consent and proportionality and, whenever aiming at surveillance
purposes, they should comply with the rules set out hereunder in
Section 6.4.6.

The EGE emphasizes that where adults give their informed consent
to specific applications, the provided information should include
clear data on possible health disturbances in the short and/or
long term as well as problems of unwilling data processing.

[...]

6.4.6. ICT Implants for Surveillance Purposes

ICT implants for surveillance in particular threaten human
dignity. They could be used by state authorities, individuals and
groups to increase their power over others. The implants could be
used to locate people (and also to retrieve other kinds of
information about them). This might be justified for security
reasons (early release for prisoners) or for safety reasons
(location of vulnerable children).

However, the EGE insists that such surveillance applications of
ICT implants may only be permitted if the legislator considers
that there is an urgent and justified necessity in a democratic
society (Article 8 of the Human Rights Convention) and there are
no less intrusive methods. Nevertheless the EGE does not favour
such uses and considers that surveillance applications, under all
circumstances, must be specified in legislation. Surveillance
procedures in individual cases should be approved and monitored by
an independent court.

The same general principles should apply to the use of ICT
implants for military purposes.

[...]

Rather than just being a future issue, much of this technology has
existed for years. For example, a tooth implant device capable of
sending auditory signals to a person that only he or she can hear has
existed since at least the late 1950s. Jose Delgado tested his
transdermal "stimoceiver" brain implants on human subjects back in the
1970s. Modern RF-controlled, individually addressable microstimulator
chips can be built on a submillimeter scale. A Senate subcommittee
chaired by Sam Ervin, Jr. issued a report similar to this EGE report,
titled _Individual Rights and the Federal Role in Behavior
Modification_, back in 1974.

As the EGE report points out, there are clearly military applications
for these technologies. Compared with the open technologies, devices
developed in largely unaccountable black-budget "special access
programs" would be like a stealth bomber versus a Boeing 747 (back
before stealth bombers even officially existed). Just as with the
human radiation experiments, the US has a long history of conducting
nonconsensual experimentation in the area of covert behavioral
influencing. These human rights issues *also* need to be openly
addressed.]

--------

OPINION OF THE EUROPEAN GROUP ON ETHICS
IN SCIENCE AND NEW TECHNOLOGIES
TO THE EUROPEAN COMMISSION
N° 20
Adopted on 16/03/2005
Original in English

******************************************************************
ETHICAL ASPECTS OF ICT IMPLANTS IN THE HUMAN BODY
Reference: Opinion produced on the direct initiative of the EGE
Rapporteurs: Professor Stefano Rodotà and Professor Rafael Capurro
******************************************************************

The European Group on Ethics in Science and New Technologies (EGE),
Having regard to the European Union Treaty and in particular Article 6
of the common provisions concerning the respect for fundamental
rights;

[...]

1. INTRODUCTION

Information and communication technologies (ICT) pervade our
lives. Thus far, this pervasive influence has mainly involved devices
that we use for private purposes or at the work place such as personal
computers, mobile phones, laptops and the like. Due to new
developments these devices are becoming more and more part of our
bodies, either because we wear them (wearable computing) or because
they are implanted in our bodies.

At first sight ICT implants are ethically unproblematic if we think
for instance about cardiac pacemakers. However, although ICT implants
may be used to repair deficient bodily capabilities they can also be
misused, particularly if these devices are accessible via digital
networks. One might even think of such devices as a threat to human
dignity and particularly to the integrity of the human body (see
Section 5), while for others such implants might be seen primarily as
a means for restoring damaged human capabilities and therefore as a
contribution to the promotion of human dignity.

The idea of letting ICT devices get under our skin in order not just
to repair but even to enhance human capabilities gives rise to science
fiction visions with threat and/or benefit characteristics. However,
in some cases, the implantation of microchips is already taking place
with the potential for individual and social forms of control.

The intimate relation between bodily and psychic functions is basic to
our personal identity. Modern neurosciences are emphasising this
view. Language and imagination influence in a unique way our
perception of time and space; the way we perceive ourselves and
others; the way we relate to other non-human living beings and to the
natural environment; the way we create historically, culturally,
politically, legally, economically, and technically our societies; the
way we acquire knowledge about ourselves and about the world; and the
way we produce, create, and exchange things.

ICT devices are the products of human invention. The functions they
achieve are based on programmable or algorithmic calculations mostly
using non-biological substances such as silicon. This allows a
simulation of some biological and psychic functions . Furthermore, it
is in principle, and today also in practice, possible to implant ICT
devices in the human body in order for instance to restore bodily
functions or, as in the case of prostheses and artificial limbs, to
substitute some body parts.

These are the essential reasons why potential and actual ICT implants
in the human body have large and important ethical consequences.
Consequently, the objective of this Opinion is primarily to raise
awareness and questions concerning the ethical dilemmas created by a
range of ICT implants in this rapidly expanding field. Ethical
awareness and analysis must take place now in order to ensure an
appropriate and timely impact on the various technological
applications. Nevertheless, where necessary this Opinion proposes
clear ethical boundaries, legal principles and suggests several steps
that should be taken by responsible regulators in Europe. The Opinion
focuses on ICT implants in the human body (see Section 6.1).

2. GLOSSARY

ICT devices: Devices using information and communication technologies
usually based on silicon chip technology.

Active medical device: Any medical device relying for its functioning
on an internal and independent source of electrical energy or any
source of power other than that directly generated by the human body
or gravity.

Active implantable medical device: Any active medical device which is
intended to be totally or partially introduced surgically or
medically, into the human body or by medical intervention into a
natural orifice, and which is intended to remain after the procedure.

Passive ICT implants: ICT implants in the human body that rely on an
external electromagnetic field for their operation (see for example
Section 3.1.1 the "Verichip").

Online ICT implants: ICT implants that rely for their operation on an
("online") connection to an external computer or which can be
interrogated ("online") by an external computer (see for example
Section 3.1.2 Biosensors).

Offline ICT implants: ICT implants that operate independently of
external ICT devices (perhaps after an initial setting up operation)
(see for example Section 3.1.1 Deep Brain Stimulation).

3. SCIENTIFIC AND TECHNICAL BACKGROUND

(See detailed report by Dr Fabienne Nsanze "ICT implants in the human
body -- a review" of February 2005 -- annexed to this Opinion)

3.1. Current Applications and Research

3.1.1. Applications: ICT implants on the market

This section contains information about implants in the human body
that are available in commercial form and have been researched, in
some cases, for decades.

Active medical devices

The history of implantable devices in clinical practice started in the
1960s with the development of the first heart pacemakers to replace
the autonomic rhythm of the heart. Systems for bladder stimulation
that allow paraplegics (paralysis of the lower limbs often resulting
from spinal cord injuries) to control voiding followed in the
1980s. The most recent examples of active implants for functional
electrical stimulation are stimulators to treat pain in patients with
tumours and trembling caused by Parkinson's disease, and to restore
the grasp function in quadriplegics (paralysis of the arms, legs and
trunk below the level of an associated spinal cord injury). Typical
devices include the following:

-- Cardiovascular pacers for patients with conduction disorders or
heart failure

-- Cochlear implants: the cochlear implant differs from the hearing
aid in that it does not amplify sound and bypasses the damaged part to
send sound signals directly to the auditory nerve.

-- Auditory Brainstem implant (ABI) is an auditory prosthesis that
bypasses the cochlea and auditory nerve to help individuals who cannot
benefit from a cochlear implant because the auditory nerves are not
working. The brainstem implant stimulates directly the cochlear
nucleus situated in the brainstem.

-- Implantable programmable drug delivery pumps: Administration of
Baclofen for patients with Multiple Sclerosis with severe spasticity
(intrathecal administration i.e. within the spinal canal) Insulin pump
for Diabetes

-- Implantable Neurostimulation Devices: the term "neurostimulation"
relates to technologies that do not directly stimulate a muscle as a
functional electrical stimulation device (i.e., cardiac
pacemakers). Rather, neurostimulation technologies modify electrical
nerve activity. Spinal cord stimulation for chronic pain management
Sacral nerve stimulation for treatment of refractory urinary urge
incontinence Vagus nerve stimulation (VNS) for seizure control in
epilepsy or for mood control in severe depression cases

-- Deep brain stimulation (DBS): for tremor control in patients with
Parkinson's disease for essential tremor: Patients with essential
tremor have no symptom other than tremor, which may occur in their
hands, head, legs, trunk or voice. As for patients with Parkinson's
disease, they can be helped with deep brain stimulation therapy.

-- Artificial chip-controlled leg: the German company Otto Bock
Healthcare GmbH has developed a prosthesis called "C-Leg® "which is a
chip-controlled leg.

Identification and location devices

Microchip devices come in three forms:

1) Read-Only: this is the simplest form of devices that have a
read-only character, similar to that now used for identification of
animals. Even this most basic form would have numerous applications,
for example, to identify Alzheimer's patients, children and the
unconscious. A broader use would be as a sort of national
identification card, based upon the identifying number carried on the
microchip.

2) Read-Write: this type of microchip would be capable of carrying a
set of information which could be expanded as necessary. It allows the
storage of data and is programmable at distance. For example, when the
microchip carries a person's medical history and the history evolves,
the subsequent information could also be added to the microchip
without the necessity of removing the implanted chip. It could also
facilitate and record financial transactions. The third important set
of information that a read-write microchip could carry might be
criminal records.

3) Devices with tracking capabilities: besides the read-write
capabilities described above, a device can also emit a radio signal
which could be tracked. Applications would again be numerous as
evidenced by the less advanced technologies already in existence. Such
a device needs a power source that has to be miniaturized before being
implantable. With a microchip implant, constant monitoring would be
possible. If each chip emitted a signal of a unique identifying
frequency, implanted individuals could be tracked by simply dialling
up the correct signal. Because the receiver is mobile, the tagged
individual could be tracked anywhere.

Typical devices include:

-- RFID devices: millions of Radio frequency identification (RFID)
tags have been sold since the early 1980s. They are used for
livestock, pet, laboratory animals, and endangered- species
identification. This technology contains no chemical or battery. The
chip never runs down and has a life expectancy of 20 years.

-- VeriChip(TM) or the "human bar code": VeriChip(TM)
(www.4verichip.com) is a subdermal RFID device, about the size of a
grain of rice, which is implanted in the fatty tissue below the
triceps. Current applications of the VeriChip include:

Medical records and healthcare information (blood type, potential
allergies and medical history)

Personal information/identity: In the Baja Beach Club (in Spain and
The Netherlands, http://www.baja.nl), people use the VeriChip(TM) like
a smartcard to speed up drink orders and payment.

Financial information (secondary verification)

Besides these areas, the extended applications include public
transportation security, access to sensitive buildings or
installations and tracking down people on parole, ex- convicts,
criminals, etc. Currently, a person has to stand within a few feet
from a scanner for the tag to "wake up". Thus, the tags can be used to
follow someone's steps only when they are near scanners. Consequently,
the VeriChip(TM) is, for the moment, not an implantable GPS (Global
Positioning System) device.

-- The Bavarian company Ident Technology
(http://www.ident-technology.com) offers tracking devices using the
human body (particularly the skin) as a digital data transmitter.

-- Female remote-control Orgasm Implant: A machine that delivers an
orgasm at the push of a button was patented in the US in January
(2004).

3.1.2. Research on ICT Implants

Medical devices

-- Biosensors: Biosensors or MEMS (Micro Electro-Mechanical System)
devices are sensors implanted inside the human body for accurate
monitoring of inaccessible parts of the body. The biosensors form a
network and collectively monitor the health condition of their host.
This involves the collection of data about physiological parameters
like blood pressure or glucose levels and making decisions based on
it, such as alerting doctors to a potential medical crisis.

The information to be transmitted is crucial medical information that
is required by law to be secure. Consequently, information technology
is a critical component of these biological implants that, with the
energy, memory and computational capabilities, present challenging
research issues.

There are several biomedical applications where this technology will
be useful. Examples include sensors implanted in the brain of patients
with Parkinson's disease or epilepsy, acoustic and optical biosensor
arrays for blood analysis, and sensors implanted in the body of a
recovering cancer patient to detect cancer cells.

-- Artificial hippocampus: an example of a future brain prosthesis is
the implantable brain chip that could restore or enhance memory. The
hippocampus plays a key role in the laying down of memories. Unlike
devices such as cochlear implants, which merely stimulate brain
activity, this chip implant will perform the same processes as the
damaged part of the brain it is replacing. It promises to be a way to
help people who have suffered brain damage due to stroke, epilepsy or
Alzheimer's disease.

-- Cortical implant for the blind: it has been known for many years
that electrical stimulation of the eyes evokes phosphenes leading to
visual perception. With a cortical implant, information from a tiny
digital camera could be transmitted to electrodes implanted in the
visual cortex, bypassing the non-working retina or optic nerve.

-- Ocular implant or artificial retina: other researchers are focusing
on new technologies to replace damaged retina, the light-sensitive
cell layer in the eye. A retinal prosthesis involves electrically
stimulating retinal neurons beyond the receptor layer with signals
(light) from a microscopic digital camera; it is feasible when the
inner retina and optic nerve remain intact. In fact, currently two
approaches are being investigated for retinal prosthesis: sub-retinal
and epi-retinal.

-- Brain-computer interfaces (BCI) or direct brain control: the
technologies involved above are communication technologies; they take
information from the brain and externalize it. There are internalizing
technologies (cochlear or optic-nerve implants) whose purpose is to
take information from the outside and provide individual access to
it. These two technologies will eventually come together to form
interactive technologies which would allow input-output
interactions. These systems could allow people to use signals directly
from the brain for communication and control of movement.

Although human studies demonstrate the feasibility of using brain
signals to command and control external devices, researchers emphasize
that many years of development and clinical testing will be required
before such devices - including "neuro-prosthetic" limbs for paralyzed
people, become available.

Surveillance or tracking devices

-- Wearable ICT devices for tracking the human body: such a device
allows an individual with a receiver to pinpoint someone's position
worldwide.

-- Subdermal GPS Personal Location Devices: in May 2003, Applied
Digital Solutions (ADS) (http://www.adsx.com) claimed that "Digital
Angel", a prototype implantable GPS tracking device had been
successfully tested. However, technical experts are questioning
whether the system could really work. The disc-shaped "personal
location device" measures 6.35 centimetres in diameter and 1.27
centimetres in depth - roughly the same size as a pace- maker. This
GPS monitoring could be used for several purposes, such as for
example, in case of medical emergencies (heart attack, epilepsy or
diabetes), or for identification and location purposes (for people in
high risk occupations, children, stalkers or suspected terrorists).

Enhancement or commodity devices

Computer scientists have predicted that within the next twenty years
neural interfaces will be designed that will not only increase the
dynamic range of senses, but will also enhance memory and enable
"cyber think" -- invisible communication with others.

Possible devices include:

-- Prosthetic cortical implant (intelligence or sensory "amplifiers"):
initially developed for the blind, the cortical implant will allow
"healthy" people permanent access to information from a computer based
either on what a digital camera sees or based on an artificial
"window" interface.

-- Artificial Vision: according to recent research undertaken to
develop an artificial retina, it will be possible, one day, to see
light in the infrared. In this case, instead of using a standard video
camera, an infrared camera could be used.

-- Audio tooth implant or tooth phone: designed in 2002, the Audio
tooth implant, still only exists in concept form. A micro-vibration
device and a wireless low frequency receiver are implanted in the
tooth during routine dental surgery. The tooth communicates with an
array of digital devices, such as mobile telephones, radio and
computers. Sound information is transferred from the tooth into the
inner ear by bone transduction. Sound reception is totally discreet
enabling information to be received anywhere at anytime.

-- Artificial hippocampus: as mentioned above, this implantable brain
chip could enhance memory.

3.2. Other Potential Uses

Other potential uses of implantable ICT devices include:

-- Microsoft patent number 6,754,472 (June 22, 2004) concerns the
human body as a medium for transmission of data (and energy) to "other
devices" like PDAs (Personal Digital Assistant), cellular phones,
medical devices (for surveillance purposes: like for instance in
retired people's homes), RFID making possible to localize other
persons. In a family website your children could log onto the
surveillance system and look at what their parents or grandparents are
doing. The patent does not describe any specific device.

-- "Smart guns": Applied Digital Solutions (ADS), which created the
VeriChip(TM), announced in April 2004 a partnership with gun
manufactures FN Manufacturing to produce so-called "smart guns". Such
weapons can be fired only if operated by their owner with a RFID-chip
implanted in his or her hand.

3.3. The 6th Research and Development Framework Programme (FP6)

"The objectives of the Information Society Technologies (IST) theme
within FP6 are to ensure European leadership in generic and applied
technologies at the heart of the knowledge economy. It aims to
increase innovation and competitiveness in European businesses and
industry and to contribute to greater benefits for all European
citizens. The focus of IST in FP6 is on the future generation of
technologies in which computers and networks will be integrated into
the everyday environment, rendering accessible a multitude of services
and applications through easy-to-use human interfaces. This vision of
"ambient intelligence" places the user at the centre of future
developments for an inclusive knowledge- based society for all".

Examples of Projects funded by the FP6

Nano scale materials and sensors and Microsystems for medical implants
improving health and quality of life

In this project key micro system technologies and communication
methods will be developed that bring intelligence directly to the
human, in the form of medical implants and ambulatory measurement
systems, and also enable information from these devices to be
transmitted out into the wider environment. The overall objective is
to develop the technologies that go to make up a micro system, and
then to produce specific medical devices to exploit these
technologies. The resulting final medical products include cochlear
and retina implants, nerve stimulation, bladder control and pressure
monitoring systems. It is estimated from the available statistics that
around 50% of the western population i.e. around 500 million citizens,
will suffer from at least one of the health problems targeted in this
project.

The OPTIVIP project

The aim of OPTIVIP is the optimization of an implantable visual
prosthesis based on the stimulation of the optic nerve and its
demonstration within a pre-clinical study.

Ethical issues are tackled in this project by specific project tasks
being devoted to obtaining input from the blind community and
especially from patients and their representatives. Various aspects of
the prosthesis, namely functionality, appearance and ethics are
covered. This is essential in order to direct research efforts in
accordance with real needs.

4. LEGAL BACKGROUND

4.1. General Principles

The innovative features of the issues addressed in this Opinion make
it difficult to pinpoint rules that are specifically applicable to ICT
implants in the human body. Therefore, the legal background should be
derived from general principles underlying national legislation and
international instruments. Such general principles can provide the
guidance required to outline the legal standards necessary for the
regulation of a technology that modifies the body and its relationship
with the environment and thereby impacts deeply on personal identity
and life. These legal principles can be found in texts concerning
different subject matters: from bioethics to electronic information
processing, from the limitations on consent to the definition of
medical devices.

As for the European legal background, specific importance should be
attached to the Charter of Fundamental Rights of the EU, which is
currently Part II of the Treaty Establishing a Constitution for
Europe. This sets out the general principles of dignity, freedom,
equality, solidarity, citizenship and justice, as well as integrity
and inviolability of the body, with particular regard to informed
consent (Article 3), and personal data protection (Article 8). Data
protection issues are developed in Directives 95/46 and 2002/58. The
precautionary principle is expressly referred to in Article 174 of the
EC Treaty as well as, in greater detail, by the Commission's
Communication (2000/1) of 2 February 2000. Active medical devices are
defined and regulated by Directive 90/385.

Among international instruments, specific importance is to be attached
to the Convention on Human Rights and Biomedicine of the Council of
Europe (1997) and UNESCO's Universal Declaration on the Human Genome
and Human Rights (1997), in particular as regards respect for the
dignity and integrity of individuals and the informed consent
principle. Significant guidelines are also provided by points 58 and
59 of the Declaration of Principles of the World Summit on the
Information Society (2003), which point out the need for ICT to be
always implemented in such a manner as to respect fundamental rights
and private life.

National constitutional charters and domestic laws contain several
provisions applying to respect for dignity, protection of physical
integrity and health, informed consent, and transplantation matters.

A number of judicial and administrative decisions deal directly or
indirectly with the issues addressed in this Opinion, such as the
judgment of 14 October 2004 by the European Court of Justice in the
Omega v. Oberbürgermeister Bonn case (Case C-36/02) and the Order of
12 October 2004 by the US Food and Drug Administration on the testing
of the VeriChip for medical purposes.

On the whole, these instruments allow one to derive a set of
principles on which the legal framework can be built and on which the
lawfulness of ICT implants in the human body can be assessed.

4.2. Human Dignity

The Charter of Fundamental Rights of the European Union opens with the
dignity principle. Article 1 of which states that "human dignity is
inviolable". This is modelled on the German Grundgesetz and is in line
with the declaration made in the Preamble to the Charter, whereby the
Union is said to "place the individual at the heart of its
activities". This principle was upheld as an absolute boundary in the
Omega decision, which considered it lawful for German authorities to
prohibit a game called "Playing at Killing" because it was found to be
"a threat to public policy by reason of the fact that, in accordance
with the concept prevailing in the public opinion, the commercial
exploitation of games involving the simulated killing of human beings
infringed a fundamental value, enshrined in the national constitution,
namely human dignity".

This "affront to human dignity" is not only of such import as to
legitimise a prohibition limiting freedom of enterprise; it also acts
as a boundary on the freedom of individual choice, because it rules
out that the players' informed consent can be regarded as an item
making the game in question something that is socially and legally
acceptable. Therefore, the dignity principle should be regarded as a
tool to identify the cases in which the body should be absolutely
"inviolable".

In the very well-known Census Act Case of Germany, it was stressed
exactly that "the focus of the constitutional order is the value and
dignity of the person, who operates in self-determination as a member
of a free society" (Judgement of the Bundesverfassungsgericht of 15
December 1983). This is in line with the clear-cut guidance contained
in the Preamble as well as in Article 1 of the 1948 Universal
Declaration of Human Rights, which expressly refers to dignity as an
essential component of the human being and a condition for freedom and
equality. As regards more recent constitutional experiences, one need
only consider Article 16 in the French Civil Code or Article 2 in the
Italian Data Protection Code, which expressly mention dignity. This
also applies in international instruments such as the Helsinki
Declaration (1964), the Council of Europe's Convention on Human Rights
and Biomedicine (1997), which begins by re-affirming the principle of
human dignity, and UNESCO's Universal Declaration on the Human Genome
(1997). Finally, Article 1 of the Charter of Fundamental Rights of the
EU (2000) states that "Human dignity is inviolable. It must be
respected and protected".

One can therefore reach the conclusion that dignity is a universal,
fundamental, and inescapable term of reference even though it should
always be seen against a specific cultural background. This
conclusion might be supported nowadays by underlining that dignity is
referred to with ever-increasing frequency in the instruments adopted
by international organisations representing all world cultures -- such
as UNESCO (indeed, dignity is mentioned fifteen times in the Universal
Declaration on the Human Genome). From this standpoint, dignity is
bound to become a cross-cultural concept. However, one should take
into account that there is also a measure of ambiguity in the
reference made to this word. "Dignity" is used both to convey the need
for absolutely respecting an individual's autonomy and rights and to
support the claim to controlling individuals and their behaviour for
the sake of values that someone plans to impose on other individuals.
Moreover, Article 1 of the Charter of Fundamental Rights provides that
dignity is to be not only "respected", but also "protected" -- after
the pattern followed in the German Grundgesetz. This means that public
authorities are required not only to refrain from tampering or
interfering with an individual's private sphere, but also to take
steps actively in order to bring about the conditions allowing
individuals to live with dignity.

4.3. Human Inviolability

The principle of inviolability of the body and physical and
psychological integrity set out in Article 3 of the Charter of
Fundamental Rights rules out any activity that may jeopardise
integrity in whole or in part - even with the data subject's
consent. WHO observes that "health is a state of complete physical,
mental and social well-being and not merely the absence of disease or
infirmity". However, here one has to deal with a different situation
because integrity is not regarded as absolutely inviolable --
reference being made to interventions that cause "permanent
diminution" of one's body (as per Section 5 of Italy's Civil Code) or
else are in conflict with public order and/or morals.

This is the framework applying, for instance, to the assessment of the
lawfulness of organ donation, which is limited by the loss of
essential functions. This consideration might lead one to conclude
that the integrity principle should not be referred to whenever body
functions are actually reintegrated and/or enhanced. Furthermore, the
freedom to use one's body is specifically limited by the many
provisions under which it is prohibited to turn the body, its parts
and/or products into sources of profit (Article 3 of the Charter of
Fundamental Rights; Article 21 of the Convention on Human Rights and
Biomedicine; Article 4 of UNESCO's Universal Declaration). Extensive
construction of the principles of non-commodification and
non-instrumentalisation might lead one to conclude that implanting ICT
for purposes that are, broadly speaking, profit-related (e.g. to get
into a disco under preferential conditions) should not be
permitted. (see Opinion Section 6.4).

4.4 Privacy and Data Protection

The view that data subjects are not free to make whatever use of their
own bodies they wish is confirmed, albeit indirectly, by Article 8(2)
of EC Directive 95/46 on personal data protection. Here, it is stated
that States can provide that the data subject's express consent is not
enough to allow others to use his/her "sensitive data" -- concerning
sex life, opinions, health, ethnic origin -- without an ad hoc
authorisation issued, for instance, by a supervisory authority (see
Section 26 of the Italian Personal Data Protection Code). This is
meant to protect the most sensitive portion of the "electronic body"
by preventing data subjects themselves from making available parts of
their electronic bodies in such a manner as to jeopardise their
integrity.

From a more general standpoint, the Charter of Fundamental Rights of
the EU has drawn distinctions between the protection of private and
family life (Article 7), and the protection of personal data (Article
8), which consequently has become an autonomous individual
right. Thus, one has to deal with a kind of protection that is opposed
to any relevant intrusion into one's private sphere and, on the other
hand, confers the right of informational self-determination on each
individual -- including the right to remain master of the data
concerning him or her. This is a veritable instance of
"constitutionalisation of the individual", which mandates respect for
both the physical and the electronic body. More specifically,
protection of personal data in the EU is based on EC Directive 95/46
as well as on EC Directive 2002/58. The latter also contains specific
provisions applying to the location of individuals. The set of
principles and rules on personal data protection is currently shared
by all the Member States of the EU as well as by several other states
that -- from Canada to Australia, from Japan to many Latin American
countries -- have endorsed a strong data protection standard based
first and foremost on the provision of detailed information coupled
with the data subjects' explicit consent. Therefore, any type of ICT
implant requires a strict preliminary evaluation in order to assess
the "privacy impact".

4.5. The Precautionary Principle

The precautionary principle does not necessitate impassable boundaries
or downright bans. It is a general risk management tool, which was
originally restricted to environmental matters. In the Commission's
Communication of February 2000 it is stated that "The precautionary
principle is not defined in the Treaty, which prescribes it only once
-- to protect the environment. But in practice, its scope is much
wider, and specifically where preliminary objective scientific
evaluation indicates that there are reasonable grounds for concern
that the potentially dangerous effects on the environment, human,
animal or plant health may be inconsistent with the high level of
protection chosen for the Community" (Communication Summary paragraph
3). Accordingly, the Commission believes that "the precautionary
principle is a general one" (i.e. a general principle) (Section 3 of
the Communication), whose scope goes beyond the EU -- as shown by
several international instruments starting with the Declaration on
Environment and Development adopted in Rio de Janeiro in 1992.

The basic constituents and the prerequisites for the application of
the precautionary principle are existence of a risk, possibility of
harm, and scientific uncertainty concerning the realisation of this
harm. Having invoked the precautionary principle the risk manager has
to decide on precautionary actions that are proportionate to the
potential harm being mitigated and which do not attempt to create
"zero risk" situations. The risk management actions should be aimed at
identifying the "acceptable risk" threshold with regard to the values
at stake -- and respect for the human body is undoubtedly one of the
values deserving the highest legal protection. However, though rooted
in fundamental requirements, the precautionary principle is of a
"procedural" rather than "substantive" nature, which means that it is
not applied to gauge an innovation as such but rather its effects. If
the negative effects are found to be absent, or if the application
mechanisms are modified, then a given scientific or technological
innovation may be regarded as acceptable. Therefore, the
precautionary principle is a dynamic tool that can follow the
evolution of a sector and continuously verify that the acceptability
conditions of a given innovation are fulfilled -- thereby enhancing
governance in what has been called the "risk society".

The risks related to ICT implants were highlighted by the Order of the
US Food and Drug Administration in respect of a subcutaneous chip
called "VeriChip" (see Section 3): "adverse tissue reaction; migration
of the implanted transponder; compromised information security;
failure of implanted transponder; failure of inserter; failure of
electronic scanner; electromagnetic interference; electrical hazards;
magnetic resonance imaging incompatibility; and needle stick". One
might wonder that the tests on the VeriChip were authorised for
medical purposes in the face of such a detailed list of potential
risks! The authorisation might have been denied if the precautionary
principle had been taken into account in regard to those risks with
high uncertainty. 4.6. Data Minimisation, Purpose Specification,
Proportionality Principle and Relevance Specific importance is also to
be attached to the principles of data minimisation, purpose
specification, proportionality, and relevance. All of these principles
are unrelated to the lawfulness of using the individual ICTs, but
relate more to the specific conditions applying to their use -- i.e.,
the context within which they are used.

The data minimisation principle is expressly referred to, for
instance, in Article 16(2) of the French Civil Code, where it is
provided that "il ne peut être porté atteinte à l'integrité du corps
humain qu'en cas de nécessité pour la personne" (it can only violate
the integrity of the human body in the case of personal
necessity). Objectively, this principle means that one should only
avail oneself of a given tool if the relevant target cannot be
achieved by means of less "body-intrusive" tools. This is basically
the "minimisation" principle set out in several privacy laws, such as
Section 3(a) of the German Bundesdatenschutzgesetz and Section 3 of
the Italian data protection code. Subjectively, the data minimisation
principle postulates the existence of a personal condition that cannot
be coped with unless by using a specific tool, which proves
indispensable.

The purpose specification principle entails the need for selecting the
targets to be achieved. For instance, the Convention on Human Rights
and Biomedicine provides that tests predictive of genetic diseases
"may be performed only for health purposes or for scientific research
linked to health purposes" (Article 12). Basically, a relationship is
established between specific circumstances, available tools, and
reference values. Only those tools that, within a given context, pass
the consistency test with such values may be used lawfully.

The proportionality principle is also grounded on the relationship
between tools to be used and purposes sought. However, here emphasis
is not put on the nature of the purposes in question, but on the
proportionality of the tools that are used, i.e., even if the purpose
as such is legitimate, it may not be pursued by using disproportionate
tools. In fact, the aforementioned Communication by the Commission
sets forth an express relationship between precaution and
proportionality when it says that "A total ban may not be a
proportional response to a potential risk in all cases. However, in
certain cases, it is the sole possible response to a given risk."

As for the relevance principle, which is expressly laid down in
Article 6 of Directive 95/46, it can be taken into consideration with
regard to ICT implants as well. Indeed, a given technology may be
lawfully applied if it is closely and unambiguously relevant to the
circumstances. This is meant to prevent excessive and/or inappropriate
applications of the available tools.

Ultimately, all these principles supplement one another. After
identifying a legitimate purpose for using an ICT implant, one should
establish whether this is actually necessary as well as whether the
tools (to be) used are relevant and proportionate.

4.7. Autonomy and Limits on ICT Implants

The limitations on ICT implants in the human body as deriving from an
analysis of the principles contained in various legal instruments
should be assessed further by having regard to general principles and
rules concerning the autonomy of individuals, which here takes the
shape of freedom to choose how to use one's body, to quote a
well-known slogan, "I am the ruler of my own body", freedom of choice
as regards one's health, freedom from external controls and influence.

As regards any choice related to one's body, the considerations made
in respect of integrity and inviolability principles still apply -- in
particular as for the consent requirement. Indeed, consent is
necessary, but is not sufficient, in order to legitimise use of
implants -- which anyhow should never be performed against the data
subject's wishes and/or unbeknownst to him/her.

As regards any choice related to one's health, the data subject has
the right to always object to an implant and have it removed, if this
is technically possible -- without prejudice to the informed consent
requirement as well as to the right to refuse medical treatment.

As regards external controls and influence, autonomy of the individual
becomes especially important in connection with the right to rule out
that a person's conduct may be determined and/or influenced by the
entities managing electronic links -- if the latter give rise to
permanent connections with external entities. Even in the absence of
this type of permanent connection, it should be taken into account
that ICT implants may:

a) allow individuals to be located on a permanent and/or occasional
basis;

b) allow the information contained in electronic devices to be changed
remotely without the data subject's knowledge.

These risks are bound to increase with the adoption of unified
technical standards, which may allow data to be read and modified also
by entities other than the data subject and the bodies/organisations
lawfully managing the relevant plant or connection. Both circumstances
are clearly in conflict with data protection rules concerning
collection and processing of the information. In particular,
"re-writing" the data impacts on the right to personal identity that
is expressly recognised by Article 1 of EC Directive 95/46.

4.8. Concluding Comments

For the legal background, it should be noted that:

a) the existence of a recognised serious but uncertain risk, currently
applying to the simplest types of ICT implant in the human body,
requires application of the precautionary principle. In particular,
one should distinguish between active and passive implants, reversible
and irreversible implants, and between offline and online implants;

b) the purpose specification principle mandates at least a distinction
between medical and non-medical applications. However, medical
applications should also be evaluated stringently and selectively,
partly to prevent them from being invoked as a means to legitimise
other types of application;

c) the data minimisation principle rules out the lawfulness of ICT
implants that are only aimed at identifying patients, if they can be
replaced by less invasive and equally secure tools;

d) the proportionality principle rules out the lawfulness of implants
such as those that are used, for instance, exclusively to facilitate
entrance to public premises;

e) the principle of integrity and inviolability of the body rules out
that the data subject's consent is sufficient to allow all kinds of
implant to be deployed; and

f) the dignity principle prohibits transformation of the body into an
object that can be manipulated and controlled remotely -- into a mere
source of information.

These considerations might lead one to conclude that, given the
current circumstances, many actual or potential ICT implants in the
human body are legally inadmissible, subject to the specific
consideration of exceptional situations as set out hereunder in the
Opinion Section (see Section 6.4.6).

5. ETHICAL BACKGROUND

Contemporary society is confronted with changes that have to do with
the anthropological essence of individuals. There is a stepwise shift
in progress -- after being observed, via video surveillance and
biometrics, individuals are being modified, via various electronic
devices, under skin chips and smart tags, to such an extent that they
are increasingly turned into networked individuals. Thus we might be
continuously connected and could be configured differently so that
from time to time we would transmit and receive signals allowing
movements, habits and contacts to be traced and defined. This would be
bound to modify the meaning and contents of an individuals' autonomy
and to affect their dignity.

This unrelenting erosion of personal prerogatives -- going as far as
transforming the body -- co- exists not only with the growing
attention paid to dignity, but also with the already mentioned fact
that the person is at the centre of the constitutional order (see
Preamble and Articles 1, 3 and 8 of the Charter of Fundamental Rights
of the European Union and see the Legal Background of this Opinion,
Sections 4.2 and 4.4).

5.1. Fundamental Ethical Principles

As in former EGE Opinions, as well as in a number of Conventions,
Declarations and Charters accepted in Europe and as highlighted in the
Legal Background (Section 4), the fundamental principles are human
dignity and integrity. These fundamental principles entail in turn
several derived principles (described below) which are relevant in the
context of this Opinion and which are closely related to one another.

Human Dignity (also discussed in Legal Background Section 4.2)

The EU's draft Treaty Establishing a Constitution for Europe , which
states that "Human dignity is inviolable. It must be respected and
protected" (Article II-61), goes on to explain that "The dignity of
the human person is not only a fundamental right in itself but
constitutes the real basis of fundamental rights" (Declaration
concerning the explanations relating to the Charter of Fundamental
Rights). This explanation doesn't strictly define human dignity and so
various writers have attempted to fill this gap. One such attempt
suggests that human dignity be defined as follows: "the exalted moral
status which every being of human origin uniquely possesses. Human
dignity is a given reality, intrinsic to human substance, and not
contingent upon any functional capacities which vary in degree. (...)
The possession of human dignity carries certain immutable moral
obligations. These include, concerning the treatment of all other
human beings, the duty to preserve life, liberty, and the security of
persons, and concerning animals and nature, responsibilities of
stewardship."

This provides the essential context for the following derived ethical
principles, which are of direct relevance to this Opinion on ICT
implants.

-- Non-instrumentalisation: The ethical requirement of not using
individuals merely as a means but always as an end of their own (see
for example Opinion Section 6.4.2).

-- Privacy: The ethical principle of not invading a person's right to
privacy (see Charter of Fundamental Rights of the European Union,
Articles 7 & 8 ) (see for example Opinion Sections 6.4.2 and 6.4.3).

-- Non-discrimination: People deserve equal treatment, unless there
are reasons that justify difference in treatment. It is a widely
accepted principle and in this context it primarily relates to the
distribution of health care resources (see for example Opinion section
6.3.5).

-- Informed Consent: The ethical principle that patients are not
exposed to treatment or research without their free and informed
consent (see for example Opinion Section 6.3.3).

-- Equity: The ethical principle that everybody should have fair
access to the benefits under consideration.

-- The Precautionary Principle: The EGE has stressed that modern
information and communication technologies make mankind more powerful
but at the same time more vulnerable. Ethics should aim at ensuring
the respect for human rights and freedoms of the individual, in
particular the confidentiality of data. In other words, the EGE has
recommended caution as a general ethical principle with regard to
information and communication technologies. This principle entails the
moral duty of continuous risk assessment with regard to the not fully
foreseeable impact of new technologies as in the case of ICT implants
in the human body. This assessment concerns particularly the analysis
of present and future situations in which the use of ICT implants in
the human body may be considered as a potential risk, or even as a
potential threat to human dignity or to other ethical principles. It
should be stressed that there are no reliable scientific
investigations concerning the long-term health impact of ICT implants
in the human body (cf. Legal Section 4.5) (see also for example
Opinion Section 6.5.1).

5.2. Value Conflicts

There could be conflict between the personal freedom to use one's
economic resources to get an implant that will enhance one's physical
and mental capabilities and what society at large considers desirable
or ethically acceptable. Another value conflict concerns the potential
conflict between limiting the freedom of people dangerous to others by
surveillance and promoting the safety of others. Freedom of
researchers may conflict with the obligation to safeguard the health
of research subjects. Concern for economic competitiveness and other
economic values (economic growth) may come into conflict with respect
for human dignity. The unrestricted freedom of some may endanger the
health and safety of others. Therefore a balance has to be struck
between values that are all legitimate in our culture.

As in other areas, the freedom to use ICT implants in ones own body,
i.e. the principle of freedom itself might collide with potential
negative social effects. In these cases ethical counselling as well as
social and political debate might be necessary.

The borderline between repairing and enhancing is not
strict. (Although there are clear examples of both applications.)
Legislation is necessary in order to avoid a situation in which
society is becoming more and more dependent on such intrusive
technology in order to provide social security while at the same time
the technical perfection of such implants is helpful for all kinds of
medical purposes as well as for legitimate social
applications. Consequently, the EGE stresses the need for a
continuing, inclusive debate on which kinds of enhancement should be
allowed -- under what conditions and in which situations (see Opinion
Section 6.4.4).

A particular case, which challenges the view that there is a general
standard for human capabilities, concerns cochlear implants for deaf
children. The technological drive to promote cochlear implants raises
ethical questions concerned with how this drive impacts on the
individual and on the deaf community (and of the signing community in
particular). It leaves unquestioned the social integration of the deaf
person with the deaf community. It does not pay sufficient attention
to the psychological, linguistic and sociological issues. Above all it
promotes a particular view of "normality". In the view of the EGE this
issue, the risk benefit assessment and the problem of fair access need
further study (paying attention to the distinction between unilateral
and bilateral cochlear implants).

5.3. Some Important Knowledge Gaps Regarding ICT Implants in the Human
Body

It is clear from the preceding sections that there are important
knowledge gaps that are relevant both to future research programmes
and to the primary ethical concerns. These include: Human Dignity,
Integrity and Autonomy

-- How far can such implants be a threat to human autonomy
particularly when they are implanted in our brains?

-- How far can such implants have irreversible impacts in the human
body and/or in the human psyche and how can reversibility be
preserved?

-- How will they influence human memory?

-- Does a human being cease to be such a "being" in cases where some
parts of his or her body -- particularly the brain - are substituted
and/or supplemented by ICT implants? Particularly as ICT implants can
contribute to creating "networked persons" that are always connected
and could be configured differently so that from time to time they can
transmit and receive signals allowing movements, habits and contacts
to be traced and defined. This is bound to affect their dignity.

Privacy and Surveillance

-- How far can ICT implants become a threat to privacy?

-- How far can ICT implants give an individual, or a group, specific
capabilities that could become a threat to society?

-- What are the potential invasions of privacy through ICT implants as
sources and/or receivers of information in a network environment?

-- How far should we be subject to the control of such devices or by
other people using these devices?

Enhancement and Human Self Awareness

-- What lies behind the idea of an "enhanced" human being?

-- What does perfectibility of human beings mean?

Does the creation of an improved "race" on the basis of ICT
enhancements mean necessarily a new form of racism? The potential
industrial use of ICT implants raises the question of the limits of
such implants for the creation of more efficient bodies and brains for
economic purposes. The question of the use of ICT implants as a
cultural leap in human evolution, similar to the invention of machines
or to the invention of devices complementing and enhancing such
devices as human memory (through writing, printing, digital
technology) or other human capabilities.

-- How far should the use of such implants to enhance human
capabilities be allowed?

-- How far can such implants be considered as part of what could be
called 'body design' including the personal free design of one's
(enhanced) bodily and psychic capabilities? Social Aspects

-- How do we relate to persons with ICT implants that are connected
online?

-- How far should ICT implants remain invisible to an external
observer?

-- How far are such possibilities dependent on such values as control
or efficiency that may lead human beings to become even more dependent
on market forces and even on the possibility of their (legal) use in
the work place?

-- How far do we transform our social and cultural environment through
ICT implants?

-- How far can they be used in order to track human beings and in
which cases should this be legally allowed?

-- To what extent does this technology allow manipulation by and for
advertising?

-- To what extent might this technology be misused by the military?

Risk Predictability

-- How far can we predict today the benefits and threats of such ICT
implants?

ICT Implants for which Special Caution is Necessary

-- ICT implants that cannot be removed easily.

-- ICT implants that influence, determine or change psychic functions.

-- ICT implants that due to their network capability could be misused
in several ways for all kinds of social surveillance and manipulation,
such as for instance in the case of children, or disabled persons.

-- ICT implants influencing the nervous system and particularly the
brain and thus human identity as a species as well as individual
subjectivity and autonomy.

-- Military applications.

-- The distinction between therapeutic applications and enhancements
(see Section 6.4.4) is not always clear.

-- "Intrusive" technology that by-passes normal sensory experience.

-- Implants that will influence biologically and/or culturally future
generations.

5.4. Previous Relevant EGE Opinions

Opinion N° 14 on the ethical aspects arising from doping in sport

In its Opinion N° 14, the EGE stated that "There is an urgent need for
policy to take into account the profound change that has taken place
in sport in this century due to the influences of growing economic
interests and of the mass media on an increasingly global scale. These
influences have accelerated medical and technological developments in
sport and related industries as well as increased the pressure put on
the sports person. As a result, all action concerning doping must take
into consideration, in accordance with this change, the realisation
that today performance and victory prevail over competition and
participation. The Group thus intends to stress the tension that
exists between anti doping measures and an unlimited demand for
enhanced performance."

A parallel can easily be drawn between doping in sport and implants,
especially those dedicated to enhancement.

Opinion N° 17 on the ethical aspects of clinical research in
developing countries

Most of the recommendations made in EGE Opinion N° 17 on the ethical
aspects of clinical research in developing countries are relevant to
this Opinion in respect of clinical trials of ICT implants. This is
particularly important as medical devices are not covered by Directive
2001/20/EC of the European Parliament and of the Council of 4 April
2001 on the approximation of the laws, regulations and administrative
provisions of the Member States relating to the implementation of good
clinical practice in the conduct of clinical trials on medicinal
products for human use.

5.5. General Ethical Questions Relating to ICT Implants in the Human
Body

In former Reports and Opinions such as "Citizens Rights and New
Technologies: A European Challenge" (23 May 2000), and "Ethical Issues
of Healthcare in the Information Society" (Opinion N° 13, 30 July
1999), the Group has identified key ethical values with regard to
information and communication technologies in particular:

-- to improve the protection of privacy (data protection), respecting
people's right to maintain boundaries and also to preserve privacy,
autonomy and confidentiality; and

-- to empower individuals against the introduction of systems likely
to reduce their freedom and autonomy (video surveillance, behaviour
control, and personal profiling based on Internet transactions) or
likely to increase people's dependency on selection and decision
mechanisms which are not transparent or understandable.

Human beings are neither purely natural nor purely cultural
beings. Indeed our very nature depends on the possibility of
transforming ourselves. Information technologies have been considered
under this anthropomorphic bias as extensions of man. However, the
transformation of the human body has consequences also on the cultural
human environment. Under these premises, human beings are seen as
parts of a complex system of natural and artificial messages that
function on a digital basis. In this sense the human body can be seen
as data. This view has large cultural effects particularly as it
precludes higher level phenomena such as human psyche and human
language or conceives them mainly under the perspective of its
digitization, giving rise to reductionism that oversimplifies the
complex relations between the human body, language and imagination.

Furthermore, such a reductive view permits different kinds of
scientific and technological developments and inventions. ICT implants
in the human body might thus play a major role in questions of health
care and even lead to the enhancement of biological and/or psychic
capabilities. Extrapolating into the future, this logic might even
lead to the transformation of the human race.

How far should we let ICT devices get "under our skins"? When do ICT
implants threaten the dignity of the human body, its identity and its
basic capabilities? ICT implants may seem to be mainly of benefit for
human health, as with e.g. cardiac pacemakers. However, are there
possible situations in which ICT devices may be used for other goals,
due, for instance, to the interconnection of digital data within a
networked world? When might such devices be used for instance for
surveillance and in which cases would this be legitimate? Where are
the threats related to the hopes of enhanced capabilities based on ICT
implants?

The question of ICT implants in the human body is thus located between
two extremes. On the one hand, the protection of the natural human
body, that is to say, the medical use of ICT implants for health care,
and, on the other hand, the elimination of the human body as we know
it today and its substitution by an artificial one -- with all
possibilities in between. Human dignity concerns the human self as an
embodied self. Thus the question of autonomy and respect of the self
cannot be separated from the question of bodily care and of the
possible changes due to ICT implants.

EGE OPINION:

Against this background, the European Group on Ethics of Science and
New Technologies submits the following Opinion:

6.1. SCOPE

This Opinion focuses on the question of ICT implants in the human
body. It does not deal with the whole field of ICT devices or with
"wearable" computing in general, although there may be cases in which
such devices could be considered as quasi-implants.

This Opinion does not address the question of ICT implants in animals
although these applications provide examples of what could be done
with humans.

This Opinion addresses the ethical problems raised by the potential or
actual online accessibility of such ICT implants as well as of
stand-alone devices (i.e. those that do not form part of a network).

Legal principles and rules act in general as a check against
technological drift and serve to highlight that not everything that is
technically possible is also ethically admissible, socially
acceptable, and legally approved. On the other hand, the power of a
technology manifesting itself with an unlimited range of applications
cannot be constrained by a weak law that lacks its ultimate
reason. Hence, it is necessary to always refer to strong values,
capable to breathe life into the constitutionalisation of the
individual that is the outcome of a complex process and was clearly
outlined in the Charter of Fundamental Rights of the EU -- starting
from its Preamble, where it is stated exactly that the Union "places
the individual at the heart of its activities".

"We shall not lay hand upon thee". This was the promise made in the
Magna Carta -- to respect the body in its entirety: Habeas
Corpus. This promise has survived technological developments. Each
intervention on the body, each processing operation concerning
individual data is to be regarded as related to the body as a whole,
to an individual that has to be respected in its physical and mental
integrity. This is a new all-round concept of individual, and its
translation into the real world entails the right to full respect for
a body that is nowadays both physical and electronic. In this new
world, data protection fulfils the task of ensuring the "habeas data"
required by the changed circumstances -- and thereby becomes an
inalienable component of civilisation, as has been the history for
habeas corpus.

At the same time, this is a permanently unfinished body. It can be
manipulated to restore functions that either were lost or were never
known -- only think of maiming, blindness, deafness; or, it can be
stretched beyond its anthropological normality by enhancing its
functions and/or adding new functions -- again, for the sake of the
person's welfare and/or social competitiveness, as in the case of
enhanced sports skills or intelligence prostheses. We have to contend
with both repairing and capacity enhancing technologies, the
multiplication of body-friendly technologies that can expand and
modify the concept of body care and herald the coming of "cyborgs" --
of the post- human body. "In our societies, the body tends to become a
raw material that can be modelled according to environmental
circumstances". The possibilities of customised configuration
undoubtedly increase, and so do the opportunities for political
measures aimed at controlling the body by means of technology.

The downright reduction of our body to a device does not only enhance
the trend -- already pointed out -- towards turning it increasingly
into a tool to allow continuous surveillance of individuals. Indeed,
individuals are dispossessed of their own bodies and thereby of their
own autonomy. The body ends up being under others' control. What can a
person expect after being dispossessed of his or her own body?

6.2. ICT IMPLANTS AND HUMAN DIGNITY

The respect for human dignity must be the fundamental basis of
discussions of where the limits should be drawn for different uses of
ICT implants.

The Group considers that ICT implants are not per se a danger to human
freedom or dignity but in the case of applications, which entail for
instance the possibility of individual and/or group surveillance, the
potential restriction of freedom must be carefully evaluated (see
Section 6.4.6). The protection of the health and/or security of
people with severe neurological disorders on the basis of ICT implants
does not create necessarily an ethical dilemma between the
inviolability of freedom and the need for health protection. However,
even in these cases, the use of such implants should not result in any
discrimination or abuse contrary to human rights.

6.3. ICT IMPLANTS FOR HEALTH PURPOSES

It goes without saying that informed consent is required, when ICT
implants are to be used for health purposes. This information should
not only concern possible benefits and health risks, but also risks
that such implants could be used to locate people and/or obtain access
to information stored in these devices without the permission of the
person in whom the devices are implanted. When risks are difficult to
predict, this should be made clear in the supplied information.
Implantation of ICT devices for health purposes should be governed by
the principles that:

a) the objective is important, like saving lives, restoring health or
improving the quality of life;

b) the implant is necessary to achieve this objective; and,

c) there is no other less invasive and more cost-effective method of
achieving the objective. The question of mixed bio-artificial
implants should be specifically considered taking into consideration
their problems and possibilities.

6.3.1. The Individual and the Network

To the extent that an individual via an ICT implant has become part of
an ICT network, the operation of this whole network -- not just the
ICT implant -- needs to be considered. It is particularly important
that the power over this network (who has access to it, who can
retrieve information from it, who can change it, and so forth) is
transparent. This is based on the principle of respect for persons, as
well as the principle of avoiding harm.

6.3.2. Freedom of Research

Although the necessity for research can sometimes be questioned, new
knowledge is essential for the development of individuals and
societies. However, the freedom of research has to be restricted by
respect for other important values and ethical principles, for example
respect for persons and the obligation to avoid physical, mental and
economic harm as a result of participation in research.

The ethical notion of the inviolability of the human body should not
be understood as a barrier against the advancement of science and
technology but as a barrier against its possible misuse. The freedom
of research in this field should be subject not only to the informed
consent of the persons willing to participate in new experiments
aiming at health recovery but also to the awareness of the possibility
of damaging not only bodily but also psychic functions of the people
participating in clinical trials (see EGE Opinion N° 17 on the ethical
aspects of clinical research in developing countries, February 2003).

6.3.3. Participation in Research on ICT Implants

Informed consent is required when research on e.g. the effects of ICT
implants is carried out on healthy volunteers or on patients. This
information should not only concern possible benefits and present
health risks, but also long term risks as well as risks that such
implants can be used to locate people and/or obtain access to
information stored in these devices without the permission of the
person in whom the devices are implanted. The right to discontinue
participation in a research project should always be respected, and it
should be made clear to participants how this right (when ICT devices
are implanted in a person's body) will be respected, in practice.

6.3.4. ICT Implants, Minors and Legally Incapacitated

Informed consent is an ethical principle which applies also in the
field of ICT implants in the human body. However, this needs
specification particularly in cases in which persons due to their age
(children, elderly people) and/or psychic constitution are supposed to
submit to ICT implants for reasons of health surveillance. ICT devices
should be implanted in minors and legally incapacitated only if this
is done in accordance with the principles set out in the Council of
Europe Convention on Biomedicine and Human Rights.

The question of cochlear implants for children requires special
attention (see Section 5.2 -- Value Conflicts).

6.3.5. Access to ICT Implants for Health Purposes

There should be fair access to ICT implants for health purposes. This
means that such access should be based on health care needs rather
than on economic resources or social position.

6.3.6. Irreversible ICT Implants

The requirements of informed consent and data protection (privacy and
confidentiality of the data in particular) need to be strictly
enforced in cases where the ICT implants are irreversible and cannot
be removed from the body without risk of severe damage or the
individual's life. Such implants should not be used for research
purposes unless the objective of the research is to provide a clear
therapeutic benefit for the individual research subject.

6.4. ICT IMPLANTS FOR NON-MEDICAL PURPOSES

The wide range of potential non-medical applications of ICT implants
also demands informed consent, respect for privacy, etc. Some of these
applications are analysed in the following sections. The EGE makes the
general point that non-medical applications of ICT implants are a
potential threat to human dignity and democratic society. Therefore,
such applications should respect in all circumstances the principles
of informed consent and proportionality and, whenever aiming at
surveillance purposes, they should comply with the rules set out
hereunder in Section 6.4.6.

The EGE emphasizes that where adults give their informed consent to
specific applications, the provided information should include clear
data on possible health disturbances in the short and/or long term as
well as problems of unwilling data processing.

6.4.1. Mental Functions and Personal Identity

Personal identity is crucial for the attribution of moral
responsibility according to many ethical theories. ICT devices should
therefore not be used to manipulate mental functions or change
personal identity. The right to respect of human dignity, including
the right to the respect of physical and mental integrity, is the
basis for this.

6.4.2. ICT Implants and Personal Data

The principles of data protection need to be applied to this area,
since data about the human body can be generated via such
implants. The privacy and confidentiality of such data need to be
guaranteed. The individual has a right to determine what data about
oneself is to be processed, by whom and for what purposes. In
particular the right of the individual to decide who should have
access to such data and for what purpose is crucial.

These rights are particularly important in the case where ICT implants
function with an online system and particularly in the case where the
implants are part of a surveillance system. This means that the EGE
stresses the importance that not only the individual has the right to
protect his or her own personal data but that society should take care
that such systems, where they are permitted, should not become systems
of untenable restriction or even negation of basic rights. This
should be particularly considered in case such systems become part of
health systems in which data is permanently or occasionally
transmitted to other parties. The use of ICT implants in order to have
a remote control over the will of people should be strictly
prohibited.

Legislation and guidelines should be developed to ensure this. The
responsibility for this rests with the Member States. However, the EGE
suggests that the European Commission should initiate such a process
(see Section 6.5.4).

6.4.3. Privacy and ICT Implants

Provided that ICT devices are implanted in accordance with the
principles outlined in this Opinion, there is no need to declare these
implants. They could and should remain unrecognizable to an external
observer. The right to privacy includes the right to have an ICT
implant.

6.4.4. ICT Implants and Enhancement of Physical and Mental
Capabilities

Efforts should be made to make sure that ICT implants are not used to
create a two class society or to increase the gap between the
industrialized countries and the rest of the world. Access to ICT
implants for enhancement should be used only:

-- To bring children or adults into the "normal" range for the
population, if they so wish and give their informed consent, or,

-- To improve health prospects (e.g. to enhance the immune system to
be resistant to HIV). As for health purposes, access to ICT implants
for these purposes should be based on need rather than on economic
resources or social position.

The EGE stresses that the following possibilities should be banned:

-- ICT implants used as a basis for cyber-racism.

-- ICT implants used for changing the identity, memory, self
perception and perception of others.

-- ICT implants used to enhance capabilities in order to dominate
others.

-- ICT implants used for coercion towards others who do not use such
devices.

6.4.5. ICT Implants, Commercialisation and Consumer Interests

Whilst the human body, as such, should not give rise to financial
gain, there is -- as has been documented in the scientific background
part of this report -- already a commercial market for various kinds
of ICT devices. It is essential that these products are not put on the
market without adequate control. For instance, products that can be
regarded as medical products should be controlled according to the
relevant legal framework. Efforts should be made to make sure that all
ICT devices are checked for safety and security before being put on
the market.

6.4.6. ICT Implants for Surveillance Purposes

ICT implants for surveillance in particular threaten human
dignity. They could be used by state authorities, individuals and
groups to increase their power over others. The implants could be used
to locate people (and also to retrieve other kinds of information
about them). This might be justified for security reasons (early
release for prisoners) or for safety reasons (location of vulnerable
children).

However, the EGE insists that such surveillance applications of ICT
implants may only be permitted if the legislator considers that there
is an urgent and justified necessity in a democratic society (Article
8 of the Human Rights Convention) and there are no less intrusive
methods. Nevertheless the EGE does not favour such uses and considers
that surveillance applications, under all circumstances, must be
specified in legislation. Surveillance procedures in individual cases
should be approved and monitored by an independent court.

The same general principles should apply to the use of ICT implants
for military purposes.

6.5. GENERAL CONSIDERATIONS

6.5.1. Development of the Information Society

The EGE considers that the ethical questions related to ICT implants
in the human body are intimately related to the development of the
Information Society as a whole. The EGE strongly supports the vision
of a people-centred, inclusive and development-oriented Information
Society as proclaimed in the Declaration of Principles of the World
Summit on the Information Society (Geneva 2003).

6.5.2. Public Debate and Information

A broad social and political debate is needed as to what kind of
applications should be accepted and legally approved, particularly
concerning surveillance and enhancement. A precautionary approach is
recommended by the EGE. The Member States and their national ethics
councils (or corresponding institutions) have a responsibility to
create conditions for education and constructive, well-informed
debates in this area.

6.5.3. Democracy and Power

This Opinion differs from several of the earlier ones of the EGE in
that it moves into a new and rapidly expanding area. The Opinion
contains the essential elements for a future agenda for responsible
regulators in Europe.

Public debate and education are essential to ensure transparency and
the Member States have a responsibility to ensure that the power of
development and access to ICT implants are decided through democratic
processes.

6.5.4. Need for Regulation

It is clear that this field needs regulation. Currently, non-medical
ICT implants in the human body are not explicitly covered by existing
legislation, particularly in terms of privacy and data protection. Any
regulations need to be based on the following principles: dignity,
human rights, equity, autonomy and the derived principles,
precautionary, data minimisation, purpose specification,
proportionality and relevance (see Sections 4 and 5).

In the EGE's view, implantable devices for medical purposes should be
regulated in the same way as drugs when the medical goal is the same,
particularly as such implants are only partly covered by Council
Directive 90/385/EEC on the approximation of the laws of the Member
States relating to active implantable medical devices.

The EGE recommends that the European Commission should launch
legislative initiatives in these areas of ICT implant applications.

6.5.5. Impact Research and ICT Devices

More research on the long term social, cultural and health impact of
different types of ICT implants needs to be carried out, with a
particular focus on risk characterisation, risk assessment, risk
management and risk communication. The EGE considers that this should
be kept in mind for the Seventh EU Research Framework Programme. This
sort of precautionary research in a rapidly developing field is of
crucial importance.

6.5.6. Need for Review

The field of ICT implants is in its infancy and rapid developments are
taking place that raise societal fears as well as hopes. Consequently,
the EGE has addressed the key ethical issues regarding developments
that are current or can be foreseen at the present time. However, it
is clear that the EGE will have to return to this subject to update
our advice in the light of future applications of ICT
implants. Particularly care will need to be taken concerning
developments that appear benign at first sight (addressing for example
a serious health problem) but which prove to be less benign when used
for other applications. Consequently, we consider that a review of
this Opinion by the EGE may be necessary in about three to five years
time.

The European Group on Ethics in Science and New Technologies

The Chairperson: Göran Hermerén
The Members:
Nicos C. Alivizatos
Inez de Beaufort
Rafael Capurro
Yvon Englert
Catherine Labrusse-Riou
Anne McLaren
Linda Nielsen
Pere Puigdomenech-Rosell
Stefano Rodota
Günter Virt
Peter Whittaker

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