In this text, our question is what is the current regulatory trend in countries that are not considered central in the development of artificial intelligence, such as Brazil: a preventive approach, or an experimental approach? We will analyze the bills (PL) that are being processed in legislative houses at the state level, and at the federal level, highlighting some elements, such as: Delimitation of the object (conceptualization), fundamental principles, ethical guidelines, relationship with human work, human supervision, and guidelines for (...) class='Hi'>public authorities. Based on these elements, we identified how the issues that drive the contemporary debate on AI have been addressed in these legislative initiatives. The results indicate that the strongest national regulation proposal mentions risks, rights, governance, economic agents; these mentions dialogue with the concerns discussed by researchers around the world, regarding the mitigation and prevention of risks, regarding the preservation of individual and collective rights, the role of the State as a regulator and supervisor, and, as was to be expected, the maintenance of economic policies that possibly tend to protect the market; proposes that the foundations of the development, implementation and use of AI have values consistent with ‘human centered AI’ (Bingley et al. 2023), but also points to the neoliberal matrix; introduces human supervision as an effective element in the AI systems cycle; the trend that we can observe in Brazil is the configuration of a regulation that harmonizes articles that favor the preventive approach, with the presence of articles that favor the experimentation approach. (shrink)

To analyze which ethically relevant biases have been identified by academic literature in artificial intelligence algorithms developed either for patient risk prediction and triage, or for contact tracing to deal with the COVID-19 pandemic. Additionally, to specifically investigate whether the role of social determinants of health have been considered in these AI developments or not. We conducted a scoping review of the literature, which covered publications from March 2020 to April 2021. ​Studies mentioning biases on AI algorithms developed (...) for contact tracing and medical triage or risk prediction regarding COVID-19 were included. From 1054 identified articles, 20 studies were finally included. We propose a typology of biases identified in the literature based on bias, limitations and other ethical issues in both areas of analysis. Results on health disparities and SDOH were classified into five categories: racial disparities, biased data, socio-economic disparities, unequal accessibility and workforce, and information communication. SDOH needs to be considered in the clinical context, where they still seem underestimated. Epidemiological conditions depend on geographic location, so the use of local data in studies to develop international solutions may increase some biases. Gender bias was not specifically addressed in the articles included. The main biases are related to data collection and management. Ethical problems related to privacy, consent, and lack of regulation have been identified in contact tracing while some bias-related health inequalities have been highlighted. There is a need for further research focusing on SDOH and these specific AI apps. (shrink)

The rapid evolution of Artificial Intelligence (AI) has broadened discussions about its social and technological implications. The purpose of this study is to examine the perception of risks and benefits associated with AI, focusing on privacy, cybersecurity, trust in government management, and online device acceptance over time. We used an integrative approach that combined questionnaires and data analysis from X via Natural Language Processing (NLP). The traditional survey had 1013 participants in 2018 and 1000 in 2021, while X’s analysis examined (...) approximately 7.5 million tweets in the same period. The results indicate a constant concern with the risks of AI, such as the dehumanization of services (86%), job loss (82%), changes in labor functions (89%), privacy (87%), and cyber-attacks (87%). X also highlighted ethical concerns and the use of algorithms, perceived as a “threat cloud.” Acceptance of connected devices was low (23%), reflecting security and privacy concerns. Confidence in government management was remarkably low in relation to cybersecurity (12%) and privacy (13%). Nevertheless, there is a modest increase in the perception of the benefits of AI, such as technological advances and efficiency. This study underscores the need for collaborative and effective policies and the promotion of a culture of responsibility to maximize the benefits of AI while mitigating risks. The practical implications of these findings are discussed, emphasizing the importance of policies and regulations to address emerging digital threats. (shrink)

Recent technological advancements have deeply transformed society and the way people interact with each other. Instantaneous communication platforms have allowed connections with other people, forming global communities, and creating unprecedented opportunities in many sectors, making access to online resources more ubiquitous by reducing limitations imposed by geographical distance and temporal constrains. These technological developments bear ethically relevant consequences with their deployment, and legislations often lag behind such advancements. Because the appearance and deployment of these technologies happen much faster than legislative (...) procedures, the way these technologies affect social interactions have profound ethical effects before any legislative regulation can be built, in order to prevent and mitigate those effects. Ethics in Online AI-Based Systems: Risks and Opportunities in Current Technological Trends features a series of reflections from experts in different fields on potential ethically relevant outcomes that upcoming technological advances could bring about in our society. Creating a space to explore the ethical relevance that technologies currently still under development could have constitutes an opportunity to better understand how these technologies could or should not be used in the future in order to maximize their ethically beneficial outcomes, while avoiding potential detrimental effects. Stimulating reflection and considerations with respect to the design, deployment and use of technology will help guide current and future technological advancements from an ethically informed position in order to ensure that, tomorrow, such advancements could contribute towards solving current global and social challenges that we, as a society, have today. This will not only be useful for researchers and professional engineers, but also for educators, policy makers, and ethicists. (shrink)

Informed by a search of the literature about the usage of genetic testing information (GTI) by insurance companies, this paper presents a practical ethical analysis of several distinct public policy options that might be used to govern or constrain GTI usage by insurance providers. As medical research advances and the extension to the Human Genome Project (2016, https://en.wikipedia.org/wiki/human_genome_project_-_write) moves to its fullness over the next decade, such research efforts will allow the full synthesis of human DNA to be (...) connected to predictive health dispositions. As testing costs fall, there will be ever more pressure for citizens to disclose GTI. Genetic testing information is integral to future medical care because it can be used to better assess individually tailored medical therapies as well as to allow a more informed risk analysis by the insurance industry, which in some countries such as the USA underwrites a majority of citizen medical expenses. As discussed in this examination, the revelation of people’s uniquely personal GTI to insurers has enormous societal implications. The major contribution of the paper is to offer policy makers and concerned citizens a nuanced articulation of the basic options to regulate GTI, with a special consideration for ethical fairness and equity. As genetic-based medicine blossoms and pressures to reduce healthcare costs increase, there will be an ever greater impetus for countries to revisit their genetic testing policies. Organizations and policy makers striving to create GTI oversights perceived to be both “fair and effective” need to be aware of the ethical perspectives discussed in this paper. (shrink)

An anthropogenic global catastrophic risk is a human-induced risk that threatens sustained and wide-scale loss of life and damage to civilisation across the globe. In order to understand how new research on governance mechanisms for emerging technologies might assuage such risks, it is important to ask how perceptions, beliefs, and attitudes towards the governance of global catastrophic risk within the research community shape the conduct of potentially risky research. The aim of this study is to deepen our (...) understanding of emerging technology research culture as it relates to global catastrophic risks, and to shed new light on how new research governance mechanisms might be developed. We analyse in-depth interviews with leading AI and biotech researchers both from universities and the private sector. We develop new insights in terms of four salient themes. First, ‘engineering mindset’, which highlights the premium placed by many interviewees on pursuing interesting research about the physical world for its own sake. Second, ‘self-government’, which looks at how self-regulation of technological development currently occurs. Third, ‘pure incentives’, focussing on how career and other incentives shapes research. Fourth, ‘norms and persuasion’, which examines the role of moral considerations in guiding the research choices of scientists. We end by considering the implications of these findings for future research on governance of anthropogenic global catastrophic risk. (shrink)

Undisputedly, the United States’ health care system is in the midst of unprecedented complexity and transformation. In 2014 alone there were well over thirty‐five million admissions to hospitals in the nation, indicating that there was an extraordinary number of very sick and frail people requiring highly skilled clinicians to manage and coordinate their complex care across multiple care settings. Medical advances give us the ability to send patients home more efficiently than ever before and simultaneously create ethical questions about (...) the balance of benefits and burdens associated with these advances. Every day on every shift, nurses at the bedside feel an intense array of ethical issues. At the same time, administrators, policy‐makers, and regulators struggle to balance commitments to patients, families, staff members, and governing boards. Ethical responsibilities and the fiduciary, regulatory, and community service goals of health care institutions are not mutually exclusive; they must go hand in hand. If they do not, our health care system will continue to lose valued professionals to moral distress, risk breaking the public's trust, and potentially undermine patient care. At this critical juncture in health care, we must look to new models, tools, and skills to confront contemporary ethical issues that impact clinical practice. The antidote to the current reality is to create a new health care paradigm grounded in compassion and sustained by a culture of ethical practice. (shrink)

ABSTRACT This study is an ethical reflection on the formulation and application of public policies regarding reproductive health in Brazil. The Integral Assistance Program for Women's Health (PAISM) can be considered advanced for a country in development. Universal access for family planning is foreseen in the Brazilian legislation, but the services do not offer contraceptive methods for the population in a regular and consistent manner. Abortion is restricted by law to two cases: risk to the woman's (...) life and rape. This reality favors the practice of unsafe abortion, which is the third largest cause of maternal death in Brazil. Legal abortion is regulated by the State and the procedure is performed in public health centers. However, there is resistance on the part of professionals to attend these women. Prenatal care is a priority strategy for promoting the quality of life of these women and of future generations. Nonetheless, it is still difficult for these women to access the prenatal care services and to have the required number of consultations. Moreover, managers and health professionals need to be made aware of the importance of implementing the actions indicated by the public policies in the area of sexual and reproductive health, favoring respect for autonomy in a context of personal freedom. (shrink)

Social policies are used to regulate how members of a society interact and share resources. If we expand our sense of community to include the ecosystem of which we are a part, we begin to develop an ethical obligation to this broader community. This ethic recognizes that the environment has intrinsic value, and each of us, as members of society, are ethically bound to preserve its sustainability. In assessing the environmental risks of new agricultural methods and technologies, society should not (...) freely trade economic gains for ecological damage, but rather seek practices that are compatible with ecosystem health. This approach is used to evaluate the environmental risks associated with genetically engineered insect-resistant trees. The use of insect-resistant trees is a biologically based pest control strategy that has several advantages over pesticide use. However, the use of genetically engineered trees presents particular ecological concerns because the trees are long lived and often are not highly domesticated. The main environmental concerns reviewed include: (1) adaptation of pests to the trees, leading to a non-sustainable agricultural practice, (2) transgenic trees producing environmental toxins, (3) insect resistance enhancing the invasiveness of the tree, causing it to become weedy or invade wild habitats, and (4) transfer of the transgene to wild or feral relatives of the tree, possibly increasing the invasiveness of weeds or wild plants. Some methods are available to offset these risks; however, the environmental risks associated with this technology have been poorly researched and need to be more clearly identified so that when we evaluate the risks, it is based on the best information obtainable. To fulfil an ethical obligation to the environment, public policies and government regulations are needed to preserve the sustainability of both the environment and the future of our production systems. A better understanding of both the ecological issues and of genetic engineering in general are needed on the part of citizens and policy makers alike to ensure that sound environmental decisions are made. Otherwise, the environmental benefits of this technology, mainly decreasing the use of more toxic pesticides in tree crops and forests, will either be lost or traded for other environmental hazards. (shrink)

This article explores four major areas of moral concern regarding virtual reality technologies. First, VR poses potential mental health risks, including Depersonalization/Derealization Disorder. Second, VR technology raises serious concerns related to personal neglect of users’ own actual bodies and real physical environments. Third, VR technologies may be used to record personal data which could be deployed in ways that threaten personal privacy and present a danger related to manipulation of users’ beliefs, emotions, and behaviors. Finally, there are other moral (...) and social risks associated with the way VR blurs the distinction between the real and illusory. These concerns regarding VR naturally raise questions about public policy. The article makes several recommendations for legal regulations of VR that together address each of the above concerns. It is argued that these regulations would not seriously threaten personal liberty but rather would protect and enhance the autonomy of VR consumers. (shrink)

The accelerating adoption of electronic health record systems will have profound impacts on clinical care. It will also have far-reaching implications for public health research and surveillance, which in turn could lead to changes in public policy, statutes, and regulations. The public health benefits of EHR use can be significant. However, researchers and analysts who rely on EHR data must proceed with caution and understand the potential limitations of EHRs.Much has been written (...) about the risk of EHR privacy breaches. This paper focuses on a different set of concerns, those relating to data quality. Unlike clinical trial data, EHR data is not recorded primarily to meet the needs of researchers. Because of clinicians’ workloads, poor user-interface design, and other factors, EHR data is surprisingly likely to be erroneous, miscoded, fragmented, and incomplete. Although EHRs eliminate the problem of cryptic handwriting, other kinds of errors are more common with EHRs than with paper records. (shrink)

Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of (...) the ethical standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation. (shrink)

The popularisation of Artificial Intelligence (AI) technologies has sparked discussion about their ethical implications. This development has forced governmental organisations, NGOs, and private companies to react and draft ethics guidelines for future development of ethical AI systems. Whereas many ethics guidelines address values familiar to ethicists, they seem to lack in ethical justifications. Furthermore, most tend to neglect the impact of AI on democracy, governance, and public deliberation. Existing research suggest, however, that AI can threaten key (...) elements of western democracies that are ethically relevant. In this paper, Rawls’s theory of justice is applied to draft a set of guidelines for organisations and policy-makers to guide AI development towards a more ethical direction. The goal is to contribute to the broadening of the discussion on AI ethics by exploring the possibility of constructing AI ethics guidelines that are philosophically justified and take a broader perspective of societal justice. The paper discusses how Rawls’s theory of justice as fairness and its key concepts relate to the ongoing developments in AI ethics and gives a proposition of how principles that offer a foundation for operationalising AI ethics in practice could look like if aligned with Rawls’s theory of justice as fairness. (shrink)

The idea that the degree of infringement public health interventions have on individual rights should be proportional to the degree of expected benefits has emerged as an influential principle in public health ethics and policy. While proportionality makes sense in theory, it may be difficult to implement in practice, due to the inherent conflict between individual rights and the common good underlying the principle. To apply the proportionality principle to a decision of policy, (...) one must still find a reasonable way of balancing these competing values in light of the available options and empirical evidence. In this article, I consider how the proportionality principle applies to the regulation of dietary supplements and examine some critiques of the current oversight system. I argue that it may be difficult maintain proportional oversight because the risks of dietary supplements vary considerably. Strengthening the regulations may therefore promote an appropriate level of regulation in some cases but lead to overregulation in others. (shrink)

Over the past year, technology companies have made headlines claiming that their artificially intelligent (AI) products can outperform clinicians at diagnosing breast cancer, brain tumours, and diabetic retinopathy. Claims such as these have influenced policy makers, and AI now forms a key component of the national health strategies in England, the United States, and China. While it is positive to see healthcare systems embracing data analytics and machine learning, concerns remain about the efficacy, ethics, and safety (...) of some commercial, AI health solutions. This paper argues that improved regulation and guidance is urgently required to mitigate risks, ensure transparency and best practice, Without this, patients, clinicians, and other stakeholders cannot be assured of an app’s efficacy, and safety. (shrink)

Universal access to antiretroviral treatment (ART) in Chad was officially declared in December 2006. This presidential initiative was and is still funded 100% by the country’s budget and external donors’ financial support. Many factors have triggered the spread of AIDS. Some of these factors include the existence of norms and beliefs that create or increase exposure, the low-level education that precludes access to health information, social unrest, and population migration to areas of high economic opportunities and gender-based discrimination. Social (...) forces that influence the distribution of dimensions of well-being and shape risks for infection also determine the persistence of access barriers to ART. The universal access policy is quite revolutionary but should be informed by the systemic barriers to access so as to promote equity. It is not enough to distribute ARVs and provide health services when health systems are poorly organized and managed. Comprehensive access to ART raises many organizational, ethical and policy problems that need to be solved to achieve equity in access. This paper argues that the persistence of access barriers is due to weak health systems and a poor public health leadership. AIDS has challenged health systems in a manner that is essentially different from other health problems. (shrink)

This paper considers the ethical risks and opportunities presented by generalist medical artificial intelligence (GMAI), a kind of dynamic, multimodal AI proposed by Moor et al. (2023) for use in health care. The research objective is to apply widely accepted principles of biomedical ethics to analyze the possible consequences of GMAI, while emphasizing the distinctions between GMAI and current-generation, task-specific medical AI. The principles of autonomy and health equity in particular provide useful guidance for the ethical risks (...) and opportunities of novel AI systems in health care. The ethics of two applications of GMAI are examined: enabling decision aids that inform and educate patients about certain treatments and conditions, and expanding AI-driven diagnosis and treatment recommendation. Emphasis is placed on the potential of GMAI to improve shared decision-making between patients and providers, which supports patient autonomy. Another focus is on health equity, or the reduction of health and access disparities facing underserved populations. Although GMAI presents opportunities to improve patient autonomy, health literacy, and health equity, premature or inadequately regulated adoption of GMAI has the potential to compromise both health equity and patient autonomy. On the other hand, there are significant risks to health equity and autonomy that may arise from not adopting GMAI that has been thoroughly validated and tested. A careful balancing of these risks and benefits will be required to secure the best ethical outcome, if GMAI is ever employed at scale. (shrink)

What does Artificial Intelligence (AI) have to contribute to health care? And what should we be looking out for if we are worried about its risks? In this paper we offer a survey, and initial evaluation, of hopes and fears about the applications of artificial intelligence in medicine. AI clearly has enormous potential as a research tool, in genomics and public health especially, as well as a diagnostic aid. It’s also highly likely to impact on the organisational (...) and business practices of healthcare systems in ways that are perhaps under-appreciated. Enthusiasts for AI have held out the prospect that it will free physicians up to spend more time attending to what really matters to them and their patients. We will argue that this claim depends upon implausible assumptions about the institutional and economic imperatives operating in contemporary healthcare settings. We will also highlight important concerns about privacy, surveillance, and bias in big data, as well as the risks of over trust in machines, the challenges of transparency, the deskilling of healthcare practitioners, the way AI reframes healthcare, and the implications of AI for the distribution of power in healthcare institutions. We will suggest that two questions, in particular, are deserving of further attention from philosophers and bioethicists. What does care look like when one is dealing with data as much as people? And, what weight should we give to the advice of machines in our own deliberations about medical decisions? (shrink)

“One man’s ceiling is another man’s floor”Paul SimonThe words of Paul Simon capture the essence of what the courts are called upon to deal with when adjudicating matters of health. Wealthier and healthier neighbors living in the upstairs apartment are, all things being equal, not overly interested in raising the floor of their apartment in order to create more space for those in the apartment below. The floor is tangible, measurable and movable, and thus a subject where science can (...) contribute much. However, where to locate the floor is a matter of values and thus largely in the realm of politics.Resorting to the courts in matters of public policy can be seen as the residual of the inability of the remaining two branches of government, the legislature and the executive, to succeed in allocating resources and regulating the system. When the combination of science and politics falters, enter the judiciary. (shrink)

Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, (...) with the General Data Protection Regulation being a prominent example in a European context. Recent regulatory developments related to clinical trial transparency, trade secrecy, data access, AI training data, and health data spaces further contribute to the difficulties. Simultaneously, government initiatives often encourage scientists to embrace principles of “open data” and “open innovation.” The variety of regulations in this domain has the potential to impede widespread data sharing and hinder innovation. This edited volume, therefore, compiles comparative case studies authored by leading scholars from diverse disciplines and jurisdictions. The book aims to outline the legal complexities of data sharing. By examining real-world scenarios from diverse disciplines and a global perspective, it explores the normative, policy, and ethical dilemmas that surround data sharing in the health sciences today. Chapter Patient Perspectives on Data Sharing, Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. (shrink)

‘Disruptive technologies’ is a euphemism for new technologies released lacking adequate regulation, causing significant unemployment and costly, inefficient additional labour. So it stands with LLMs. They output lookalikes of authored writing. Most output remixes existing materials, effectively stealing, since lacking understanding and intention original meaning is not added. LLMs enable low-cost, high-reward dishonesty. Students attempt to submit these products as their own texts. Some in education propose to use LLMs to allow students to generate text and then revise it. (...) This is feasible in groups small enough to ensure that students can be monitored continuously and substantially rewrite the texts while reflecting on the editing process. However, such highlighting of what is important about rewriting tasks reveals that LLMs do not add value to such activities. The recommended policy is to restrict and regulate LLMs. This protects jobs; it ensures that students have to develop skills that enhance their agency and their character development; and alleviates the problem of massive scale intellectual property misuse. Resistance to AI is urgent: no company promoting it will back down from doing so, no matter the risks of their products. This is a case of a game where one agent will never cooperate, and both agents endorse incompatible value sets. Consequently, no group potentially adversely affected should have qualms about intense opposition and has a duty to lobby for regulation and conditional supervised rollout of LLMs. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss (...) include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Machine unlearning (MU) is often analyzed in terms of how it can facilitate the “right to be forgotten.” In this commentary, we show that MU can support the OECD’s five principles for trustworthy AI, which are influencing AI development and regulation worldwide. This makes it a promising tool to translate AI principles into practice. We also argue that the implementation of MU is not without ethical risks. To address these concerns and amplify the positive impact of MU, we offer (...) policy recommendations across six categories to encourage the research and uptake of this potentially highly influential new technology. (shrink)

Part of the National Placebo Initiative in Canada included public consultations, based on the belief that the views of the public should inform Canadian policy development on what constitutes appropriate placebo use. Public consultations took place nationally in 2003. A deliberative dialogue approach was used, or a structured discussion format designed to facilitate the consideration of complex issues and build consensus. The placebo debate was characterized as having 3 distinct approaches and each were explored. The first (...) approach “Maximize Patient Protection” identified the need for experts to determine appropriate placebo use and that placebos should only be allowed under very restricted conditions. The second approach “Maximize Medical Knowledge” identified that placebos give essential information about the safety and efficacy of new drugs, and are appropriate when the rights, safety and well-being of research participants are ensured. The third approach “Maximize Patient Autonomy” identified that the current system of regulating placebo use is paternalistic and that patients should be able to define what is in their best interests and have more leeway to determine for themselves if they wish to participate in a placebo-controlled trial. Advantages and disadvantages of each approach were considered and feedback on what constitutes appropriate placebo use was sought. The major findings were that: PCTs were considered a valuable and acceptable part of advancing medical knowledge; research using placebos must be valid and justifiable; a patient-centred approach needs to be fostered; patient autonomy (choice) should be a first consideration and take clear precedence in trials of low to medium risk; patient protection (or health) may need to “trump” patient autonomy at higher levels of risk and/or patient vulnerability; placebos are not a violation of the duty of care as duty of care is best met by identifying a choice for patients, whenever a choice is available. These consultations clearly were not designed to produce conclusive evidence, but rather to provide some useful insights into what the public may think about placebo use; additional studies are indicated. (shrink)

Given the need for enforceable guardrails for artificial intelligence (AI) that protect the public and allow for innovation, the U.S. Government recently issued a Blueprint for an AI Bill of Rights which outlines five principles of safe AI design, use, and implementation. One in particular, the right to notice and explanation, requires accurately informing the public about the use of AI that impacts them in ways that are easy to understand. Yet, in the healthcare setting, it is unclear (...) what goal the right to notice and explanation serves, and the moral importance of patient-level disclosure. We propose three normative functions of this right: (1) to notify patients about their care, (2) to educate patients and promote trust, and (3) to meet standards for informed consent. Additional clarity is needed to guide practices that respect the right to notice and explanation of AI in healthcare while providing meaningful benefits to patients. (shrink)

Government agencies and private risk assessors use (quasi) scientific risk assessment procedures to try to estimate or predict risk to human health or the environment that might result from exposure to toxic substances in order to take steps to prevent such risks from arising or to eliminate the risks if they already exist. In this paper I discuss several ways in which the "science" of carcinogen risk assessment differs from ordinary scientific enterprises. I also consider (...) several ways in which normative policy considerations infect this regulatory science. Scientists, philosophers of science, moral philosophers and policy makers should address these issues forthrightly in order to serve better the aims of science and regulation. (shrink)

Healthcare applications of AI have the potential to produce great benefit, but also come with significant ethical risks. This has brought ethics to the forefront of academic, policy and public debates about AI in healthcare. To help navigate these debates, we distinguish three general modes of ethical theorizing in contemporary secular AI ethics: (1) idealism, which seeks to articulate moral ideals that can be applied to concrete problems; (2) realism, which focuses on understanding complex social realities (...) that underpin ethical problems; and (3) pragmatism, which promotes deliberate methods that allow joint action in the present but also enable to future moral growth and progress. We discuss the strengths and weaknesses of each of these modes and illustrate their relevance to salient ethical problems arising from AI in healthcare. Finally, we argue that, while all three have merits, pragmatist approaches deserve more attention they have received thus far. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss (...) include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos—that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders—researchers and regulators alike—who attempt to navigate these landscapes. This Delphi study was undertaken in (...) order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders—including researchers, regulators, publics and research sponsors—can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation—including the public interest and public engagement—our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty—both as a human practice and a regulatory objective—may represent the brighter future for health research. (shrink)

Public trust is paramount for the well functioning of data driven healthcare activities such as digital health interventions, contact tracing or the build-up of electronic health records. As the use of personal data is the common denominator for these healthcare activities, healthcare actors have an interest to ensure privacy and anonymity of the personal data they depend on. Maintaining privacy and anonymity of personal data contribute to the trustworthiness of these healthcare activities and are associated with the (...) public willingness to trust these activities with their personal data. An analysis of online news readership comments about the failed care.data programme in England revealed that parts of the public have a false understanding of anonymity in the context of privacy protection of personal data as used for healthcare management and medical research. Some of those commenting demanded complete anonymity of their data to be willing to trust the process of data collection and analysis. As this demand is impossible to fulfil and trust is built on a false understanding of anonymity, the inability to meet this demand risks undermining public trust. Since public concerns about anonymity and privacy of personal data appear to be increasing, a large-scale information campaign about the limits and possibilities of anonymity with respect to the various uses of personal health data is urgently needed to help the public to make better informed choices about providing personal data. (shrink)

Public controversy over animalbiotechnology is analyzed as a case that illustratestwo broad theoretical approaches for linking science,political or ethical theory, and public policy. Moralpurification proceeds by isolating the social,environmental, animal, and human health impacts ofbiotechnology from each other in terms of discretecategories of moral significance. Each of thesecategories can also be isolated from the sense inwhich biotechnology raises religious or metaphysicalissues. Moral purification yields a comprehensive andsystematic account of normative issues raised bycontroversial science. Hybridization proceeds bytaking (...) concern for all these elements to be a mark ofsound moral character. The advocate of hybridizationinfers that those who employ a strategy ofpurification seek to avoid accountability by dividingissues, and hence are not to be trusted. Lack of trustincreases perceived risk and challenges the legitimacyof government regulations to control social,environmental, and human health risks that areestablished under separate mandate, and administeredby separate agencies.The close alignment between government agencies, theiracademic affines, and the categories of purificationplaces the purified analysis in a favored politicalposition. Legitimation of science-based policy inareas like animal biotechnology becomes problematicbecause the concern of those who would take a hybridapproach (arguably the majority of lay persons) tounderstanding controversial science are excluded.Ironically, this exclusion heightens the perception ofrisk from animal biotechnology. The paper concludeswith a call for procedural approaches to incorporatingthe hybrid view of science‘s moral significance. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 115-116 [Access article in PDF] The Ethics of Medical Mistakes: Historical, Legal, and Institutional Perspectives Introduction In late 1999, the Institute of Medicine (IOM) released its report on medical errors, To Err is Human: Building a Safer Health System. The report estimated almost 50,000 deaths per year nationally due to medical mistakes, making it a leading cause of death. (...) IOM speculated that more than half of the deaths related to medical error are preventable. The IOM report shocked the public and medical professionals alike, sparking a national discussion of how to make the health care system safer. This multifaceted issue has profound implications for all aspects of health care, from the very personal--e.g., the relationship of caregiver and patient--to the societal--e.g., a nation's responsibility to its citizens.On 15 May 2000, the University of Pittsburgh Medical Center hosted an ethics conference devoted to the topic of medical mistakes. The goal was to bring together experts from various disciplines, before an audience of both providers and patients, to discuss medical mistakes and their implications. In this issue of the Kennedy Institute of Ethics Journal, we present selected papers resulting from that conference. These papers reflect not only the original oral presentations, but also much of the discussion those presentations generated. Three key perspectives on the ethics of medical mistakes are offered: historical, legal, and institutional.Rosa Lynn Pinkus offers a revealing historical perspective on the ethics of medical mistakes. In analyzing the history of mistake reporting in neurosurgery, she shows how the notion of a mistake developed only as the notion of a standard of practice emerged. Although much of managed care is directed toward systematically fostering a standard of care, this pursuit is relatively new in health care. One might speculate that as more standards are created, mistakes--defined as deviations from standard practice--must increase. If deviation from standard practice is overly castigated, however, then needed innovation in practice may be stifled. Interestingly, as Pinkus discusses, medical malpractice suits quickly followed the emergence of practice standards, driving the initial open reporting of mistakes underground. [End Page 115]Taking up the issue of medical malpractice, Thomas May and Mark Aulisio consider the ramifications of the current malpractice system for mistake prevention. The current system, they argue, while failing to adequately achieve its purported goals of deterring medical mistakes and compensating victims, itself creates a climate that deters the open reporting of mistakes by engendering fear and shame in clinicians. According to May and Aulisio, this failure to report medical mistakes openly has serious ramifications. Chief among these is the inability to do root cause analysis of mistakes, and then, where possible, to implement safeguards to minimize the occurrence of future mistakes. Ultimately, both the prevention of medical mistakes and the goals of malpractice litigation itself will be better served if substantial malpractice reform is undertaken.Andy Thurman argues that even in the current climate institutions ought to have a policy (and practice) of admitting to and openly reporting medical mistakes. Thurman argues that doing so not only is the right thing to do, but is also in the interest of institutions. Interestingly, he contends that failing to admit and openly report mistakes is both at odds with the mission of health care institutions and puts them at higher risk of litigation, and liability. In light of this, Thurman then suggests an institutional process for handling medical mistakes.Michael DeVita concedes that disclosing mistakes is widely supported by the health professionals' principles of ethics, but argues that there are a number of factors that conspire to make doing so a very difficult task. In analyzing an index case, DeVita contends that platitudes about being honest are not nearly enough to foster honest behavior and that policies that offer specific guidance on handling unfavorable events are needed in health care institutions.Finally, we conclude with the policy on disclosure of unfavorable events (this terminology is chosen because it includes both iatrogenic and natural diseases and conditions) that resulted from... (shrink)

Sovereignty and strategic autonomy are felt to be at risk today, being threatened by the forces of rising international tensions, disruptive digital transformations and explosive growth of cybersecurity incidents. The combination of AI and cybersecurity is at the sharp edge of this development and raises many ethical questions and dilemmas. In this commentary, I analyse how we can understand the ethics of AI and cybersecurity in relation to sovereignty and strategic autonomy. The analysis is followed by policy (...) recommendations, some of which may appear to be controversial, such as the strategic use of ethics. I conclude with a reflection on underlying concepts as an invitation for further research. The goal is to inspire policy-makers, academics and business strategists in their work, and to be an input for public debate. (shrink)

'Trade in Health is a timely reflection on the interface of economics with the ethics and public policy facets of the international movement of patients. Health issues such as these are at the forefront of modern political economy."National" health is increasingly less so. Reisman's previous scholarship in this area is brought to bear in an insightful and eminently readable and engaging fashion. In an area where uncovering the facts is more difficult than "decyphering the (...) Dead Sea Scrolls", such a reflective work on the critical aspects of political economy helps to fill a void in considering whether such trade is likely to be in the interests of patients, nations and the global community. In addition to the rosy picture of healthy and wealthy tourists having a sojourn for medical care during a vacation, Reisman is not afraid to tackle the thorny issues concerning trade in organs, eggs and even death, in this sobering and comprehensive volume. It is a rare skill to bring the luminaries of Smith, Marshall, Mill and Confucius to bear on such a contemporary tale! International travel by patients is at the nexus of a revolution in global health. It is driving and affecting aspects of foreign investment, health worker migration and e-health provision. Reisman skilfully links these foundations of health care, and as such provides critical text for consideration by those seeking to build and strengthen future health systems. Trade in Health is an excellent overview. It provides critical insights for those new to the area as well as new information and challenges for those of us involved for a number of years.' - Richard Smith, Professor of Health Ssytem Economics and Dean of Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, UK. Once exports and imports meant agriculture and industry. In the global economy and the electronic age, trade is also expanding into the service sector. This timely book closely examines trade in health. It documents the growth of a cross-national service that in the past was mainly consumed at home. Following from his highly successful book Health Tourism, Professor David Reisman offers a comprehensive and searching multidisciplinary account of the way in which medical services, patients, capital and professionals are making up a global healthcare economy that crosses borders. He reflects on their pursuit of lower prices, better quality and a differentiated product, and suggests that public policy is essential if the ethical capital of interdependent societies is not to be eroded by the international market in health and care. Written in a concise and lucid form, this original book will be of great interest to all people interested in the internationalization of health care. Combining theory and empirical evidence from economics, tourism and medical care, scholars involved in health policy and social administration will find much of significance in this authoritative study. (shrink)

Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the (...) precautionary principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed. (shrink)

Machine generated contents note: Preface; Introduction; Part I. Global Health, Definitions and Descriptions: 1. What is global health? Solly Benatar and Ross Upshur; 2. The state of global health in a radically unequal world: patterns and prospects Ron Labonte and Ted Schrecker; 3. Addressing the societal determinants of health: the key global health ethics imperative of our times Anne-Emmanuelle Birn; 4. Gender and global health: inequality and differences Lesley Doyal and Sarah Payne; 5. (...) Heath systems and health Martin McKee; Part II. Global Health Ethics, Responsibilities and Justice: Some Central Issues: 6. Is there a need for global health ethics? For and against David Hunter and Angus Dawson; 7. Justice, infectious disease and globalisation Michael Selgelid; 8. International health inequalities and global justice: toward a middle ground Norman Daniels; 9. The human right to health Jonathan Wolff; 10. Responsibility for global health? Allen Buchanan and Matt DeCamp; 11. Global health ethics: the rationale for mutual caring Solly Benatar, Abdallah Daar and Peter Singer; Part III. Analyzing Some Reasons for Poor Health: 12. Trade and health: the ethics of global rights, regulation and redistribution Meri Koivusalo; 13. Debt, structural adjustment and health Jeff Rudin and David Sanders; 14. The international arms trade and global health Salahaddin Mahmudi-Azer; 15. Allocating resources in humanitarian medicine Samia Hurst, Nathalie Mezger and Alex Mauron; 16. International aid and global health Anthony Zwi; 17. Climate change and health: risks and inequities Sharon Friel, Colin Butler and Anthony McMichael; 18. Animals, the environment and global health David Benatar; 19. The global crisis and global health Stephen Gill and Isabella Bakker; Part IV. Shaping the Future: 20. Health impact fund: how to make new medicines accessible to all Thomas Pogge; 21. Biotechnology and global health Hassan Masun, Justin Chakma and Abdallah Daar; 22. Food security and global health Lynn McIntyre and Krista Rondeau; 23. International taxation Gillian Brock; 24. Global health research: changing the agenda Tikki Pang; 25. Justice and research in developing countries Alex John London; 26. Values in global health governance Kearsley Stewart, Gerald T. Keusch and Arthur Kleinman; 27. Poverty, distance and two dimensions of ethics Jonathan Glover; 28. Teaching global health ethics James Dwyer; 29. Towards a new common sense: the need for new paradigms of global health Isabella Bakker and Stephen Gill; Index. (shrink)

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. (...) Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children. The first ethical issue raised by these experiments is: did the severity of illness in these children justify their exposure to short and long-term risks? The ethics of the experiments will be evaluated by referring to existing codes of medical research ethics-the Nuremberg Code, the Declaration of Helsinki, and the federal Code of Regulations. The thirteen cases presented will demonstrate that children are being used in ever more speculative experiments, often in the absence of a therapeutic intent, but a significant chance for causing harm and / or discomfort. Some of the experiments were designed to explore the mechanisms of pathology and pharmacological interventions, or the response of neurological brain receptors to chemical provocation ("challenge"). Others were designed to test the safety or efficacy of new drugs, even to test these drugs on healthy children who were hypothesized to be "at risk." Children and adolescents have been subjected to "forced dose titration" experiments that induced a spectrum of severe adverse effects, including insomnia, extreme restlessness, agitation, (akathisia) and self-injurious behavior. FDA reports show that suicide is a significant issue in psychotropic drug trials-in pediatric trials the problem is even greater. The paper aims to demonstrate how the enactment of the Better Pharmaceuticals for Children Act (incorporated into the Food and Drug Administration Modernization Act, FDAMA), set in motion a radical shift in public policy by providing huge financial incentives to pharmaceutical companies to test new or patented drugs in children. Federal policy shifted from one aimed at protecting children by setting limits on permissible research risks, to a policy aimed at broadening the inclusion of children as test subjects. It will be shown how the FDA and the Department of Health and Human Services lifted regulatory restrictions to permit research involving greater than minimal risk to be conducted on healthy children, claiming that all children are potentially "at risk" of a future condition. Children were in this way deprived of regulatory protections. An argument will be made that the approval of nontherapeutic, harmful experiments-such as exposure of toddlers to lead poison-under the current gate keeping system raises serious doubts about the sustainability of institutional review boards (IRBs) as protectors of human research subjects. Children, who are precluded from exercising the adult human's right to informed consent, are being exploited as commodities for commercial ends. It is the position of the author that nothing less than the enactment of a federal law mandating a radical overhaul of the current research review system, with independent checks and balances, will provide children the legal protections they need. Ten specific recommendations are offered to protect children from harmful experiments. (shrink)

BackgroundAdvances in healthcare artificial intelligence (AI) are occurring rapidly and there is a growing discussion about managing its development. Many AI technologies end up owned and controlled by private entities. The nature of the implementation of AI could mean such corporations, clinics and public bodies will have a greater than typical role in obtaining, utilizing and protecting patient health information. This raises privacy issues relating to implementation and data security. Main bodyThe first set of concerns includes access, use (...) and control of patient data in private hands. Some recent public–private partnerships for implementing AI have resulted in poor protection of privacy. As such, there have been calls for greater systemic oversight of big data health research. Appropriate safeguards must be in place to maintain privacy and patient agency. Private custodians of data can be impacted by competing goals and should be structurally encouraged to ensure data protection and to deter alternative use thereof. Another set of concerns relates to the external risk of privacy breaches through AI-driven methods. The ability to deidentify or anonymize patient health data may be compromised or even nullified in light of new algorithms that have successfully reidentified such data. This could increase the risk to patient data under private custodianship.ConclusionsWe are currently in a familiar situation in which regulation and oversight risk falling behind the technologies they govern. Regulation should emphasize patient agency and consent, and should encourage increasingly sophisticated methods of data anonymization and protection. (shrink)

Background: Artificial intelligence (AI) is the simulation of human intelligence processes by machines, such as learning, reasoning, and problem-solving. AI has the potential to transform the field of public health, which is concerned with promoting and protecting the health of populations and preventing diseases. AI can help public health organizations perform their essential functions more efficiently, effectively, and equitably; AI can transform the public health field, but it also poses some challenges and risks (...) that must be addressed carefully and responsibly. Objectives: This paper reviews the current and potential applications of AI in public health, discusses the opportunities and challenges of AI for public health, and provides recommendations for the ethical and responsible use of AI in public health. Results: AI can improve the speed and accuracy of diagnosis, screening, and treatment of various diseases and support disease surveillance, outbreak response, and health systems management. However, AI poses significant challenges and risks, such as ethical, legal, and social implications, data quality and security, algorithmic bias and fairness, and environmental impact. Conclusion: AI has the potential to revolutionize public health, but it comes with risks that must be addressed. Promoting digital literacy, establishing modern data governance frameworks, and investing in advanced data infrastructure and procedures are essential. Public health organizations must also train their workforce to collaborate with AI. By doing so, they can improve health outcomes, reduce health disparities, and advance public health science and practice. (shrink)

Artificial Intelligence (AI) is taking centre stage in economic growth and business operations alike. Public discourse about the practical and ethical implications of AI has mainly focussed on the societal level. There is an emerging knowledge base on AI risks to human rights around data security and privacy concerns. A separate strand of work has highlighted the stresses of working in the gig economy. This prevailing focus on human rights and gig impacts has been at the expense of a (...) closer look at how AI may be reshaping traditional workplace relations and, more specifically, workplace health and safety. To address this gap, we outline a conceptual model for developing an AI Work Health and Safety (WHS) Scorecard as a tool to assess and manage the potential risks and hazards to workers resulting from AI use in a workplace. A qualitative, practice-led research study of AI adopters was used to generate and test a novel list of potential AI risks to worker health and safety. Risks were identified after cross-referencing Australian AI Ethics Principles and Principles of Good Work Design with AI ideation, design and implementation stages captured by the AI Canvas, a framework otherwise used for assessing the commercial potential of AI to a business. The unique contribution of this research is the development of a novel matrix itemising currently known or anticipated risks to the WHS and ethical aspects at each AI adoption stage. (shrink)

Several proposals for moral enhancement would use AI to augment (auxiliary enhancement) or even supplant (exhaustive enhancement) human moral reasoning or judgment. Exhaustive enhancement proposals conceive AI as some self-contained oracle whose superiority to our own moral abilities is manifest in its ability to reliably deliver the ‘right’ answers to all our moral problems. We think this is a mistaken way to frame the project, as it presumes that we already know many things that we are still in the process (...) of working out, and reflecting on this fact reveals challenges even for auxiliary proposals that eschew the oracular approach. We argue there is nonetheless a substantial role that ‘AI mentors’ could play in our moral education and training. Expanding on the idea of an AI Socratic Interlocutor, we propose a modular system of multiple AI interlocutors with their own distinct points of view reflecting their training in a diversity of concrete wisdom traditions. This approach minimizes any risk of moral disengagement, while the existence of multiple modules from a diversity of traditions ensures pluralism is preserved. We conclude with reflections on how all this relates to the broader notion of moral transcendence implicated in the project of AI moral enhancement, contending it is precisely the whole concrete socio-technical system of moral engagement that we need to model if we are to pursue moral enhancement. (shrink)

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research (...) class='Hi'>ethics is necessary to effectively address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)

We are unlikely to stop seeking pleasure, as this would prejudice our health and well-being. Yet many psychoactive substances providing pleasure are outlawed as illicit recreational drugs, despite the fact that only some of them are addictive to some people. Efforts to redress their prohibition, or to reform legislation so that penalties are proportionate to harm have largely failed. Yet, if choices over seeking pleasure are ethical insofar as they avoid harm to oneself or others, public health (...) strategies should foster ethical choice by moving beyond current risk management practices embodied in the harm reduction movement. The neuroscience of pleasure has much to offer neuroethics and public health strategies. Distinguishing between ‘wanting’ and ‘liking’ fosters new understandings of addiction. These hold promise for directing the search for pharmacotherapies which prevent addiction and relapse or disrupt associated neuromechanisms. They could inform new research into creating lawful psychoactive substances which give us pleasure without provoking addiction. As the health and well being of human and other animals rests upon the experience of pleasure, this would be an ethical objective within public health strategy. Were ethical and neurobiological obstacles to ending addiction to be overcome, problems associated with excessive consumption, the lure of unlawful psychoactive substances and the paucity of lawful means to achieve pleasurable altered states would remain. Non-addictive designer drugs, which reliably provided lawful access to pleasures and altered states, would ameliorate these public health concerns insofar as they fostered citizens’ informed, ethical choices according to a neurobiological taxonomy of pleasures. (shrink)

Recent advancements in AI have prompted a large number of AI ethics guidelines published by governments and nonprofits. While many of these papers propose concrete or seemingly applicable ideas, few philosophically sound proposals are made. In particular, we observe that the line of questioning has often not been examined critically and underlying conceptual problems not always dealt with at the root. In this paper, we investigate the nature of ethical AI systems and what their moral status might be (...) by first turning to the notions of moral agency and patience. We find that their explication would come at a too high cost which is why we, second, articulate a different approach that avoids vague and ambiguous concepts or the problem of other minds. Third, we explore the impact of our philosophical and conceptual analysis on the regulatory landscape, make this link explicit, and finally propose a set of promising policy steps. (shrink)

Currently, health systems research is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees, as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, (...) there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted, no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step towards a larger dialogue on the topic. (shrink)

This paper conducts a comparative analysis of data governance mechanisms concerning the secondary use of health data in Taiwan and the European Union (EU). Both regions have adopted distinctive approaches and regulations for utilizing health data beyond primary care, encompassing areas such as medical research and healthcare system enhancement. Through an examination of these models, this study seeks to elucidate the strategies, frameworks, and legal structures employed by Taiwan and the EU to strike a delicate balance between the (...) imperative of data-driven healthcare innovation and the safeguarding of individual privacy rights. This paper examines and compares several key aspects of the secondary use of health data in Taiwan and the EU. These aspects include data governance frameworks, legal and regulatory frameworks, data access and sharing mechanisms, and privacy and security considerations. This comparative exploration offers invaluable insights into the evolving global landscape of health data governance. It provides a deeper understanding of the strategies implemented by these regions to harness the potential of health data while upholding the ethical and legal considerations surrounding its secondary use. The findings aim to inform best practices for responsible and effective health data utilization, particularly in the context of medical AI applications. (shrink)

The term ‘responsible AI’ has been coined to denote AI that is fair and non-biased, transparent and explainable, secure and safe, privacy-proof, accountable, and to the benefit of mankind. Since 2016, a great many organizations have pledged allegiance to such principles. Amongst them are 24 AI companies that did so by posting a commitment of the kind on their website and/or by joining the ‘Partnership on AI’. By means of a comprehensive web search, two questions are addressed by this study: (...) Did the signatory companies actually try to implement these principles in practice, and if so, how? What are their views on the role of other societal actors in steering AI towards the stated principles? It is concluded that some three of the largest amongst them have carried out valuable steps towards implementation, in particular by developing and open sourcing new software tools. To them, charges of mere ‘ethics washing’ do not apply. Moreover, some 10 companies from both the USA and Europe have publicly endorsed the position that apart from self-regulation, AI is in urgent need of governmental regulation. They mostly advocate focussing regulation on high-risk applications of AI, a policy which to them represents the sensible middle course between laissez-faire on the one hand and outright bans on technologies on the other. The future shaping of standards, ethical codes, and laws as a result of these regulatory efforts remains, of course, to be determined. (shrink)

Through hypothetical scenarios, this paper analyses whether machine learning (ML) could resolve one of the main shortcomings present in Christopher Boorse’s Biostatistical Theory of health (BST). In doing so, it foregrounds the boundaries and challenges of employing ML in formulating a naturalist (i.e., prima facie value-free) definition of health. The paper argues that a sweeping dataist approach cannot fully make the BST truly naturalistic, as prior theories and values persist. It also points out that supervised learning introduces circularity, (...) rendering it incompatible with a naturalistic perspective. Additionally, it underscores the need for pre-existing auxiliary theories to assess results from unsupervised learning. It emphasizes the importance of understanding the epistemological entanglements between data and data processing methods to manage expectations about what data patterns can predict. In conclusion, the paper argues against delegating the final authority for defining complex concepts like health to AI systems, as it necessitates ethical judgment and capacities for deliberation that AI currently lacks. It also warns against granting creators and deployers of AI systems the discretionary authority to determine these definitions outside the wider social discussion, advocating for ongoing public engagement on normative notions. Failure to do so risks limiting individuals and collectives’ ability to shape a just digital future and diminishes their fundamental epistemic agency. (shrink)

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual (...) meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

This study is rooted in the research traditions of cultivation theory, construct accessibility, and availability heuristic. Based on a survey with 221 subjects, this study finds that familiarity with direct-to-consumer (DTC) print advertisements for antidepressant brands is associated with inflated perceptions of the prevalence and lifetime risk of depression. The study concludes that DTC advertising potentially has significant effects on perceptions of depression prevalence and risk. Interpersonal experiences with depression coupled with DTC advertising appear to significantly predict individuals’ (...) perceived lifetime risk of depression. The study ultimately demonstrates that DTC advertising may play a role in constructing social reality of diseases and medicine. The findings strongly suggest that the social cognitive effects of DTC advertising are far-reaching, impacting pharmaceutical marketing strategy as well as presenting issues regarding public health and the business ethics of advertising drugs to consumers. (shrink)