We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). There is no (...) national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country. (shrink)

Post COVID-19 infections resulting in long COVID symptoms remain persistent yet neglected in healthcare priorities. Although long COVID symptoms are expected to decline after some time, many people continue to endure its debilitating effects affecting their daily lives. The diversity of characteristics amongst long COVID patients adds to the complexity of communicating personal health predicaments to healthcare providers. Recent research towards building an evidence base for long COVID with the aim of delivering responsive healthcare interventions for long COVID patients has (...) utilised datasets generated from wearable devices. This paper examines the prospects presented by wearable devices for long COVID patients and physicians. It highlights distinct ethical and legal challenges arising from their use in practice. Several recommendations aiming to support their usage amongst long COVID patients are outlined for future research using wearable devices for long COVID treatment. (shrink)

Large data-intensive health research programmes benefit from collaboration amongst researchers who may be located in different institutions and international contexts. However, complexities in navigating privacy frameworks and data protection laws across various jurisdictions pose significant challenges to researchers seeking to share or transfer data outside of institutional boundaries. Research on the awareness of data protection and privacy laws amongst stakeholders is limited. Our qualitative study, drawn from a larger project in Singapore, revealed insights into stakeholders’ perceptions of the role of (...) law in cross-national health data research. Stakeholders in our study demonstrated a range of perceptions regarding the role of data protection law in governing the collection and transfer of health data for research. The main criticisms included inadequate legal protection to data and lack of uniformed data protection standards. Despite these criticisms, participants recognised the importance of data protection law in supporting cross-border data transfers and proposed measures to improve perceived limitations of existing laws. These measures include strengthening existing legal framework, establishing contractual agreements and imposing severe punishments for data misuse. (shrink)

Hospital ethics committees (HECs) are relatively new in non-Western countries. This article examines the effectiveness of a HEC established in Bursa/Turkey over ten years, aiming to contribute insights for the wider implementation and enhancement of HECs. The evaluative methodology combines quantitative and qualitative approaches to assess its effectiveness. Patients are the primary users of the HEC, although applications from physicians, hospital managers, and the Patient Rights Board are also observed. Surgical specialities account for the majority of applications, particularly from obstetrics (...) and gynecology, anesthesiology, and emergency medicine. The study identifies the types of applications, with malpractice claims, ethical inquiries, and access-related complaints being the most common. Despite many healthcare professionals encountering ethical dilemmas, the HEC was underutilized for consultations due to factors such as low awareness, perceived autonomy challenges, and skepticism regarding its efficacy. Additionally, the study describes how HEC recommendations contribute to policy development, addressing organizational issues and promoting ethical practices. The decision-making process within the HEC was also scrutinized, emphasizing the necessity of a structured methodology for moral deliberation. Concerns are raised about committee members lacking specific training in ethical analysis, potentially resulting in biases and suboptimal decisions. Contextual factors, including institutional culture and economic considerations, are also recognized for their influence on decision-making. This analysis highlights the multifaceted nature of HECs and the challenges they face in achieving effectiveness. It underscores the need for standardized measures, improved training for committee members, and contextual awareness to enhance the impact and functionality of HECs in healthcare institutions. (shrink)

The COVID-19 pandemic prompted a nudge for public–private cooperation in healthcare to rapidly cope with limited resource. However, Vietnam’s historical reliance on a public healthcare system, combined with a traditional emphasis on socialization in the Polanyian sense, hindered the swift integration of the private sector. This research investigates path dependency in Vietnam’s public health sector, using theories including path dependency, Karl Polanyi’s double movement with legal analysis method to analyze the interplay of historical decisions, and socialist policies in healthcare. Recognizing (...) these institutional and market governance flaws, a deeper understanding of the role of law becomes vital in crafting strategies for a more resilient and sustainable healthcare system in Vietnam. In this article, Ho Chi Minh City is chosen as a case study due to its notable mix of public–private healthcare facilities and its status as a leading area in infection cases during the third COVID-19 wave. The article suggests that there should be a change in the way public and private sectors work together, one that is more in line with market-driven solutions which requires solid legal framework for cooperation beyond merely mobilizing resources. (shrink)

When it comes to invasive manipulation of animals on the biological level, reactions of disgust are common and often influential on people’s moral judgments. As a case in point, the Belgian Blue, a breed of hyper-enhanced cattle which will serve as a case study for the present article, has historically been met with revulsion. Traditionally, in bio- and animal ethics, this ‘yuck factor,’ has been denied any productive role in proper moral justification, since rationalism is still a dominant paradigm in (...) those disciplines. This is not surprising since rationalism offers the fulfilment of certain expectations we have of morality, like universality, intersubjective communicability, and objectivity. Increasingly, however, the preconceptions of rationalism have been brought into question, both through empirical as well as philosophical insights. In this paper, we will explore a way in which researchers who are, accordingly, critical of rationalism, and who wish to take seriously the role disgust plays in the formation of moral judgments when it comes to biological manipulation of animals, can do so without abandoning those virtues of rationalism which make it such an appealing position. We will do so by offering what we call a ‘tempered’ kind of rationalism, that is, one which conceives of rationality in the terms of Mary Midgley, not as distinct from, but as a possible function of, well-ordered emotion. (shrink)

Assisted reproductive technologies (ARTs) have become a widely utilized medical technology for treating infertility worldwide. However, societies and countries have applied these technologies in accordance with their cultural practices and belief systems. This paper presents an overview of ART providers in Bangladesh and analyzes their online content in addressing potential infertile couples. Examining the topic within the context of socio-economic and public health challenges in Bangladesh, particularly overpopulation, poverty, and lack of education, the research conducted a web content analysis of (...) ART providers in Bangladesh from July 1 to September 1, 2023. Twenty active ART providers were identified using Google searches and an exploratory key. The analysis considered locations, landing page information, ethical standards, quality certification, foreign affiliations, and success rates. The findings revealed a concentration of centers in urban areas, raising concerns about equitable access. The absence of regulation and guidelines, coupled with the lack of ART clinic registration, highlighted potential risks to patient well-being. Landing page statements utilized highly emotive language and ambiguous terms, raising ethical concerns. The absence of explicit mention of quality standards, including ISO 9001:2000 certification, indicated potential gaps in transparency. Foreign affiliations were employed for credibility, raising concerns of misleading advertising. Limited and ambiguous reporting of success rates posed challenges for informed decision-making. Evident exploitative and commercialized practices raised concerns about potentially commodifying reproductive services. The study emphasizes the need for regulatory frameworks, transparency in reporting, adherence to ethical advertising, and increased cultural sensitivity to enhance the ethical standards of ART providers in Bangladesh. (shrink)

In an increasingly globalized world, the accessibility of healthcare and medication has expanded beyond local healthcare systems and national borders. This study aims to investigate the transnational health and self-care experiences of 11 Japanese women who have resided in South Korea for a minimum of six months and have utilized oral contraceptives, including those that were acquired over-the-counter (OTC). Data were gathered through semi-structured interviews and analyzed by utilizing the NVivo software. The analysis yielded three significant thematic categories, namely (1) (...) experiences and perceptions of obtaining and utilizing contraceptive pills, including OTC access; (2) individual and social perceptions of pills and their accessibility in Japan, insights from actual users; and (3) enhancing pill accessibility, transnational health and self-care experiences and perspectives. Participants acknowledged that oral contraceptives are a global product and experienced communication challenges with healthcare providers as a result of differing understandings of these medications. Additionally, this study identified transnational strategies, such as purchasing an adequate supply of pills just before departure and seeking pills from local families or acquaintances. This study not only highlights the implications of clinical care for transnational patients but also underscores their critical global perspectives on access to oral contraceptives. Furthermore, it proposes two models for improving accessibility within the Japanese healthcare system, even in prescription-only contexts, by introducing OTC options. (shrink)

Ensuring diversity within the healthcare sector is essential for improving team dynamics and ultimately patient outcomes. Diversity among medical students is fundamental to embody this philosophy. With the demand for diversity in the admissions process gaining traction, the authors expanded this conversation to the editorial boards (EBs) of Medical Student Journals (MSJs). The authors designed a cross-sectional study to evaluate the diversity status of EBs of MSJs under gender, geographic, and socioeconomic parameters using the Journal Diversity Index (JDI). Relevant information (...) regarding the journal characteristics and the editorial board members (EBMs) of systematically screened journals was sequentially extracted along with job roles, which were later categorized into eight categories. Chi-squared test was applied to study the association between gender of the editor and the global distribution of the journal. Out of 22 included journals, 90.9% were published by institutions based in high-income countries (HICs). On regional analysis, none of the journals originated from “South Asia,” “Latin America and the Caribbean,” and “Middle East and North Africa”. Disparity in gender representation of EBMs became more prominent in senior roles. Additionally, 78.8% EBMs belonged to HICs. Regional analysis of EBMs revealed 83% belonging to the Global North. This disparity was seen across all editorial job roles. A greater disparity was seen among editors from the Global South with men comprising 66.4% of the total editors (p<0.001). On JDI, 95.5% journals demonstrated poor diversity. Moreover, 72.7% and 77.3% journals had all members of the EB belonging to the same region and the same country income level respectively. As EBs of MSJs offer opportunities for further advancement, networking, and promotion, a commitment to prioritizing diversity, equity, and inclusion accompanied by development and implementation of actionable plans and allocation of sufficient resources should be given precedence. (shrink)

In Western countries, the ideal professional and ethical attributes of healthcare providers and the ideal patient-doctor relationship have been analysed in detail. Other cultures, however, may have different norms, arising in response to diverse healthcare needs, cultural values and offering alternative perspectives. In this paper, drawing a case study, we introduce the concept of Shinmi, used in Japan to describe a desirable approach to medical care. Shinmi means kind or cordial in Japanese. In the medical context, it refers to doctors (...) treating patients with a degree of emotional closeness as if they were the doctors’ own family. We analyse the concept of Shinmi, drawing on virtue ethics. We distinguish two different elements to a Shinmi-na attitude. As illustrated in our example, excessive Shinmi can be problematic for patients and doctors. Furthermore, elements of Shinmi may conflict with existing Western values (for example, norms that encourage emotional detachment and discourage doctors’ treatment of family members). However, if pursued appropriately, we argue that a balanced Shinmi-na approach can be conducive to the goals of medicine. The concept of Shinmi may be valuable for medical students, in Japanese and potentially other health care systems, and help them to cultivate a virtuous approach to meeting the emotional needs of patients. (shrink)

Clinical bioethics plays a significant role in hospital settings through bioethics consultations, which focus on providing ongoing assistance in complex situations within the doctor-patient dynamic. These consultations entail regular interaction between physicians and clinical bioethicists. This situation prompts an exploration into how bioethics consultations affect physicians. The current research aims to understand the influence of bioethics consultations on physicians’ bioethical knowledge by analyzing the lexical content in their patients’ medical records. Medical records are a synthesis carried out by physicians, often (...) reflecting collaborative efforts, and capturing verbal statements indicative of thought processes suggestive of learning. The study is a sequential mixed-methods design with a retrospective descriptive approach, comparing medical records from the early years of the Department of Humanism and Bioethics’ operation (2013–2015) to the more recent ones (2019). Technical bioethical terminology such as “therapeutic effort limitation,” “futility,” “beneficence,” and “respect for autonomy” is more prevalent in recent medical records. This trend may stem from the positive impact of bioethics consultations conducted by the Department, with haptic communication serving as a particularly effective form of interaction with others during experiences of moral distress. This appears to be characteristic of cultures like those in Latin America. (shrink)

The Universal Declaration of Human Rights (UDHR) approved by the United Nations (UN) in 1948 includes the most widely accepted list of individual rights all over the world. Although it has been a catalyst in the pursuit of a universal ethic for human rights, it has not been updated for over 75 years during which significant progress has been made in the recognition of more human rights. It is time to examine whether the current global society aspires for more/other human (...) rights that are not reflected in previous declarations. We offer a review of literature on the potential areas that human rights may be extended to in the current sociocultural atmosphere and share the results of a survey at an international university in Japan which examines the views of 232 young Asian students from Japan, Korea, Vietnam, Thailand, China, Indonesia, etc. regarding the human rights declaration items and their implications, as well as new hypothetical items that they would like to see recognized as human rights. The results demonstrate stronger support for 15 out of the 21 surveyed items by all respondents, as well as stronger support for 10 out of the 21 items by female respondents. These results suggest a variable expansion in the breadth of the human rights concept which is worthy of further research. Also, gender inequality may be the basis for the stronger support of certain human rights by female respondents. (shrink)

Physician–patient disputes are a major problem in healthcare. Physician–patient conflicts, workplace violence, and direct involvement in disputes have a significant negative impact on the well-being of physicians. China and Japan have similar cultures but differing healthcare systems. The present study aimed to examine and compare the experiences and perceptions of Chinese and Japanese physicians regarding medical disputes. Qualitative descriptive content analysis was performed for 18 cases from each country to assess the major issues involved in each case and their impact (...) on the physicians. Common issues in medical disputes for both countries included monetary motives of patients and/or families, violence/threats from patients and/or families, the inability of patients and/or families to understand the risk of complications, and the uncertainties of medicine. The serious impact of medical disputes on the mental health and professionalism of physicians was also an issue shared by physicians of both countries. There were, however, differences in the magnitude and frequency of these issues between the two countries. Pre-existing distrust of physicians among patients and/or families was noted only by Chinese physicians, and insufficient information disclosure by physicians was noted only by Japanese physicians. In conclusion, there were similarities and differences between the two countries in the perceptions of physicians regarding medical disputes. Our analysis revealed differing healthcare situations due to cultural and institutional differences as well as universal problems intrinsic to medicine. Based on our results, we propose several key principles to improve the physician–patient relationship. (shrink)

Artificial intelligence (AI) is the ability of a digital computer or computer-controlled robot to perform tasks commonly associated with intelligent beings. Artificial intelligence can be both a blessing and a curse, and potentially a double-edged sword if not carefully wielded. While it holds massive potential benefits to humans—particularly in healthcare by assisting in treatment of diseases, surgeries, record keeping, and easing the lives of both patients and doctors, its misuse has potential for harm through impact of biases, unemployment, breaches of (...) privacy, and lack of accountability to mention a few. In this article, we discuss the fourth industrial revolution, through a focus on the core of this phenomenon, artificial intelligence. We outline what the fourth industrial revolution is, its basis around AI, and how this infiltrates human lives and society, akin to a transcendence. We focus on the potential dangers of AI and the ethical concerns it brings about particularly in developing countries in general and conflict zones in particular, and we offer potential solutions to such dangers. While we acknowledge the importance and potential of AI, we also call for cautious reservations before plunging straight into the exciting world of the future, one which we long have heard of only in science fiction movies. (shrink)

The increasing integration of artificial intelligence (AI) in healthcare presents a host of ethical, legal, social, and political challenges involving various stakeholders. These challenges prompt various studies proposing frameworks and guidelines to tackle these issues, emphasizing distinct phases of AI development, deployment, and oversight. As a result, the notion of responsible AI has become widespread, incorporating ethical principles such as transparency, fairness, responsibility, and privacy. This paper explores the existing literature on AI use in healthcare to examine how it addresses, (...) defines, and discusses the concept of responsibility. We conducted a scoping review of literature related to AI responsibility in healthcare, searching databases and reference lists between January 2017 and January 2022 for terms related to “responsibility” and “AI in healthcare”, and their derivatives. Following screening, 136 articles were included. Data were grouped into four thematic categories: (1) the variety of terminology used to describe and address responsibility; (2) principles and concepts associated with responsibility; (3) stakeholders’ responsibilities in AI clinical development, use, and deployment; and (4) recommendations for addressing responsibility concerns. The results show the lack of a clear definition of AI responsibility in healthcare and highlight the importance of ensuring responsible development and implementation of AI in healthcare. Further research is necessary to clarify this notion to contribute to developing frameworks regarding the type of responsibility (ethical/moral/professional, legal, and causal) of various stakeholders involved in the AI lifecycle. (shrink)

More than 5 billion people in the world own a smartphone. More than half of these have been used to collect and process health-related data. As such, the existing volume of potentially exploitable health data is unprecedentedly large and growing rapidly. Mobile health applications (apps) on smartphones are some of the worst offenders and are increasingly being used for gathering and exchanging significant amounts of personal health data from the public. This data is often utilized for health research purposes and (...) for algorithm training. While there are advantages to utilizing this data for expanding health knowledge, there are associated risks for the users of these apps, such as privacy concerns and the protection of their data. Consequently, gaining a deeper comprehension of how apps collect and crowdsource data is crucial. To explore how apps are crowdsourcing data and to identify potential ethical, legal, and social issues (ELSI), we conducted an examination of the Apple App Store and the Google Play Store in North America and Europe to identify apps that could potentially gather health data through crowdsourcing. Subsequently, we analyzed their privacy policies, terms of use, and other related documentation to gain insights into the utilization of users’ data and the possibility of repurposing it for research or algorithm training purposes. More specifically, we reviewed privacy policies to identify clauses pertaining to the following key categories: research, data sharing, privacy/confidentiality, commercialization, and return of findings. Based on the results of these app search, we developed an App Atlas that presents apps which crowdsource data for research or algorithm training. We identified 46 apps available in the European and Canadian markets that either openly crowdsource health data for research or algorithm training or retain the legal or technical capability to do so. This app search showed an overall lack of consistency and transparency in privacy policies that poses challenges to user comprehensibility, trust, and informed consent. A significant proportion of applications presented contradictions or exhibited considerable ambiguity. For instance, the vast majority of privacy policies in the App Atlas contain ambiguous or contradictory language regarding the sharing of users’ data with third parties. This raises a number of ethico-legal concerns which will require further academic and policy attention to ensure a balance between protecting individual interests and maximizing the scientific utility of crowdsourced data. This article represents a key first step in better understanding these concerns and bringing attention to this important issue. (shrink)

This perspective article explores the use of digital twins (DTs) in medicine, highlighting its capacity to simulate risks and personalize treatments while examining the emerging bioethical concerns. Central concerns include power dynamics, exclusion, and misrepresentation. We propose adopting a relational bioethical approach that advocates for a comprehensive assessment of DTs in medicine, extending beyond individual interactions to consider broader structural relations and varying levels of access to power. This can be achieved through two key relational recommendations: acknowledging the impact of (...) uneven relational structures on access to medical care and promoting social justice by evaluating resource allocation. While DTs in medicine offer promising advancements, a relational bioethical lens may provide a nuanced understanding, fostering equitable, inclusive and responsible integration of DTs into medical practice. (shrink)

With focus on the development and use of artificial intelligence (AI) systems in the digital health context, we consider the following questions: How does the European Union (EU) seek to facilitate the development and uptake of trustworthy AI systems through the AI Act? What does trustworthiness and trust mean in the AI Act, and how are they linked to some of the ongoing discussions of these terms in bioethics, law, and philosophy? What are the normative components of trustworthiness? And how (...) do the requirements of the AI Act relate to these components? We first explain how the EU seeks to create an epistemic environment of trust through the AI Act to facilitate the development and uptake of trustworthy AI systems. The legislation establishes a governance regime that operates as a socio-epistemological infrastructure of trust which enables a performative framing of trust and trustworthiness. The degree of success that performative acts of trust and trustworthiness have achieved in realising the legislative goals may then be assessed in terms of statutorily defined proxies of trustworthiness. We show that to be trustworthy, these performative acts should be consistent with the ethical principles endorsed by the legislation; these principles are also manifested in at least four key features of the governance regime. However, specified proxies of trustworthiness are not expected to be adequate for applications of AI systems within a regulatory sandbox or in real-world testing. We explain why different proxies of trustworthiness for these applications may be regarded as ‘special’ trust domains and why the nature of trust should be understood as participatory. (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)

Healthcare has emerged as a key setting where expectations are rising for the potential benefits of artificial intelligence (AI), encompassing a range of technologies of varying utility and benefit. This paper argues that, even as the development of AI for healthcare has been pushed forward by a range of public and private actors, insufficient attention has been paid to a key contradiction at the center of AI for healthcare: that its pursuit to improve health is necessarily accompanied by environmental costs (...) which pose risks to human and environmental health—costs which are not necessarily directly borne by those benefiting from the technologies. This perspective paper begins by examining the purported promise of AI in healthcare, contrasting this with the environmental costs which arise across the AI lifecycle, to highlight this contradiction inherent in the pursuit of AI. Its advancement—including in healthcare—is often described through deterministic language that presents it as inevitable. Yet, this paper argues that there is need for recognition of the environmental harm which this pursuit can lead to. Given recent initiatives to incorporate stakeholder involvement into decision-making around AI, the paper closes with a call for an expanded conception of stakeholders in AI for healthcare, to include consideration of those who may be indirectly affected by its development and deployment. (shrink)

Discussion around the increasing use of AI in healthcare tends to focus on the technical aspects of the technology rather than the socio-technical issues associated with implementation. In this paper, we argue for the development of a sustained societal dialogue between stakeholders around the use of AI in healthcare. We contend that a more human-centred approach to AI implementation in healthcare is needed which is inclusive of the views of a range of stakeholders. We identify four key areas to support (...) stakeholder involvement that would enhance the development, implementation, and evaluation of AI in healthcare leading to greater levels of trust. These are as follows: (1) aligning AI development practices with social values, (2) appropriate and proportionate involvement of stakeholders, (3) understanding the importance of building trust in AI, (4) embedding stakeholder-driven governance to support these activities. (shrink)

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for AI Researchers in Healthcare’ published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers identified (...) similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers’ ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future. (shrink)

This paper discusses the key role medical regulators have in setting standards for doctors who use artificial intelligence (AI) in patient care. Given their mandate to protect public health and safety, it is incumbent on regulators to guide the profession on emerging and vexed areas of practice such as AI. However, formulating effective and robust guidance in a novel field is challenging particularly as regulators are navigating unfamiliar territory. As such, regulators themselves will need to understand what AI is and (...) to grapple with its ethical and practical challenges when doctors use AI in their care of patients. This paper will also argue that effective regulation of AI extends beyond devising guidance for the profession. It includes keeping abreast of developments in AI-based technology and considering the implications for regulation and the practice of medicine. On that note, medical regulators should encourage the profession to evaluate how AI may exacerbate existing issues in medicine and create unintended consequences so that doctors (and patients) are realistic about AI’s potential and pitfalls when it is used in health care delivery. (shrink)

This paper examines the Saudi Food and Drug Authority’s (SFDA) Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (the MDS-G010). The SFDA has pioneered binding requirements designed for manufacturers to obtain Medical Device Marketing Authorization. The regulation of AI in health is at an early stage worldwide. Therefore, it is critical to examine the scope and nature of the MDS-G010, its influences, and its future directions. It is argued that the guidance is a patchwork of (...) existing international best practices concerning AI regulation, incorporates adapted forms of non-AI-based guidelines, and builds on existing legal requirements in the SFDA’s existing regulatory architecture. There is particular congruence with the approaches of the US Food and Drug Administration (FDA) and the International Medical Device Regulators Forum (IMDRF), but the SFDA goes beyond those approaches to incorporate other best practices into its guidance. Additionally, the binding nature of the MDS-G010 is complex. There are binding ‘components’ within the guidance, but the incorporation of non-binding international best practices which are subordinate to national law results in a lack of clarity about how penalties for non-compliance will operate. (shrink)

Population biobanks are an increasingly important infrastructure to support research and will be a much-needed resource in the delivery of personalised medicine. Artificial intelligence (AI) systems can process and cross-link very large amounts of data quickly and be used not only for improving research power but also for helping with complex diagnosis and prediction of diseases based on health profiles. AI, therefore, potentially has a critical role to play in personalised medicine, and biobanks can provide a lot of the necessary (...) baseline data related to healthy populations that will enable the development of AI tools. To develop these tools, access to personal data, and in particular, sensitive data, is required. Such data could be accessed from biobanks. Biobanks are a valuable resource for research but accessing and using the data contained within such biobanks raise a host of legal, ethical, and social issues (ELSI). This includes the appropriate consent to manage the collection, storage, use, and sharing of samples and data, and appropriate governance models that provide oversight of secondary use of samples and data. Biobanks have developed new consent models and governance tools to enable access that address some of these ELSI-related issues. In this paper, we consider whether such governance frameworks can enable access to biobank data to develop AI. As Italy has one of the most restrictive regulatory frameworks on the use of genetic data in Europe, we examine the regulatory framework in Italy. We also look at the proposed changes under the European Health Data Space (EHDS). We conclude by arguing that currently, regulatory frameworks are misaligned and unless addressed, accessing data within Italian biobanks to train AI will be severely limited. (shrink)

Hinduism is considered one of the most ancient religions in the world. Although the technological innovation of modernization has undermined the reliance on their traditions, Hindus may still rely on Hindu Scripture when making decisions. From their standpoint, contrary to Western medicine, human lives cannot be reduced to statistical and empirical facts. They focus more on preserving the spirit, rather than considering survival as one of the goals of medicine. Consequently, when a preterm infant is born, Hindu parents might struggle (...) to understand the goals of Western neonatologists. This divergence may create misunderstandings when discussing end-of-life decisions. Since they value relational aspects to be of utmost importance, they may accept treatments only in the likelihood of good neurological outcomes. Being able to interact allows Hindus to act virtuously with the aim of purifying their soul toward moksa. When it comes to end-of-life decisions on behalf of newborns, Hindu parents may opt to forgo treatments and let the baby peacefully die, while praying for their soul to have a better rebirth. This paper aims to evaluate quality-of-life assessment in the Hindu tradition in comparison with the Catholic tradition. It draws parallelisms between these two different religions to investigate whether an inter-religious dialogue is possible. This work will help Catholic, and more broadly Western, doctors to have a better understanding of the Hindu end-of-life views. (shrink)

The increase of high-risk newborns due to societal changes has presented neonatal intensive care unit nurses with more ethical challenges and heightened their perception of neonatal palliative care. Therefore, this study was a descriptive survey exploring the perceptions of neonatal intensive care unit nurse regarding biomedical ethics and neonatal palliative care in neonatal intensive care units. The research participants were 97 neonatal intensive care unit nurses who had been directly involved with end-of-life care for high-risk babies. Data were collected from (...) November to December 2021 through an online survey. The Korean version of Neonatal Palliative Care Attitude Scale and the tool of biomedical ethics were used. The collected data were analyzed using the T-test, ANOVA, Scheffé test, Pearson correlation coefficient, and multiple regression analysis. The mean score for perception of biomedical ethics in neonatal intensive care unit nurses was 2.89 of 4, and that of neonatal palliative care in neonatal intensive care unit nurses was 3.10 of 5. Existence of a protocol of neonatal palliative care, the experience of patients dying, and the right to life of neonates were factors influencing the perception of neonatal palliative care. The explanatory power was 12.5%. The data support the importance of guidelines regarding systematic neonatal palliative care. Also, developing programs for sharing and supporting experiences of patients dying among colleagues and persistent education about the right to life of neonates for neonatal intensive care unit nurses can improve perception of neonatal palliative care. (shrink)

With the development of assisted reproductive technologies, medical, ethical, legal, and social issues have arisen that did not exist when natural conception was the only means of childbirth. In Japan, men tend to believe that assisted reproductive technologies are not directly related to them, with the literature showing that men are often reluctant to be involved in fertility treatment processes. To better understand this situation, this study analyzes the role of male consent during assisted reproductive technology procedures in Japan. First, (...) we examined Japanese court cases that dealt with issues related to male consent during assisted reproductive technology procedures and identified three situations in which problems related to male consent during such procedures may arise. Next, we analyzed the background of such issues and the implications of the lack of consent regarding men’s reproductive rights. Finally, we explored the need for legislation on assisted reproductive technologies. The study concludes that discussions on the scope of male partner rights in assisted reproductive technology procedures are key for minimizing unnecessary conflict between partners, thus ensuring both the rights of women who wish to have children and the welfare of their children. (shrink)