Scientific writings and policy documents define the terms nanomaterial and nanoparticle in various ways. This variation is considered problematic because the absence of a shared definition is understood as potentially hindering nanomaterial knowledge production and regulation. Another view is that the existence of a shared definition may itself cause problems, as rigid definitions arguably exclude important aspects of the studied phenomena. The aim of this paper is to inform this state of disagreement by providing analytical concepts for a systematic understanding (...) of how, and even whether, nanomaterial and nanoparticle could and should be defined. To do this, we review definitions of nanomaterial and nanoparticle presented in research articles and policy documents. Definitions were identified by first conducting a Scopus search and then tracing cited definitions back to their sources. In total, 36 definitions were identified. Theories of definition from philosophy and linguistics provide analytical guidance for structuring and categorizing the identified definitions, and the main analytical dimensions of the definitions are then identified and discussed. Finally, we propose a framework for understanding the process of defining nanomaterial and nanoparticle. This framework considers both the generality needed for a shared understanding and the level of precision required for different purposes. (shrink)

This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of “law in action” leading to a legal uncertainty and ultimately to a (...) public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth “epistemological transformation” that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine. (shrink)

This article examines the potential implications of the implementation of artificial intelligence in health care for both its delivery and the medical profession. To this end, the first section explores the basic features of AI and the yet theoretical concept of autonomous AI followed by an overview of current and developing AI applications. Against this background, the second section discusses the transforming roles of physicians and changes in the patient–physician relationship that could be a consequence of gradual expansion of AI (...) in health care. Subsequently, an examination of the responsibilities physicians should assume in this process is explored. The third section describes conceivable practical and ethical challenges that implementation of a single all-encompassing AI healthcare system would pose. The fourth section presents arguments for regulation of AI in health care to ensure that these applications do not violate basic ethical principles and that human control of AI will be preserved in the future. In the final section, fundamental components of a moral framework from which such regulation may be derived are brought forward, and some possible strategies for building a moral framework are discussed. (shrink)

Expectations play a central role in understanding scientific and technological changes. Future-oriented representations are also central with regard to nanotechnologies as they can guide policy activities, provide structures and legitimation, attract different interests, focus policy-makers’ attention and foster investments for research. However, the emphasis on future scenarios tends to underrate the complexity of the challenges of the present market of nanotechnologies by flattening them under the needs and promises of scientific research. This is particularly apparent if we consider the viewpoint (...) of the regulator who faces two different ranges of problems with regard to the market and research and is expected, simultaneously, to manage two different types of regulatory instruments, pursuing at the same time the same goals. Instead, by favoring only the future scenarios, the regulator runs the risk of abruptly shifting from more flexible and elastic tools to forms of hard legislation, wasting, thus, the resources of the soft-regulation, in particular those of self-regulation. By referring primarily to the European context, human rights, also thanks to their normative structure of principles, can help in strengthening both the legislation needed for regulating the present market and the soft instruments needed for steering research and for fostering the stakeholders’ participation without sacrificing the coherence of the regulatory response. (shrink)

Among the various experiments in ‘new governance’, the model of Responsible Research and Innovation is emerging in the European landscape as quite promising. Up to now, there have been two versions of RRI: a socio-empirical version which tends to underline the role of democratic processes aimed at identifying values on which governance needs to be anchored and a normative version which stresses the role of EU goals as ‘normative anchor points’ of both governance strategies and policy making. Both versions are (...) unsatisfactory. The first since it suggests movable anchorage which could clash with prefixed values, such as individual rights. The second since it does not safeguard fundamental rights in the process of balancing ‘anchor points’. This result is counterintuitive because it exposes governance to the risk of facing adverse court decisions in the defense of individual rights, thus losing its anticipative attitude. In order to avoid this outcome, the paper argues that it is only through better integration between the system of human rights and that of EU fundamental rights that the anticipative feature of RRI can be preserved. (shrink)

The field of nanoscience and nanotechnology is expanding rapidly, promising great benefits for society in the form of better medicine, more efficient energy production, new types of materials, etc. Naturally, in order for the science and technology to live up to these promises, it is important to continue scientific research and development, but equally important is the ethical dimension. Giving attention to the social, ethical and legal aspects of the field, among others, will help in developing a fully responsible—and thereby (...) capable—science and technology. Nanoethics has emerged as a field concerned with such ethical issues related to nanoscience and nanotechnology. Even though this field is relatively new, a significant amount of literature has already been published. This paper focuses on three of the major issues which are discussed in the literature of nanoethics, and also points to a certain bias in this literature. Each quite different in nature, these issues are: (1) The naming and (2) the timing of and approach to the field, as well as (3) the issue of safety. As will be seen, these issues are almost exclusively discussed by ethicists, (throughout the article, the term’ethicist’ is used in a broad definition covering philosophers, social and political scientists as well as philosophers of science) thus having no direct influence on the work being carried out by scientists. One can argue, therefore, that this bias creates a distortion of the ethical debate, making it insufficient and misleading. Ultimately, this bias is caused by the lack of communication and collaboration between ethicists on the one hand, and nanoscientists on the other. Thus, an argument is made for the different disciplines to begin collaborating, so as to more effectively and responsibly develop the field of nanoscience. (shrink)

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; regulatory systems need to be flexible (...) and adaptive to rapidly changing technologies; ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and international harmonization of regulation may be beneficial in a rapidly globalizing world. (shrink)

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when and (...) how.Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship to nanotechnology products. (shrink)

The literature concerning ethical issues associated with nanotechnologies has become prolific. However, it has been claimed that ethical problems are only at stake with rather sophisticated nanotechnologies such as active nanostructures, integrated nanosystems and heterogeneous molecular nanosystems, whereas more basic nanotechnologies such as passive nanostructures mainly pose technical difficulties. In this paper I argue that fundamental ethical issues are already at stake with this more basic kind of nanotechnologies and that ethics impacts every kind of nanotechnologies, already from the simplest (...) kind of engineered nanoproducts. These ethical issues are mainly associated with the social desirability of nanotechnologies, with the difficulties to define nanotechnologies properly, with the important uncertainties surrounding nanotechnologies, with the threat of ‘nano-divide’, and with nanotechnology as ‘dual-use technology’. (shrink)

Nanotechnology is the new(est) star in the high technologies sky. While nanotechnologies remain technologies of promise and potential, a growing number of nano-materials and nano-particle-reliant products are being produced. And although a growing number of academic, policy and industry reports are exploring nanotechnologies, there are very few genuine ethical assessments of nanotechnologies as they exist and might evolve in the coming years. Many questions have yet to be answered about the nature, development, and social and commercial deployment of nanotechnologies and (...) what that means for the human condition and the preservation of our core values. We argue that the early and potentially risky nature of this interdisciplinary science does not justify a blinkered focus on risk assessment and management to the detriment of deep and ranging ethical evaluations. Much improved ethics evaluations must be undertaken, particularly in Taiwan where very little has happened despite grand expectations for, and funding of, the science. In this paper, we uncover the development imperatives for nanotechnologies, demonstrate the paucity of genuine nanoethics exercises, outline key questions for stakeholders undertaking nanoethics exercises to consider, and we articulate some preliminary actions for Taiwan (and other similarly situated jurisdictions). (shrink)

Soft regulatory measures are often promoted as an alternative for existing regulatory regimes for nanotechnologies. The call for new regulatory approaches stems from several challenges that traditional approaches have difficulties dealing with. These challenges relate to general problems of governability, tensions between public interests, but also (and maybe particularly) to almost complete lack of certainty about the implications of nanotechnologies. At the same time, the field of nanotechnology can be characterized by a high level of diversity. In this paper, we (...) discuss and compare two models for framing public policy in relation to technology regulation: the first is a deliberative model based on foresight knowledge and the second the wide reflective equilibrium model, developed by political philosopher John Rawls. In both models, the aim is to find consensus on (a framework for) policy measures and regulation. On the basis of a critical discussion of the strengths and weaknesses of both models, some tentative conclusions are drawn for effective policy making and implementation based on soft law. (shrink)

Atomically precise manufacturing (APM) is the assembly of materials with atomic precision. APM does not currently exist, and may not be feasible, but if it is feasible, then the societal impacts could be dramatic. This paper assesses the net societal impacts of APM across the full range of important APM sectors: general material wealth, environmental issues, military affairs, surveillance, artificial intelligence, and space travel. Positive effects were found for material wealth, the environment, military affairs (specifically nuclear disarmament), and space travel. (...) Negative effects were found for military affairs (specifically rogue actor violence and AI. The net effect for surveillance was ambiguous. The effects for the environment, military affairs, and AI appear to be the largest, with the environment perhaps being the largest of these, suggesting that APM would be net beneficial to society. However, these factors are not well quantified and no definitive conclusion can be made. One conclusion that can be reached is that if APM R&D is pursued, it should go hand-in-hand with effective governance strategies to increase the benefits and reduce the harms. (shrink)