Journal of Law Medicine & Ethics最新文献

Narratives and frames have shaped the overdose crisis since its early stages. Efforts to control knowledge about the role of opioids in chronic pain have influenced clinical guidelines and prescribing behaviour. Dominant narratives shape policy by influencing how problems are defined, and which solutions are considered appropriate. A more nuanced understanding of how framing shapes interactions among stakeholders, including patients, clinicians, advocacy groups, industry, educators, and regulators, can clarify these dynamics. Engaging multiple perspectives, rather than relying on a single dominant narrative, offers a more effective path for addressing complex public health emergencies such as the overdose crisis.

Over the past ten years, global health lawyers have actively engaged with noncommunicable diseases (NCDs). A pivotal instrument in this regard is the Framework Convention on Tobacco Control, adopted by the World Health Organization (WHO) in 2003. Despite its open-ended wording, it has significantly influenced domestic tobacco regulation. For instance, thanks to this treaty, the Dutch government no longer engages with the tobacco industry and has (independent from the tobacco industry) implemented various tobacco control measures, resulting in a significant reduction in smoking. The treaty also serves as an exemplary model for the adoption of similar treaties to regulate other behavioral risk factors such as unhealthy diets and alcohol use, as well as broader environmental determinants.

From its beginnings in the 1978 Declaration of Alma-Ata, universal health coverage (UHC) has been constantly evolving, notably so within the last ten years. Although the 2015 Sustainable Development Goals, which identify both UHC and social protection among its targets, represent an important juncture in this evolution, several States are unlikely to meet the 2030 target deadline. This article traces the history of UHC and social (health) protection in global health law, focusing on their development over the past ten years. It concludes by reflecting on what the future of UHC and social (health) protection should look like and what is needed to fully realize their potential to achieve equity and to meaningfully contribute to the betterment of people and planet, highlighting human rights, One Health, legal and financial considerations as key for the future.

Global health law has now emerged as an area of specialisation for students interested in global problems concerning health due largely, if not principally, to the inspiring lifelong scholarly work of Professor Lawrence Gostin. A growing number of universities in the world have established programs on global health law in which they address questions of equity and solidarity in addressing public health issues and emergencies, global and national preparedness for pandemics and other health related emergencies, international health regulations, and the intersection between health and human rights, to mention a few. We can expect that as global health threats and inequalities in access to health continue to rise, interest in global health law as a field of legal research and education will continue to grow.

I write in tribute to my friend Larry Gostin, who has long emphasized that accountability and governance are central to global health policy.

Human rights offer to ground global health law in equity and justice. Human rights norms, advocacy, and strategies have proven successes in challenging private and public inequities and in realizing more equitable domestic and global health governance. However, mobilizing human rights within global health law faces enormous political, economic, technological, and epidemiological challenges, including from the corrosive health impacts of power, politics, and commerce. This article focuses on what human rights could bring to three major global health law challenges - health systems strengthening and universal health coverage, the commercial and economic determinants of health, and pandemic disease threats. We argue that human rights offer potentially powerful norms and strategies for achieving equity and justice in these and other key global health domains. The challenge for those working in human rights and global health law is to work nimbly, creatively, and courageously to strengthen the contribution of these instruments to health justice.

The participation of non-state actors in global health law has undergone tremendous change over the years, with non-state actors playing an increasingly important role in the formation of global health law - in terms of engagement in international health governance forums and health policy decision processes. Global health movements and advocacy groups dedicated to specific diseases (for instance HIV/AIDS, tuberculosis and malaria) and health rights have been increasingly pivotal in ensuring that global health policies are rights-based. This article interrogates the role that nongovernmental organizations (NGOs) have played in shaping global health law. Looking at how the historical and traditional roles of NGOs have evolved over time, this article analyzes the contribution that NGOs have made in advancing and defining a rights-based approach to health.

Artificial Intelligence (AI) has the potential to revolutionize public health surveillance by analyzing large datasets to detect outbreaks. However, privacy, consent, and governance issues persist. While the International Health Regulations do not explicitly mention the use of AI in infectious disease surveillance, transparent processes, accountability, and public trust are key for responsibly integrating AI in pandemic preparedness.

This paper examines in what way providers of specialized Large Language Models (LLM) pre-trained and/or fine-tuned on medical data, conduct risk management, define, estimate, mitigate and monitor safety risks under the EU Medical Device Regulation (MDR). Using the example of an Artificial Intelligence (AI)-based medical device for lung cancer detection, we review the current risk management process in the MDR entailing a "forward-walking" approach for providers articulating the medical device's clear intended use, and moving on sequentially along the definition, mitigation, and monitoring of risks. We note that the forward-walking approach clashes with the MDR requirement for articulating an intended use, as well as circumvents providers reasoning around the risks of specialised LLMs. The forward-walking approach inadvertently introduces different intended users, new hazards for risk control and use cases, producing unclear and incomplete risk management for the safety of LLMs. Our contribution is that the MDR risk management framework requires a backward-walking logic. This concept, similar to the notion of "backward-reasoning" in computer science, entails sub-goals for providers to examine a system's intended user(s), risks of new hazards and different use cases and then reason around the task-specific options, inherent risks at scale and trade-offs for risk management.