Search Results (246)

Extracellular vesicle (EV)-based therapies have attracted considerable attention as a novel class of biologics with broad clinical potential. However, their clinical translation is impeded by the fragmented and rapidly evolving regulatory landscape, with significant disparities between the United States, European Union, and key Asian jurisdictions. In this review, we systematically analyze regional guidelines and strategic frameworks governing EV therapeutics, emphasizing critical hurdles in quality control, safety evaluation, and efficacy demonstration. We further explore the implications of EVs’ heterogeneity on product characterization and the emerging direct-to-consumer market for EVs and secretome preparations. Drawing on these insights, in this review, we aim to provide a roadmap for harmonizing regulatory requirements, advancing standardized analytical approaches, and fostering ongoing collaboration among regulatory authorities, industry stakeholders, and academic investigators. Such coordinated efforts are essential to safeguard patient welfare, ensure product consistency, and accelerate the responsible integration of EV-based interventions into clinical practice. Full article

Valley fever (coccidioidomycosis) is an infection posing a significant human health risk, resulting from the soil-dwelling fungi Coccidioides. Although incidence and mortality from coccidioidomycosis are underreported in the United States, and this underreporting may impact public health policy in numerous jurisdictions, its incidence is rising. Underreporting may stem from diagnostic and testing difficulties, insufficient environmental sampling for pathogen detection to determine endemicity, and a shortage of data on Coccidioides dispersion. As climate change creates increasingly arid locations in the US favorable for Coccidioides proliferation, determining its total endemicity becomes more difficult. This literature review examining published research from 2000 to 2025 revealed a paucity of publications examining the endemicity of Coccidioides and research gaps in detection methods, including limited studies on the reliability of sampling for geographical and temporal variations, challenges in assessing various sample materials, poorly defined storage conditions, and the lack of precise, less restrictive, cost-effective laboratory procedures. Addressing these challenges requires interdisciplinary collaboration among Coccidioides researchers, wildlife experts, atmospheric and climate scientists, and policymakers. If these obstacles are solved, standardized approaches for identifying Coccidioides, classified by climate zones and ecoregions, could be developed, saving financial resources, labor, and time for future researchers studying the environmental drivers of coccidioidomycosis. Full article

In the last two decades, the prevalence of South Asian migrant workers has significantly increased in the UAE’s construction sector, and they are under huge debt. Although researchers heavily stress the role of employers in migrant workers’ debt, the role of debt before departure has not been investigated. Thus, this study bridges this gap in the literature in the context of South Asian construction migrant workers. The objective of this study is to investigate how informal recruitment fees and debt arrangements contribute to bonded labor and dependency among migrant workers. A qualitative approach was used to conduct in-depth interviews with 30 South Asian migrants employed in the construction sector. This article highlights how pre-migration debt—which is often accrued through informal loans and exploitative recruitment fees—has been underexplored in migration studies. Drawing on interviews with 30 South Asian laborers, this study identifies five interconnected themes: pre-migration debt bondage, exploitative lending practices, lack of legal recourse, emotional manipulation, and a cycle of dependency. While UAE labor policies have improved, the real vulnerabilities lie in the informal recruitment systems and weak oversight in migrant workers’ countries of origin. Consequently, five themes were generated from the analysis: pre-migration debt bondage, exploitative lending practices, no legal recourse, emotional manipulation, and cycles of dependency. This study contributes to our existing knowledge by revealing the experiences of migrant construction workers from South Asia in the UAE. While the UAE has established one of the region’s most progressive legal frameworks to protect migrant workers and set clear labor standards, many exploitative practices occur outside its jurisdiction, particularly in the workers’ countries of origin. This study underscores that the root of the problem lies in weak enforcement and informal recruitment networks in sending countries, not in UAE policy itself. Addressing these challenges requires coordinated international action to ensure that migrant protection begins well before arrival. Full article

This article examines the level of inconsistency in work, health and safety (WHS) laws across Australia’s mining sector. Despite general efforts towards national harmonisation through model WHS legislation, significant inconsistencies persist because individual states and territories retain primary regulatory control. A critical analysis of each jurisdiction’s legislative framework reveals a fragmented legal landscape. Queensland, especially, exhibits notable divergence. Key findings highlight a considerable variation in legislative approaches to risk management principles and specific obligations. In particular, a disjointed and incremental approach to serious offences such as industrial manslaughter and provisions concerning imputed conduct are evident. These inconsistencies suggest that corporations operating in multiple Australian mining regions must develop a nuanced understanding of the varying WHS requirements in each jurisdiction. This study underscores the need for caution when assessing risk management strategies aimed at preventing serious incidents because the presumption of a harmonised system can be misleading, especially concerning mining-specific legislation. Full article

The Kingdom of Saudi Arabia (KSA) Personal Data Protection Law (PDPL) was enacted in 2021. In its brief three-year existence, the PDPL has attracted significant academic and legal practitioner attention. This critical analysis focuses on three key questions: (1) What are the key PDPL objectives? (2) How does this legislation compare with privacy–data protection approaches adopted in other jurisdictions (notably the European Union General Data Protection Regulation 2016 (GDPR))? and (3) Does the PDPL achieve a reasonable, workable balance between personal data protection (‘data subjects’ interests) and risks associated with personal data being shared with KSA insurers? The analysis confirms that these PDPL measures appear sound, but a definitive assessment of the ‘balance’ objectives highlighted here requires ongoing attention—three years of PDPL use is an insufficient basis to reach final conclusions regarding PDPL fitness for purpose. However, a tentative ‘soundness’ conclusion has reasonable support when the relevant authorities are collectively assessed, particularly regarding the treatment of personal data by KSA insurers in the context of personal insurance policies. Full article

The emergence of generative AI presents complex challenges to existing copyright regimes, particularly concerning the large-scale use of copyrighted materials in model training. Legal disputes across jurisdictions highlight the urgent need for a balanced, principle-based framework that protects the rights of creators while fostering innovation. In China, a regulatory approach of “moderate leniency” has emerged—emphasizing control over downstream AI-generated content (AIGC) while adopting a more permissive stance toward upstream training. This model upholds the idea–expression dichotomy, rejecting theories such as “retained expression” or “retained style”, which improperly equate ideas with expressions. A critical legal distinction lies between real-time training, which is ephemeral and economically insignificant, and non-real-time training, which involves data retention and should be assessed under fair use test. A fair use exception specific to AI training is both timely and justified, provided it ensures equitable sharing of technological benefits and addresses AIGC’s potential substitutive impact on original works. Furthermore, technical processes like format conversion and machine translation do not infringe derivative rights, as they lack human creativity and expressive content. Even when training involves broader use, legitimacy may be established through the principle of technical necessity within the reproduction right framework. Full article

A new integrated multi-user monitoring system for Brazilian Jurisdictional Waters (BJW), developed by Instituto Nacional de Pesquisas Espaciais (INPE) with participation from leading universities and research centers in Brazil, proposes a national approach to address oil spills in the South Atlantic. The system incorporates a range of technologies, such as satellite data, AI algorithms, autonomous sensors, and high-resolution modeling, to detect and respond to oil spills and maritime threats. This initiative not only aims to strengthen Brazil’s readiness to address the oil spills but also contribute to the protection of BJW resources and ecosystems. This opinion paper presents third-party viewpoints on SisMOM, analyzing both the positive and negative aspects of the project. It also explores some expectations for SisMOM, including some main and alternative methodologies. This article only reflects the authors’ perspectives, interpretations, points of view, opinions, and discussions about SisMOM’s propositions. This paper does NOT represent an official communication of the program, nor its methodologies and developments. Full article

This article examines algorithmic bias as a pressing legal challenge, situating the issue within the broader context of artificial intelligence (AI) governance. We employed comparative legal analysis and reviewed pertinent regulatory documents to examine how the fragmented U.S. approaches and the EU’s user-centric legal frameworks, such as the GDPR, DSA, and AI Act, address the systemic risks posed by biased algorithms. The findings underscore persistent enforcement gaps, particularly concerning opaque black-box algorithmic design, which hampers bias detection and remediation. The paper highlights how current regulatory efforts disproportionately affect marginalized communities and fail to provide effective protection across jurisdictions. It also identifies structural imbalances in legal instruments, particularly in relation to risk classification, transparency, and fairness standards. Notably, emerging regulations often lack the technical and ethical capacity for implementation. We argue that global cooperation is not only necessary but inevitable, as regional solutions alone are insufficient to govern transnational AI systems. Without harmonized international standards, algorithmic bias will continue to reproduce existing inequalities under the guise of objectivity. The article advocates for inclusive, cross-sectoral collaboration among governments, developers, and civil society to ensure the responsible development of AI and uphold fundamental rights. Full article

Blockchain technology has evolved beyond financial transactions to revolutionize trust systems. This paper presents a blockchain-based model for decentralized rental agreements and dispute resolution (DRADR). By leveraging smart contracts and implementing two distinct arbitration approaches, our model offers flexible solutions for rental agreement automation, transparency enhancement, and impartial dispute resolution. Our study provides a comprehensive technical analysis of both approaches through theoretical frameworks, smart contract implementation, game-theoretic modeling, and comparative evaluation across multiple legal jurisdictions. We explore the potential of blockchain technology to address long-standing challenges in traditional rental systems, such as power imbalances, inefficiencies, and legal disputes. Key contributions include the integration of decentralized and local justice systems; a detailed game-theoretic analysis of strategic behaviors; and comparative insights into gas efficiency, economic viability, and jurisdictional adaptability across both arbitration approaches. This research paves the way for a more equitable and transparent rental market and contributes to the broader acceptance of blockchain-based solutions in everyday transactions. Full article

REDD+ is a global mechanism that reduces greenhouse gas emissions by preventing deforestation and forest degradation, enhancing forest carbon stocks, and promoting sustainable forest management in developing countries. It plays a crucial role for developing countries in achieving climate targets under the Paris Agreement and can be implemented at the project, subnational, and national levels. Subnational REDD+ offers several advantages over project-level, such as reduced risk of overestimating emissions and enhanced management of leakage. However, the comprehensive opportunities and challenges of subnational REDD+ have not been extensively investigated in the literature. This paper aims to undertake a thorough review of subnational REDD+, highlighting its potential and the obstacles it faces. This systematic review synthesizes the existing literature on subnational REDD+ implementation, analyzing 54 peer-reviewed articles published between 2005 and 2024. The review identified three key factors for the effective implementation of subnational REDD+: financial, social, and institutional factors. Within these three factors, both opportunities and challenges were discussed, drawing on case studies and synthesizing practical implications. Our findings demonstrate that successful subnational REDD+ initiatives require integrated approaches that address the causal relationships between financing mechanisms, governance structures, and stakeholder engagement. The discussion further explores these interdependencies, revealing how constraints in one dimension create cascading effects across others. This study provides empirical insights and actionable recommendations for policymakers and project developers engaged in climate change mitigation efforts. Full article

This study examines patient access to orphan medicinal products (OMPs) in Central and Eastern Europe (CEE) over the past five years, focusing on seven countries: Bulgaria, Czechia, Hungary, Poland, Romania, Slovakia, and Slovenia. While these jurisdictions have undergone rapid healthcare transformations, significant disparities in OMP access persist compared to Western Europe. This study aimed to address this gap by identifying barriers and enablers to optimize patient access to OMPs in a sustainable and equitable manner. A mixed-methodology approach was utilized, combining systematic literature reviews, in-depth interviews, and advisory board insights. Perspectives were gathered from a wide range of stakeholders, including policymakers, payers, academia, industry associations, and patient advocacy groups. Additionally, the study incorporated data from CEE-specific initiatives to triangulate findings and evaluate barriers, enablers, and best practices in OMP access. The analysis identified sub-optimal OMP access across most CEE countries, marked by prolonged delays and lower reimbursement rates compared to Western Europe, with Slovenia and Czechia as notable exceptions. Key barriers include limited awareness, inadequate health technology assessment (HTA) frameworks, insufficient financing mechanisms, underutilization of novel access schemes, and fragmented patient engagement. Conversely, enablers include the presence of rare disease policies, OMP-specific HTA frameworks, and patient-inclusive decision-making processes. Full article

The time is nigh to organize the physical landscapes of the United States under a unified land use policy and planning framework. As human populations have steadily grown, so has the urgency for agencies to plan for land uses at broader scales to overcome continued jurisdictional fragmentation and achieve sustainable and environmentally just landscapes. This paper introduces a vision, conceptual approach, and implementation strategy that applies ecoregions and proposes a unified framework for land use planning and regulation in the United States. The Sustainable Ecoregion Program (SEP) is designed to enable local landowners; public stakeholders; other land users; and state, regional, tribal, and national natural resource professionals to set and achieve future desired conditions for sustainable land uses across landscapes. The objective is to outline a comprehensive and sustainably just solution to the recurring problem of managing conflicting land uses in the face of continued degradation and multiple land tenure systems. The SEP will determine how much of the physical landscape will go to developed, agricultural, and natural landcover types. The framework includes recognition of level III ecoregions as primary boundaries, proposed secondary boundaries and shapes to enhance connectivity and movement across landscapes, a proposed structure for the environmental governance and co-management of landscapes, and definitions of physical landscape types. The benefits and challenges of the SEP are discussed. The outcomes of the SEP include ecological integrity, sustainable land use management, deliberative democracy, just sustainability, and improved quality of life for residents of the United States. Full article

In the current clinical psychiatric practice in most of the world, treatment decisions are based on a person’s capacity to make these decisions. When a person lacks the capacity to understand and appreciate treatment decisions, in many jurisdictions a third-party substitute decision maker (SDM) is appointed on his or her behalf in order to promote safety and optimal clinical outcome. In Ontario, Canada, for example, family members (typically) or public guardians are appointed as SDMs, and they form an integral part of the medical–legal system in psychiatric care. Clinicians working with both patients and their SDMs in these circumstances encounter unique challenges and deliver care in specialized ways, though little research has focused on their experiences and reflections. Based on focus group data, this qualitative study uses a descriptive and interpretative phenomenological approach through thematic analysis to examine these aspects from clinicians working in both inpatient and outpatient settings of an urban teaching hospital’s psychiatric services in Toronto, Canada. Seven key themes emerged: Clinicians (1) appreciate hardships and challenges in lives of SDMs and patients—including the challenging emotions and experiences on both sides, and the risks and relational changes from being an SDM; (2) have an understanding of the patient’s situation and respect for patient autonomy and wishes—they are promoter of autonomy and mindful of patients’ prior wishes amidst patients’ fluctuating capacity, facilitating communication, keeping patients informed and promoting transitioning from SDM to self-determination; (3) have a special working relationship with family SDMs—including supporting SDMs, avoiding harm from delayed or denied treatment, and educating and collaborating with SDMs while maintaining professional boundaries; (4) at times find it difficult working with SDMs—stemming from working with over-involved or uninterested family SDMs, coping with perceived poor SDM decisions, and they sometimes ponder if SDMs are necessary; (5) delineate differences between family and Public Guardian and Trustee (PGT) SDMs—they see PGT as closely aligned with medical decision makers, while family SDMs are more intimately involved and more likely to disagree with a physician’s recommendation; (6) recognize the importance of the SDM role in various contexts—through seeing social values in having SDMs, and acknowledging that having SDMS help them to feel better about their actions as they work to protect the patients; and (7) express ideas on how to improve the current system—at public, societal, and family SDM levels. We conclude that clinicians have unique mediating roles, with privilege and responsibility in understanding the different roles and challenges patients and SDMs face, and have opportunities to improve patient and SDM experiences, clinical outcomes, carry out education, and advocate for ethically just decisions. These clinical roles also come with frustration, discomfort, moral distress and at times vicarious trauma. Clinicians’ unique understanding of this complex and nuanced intersection of patient care provides insight into the core issues of autonomy, duty to care and protect, advocacy, and emotional dynamics involved in this sector as a larger philosophical and social movement to abolish SDMs, as advocated by the Convention on the Rights of Persons with Disability (CRPD), is taking place. We briefly discuss the role of supported decision making as an alternative as. Full article

The shift to renewable energy has become a crucial element in addressing climate change. However, the legal systems that regulate this transition are still largely fragmented, and there is no single international legal framework that governs renewable energy comprehensively. This study investigates why such a unified global framework has not emerged despite various international efforts. It identifies several key challenges, such as the lack of binding commitments in global treaties, inconsistencies between national energy laws, and overlapping jurisdictions. By examining how national policies interact with major international agreements—namely the United Nations Framework Convention on Climate Change (UNFCCC), the Kyoto Protocol, and the Paris Agreement—this study uncovers structural shortcomings that hinder global legal coordination in the renewable energy field. Using a comparative legal approach, the paper highlights how the existing agreements fall short in offering enforceable and coherent standards. In doing so, it contributes to the ongoing discussion on legal fragmentation in environmental governance and suggests possible pathways for developing more integrated legal responses to renewable energy challenges. Full article

This study focuses on Roblox as a case study to explore the legal and technical challenges of content moderation on child-focused social media platforms. As a leading Metaverse platform with millions of young users, Roblox provides immersive and interactive virtual experiences but also introduces significant risks, including exposure to inappropriate content, cyberbullying, and predatory behavior. The research examines the shortcomings of current automated and human moderation systems, highlighting the difficulties of managing real-time user interactions and the sheer volume of user-generated content. It investigates cases of moderation failures on Roblox, exposing gaps in existing safeguards and raising concerns about user safety. The study also explores the balance between leveraging artificial intelligence (AI) for efficient content moderation and incorporating human oversight to ensure nuanced decision-making. Comparative analysis of moderation practices on platforms like TikTok and YouTube provides additional insights to inform improvements in Roblox’s approach. From a legal standpoint, the study critically assesses regulatory frameworks such as the GDPR, the EU Digital Services Act, and the UK’s Online Safety Act, analyzing their relevance to virtual platforms like Roblox. It emphasizes the pressing need for comprehensive international cooperation to address jurisdictional challenges and establish robust legal standards for the Metaverse. The study concludes with recommendations for improved moderation strategies, including hybrid AI-human models, stricter content verification processes, and tools to empower users. It also calls for legal reforms to redefine virtual harm and enhance regulatory mechanisms. This research aims to advance safe and respectful interactions in digital environments, stressing the shared responsibility of platforms, policymakers, and users in tackling these emerging challenges. Full article