Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

Materialized Oppression in Medical Tools and Technologies.

It is well-known that racism is encoded into the social practices and institutions of medicine. Less well-known is that racism is encoded into the material artifacts of medicine. We argue that many medical devices are not merely biased, but materialize oppression. An oppressive device exhibits a harmful bias that reflects and perpetuates unjust power relations. Using pulse oximeters and spirometers as case studies, we show how medical devices can materialize oppression along various axes of social difference, including race, gender, class, and ability. Our account uses political philosophy and cognitive science to give a theoretical basis for understanding materialized oppression, explaining how artifacts encode and carry oppressive ideas from the past to the present and future. Oppressive medical devices present a moral aggregation problem. To remedy this problem, we suggest redundantly layered solutions that are coordinated to disrupt reciprocal causal connections between the attitudes, practices, and artifacts of oppressive systems.

Privacy-Oriented Technique for COVID-19 Contact Tracing (PROTECT) Using Homomorphic Encryption: Design and Development Study.

BACKGROUND: Various techniques are used to support contact tracing, which has been shown to be highly effective against the COVID-19 pandemic. To apply the technology, either quarantine authorities should provide the location history of patients with COVID-19, or all users should provide their own location history. This inevitably exposes either the patient's location history or the personal location history of other users. Thus, a privacy issue arises where the public good (via information release) comes in conflict with privacy exposure risks. OBJECTIVE: The objective of this study is to develop an effective contact tracing system that does not expose the location information of the patient with COVID-19 to other users of the system, or the location information of the users to the quarantine authorities. METHODS: We propose a new protocol called PRivacy Oriented Technique for Epidemic Contact Tracing (PROTECT) that securely shares location information of patients with users by using the Brakerski/Fan-Vercauteren homomorphic encryption scheme, along with a new, secure proximity computation method. RESULTS: We developed a mobile app for the end-user and a web service for the quarantine authorities by applying the proposed method, and we verified their effectiveness. The proposed app and web service compute the existence of intersections between the encrypted location history of patients with COVID-19 released by the quarantine authorities and that of the user saved on the user's local device. We also found that this contact tracing smartphone app can identify whether the user has been in contact with such patients within a reasonable time. CONCLUSIONS: This newly developed method for contact tracing shares location information by using homomorphic encryption, without exposing the location information of patients with COVID-19 and other users. Homomorphic encryption is challenging to apply to practical issues despite its high security value. In this study, however, we have designed a system using the Brakerski/Fan-Vercauteren scheme that is applicable to a reasonable size and developed it to an operable format. The developed app and web service can help contact tracing for not only the COVID-19 pandemic but also other epidemics.

A legal overview of the use of messaging platforms in healthcare.

Medical interventions are becoming more complex day by day. Moreover, compared with the past, more healthcare professionals take part in the same intervention in the field of medicine. The use of technology in medical interventions has also increased. This change in the health sector brings together several legal discussions. In this study, the legal consequences that arise from the treatment processes carried out by the residents and resident educators (registerers / attending physicians), the exchange of information between them, and the usage of some messaging platforms, especially WhatsApp, in this process will be analyzed.

La inteligencia artificial y sus aplicaciones en medicina II: importancia actual y aplicaciones prácticas / Artificial intelligence and its applications in medicine II: Current importance and practical applications

La tecnología y la medicina siguen un camino paralelo durante las últimas décadas. Los avances tecnológicos van modificando el concepto de salud y las necesidades sanitarias están influyendo en el desarrollo de la tecnología. La inteligencia artificial (IA) está formada por una serie de algoritmos lógicos suficientemente entrenados a partir de los cuales las máquinas son capaces de tomar decisiones para casos concretos a partir de normas generales. Esta tecnología tiene aplicaciones en el diagnóstico y seguimiento de pacientes con una evaluación pronóstica individualizada de los mismos. Además, si combinamos esta tecnología con la robótica, podemos crear máquinas inteligentes que hagan propuestas diagnósticas o que sean mucho más eficientes en su trabajo. Por lo tanto la IA va a ser una tecnología presente en nuestro trabajo cotidiano a través de máquinas o programas informáticos, que de manera más o menos transparente para el usuario, van a ir siendo una realidad cotidiana en los procesos sanitarios. Los profesionales sanitarios tenemos que conocer esta tecnología, sus ventajas y sus inconvenientes, porque va a ser una parte integral de nuestro trabajo. En estos dos artículos pretendemos dar una visión básica de esta tecnología adaptada a los médicos con un repaso de su historia y evolución, de sus aplicaciones reales en el momento actual y una visión de un futuro en el que la IA y el Big Data van a conformar la medicina personalizada que caracterizará al siglo XXI

Technology and medicine follow a parallel path during the last decades. Technological advances are changing the concept of health and health needs are influencing the development of technology. Artificial intelligence (AI) is made up of a series of sufficiently trained logical algorithms from which machines are capable of making decisions for specific cases based on general rules. This technology has applications in the diagnosis and follow-up of patients with an individualized prognostic evaluation of them. Furthermore, if we combine this technology with robotics, we can create intelligent machines that make more efficient diagnostic proposals in their work. Therefore, AI is going to be a technology present in our daily work through machines or computer programs, which in a more or less transparent way for the user, will become a daily reality in health processes. Health professionals have to know this technology, its advantages and disadvantages, because it will be an integral part of our work. In these two articles we intend to give a basic vision of this technology adapted to doctors with a review of its history and evolution, its real applications at the present time and a vision of a future in which AI and Big Data will shape the personalized medicine that will characterize the 21st century

The Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for Nursing.

The 21st Century Cures Act, passed in December 2016 by the United States Congress, is a public law aimed at accelerating the time it takes to get pharmaceutical drugs and medical devices into the market, in addition to shifting connected review processes from randomized controlled trials to real-world efficacy tests. As of December 2019, efforts are underway to introduce a "Cures Act 2.0" bill, with particular attention to the implementation of digital health within health systems. Research on the development of emergent health technologies is nascent; research examining health technology implications of 21st Century Cures Act for the health care workforce is nonexistent. This article fills a crucial gap in public awareness, discussing ethical implications of the 21st Century Cures Act and centering nursing. Nursing is a profession frequently acknowledged as practicing on "the front lines of care" and frequently responsible for the trialing of products in clinical settings. The article summarizes and evaluates key components of the 21st Century Cures Act related to health technology development. Discrete health technologies addressed are (a) breakthrough devices, (b) digital health software, and (c) combination products. It then connects these provisions to ethical considerations for nursing practice, research, and policy. The article concludes by discussing the relevance of emerging digital health technologies to the crafting of a "Cures 2.0" bill, with particular attention to this moment in light of digital care precedents set during the COVID-19 pandemic.

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies.

OBJECTIVE: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. METHODS: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. RESULTS: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. CONCLUSION: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

[Positive ethical regulation of digital technology in care plan]. / La régulation éthique positive du numérique dans les parcours de soins.

The shift in our healthcare system towards organisational models based on patient care management is one of the structural changes that have taken place in recent years. Digital technology represents a major lever to support this transformation, which has high stakes for improving the quality and efficiency of patient care. Positive regulation of the associated ethical issues can be achieved through the principle of a human guarantee of digital technology and artificial intelligence in health care, which is currently being recognised in the framework of the revision of the bioethics law.

Treating or Killing? The Divergent Moral Implications of Cardiac Device Deactivation.

In this article, I argue that there is a moral difference between deactivating an implantable cardioverter defibrillator (ICD) and turning off a cardiac pacemaker (CP). It is, at least in most cases, morally permissible to deactivate an ICD. It is not, at least in most cases, morally permissible to turn off a pacemaker in a fully or significantly pacemaker-dependent patient. After describing the relevant medical technologies-pacemakers and ICDs-I continue with contrasting perspectives on the issue of deactivation from practitioners involved with these devices: physicians, nurses, and allied professionals. Next, I offer a few possible analyses of the situation, relying on recent work in medical ethics. Considerations of intention, responsibility, and replacement support my distinguishing between ICDs and CPs. I conclude by recommending a change in policy of one of the leading cardiac societies.

New Technologies, New Challenges for Human Rights? The Work of the Council of Europe.

Convergence of emerging technologies (e.g. biotechnologies, information and cognitive technologies) has opened new perspectives for progress with regard to human health. However, these technologies also open new possibilities for interventions on human beings, which may be more invasive, and possibly affect and modify individuals. Established practices in the field of biomedicine are also evolving in a way that exerts pressure on existing protective mechanisms. Thus, consideration is required as to whether existing human rights provisions are still fit for purpose or whether there is a need to re-examine, clarify or re-enforce them or even a need to identify new human rights and protective measures. This article gives an overview of the main issues considered by the Committee on Bioethics of the Council of Europe to develop a Strategic Action Plan aimed at ensuring appropriate protection of human rights in the developments in biomedicine, promoting thereby progress for human health.

What Do We Have to Lose? Offloading Through Moral Technologies: Moral Struggle and Progress.

Moral bioenhancement, nudge-designed environments, and ambient persuasive technologies may help people behave more consistently with their deeply held moral convictions. Alternatively, they may aid people in overcoming cognitive and affective limitations that prevent them from appreciating a situation's moral dimensions. Or they may simply make it easier for them to make the morally right choice by helping them to overcome sources of weakness of will. This paper makes two assumptions. First, technologies to improve people's moral capacities are realizable. Second, such technologies will actually help people get morality right and behave more consistently with whatever the 'real' right thing to do turns out to be. The paper then considers whether or not humanity loses anything valuable, particularly opportunities for moral progress, when being moral is made much easier by eliminating difficult moral deliberation and internal moral struggle. Ultimately, the worry that moral struggle has value as a catalyst for moral progress is rejected. Moral progress is understood here as the discovery and application of new values or sensitization to new sources of harm.

Knowledge development, technology and questions of nursing ethics.

This article explores emerging ethical questions that result from knowledge development in a complex, technological age. Nursing practice is at a critical ideological and ethical precipice where decision-making is enhanced and burdened by new ways of knowing that include artificial intelligence, algorithms, Big Data, genetics and genomics, neuroscience, and technological innovation. On the positive side is the new understanding provided by large data sets; the quick and efficient reduction of data into useable pieces; the replacement of redundant human tasks by machines, error reduction, pattern recognition, and so forth. However, these innovations require skepticism and critique from a profession whose mission is to care for and protect patients. The promise of technology and the new biological sciences to radically and positively transform healthcare may seem compelling when couched in terms of safety, efficiency, and effectiveness but their role in the provision of ethical nursing care remains uncertain. Given the profound moral and clinical implications of how today's knowledge is developed and utilized, it is time to reconsider the relationship between ethics and knowledge development in this new uncharted area.

Ethical issues related to the use of gerontechnology in older people care: A scoping review.

BACKGROUND: Demographic trends indicate growth of population aged 65 and older in Western countries. One of the greatest challenges is to provide high-quality care for all. Technological solutions designed for older people, gerontechnology, can somewhat balance the gap between resources and the increasing demand of healthcare services. However, there are also ethical issues in the use of gerontechnology that need to be pointed out. PURPOSE: To describe what ethical issues are related to the use of gerontechnology in the care of community-dwelling older people. METHODS: A scoping review was performed to identify and analyse studies concerning ethical issues when using gerontechnology in the home care of older people. The literature search was limited to studies published after 1990 and addressed to the electronic databases CINAHL, PubMed, Cochrane, Medic, IEEE Explore and Web of Science. The search was performed in July-August 2018. Data from empirical studies were analysed using thematic analysis. ETHICAL CONSIDERATIONS: This scoping review was conducted in accordance with good scientific practice. The work of other researchers was respected and cited appropriately. RESULTS: A total of 17 studies were identified. Two main themes were found. 'Balancing between the benefits of using gerontechnology and the basic rights of older people', consisted of the subthemes safety, privacy and autonomy. The other main theme, 'Gerontechnology as a risk of insecurity for older people', included the subthemes fear of losing human contact and concern and fear. Surveillance and monitoring technologies were mainly studied. CONCLUSION: These results suggest that there may be ethical issues related to the use of gerontechnology and they must therefore be taken into consideration when implementing technology in the care of community-dwelling older people.

Regulation of Stem Cell Technology in Malaysia: Current Status and Recommendations.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy (2009) are examined. The study's findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation (2016) of the International Society for Stem Cell Research (ISSCR) containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders.

Progress bias versus status quo bias in the ethics of emerging science and technology.

How should we handle ethical issues related to emerging science and technology in a rational way? This is a crucial issue in our time. On the one hand, there is great optimism with respect to technology. On the other, there is pessimism. As both perspectives are based on scarce evidence, they may appear speculative and irrational. Against the pessimistic perspective to emerging technology, it has been forcefully argued that there is a status quo bias (SQB) fuelling irrational attitudes to emergent science and technology and greatly hampering useful development and implementation. Therefore, this article starts by analysing the SQB using human enhancement as a case study. It reveals that SQB may not be as prominent in restricting the implementation of emergent technologies as claimed in the ethics literature, because SQB (a) is fuelled by other and weaker drivers than those addressed in the literature, (b) is at best one amongst many drivers of attitudes towards emergent science and technology, and (c) may not be a particularly prominent driver of irrational decision-making. While recognizing that SQB can be one driver behind pessimism, this article investigates other and counteracting forces that may be as strong as SQB. Progress bias is suggested as a generic term for the various drivers of unwarranted science and technology optimism. Based on this analysis, a test for avoiding or reducing this progress bias is proposed. Accordingly, we should recognize and avoid a broad range of biases in the assessment of emerging and existing science and technology in order to promote an open and transparent deliberation.

Psychosis, vulnerability, and the moral significance of biomedical innovation in psychiatry. Why ethicists should join efforts.

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we (i) integrate insights from several areas of ethics, (ii) translate bioethical principles into the mental health context, and (iii) proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna's notion of 'layers of vulnerability' to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis.