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Ethical Aspects of Human Implants in the Human Body

Tuesday 2 August 2005, by Capurro Rafael, Rodota Stefano

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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 [1]. 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).

This paper is divided into six sections.

Section 1 - Introduction

ICT implants, e.g. pacemakers, are at first sight unproblematic. But they can be misused if accessible by digital networks. Discussion about technical aspects of implants.

Section 2 - glossary of common terms.

Section 3 - Scientific and Technical Background

Information about ICT implants currently on the market, including history of details of ICT devices, e.g. insulin pumps, vagus nerve simulation, deep brain stimulation.

Technical differentiation:

Read only devices: even the most basic ones have multiple uses, e.g. identification of children; more advanced models can include medical records and service as ID cards.

Read-write: these can carry information which could be expanded as necessary, e.g with updating medical records, criminal records.

Tracking devices - similar to as read-write but also carrying a transmission signal.

Details of current devices include:

RFID. The chip never runs out and the device has a 20 year life span. Widely used for livestock and endangered species identification.

Verichip ™ (www.4verichip.com) - subdermal RFID device. Current applications include medical records and personal identification, e.g. it is used as a smartcard in clubs in Spain and the Netherlands (www.baja.nl), and for providing secondary ID information for financial purposes.

Research into current devices covers issues such as cortical implants and an artificial hippocampus (to restore or enhance memory); interfaces which could eventually allow people to use signals from the brain for communication and control of movement. The GPS Personal Location Device - ‘Digital Angel’™ (www.adsx.com) could have several purposes, but experts are questioning whether it could really work.

Enhancement/commodity devices are predicted within the next 20 years: these would allow memory enhancement and ‘cyber-think’ - invisible communication with others.

Examples of projects funded by FP6 include nano-scale materials and sensors and Microsystems for medical implants. Ethical issues surrounding obtaining data from blind people and their representatives are highlighted in the OPTIVIP Project

Section 4 - Legal Issues

Legal background, including an assessment of the relevance of the Charter of Fundamental Rights of the EU, particularly Article 3 (informed consent). Also highlighted are the Convention on Human Rights and Biomedicine of the Council of Europe (1997) and UNESCO’s Declaration on the Human Genome and Human Rights (1997). Specific cases mentioned include the European Court of Justice C-36/02 and the US Food and Drug Administration on the testing of Verichip.

Privacy and data Protection: Article 8 [2] of EC Directive 95/46 provides that ‘the data subject’s express consent is not enough to allow others to use his/her sensitive data’, and other authorisation must be sought, e.g. from a supervisory authority. The purpose of this is to prevent data subjects from making available electronic information which could jeopardize their integrity.

Also point to distinction in EU Charter Fundamental Rights between private family life protection and personal data

4.5 Precautionary data: authors stress that there are no reliable scientific investigations concerning the long-term health impacts of ICT in the human body.

Under data minimisation and relevance, various examples are given, such as Article 16 (2) of the French Code, as illustrative of the principle that the necessity of an ICT implant must be determined. This is to prevent excessive application of relevant tools. Further analysis is needed about the general rules and principles on the use of ICT implants in the human body: consent is necessary but not sufficient.

Section 5 - Ethical Background

Covers fundamental principles of human dignity and integrity. Of direct relevance to ICT implants are: privacy, non-discrimination and informed consent, equity and the precautionary principle.

The freedom of an individual to use ICT implants may lead to conflict within society as a whole, e.g. using one’s economic resources for an ICT implant that may not be socially or ethically acceptable. Legislation will also be required, and a continuing debate on the types of enhancement which are permitted is vital. This leads on to an acknowledgement of important gaps in knowledge which are of relevance both to future research and to primary ethical concerns, e.g. how implants will influence memory, or how they may be seen as a threat to human autonomy.

Other issues addressed in this section include privacy and surveillance, enhancement and human awareness, social aspects and risk predictability, and general ethical questions relating to ICT implants.

Section 6 - EGE Opinion

The authors point to the human body being turned into a tool to allow continuous surveillance, and therefore being under the control of others. . The Group concludes that ICT implants are not a danger per se to human freedom or dignity, but that the capacity for restriction of freedom through their application must be carefully evaluated. Informed consent is essential in the use of ICT for medical purposes, and the objectives of their use must be carefully specified. Mixed bio-artificial implants are of special concern. The issue of transparency is also addressed in relation to those in control of networks relating to the functioning of ICT implants. Freedom of research in the field of ICT implants should be subject both to informed consent of the participating individuals, who should also be made aware of the possibilities of damage arising from the use of implants, e.g. long-term risks. Principles set out in the Council of Europe Convention on Biomedicine and Human Rights must be adhered to if ICT implants are used on minors or incapacitated people. Similar principles must be applied in the use of ICT implants for non-medical purposes. ICT implants should not be used to manipulate mental functions or change personal identity. Personal data confidentiality must also be guaranteed through new legislation: the European Commission should initiate this.

It is also important that implants are not used to create a two class society or to have an adverse effect on the developing world. Enhancement implants should only be used to bring humans into the ‘normal’ range of the population or for health improvements. Similarly, ICT implants should not be marketed without controls and checks on safety and security.

ICT implants for surveillance may only be used if there is urgent or justified need (Article 9 of the Human Rights Convention); these uses should be specified in legislation. Public debate about the application of implants is required, and member states have a duty to facilitate this.

The European Commission should instigate legislation in the areas of non-medical ICT implants, particularly data protection and privacy issues.

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Footnotes

[1] It should be noted that there is a lively debate about the mechanistic view of the brain, which is not addressed in this Opinion


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