Asian Bioethics Review最新文献

{"title":"Moving beyond Technical Issues to Stakeholder Involvement: Key Areas for Consideration in the Development of Human-Centred and Trusted AI in Healthcare","authors":"Jane Kaye,&nbsp;Nisha Shah,&nbsp;Atsushi Kogetsu,&nbsp;Sarah Coy,&nbsp;Amelia Katirai,&nbsp;Machie Kuroda,&nbsp;Yan Li,&nbsp;Kazuto Kato,&nbsp;Beverley Anne Yamamoto","doi":"10.1007/s41649-024-00300-w","DOIUrl":"10.1007/s41649-024-00300-w","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141634912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order","authors":"Barry Solaiman","doi":"10.1007/s41649-024-00285-6","DOIUrl":"10.1007/s41649-024-00285-6","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141634913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mapping the Apps: Ethical and Legal Issues with Crowdsourced Smartphone Data using mHealth Applications","authors":"Nada Farag,&nbsp;Alycia Noë,&nbsp;Dimitri Patrinos,&nbsp;Ma’n H. Zawati","doi":"10.1007/s41649-024-00296-3","DOIUrl":"10.1007/s41649-024-00296-3","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141634911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial Intelligence Needs Data: Challenges Accessing Italian Databases to Train AI","authors":"Ciara Staunton,&nbsp;Roberta Biasiotto,&nbsp;Katharina Tschigg,&nbsp;Deborah Mascalzoni","doi":"10.1007/s41649-024-00282-9","DOIUrl":"10.1007/s41649-024-00282-9","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s41649-024-00282-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141349278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Artificial Intelligence in Patient Care—Some Considerations for Doctors and Medical Regulators","authors":"Kanny Ooi","doi":"10.1007/s41649-024-00291-8","DOIUrl":"10.1007/s41649-024-00291-8","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141347396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scoping Review Shows the Dynamics and Complexities Inherent to the Notion of “Responsibility” in Artificial Intelligence within the Healthcare Context","authors":"Sarah Bouhouita-Guermech,&nbsp;Hazar Haidar","doi":"10.1007/s41649-024-00292-7","DOIUrl":"10.1007/s41649-024-00292-7","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141359035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Fourth Industrial Revolution: Its Impact on Artificial Intelligence and Medicine in Developing Countries","authors":"Thalia Arawi,&nbsp;Joseph El Bachour,&nbsp;Tala El Khansa","doi":"10.1007/s41649-024-00284-7","DOIUrl":"10.1007/s41649-024-00284-7","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141634915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"When can we Kick (Some) Humans “Out of the Loop”? An Examination of the use of AI in Medical Imaging for Lumbar Spinal Stenosis","authors":"Kathryn Muyskens, Yonghui Ma, Jerry Menikoff, James Hallinan, Julian Savulescu","doi":"10.1007/s41649-024-00290-9","DOIUrl":"https://doi.org/10.1007/s41649-024-00290-9","url":null,"abstract":"","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140977722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cross-jurisdictional Data Transfer in Health Research: Stakeholder Perceptions on the Role of Law","authors":"Hui Yun Chan,&nbsp;Hui Jin Toh,&nbsp;Tamra Lysaght","doi":"10.1007/s41649-024-00283-8","DOIUrl":"10.1007/s41649-024-00283-8","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s41649-024-00283-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140988527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Update on the Ethical Breadth of the Human Rights Concept","authors":"Steven B. Rothman,&nbsp;Karina Dyliaeva,&nbsp;Nader Ghotbi","doi":"10.1007/s41649-024-00288-3","DOIUrl":"10.1007/s41649-024-00288-3","url":null,"abstract":"<div><p>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 <i>universal ethic</i> 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.</p></div>","PeriodicalId":44520,"journal":{"name":"Asian Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140659524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}