In 2000 Bill Joy proposed that the best way to prevent technological apocalypse was to "relinquish" emerging bio-, info- and nanotechnologies. His essay introduced many watchdog groups to the dangers that futurists had been warning of for decades. One such group, ETC, has called for a moratorium on all nanotechnological research until all safety issues can be investigated and social impacts ameliorated. In this essay I discuss the differences and similarities of regulating bio- and nanotechnological innovation to the efforts to (...) regulate nuclear and biological weapons of mass destruction. I then suggest the creation of a global technology regulatory regime to ensure the safe and equitable diffusion of genetic, molecular and information technologies, and point out the principal political obstacles to implementing such a regime. (shrink)

How can law ethically regulate a future of fast-changing technologies? From recent inventions to science fiction, Future Law explores how law, ethics and regulation must respond to new technologies that challenge the boundaries of our ethics.

With the increase in use of a technology, its misuse possibility also increases in general. Moreover, there are instances where new technologies are implemented without thoroughly testing for vulnerabilities. We consider RFID, a disruptive technology, and related vulnerabilities in existing supply chain applications from an ethics perspective. We develop an extended ethics model to incorporate the effects of emerging information and communication technologies, specifically that of RFID systems, including technology selection, social consequences, and practitioners’ rationality. We introduce (...) a set of matrices for technology regulation development based on this model to serve as a communication tool for the policy maker for policy design regulation. We use the case of RFID to illustrate the model and matrices. (shrink)

The article critically examines the Assisted Reproductive Technology (Regulation) Act 2021, its development process spanning 15 years, and its potential shortcomings in addressing the needs of India’s 27 million infertile couples. By scrutinizing the recommendations presented in the Parliamentary Standing Committee on Health and Family Welfare’s 129th report, the critique argues that the Act may not effectively cater to the diverse reproductive rights of the population. The article claims that most of its suggestions are in opposition to redefining (...) families and accepting inclusive family structures other than heterosexual marriages. The study posits that the Act, with its inherent limitations, perpetuates the reinforcement of patriarchal family structures that medical science intends to disrupt. In order to foster inclusivity and comprehensibility, the article advocates for necessary amendments that align with the interest of the general populace. (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)

Generally, regulation is thought of as a constant that carries with it both a formative and conservative power, a power that standardises, demarcates and forms an order, through procedures, rules and precedents. It is dominantly thought that the singularity and formalisation of structures like rules is what enables regulation to achieve its aim of identifying, apprehending, sanctioning and forestalling/pre-empting threats and crime or harm. From this point of view, regulation serves to firmly establish fixed and stable categories (...) of what norms, customs, morals and behaviours are applicable to a particular territory, society or community in a given time. These fixed categories are then transmitted onto individuals by convention, ritual and enforcement through imperatives of law (and technology) that mark certain behaviours as permissible and others as forbidden, off bounds. In this manner, regulation serves a programming (i.e., a calculable or determinable) purpose. It functions as a pro-active management or as a mastery of threats, risks, crimes and harms that affect a society and its security both in the future and in the present. Regulation for instance, will inscribe and codify what it determines to constitute crime or harm such as pornography, incitement of terrorism, extremist speech, racial hatred etc. These determined or calculated/calculable categories will then be enforced and regulated (e.g. through automated filtering) in order to ensure a preservation of public order within society. Drawing mainly from deconstruction, this article situates law and technologies within a wider ecological process of texts, speech and writing i.e., communication. In placing regulation within disseminatory and iterable processes of communication, this article complicates, destabilises and critiques the dominant position of determinability and calculability within the regulatory operations of law. (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)

Louis Charland's ‘Technological reason and the regulation of emotion’ focuses on a specific area, that of the emotions, in which he sees a problematic dominance of the technical attitude. He argues that our technologically oriented psychiatry has taken an instrumentalist approach to regulation of emotion that severely limits and distorts the role of emotion in psychiatric practice. A prominent example is the exclusion of moral judgments and values, emotion-laden aspects of experience, from psychotherapy because they do not fit (...) the technical model. To illustrate his point, Charland both contrasts the modern notion of emotion with the traditional notion of passion, and our contemporary practice of technically regulated emotion with the ‘moral treatment’ of the nineteenth century. (shrink)

Technology regulation is one of the most important public policy issues facing society and governments at the present time, and further clarity could improve decision making in this complex and challenging area. Since the rise of the internet in the late 1990s, a number of approaches to technology regulation have been proposed, prompted by the associated changes in society, business and law that this development brought with it. However, over the past decade, the impact of (...) class='Hi'>technology has been profound and the associated issues for government have extremely challenging, ranging across cyber security, artificial intelligence, and many other areas. To that end, this article introduces a Theory of Institutional Technology Actors and Norms (TITAN), a normatively informed and institutionally-based account of technology regulation. It focuses on the moral and legal (including regulatory) rights and responsibilities of the relevant actors and seeks to inform the development of regulation that is both fit for purpose, rights compliant and fair for all concerned. The account incorporates the perspectives of four key categories of groups in society: producers of technology, users of technology, government regulators, and normative policy shapers. (shrink)

This study investigated Chinese university students’ technology-assisted self-regulated learning strategies and whether the technology-based SRL strategies mediated the associations between English language self-efficacy, English enjoyment, and learning outcomes. Data were collected from 525 undergraduate students in mainland China through three self-report questionnaires and the performance on an English language proficiency test. While students reported an overall moderate level of SRL strategies, they reported a high level of technology-based vocabulary learning strategies. A statistically significant positive relationship was noted (...) between the use of technology-based SRL strategies and students’ English learning outcomes. English language self-efficacy and English language enjoyment were both related to technology-based SRL strategies. Furthermore, SRL strategies fully mediated the relationship between English enjoyment and English learning outcomes, but the association between English enjoyment and SRL strategies was only partially mediated by English language self-efficacy. Pedagogically, findings of this study suggest that training and instruction aimed at promotion of modern educational technology among students need to give attention to developing their strategic awareness of motivation regulation in optimizing effectiveness of their technology use in learning the target language. (shrink)

Scientific knowledge and technological expertise continue to evolve rapidly. Such innovation gives rise to new benefits as well as risks, at an ever-increasing pace. Within this context, regulatory regimes must function in order to address policymakers’ objectives. Innovation, though, can challenge the functioning and effectiveness of regulatory regimes. Questions over fit, effectiveness, and capacity of these regimes to ensure the safe entry of such technologies, and their products, onto the market will be asked in parallel to their development. With this (...) in mind, this article examines the strengths and weaknesses of current regulatory frameworks, including those designed for biotechnology, cosmetics, novel organisms, and foods, in order to inform and help shape Australia’s regulatory landscape around innovation. By focusing on Australia, the article illustrates the need to assess future changes to regulatory frameworks using a careful balancing of key factors. These include, for example, horizon scanning and monitoring, availability of appropriate data, existing health, safety, environmental, ethical, and social risks and impacts, and regulatory capacity. The article argues that rather than using one of these factors in isolation, a careful assessment of where each factor stands can lead regulators to an approach that properly manages the potential risks of emerging technologies. (shrink)

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness (...) of the current Guideline for Stem Cell Research and Therapy are examined. The study’s findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation of the International Society for Stem Cell Research containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders. (shrink)

Theorists and activists favor empowering government agencies to regulate technology; but an examination of such regulation by the US government exposes the inadequacy of any such regimen. Vested interests routinely interfere, e.g., keeping administration of polio vaccine in the hands of physicians, political infighting with regard to cancer research funding, advantages gained from noncompliance with military technology-constraining treaties. Public/private salary differences limit availability of the best talents for government positions, nor are truly appropriate regulatory policies easily arrived (...) at in the absence of meaningful funding. Solutions such as a Science Court are unreliable given the influences that would undermine neutrality as well as competence. (shrink)

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has (...) an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

PurposeThe purpose of the paper is to provide an overview of the legal implications which may be relevant to the ethical aspects of emerging technologies, to explore the existing situation in the area of legal regulation at EU level, and to formulate recommendations for the lawmakers.Design/methodology/approachThe analysis is based on the premise that the law is supposed to invoke moral principles. Speculative findings are formulated on the basis of analyzing specific emerging technologies; empirical findings are based on a research (...) conducted in the whole legal corpus of the EU.FindingsIn the area of network‐based technologies the already existing and elaborated legal frameworks can be used in an extended manner; artificial intelligence‐based technologies call for alterations in several branches of law; while interface technologies show the difficulty and complexity of regulating interdisciplinary fields. The legal implications of emerging technologies have attracted only a minimal legislative attention in the competent bodies of the EU.Originality/valueThe paper provides a systemic approach towards transmitting ethical norms to the application of emerging technologies through legal regulation, and formulates detailed recommendations in various areas of such technologies. (shrink)

This article contributes to research on the regulation of technological risks in the form of a case study of the Baltic Sea ferry traffic. The analysis suggests that the social systemic features of an industry heavily influence the relationship between technological failures and risk regulation. The study augments recent work on how regulations affect the handling of technological risks and how failures influence regulatory arrangements. These issues have already been studied in the context of aviation, auto, chemical, nuclear (...) power, and railway industries, but not in shipping. As an extension to previous literature, the authors also explore how different regulatory organizations in this industry act in relation to risks and how they influence each other in risk regulation activities. The study highlights the indirect relationships between technological failures and risk regulation arrangements. It also underlines the influence of the involved actors on the regulatory responses to technological failures. (shrink)

Students experience different levels of autonomy based on the mediation of self-regulated learning, but little is known about the effects of different mediation technologies on students' perceived SRL strategies. This mixed explanatory study compared two technology mediation models, Icourse and Icourse+Pigai, with a control group that did not use technology. A quasi-experimental design was used, which involved a pre and post-intervention academic writing test, an SRL questionnaire, and one-to-one semi-structured student interviews. The aim was to investigate 280 Chinese (...) undergraduate English as a foreign language students' academic writing performance, lexical complexity, and perceptions of self-regulated strategies in academic writing. One-way ANCOVA of writing performance, Kruskal-Wallis test of lexical complexity, ANOVA of the SRL questionnaire, and grounded thematic content analysis revealed that, first, both Icourse and Icourse+Pigai provided significant support for the development of SRL strategies vs. the control group, although there was no significant difference between the two groups. Second, Icourse+Pigai-supported SRL was more helpful for improving students' academic writing performance because it enabled increased writing practice and correction feedback. Third, Icourse+Pigai-supported SRL did not significantly improve students' lexical complexity. In conclusion, we argue that both learning management systems and automated writing evaluation platforms may be used to assist students' SRL learning to enhance their writing performance. More effort should be directed toward developing technological tools that increase both lexical accuracy and lexical complexity. We conclude that the technical tools used in this study were positively connected to the use of SRL techniques. However, when creating technologically mediated SRL activities, students' psychological study preferences should be considered. (shrink)

In order to responsibly protect certain cherished values, for instance, human or environmental health, privacy, or ‘human dignity’, societies see a need for oversight, guidance and regulation of de...

This book brings together papers given at a symposium which took place in Melbourne, Australia in 2001. Like any such collection, the chapters vary in quality and in substance. Some authors have chosen to analyse one issue in considerable depth, while others attempt a broad overview of regulations in different regions of the world. Julian Savulescu, for example, confines himself to the complex question of whether gamete providers’ freedom to dispose of their unwanted embryos should take priority over infertile couples’ (...) interests in using these surplus embryos in treatment. In contrast, Jothi Kumar surveys the regulation of assisted reproductive technology throughout Asia in a mere four pages of text. In general, contributions of the first type tend to be more successful; attempts to summarise something as complex as the regulation of assisted reproductive technology across a whole continent can be difficult for the reader to digest, and inevitably offer little by way of analysis.A further problem bedevils any new publication in this fast moving area of medical law and ethics. Although providing a “snapshot” of regulation in 2001 is undoubtedly an interesting and worthwhile project, a book such as this risks being out of date before it is even published. As a result, the more discursive chapters which concentrate on especially novel or controversial ethical dilemmas are likely to be of use and interest for longer than those which describe the regulatory status quo. Certainly, Savulescu’s chapter on the public interest in embryos, and Giuliana Fuscaldo’s contribution on …. (shrink)

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has (...) an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

Ensuring fairness is a capital issue in any sporting competition. However, fairness is a complex concept. We seek here to offer an analysis of the construction and upholding of fairness within comp...

This paper argues that private property and rights assignment, especially as applied to communication infrastructure and information, should be informed by advances in both technology and our understanding of psychology. Current law in this area in the United States and many other jurisdictions is founded on assumptions about human behavior that have been shown not to hold empirically. A joint recognition of this fact, together with an understanding of what new technologies make possible, leads one to question basic assumptions (...) about how law is made and what laws we should have in a given area, if any. I begin by analyzing different aspects of U.S. law, from a high-level critique of law making to a critique of rights assignment for what I call 'simple nonrival goods.' I describe my understanding, as a non-lawyer with a background in psychology and computing, of the current conventions in U.S. law, consider the foundational assumptions that justify current conventions, describe advances in psychology and technology that call these conventions into question, and briefly note how the law might normatively change in this light. I then apply this general analysis to the question of domain name assignment by the Internet Corporation for Assigned Names and Numbers (ICANN). (shrink)

The world we inhabit is surrounded by ‘coded objects’ from credit cards to airplanes to telephones. Sadly the governance mechanisms of many of these technologies are only poorly understood, leading to the common premise that such technologies are ‘neutral’, thereby obscuring normative and power-related consequences of their design. In order to unpack supposedly neutral technologies, the following paper will try and foreground two of key questions around the technologies used on the global Internet: 1) how are content regulatory regimes governed (...) and 2) how are the algorithms embedded in software governed? The following paper will explore these two aspects in turn, before drawing conclusions on understanding the normative frameworks embedded in technological systems.Article first published online: 22 MARCH 2016. (shrink)

Risk analysis as a regulatory driver has now become firmly entrenched in public health and environmental protection. Risk analysis at any level essentially has to accommodate two gut feelings of the constituency: whether society should be risk-prone or risk averse, and whether government and its institutions can be trusted to make the necessary decisions with a high or a low degree of discretion. The precautionary principle (or rejection thereof) arguably is the ultimate reflection of the promotion of risk to a (...) societal value. There is no doubt that especially amongst the representatives of the Member States (as opposed to the officials at the European Commission), public (pre)caution with respect to the long-term environmental and public health implications of gene technology influenced the reluctance to allow marketing of GM foods and feeds until a strict regulatory regime had been rolled out. Industry would argue that the delay in regulation, as well as the eventual regime was of such a nature as to stifle the technology. This contribution reviews a number of features of standard EU risk analysis decisions, so as to assess its current propensity towards smothering rather than smoothing the introduction of new technology. The current development of a regulatory framework for nanotechnology serves as a case study. (shrink)

Everybody recognizes that most of the problems in medical ethics arise, these days, from innovations in medical technology. We would not have had to lay down laws or ethical guidelines about assisted reproduction had it not been for the new technology of in vitro fertilization, which produced the first IVF baby in 1978. We would not be currently anxious about the ethics of possible human cloning, had it not been for the production in Edinburgh of Dolly, the lamb (...) whose birth resulted from the removal of a mammary gland cell from an adult sheep. So the question is whether there is some research into developing technology that is too dangerous, that will lead to consequences too dramatic for humanity, for the research itself to be permitted. Should there be control over what technological innovation should be permitted? (shrink)

ABSTRACTGiven its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research , focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society . It then considers how and whether these concerns are dealt with in regulatory instruments in (...) Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field. (shrink)

Almost half a century ago a strong controversy opposed the philosophers advocating an unrestricted freedom of science to those advocating a moral and legal regulation of science, that dispute did not produce significant results because it rested on a lack of distinction between science and technology. The defining aim of science is acquisition of knowledge and that of technology is production of objects and performances. Humans have always developed a large display of techniques for the realization of (...) different activities and technology can be defined as that special sector of technique that consists in the application of scientific knowledge. With reference to this clarification it is possible to see that pure science enjoys a substantial freedom, being ethically limited only in the case of particular means, conditions and consequences directly involved in experimental science. Applied science must be ethically evaluated also considering the goals of the application envisaged. In the case of technology ethical evaluations are much more pertinent and articulated because actions are involved and regulations are legitimate as far as they concern limitations of the freedom of action; they also can entail legal regulations. The concrete example of Medicine, that is a special technology according to the above definition, concludes the paper and it is shown that due to the fact that Medicine has to do with human persons, it is not sufficient to take into consideration its technical aspects but several other values of psychological, social and spiritual kind must contribute to the global assessment of the medical praxis in the different concrete situations. (shrink)

Emerging technologies such as artificial intelligence, gene editing, nanotechnology, neurotechnology and robotics, which were originally unrelated or separated, are becoming more closely integrated. Consequently, the boundaries between the physical-biological and the cyber-digital worlds are no longer well defined. We argue that this technological convergence has fundamental implications for individuals and societies. Conventional domain-specific governance mechanisms have become ineffective. In this paper we provide an overview of the ethical, societal and policy challenges of technological convergence. Particularly, we scrutinize the adequacy of (...) domain-specific governance mechanisms in the face of such integrated technologies and highlight their growing ineffectiveness. Furthermore, we propose a comprehensive governance framework that is anticipatory, inclusive, and resilient. Central to this framework is the principle of participatory governance, which calls for a proactive engagement of all stakeholders, including those from marginalized and vulnerable populations, ensuring that their voices and concerns shape the trajectory of technological development. The framework emphasizes the need for protective measures that preemptively address potential risks and inequities that may arise from the adoption and integration of emerging technologies. Based on a detailed analysis of case studies and current governance models, we present and discuss a set of ten actionable recommendations. These are designed to facilitate the transition towards a governance approach that not only respects individual autonomy and privacy, but also fosters a collective responsibility towards sustainable and fair technological progress. By placing human dignity, societal welfare and the protection of the most vulnerable at the center of technological innovation, we advocate for a future where convergence is synonymous with progress that is both ethically grounded and universally beneficial. (shrink)

The aim of this paper is to explain the emergence and use of DNA fingerprinting technology in India, noting the specific concerns faced by the Indian Legal System related to the use of this novel forensic technology in the justice process. Furthermore, the proposed construction of a National DNA Data Bank is discussed taking into consideration the challenges faced by the government in legislating the DNA Bill into law. A critical analysis of the DNA Technology (Use and (...) Application) Regulation Bill, 2019 is provided to throw light upon many ethical, social, and legal issues that need to be addressed before the operationalization of the Bill to ensure that this technology is governed democratically to protect the civil liberties of citizens. (shrink)

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and (...) suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies. (shrink)

This article provides an analysis of bioprinting personalised medical device technology and its ethical challenges to regulation and research ethics. I argue the inclusion of bioprinting applications within existing regulatory frameworks does not adequately address the technologies disruption to the traditionally siloed activities of research and treatment. Using the conceptual framework of liminality, I offer a meaningful way to engage with this technology and address some identified concerns with how it will be categorised and the appropriate recognition (...) of its evidentiary thresholds. I demonstrate these concerns through the exploration of limited conventional research methodologies tasked with the production of generalisable knowledge, specifically population-based evidence that is derived from Randomised Clinical Trials. I use Australian regulatory amendments introduced in 2021 as an example of current regulatory trajectories and highlight why I believe this approach to be insufficient. The significance of this argument will be to demonstrate the disruption of bioprinting applications to current approaches in medical policy, and how various jurisdictions are enacting regulation that is not fit for purpose. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a “bottleneck” develops (...) upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a “bottleneck” develops (...) upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

This study is focused on unsustainable agri-food systems, especially intensive livestock farming and its resulting environmental harms. Specifically we focus on the development of technologies that seek to mitigate these environmental harms. These technologies are generally developed as incremental innovations in response to government regulation. Critics of these technological solutions allege that these developments legitimate unsustainable food production systems and are incapable of supporting agri-food systems transformation. At the same time, technology developers and other actors seek to present (...) these technologies as the legitimate solution to agri-environmental harms. Our study seeks to explore the perceptions and constructions of legitimacy for technologies that are developed to reduce ammonia emissions in intensive livestock farming in Flanders (Belgium). We use a qualitative case study, employing semi-structured interviews and workshops, with technology developers of ammonia-emission reducing technologies and stakeholders in the intensive livestock farming industry in Flanders. What our study shows is that technologies developed to reduce emissions are dependent on regulative legitimacy. The normative and cognitive legitimacy of these technologies is lacking, both due to ties to the intensive livestock industry and due to uncertainty over the performance of these technologies. With the delegitimation of intensive livestock farming, the legitimacy of these technologies is also under threat. In response, technology developers are looking to (re-)construct this legitimacy through knowledge claims over the performance of their technologies. We show several ways for other actors to deal with this, centred on either re-legitimising technologies to maintain the status quo, or to contest these knowledge claims and use them to disrupt path dependencies. (shrink)

Regulation by design (RBD) is a growing research field that explores, develops, and criticises the regulative function of design. In this article, we provide a qualitative thematic synthesis of the existing literature. The aim is to explore and analyse RBD's core features, practices, limitations, and related governance implications. To fulfil this aim, we examine the extant literature on RBD in the context of digital technologies. We start by identifying and structuring the core features of RBD, namely the goals, regulators, (...) regulatees, methods, and technologies. Building on that structure, we distinguish between three types of RBD practices: compliance by design, value creation by design, and optimisation by design. We then explore the challenges and limitations of RBD practices, which stem from risks associated with compliance by design, contextual limitations, or methodological uncertainty. Finally, we examine the governance implications of RBD and outline possible future directions of the research field and its practices. (shrink)

In July 2014, the roboticist Ronald Arkin suggested that child sex robots could be used to treat those with paedophilic predilections in the same way that methadone is used to treat heroin addicts. Taking this onboard, it would seem that there is reason to experiment with the regulation of this technology. But most people seem to disagree with this idea, with legal authorities in both the UK and US taking steps to outlaw such devices. In this paper, I (...) subject these different regulatory attitudes to critical scrutiny. In doing so, I make three main contributions to the debate. First, I present a framework for thinking about the regulatory options that we confront when dealing with child sex robots. Second, I argue that there is a prima facie case for restrictive regulation, but that this is contingent on whether Arkin’s hypothesis has a reasonable prospect of being successfully tested. Third, I argue that Arkin’s hypothesis probably does not have a reasonable prospect of being successfully tested. Consequently, we should proceed with utmost caution when it comes to this technology. (shrink)

The use of genetic technologies within the equine industries has become increasingly common since the horse genome was published in 2009 (Wade et al. 2009). Testing for genes coding for disease in...

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a (...) “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic. (shrink)

This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence. In commenting on that analysis, this paper suggests that looking at “oversight” in three phases — research and development, regulatory review, and market acceptance (...) — can help to determine when certain of these attributes should take precedence over others and how to structure remedies when an error occurs. The result is an approach that is precautionary with respect to research and development, prudent and open to public input in the regulatory review stage, and purposefully persuasive once market acceptability is at stake, with remedies that are risk-containing in the first phase, risk-managing in the second, and risk-assuaging in the third. Combining the key attributes with the idea of three phases can help attune oversight to society's needs. (shrink)