[Digital health in Latin America: current legislation and ethical aspectsSaúde digital na América Latina: legislação atual e aspectos éticos]. / Salud digital en América Latina: legislación actual y aspectos éticos.

Objectives: Describe the current legislation on electronic medical records (EMR) and telehealth in Latin American countries and analyze the treatment of confidentiality and professional secrecy. Methods: Between March and September 2022, a survey of the regulations in force in 21 Latin American countries was conducted at two levels: the existence of legislation on EMR and telehealth, and the treatment of confidentiality and professional secrecy in EMR and telehealth. A data extraction form was prepared for each country. Data were collected from official on-line sources. The information was analyzed qualitatively and synthesized in tables when possible. Results: The use of EMR is legally regulated in 16 countries. Nineteen countries have legislation on telehealth. All the countries analyzed safeguard confidentiality and professional secrecy through regulations. However, confidentiality and professional secrecy are mentioned in 11 countries in the context of telehealth, and in only nine countries in the context of EMR. Conclusions: Since the start of this century, Latin America has made progress in the legislation of digital tools for health care, such as EMR and telehealth. There is also interest in ethical issues related to the use of EMR and telehealth, particularly confidentiality and professional secrecy, aspects that should be strengthened in digital health.

Objetivo: Descrever a legislação vigente sobre prontuários eletrônicos e telessaúde nos países da América Latina e analisar o tratamento da confidencialidade e do sigilo profissional. Métodos: Entre março e setembro de 2022, realizou-se um levantamento sobre a regulamentação vigente nos 21 países latino-americanos incluídos no estudo, em dois níveis: i) existência de legislação sobre prontuários eletrônicos e telessaúde; e ii) tratamento da confidencialidade e do sigilo profissional em prontuários eletrônicos e telessaúde. Uma planilha para extração de dados foi elaborada para cada país. Os dados foram coletados de fontes oficiais disponíveis on-line. Foi realizada uma análise qualitativa das informações, que foram resumidas em tabelas, quando possível. Resultados: O uso dos prontuários eletrônicos é legalmente regulamentado em 16 países. Quanto à telessaúde, 19 países têm legislação sobre essa ferramenta. Todos os países analisados protegem a confidencialidade e o sigilo profissional por meio de regulamentação. No entanto, no contexto da telessaúde, eles são mencionados em 11 países; já no contexto dos prontuários eletrônicos, em apenas 9 países. Conclusões: Desde o início dos anos 2000, a América Latina vem avançando em relação à legislação sobre ferramentas digitais na atenção à saúde, como prontuários eletrônicos e telessaúde. Há também interesse nas questões éticas relacionadas ao uso de prontuários eletrônicos e telessaúde, especialmente em relação à confidencialidade e ao sigilo profissional, embora esses aspectos precisem ser reforçados na saúde digital.

Charity or empowerment? The role of COVAX for low and middle-income countries.

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts of "donations" and "charity" with "vaccine equity" and the "empowerment" of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously.

Vulnerability in practice: Peeling back the layers, avoiding triggers, and preventing cascading effects.

The concept of vulnerability is widely used in bioethics, particularly in research ethics and public health ethics. The traditional approach construes vulnerability as inherent in individuals or the groups to which they belong and views vulnerability as requiring special protections. Florencia Luna and other bioethicists continue to challenge traditional ways of conceptualizing and applying the term. Luna began proposing a layered approach to this concept and recently extended this proposal to offer two new concepts to analyze the concept of vulnerability, namely understanding external conditions that trigger vulnerability and layers of vulnerability with cascading effects. Luna's conception of vulnerability is useful, which we demonstrate by applying her layered view and the new analyses in multiple contexts. We begin by outlining Luna's view and we use vignettes from healthcare involving transgender patients, the care of patients in psychiatric contexts, and research involving prisoners to illustrate how each part of Luna's concept elucidates important moral issues.

HIV prevention research and COVID-19: putting ethics guidance to the test.

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.

Ethical challenges in global health-related stigma research.

BACKGROUND: It is critically important to conduct research on stigmatized conditions, to include marginalized groups that experience stigma, and to develop interventions to reduce stigma. However, such research is ethically challenging. Though superficial reference is frequently made to these widely acknowledged challenges, few publications have focused on ethical issues in research on stigmatized groups or conditions. In fact, a brief literature review found only two such publications. MAIN TEXT: At a recent Science of Stigma Reduction workshop comprising 60 stigma researchers from the USA and low and middle-income countries, the need for more robust and critical discussion of the ethics of the research was highlighted. In this paper we describe, illustrate through cases, and critically examine key ethical challenges that are more likely to arise because a research study focuses on health-related stigma or involves stigmatized groups or conditions. We examine the ethics of this research from two perspectives. First, through the lens of overprotection, where we discuss how the perception of stigma can impede ethical research, disrespect research participants, and narrow the research questions. Second, through the lens of research risks, where we consider how research with stigmatized populations can unintentionally result in harms. Research-related harms to participants include potential breaches of confidentiality and the exacerbation of stigma. Potential harms also extend to third parties, including families and populations who may be affected by the dissemination of research results. CONCLUSIONS: Research with stigmatized populations and on stigmatized conditions should not be impeded by unnecessary or inappropriate protective measures. Nevertheless, it may entail different and greater risks than other health research. Investigators and research ethics committees must be particularly attentive to these risks and how to manage them.

Identifying and evaluating layers of vulnerability - a way forward.

"Vulnerability" is a key concept for research ethics and public health ethics. This term can be discussed from either a conceptual or a practical perspective. I previously proposed the metaphor of layers to understand how this concept functions from the conceptual perspective in human research. In this paper I will clarify how my analysis includes other definitions of vulnerability. Then, I will take the practical-ethical perspective, rejecting the usefulness of taxonomies to analyze vulnerabilities. My proposal specifies two steps and provides a procedural guide to help rank layers. I introduce the notion of cascade vulnerability and outline the dispositional nature of layers of vulnerability to underscore the importance of identifying their stimulus condition. In addition, I identify three kinds of obligations and some strategies to implement them. This strategy outlines the normative force of harmful layers of vulnerability. It offers concrete guidance. It contributes substantial content to the practical sphere but it does not simplify or idealize research subjects, research context or public health challenges.

Public health agencies' obligations and the case of Zika.

This article focuses on the initial reactions to the Zika epidemic by national and international public health agencies. It presents and analyzes some responses public officials made about sexual and reproductive health at the inception of the epidemic. It also describes the different challenges and obligations faced by local and international public health agencies, as these have not been clearly outlined. The article argues that these agencies have different obligations and should fulfill them despite existing obstacles. While international agencies should honor their leadership role and make recommendations at a meta-level, local agencies should provide, in the case of Zika, a framework for empowerment and grant women the freedom to achieve sexual and reproductive health so that they can avoid the consequences of this epidemic.

Medical ethics and more: ideal theories, non-ideal theories and conscientious objection.

Doing 'good medical ethics' requires acknowledgment that it is often practised in non-ideal circumstances! In this article I present the distinction between ideal theory (IT) and non-ideal theory (NIT). I show how IT may not be the best solution to tackle problems in non-ideal contexts. I sketch a NIT framework as a useful tool for bioethics and medical ethics and explain how NITs can contribute to policy design in non-ideal circumstances. Different NITs can coexist and be evaluated vis-à-vis the IT. Additionally, I address what an individual doctor ought to do in this non-ideal context with the view that knowledge of NITs can facilitate the decision-making process. NITs help conceptualise problems faced in the context of non-compliance and scarcity in a better and more realistic way. Deciding which policy is optimal in such contexts may influence physicians' decisions regarding their patients. Thus, this analysis-usually identified only with policy making-may also be relevant to medical ethics. Finally, I recognise that this is merely a first step in an unexplored but fundamental theoretical area and that more work needs to be done.

Not the usual suspects: addressing layers of vulnerability.

This paper challenges the traditional account of vulnerability in healthcare which conceptualizes vulnerability as a list of identifiable subpopulations. This list of 'usual suspects', focusing on groups from lower resource settings, is a narrow account of vulnerability. In this article we argue that in certain circumstances middle-class individuals can be also rendered vulnerable. We propose a relational and layered account of vulnerability and explore this concept using the case study of cord blood (CB) banking. In the first section, two different approaches to 'vulnerability' are contrasted: categorical versus layered. In the second section, we describe CB banking and present a case study of CB banking in Argentina. We examine the types of pressure that middle-class pregnant women feel when considering CB collection and storage. In section three, we use the CB banking case study to critique the categorical approach to vulnerability: this model is unable to account for the ways in which these women are vulnerable. A layered account of vulnerability identifies several ways in which middle-class women are vulnerable. Finally, by utilizing the layered approach, this paper suggests how public health policies could be designed to overcome vulnerabilities.

Ethical research when abortion access is legally restricted.

Risks and benefits of some clinical research may be altered.

Brief communication International cooperation in a non-ideal world: the example of COVAX.

The world witnessed one of the fasted responses in history to a new disease in terms of drug and vaccine development. However, despite the fact that safe and effective vaccines for COVID-19 were developed at a remarkable pace, international cooperation seems to have failed regarding the global equitable allocation of vaccines. This article explores challenges to international cooperation in global health and specifically to the fair allocation of vaccines at a global scale. We will present major obstacles to cooperative efforts and an interesting answer such as the COVAX facility, a cooperative redistribution scheme that has recently been launched by WHO, CEPI and Gavi. Considering COVAX a laudable and necessary first step to improve international cooperation in health, we nevertheless argue that the facility needs to identify key areas of potential improvement.

O mundo foi testemunha de uma das respostas mais rápidas da história a uma nova doença em termos de desenvolvimento de medicamentos e vacinas. No entanto, apesar do facto de que as vacinas seguras e eficazes para COVID-19 foram desenvolvidas a um ritmo notável, a cooperação internacional parece ter falhado no que diz respeito à distribuição global equitativa de vacinas. Este artigo explora os desafios para a cooperação internacional em matéria de saúde global e, especificamente, para a distribuição justa de vacinas à escala global. Apresentaremos os principais obstáculos aos esforços cooperativos e uma resposta interessante, como o mecanismo COVAX, um esquema de redistribuição cooperativa que foi lançado recentemente pela OMS, CEPI e Gavi. Considerando o COVAX como um primeiro passo louvável e necessário para melhorar a cooperação internacional em saúde, argumentamos que o mecanismo precisa de identificar as áreas de potencial melhoria.

El mundo ha sido testigo de una de las respuestas más rápidas a una nueva enfermedad, en términos de desarrollo de drogas y vacunas. Sin embargo, pese al hecho de que se han desarrollado vacunas seguras y efectivas para el COVID-19 a un paso impresionante; la cooperación internacional en relación al acceso equitativo a las vacunas parece haber fallado. Este artículo explora los desafíos a la cooperación internacional que se plantean en relación a la salud global y, específicamente, a la distribución justa de vacunas a escala global. Presentaremos algunos obstáculos a los esfuerzos cooperativos, así como también una respuesta interesante como lo es la del mecanismo COVAX, un sistema cooperativo de redistribución que ha sido recientemente introducido por la OMS, CEPI y GAVI. Aunque consideramos a COVAX un primer paso meritorio y necesario para mejorar la cooperación internacional en salud; argumentamos que el mecanismo necesita identificar áreas de mejora.

Shared decision making in mental health: a novel approach.

The health system tends to underestimate the ability to make decisions of people with mental illnesses, characterizing them as vulnerable and adopting a stigmatizing attitude towards this vulnerability. Therefore, their autonomy, in the classical sense of the term, is reduced or nullified. Another way to respond to vulnerability is by promoting autonomy, conceiving it as contextual and autonomy in a relational way. This could be beneficial for people with mental suffering because it allows analyzing what conditions could improve or harm the exercise of autonomy and consider the help of others in decision-making. The shared decision-making process is a form of collaboration between professionals, patients and/or family members, in which the available evidence is shared with the patient and contextualized when faced with the task of making decisions in the medical environment.

Expert Views on COVAX and Equitable Global Access to COVID-19 Vaccines.

Objectives: We face the impossibility of having enough COVID-19 vaccines for everyone in the near future. This study aims to contribute to the debate on equitable global access to COVID-19 vaccines, tackling key ethical discussions and policy challenges regarding early phases of COVAX, the global cooperation mechanism for supporting fair vaccine allocation. Methods: We conducted in-depth interviews with twelve experts and a literature research on academic articles, media sources and public statements. We built a data analysis matrix and conducted a thematic analysis. Results: Our findings show, first, that interviewed experts who hold different views on vaccine allocation, including moderate nationalist perspectives, agree on joining a global cooperation mechanism. Second, incentives to join COVAX vary greatly among countries. Third, specific barriers to COVAX emerged in the early implementation phase. And fourth, countries might be trapped in a zero-sum game regarding the global vaccine supply. Conclusion: We present findings that enrich analyses of early phases of COVAX (April 2020-21), we introduce three ethical discussions that provide a common ground for equitable access to COVID-19 vaccines, and we highlight policy challenges.

On the Ethics of Vaccine Nationalism: The Case for the Fair Priority for Residents Framework.

COVID-19 vaccines are likely to be scarce for years to come. Many countries, from India to the U.K., have demonstrated vaccine nationalism. What are the ethical limits to this vaccine nationalism? Neither extreme nationalism nor extreme cosmopolitanism is ethically justifiable. Instead, we propose the fair priority for residents (FPR) framework, in which governments can retain COVID-19 vaccine doses for their residents only to the extent that they are needed to maintain a noncrisis level of mortality while they are implementing reasonable public health interventions. Practically, a noncrisis level of mortality is that experienced during a bad influenza season, which society considers an acceptable background risk. Governments take action to limit mortality from influenza, but there is no emergency that includes severe lockdowns. This "flu-risk standard" is a nonarbitrary and generally accepted heuristic. Mortality above the flu-risk standard justifies greater governmental interventions, including retaining vaccines for a country's own citizens over global need. The precise level of vaccination needed to meet the flu-risk standard will depend upon empirical factors related to the pandemic. This links the ethical principles to the scientific data emerging from the emergency. Thus, the FPR framework recognizes that governments should prioritize procuring vaccines for their country when doing so is necessary to reduce mortality to noncrisis flu-like levels. But after that, a government is obligated to do its part to share vaccines to reduce risks of mortality for people in other countries. We consider and reject objections to the FPR framework based on a country: (1) having developed a vaccine, (2) raising taxes to pay for vaccine research and purchase, (3) wanting to eliminate economic and social burdens, and (4) being ineffective in combating COVID-19 through public health interventions.

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response.

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group - a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy - in consultation with a variety of external experts and stakeholders.