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Amid growing interest in the integration of health and social care to improve outcomes, communities across the United States have explored development of Community Information Exchanges (CIEs). A CIE is a community governed infrastructure that enables critical health and social information to be responsibly shared among partner organizations in support of holistic coordination of care. The development and use of a CIE give rise to a host of legal and policy challenges. Use and disclosure of data through a CIE are governed by a patchwork of different legal requirements, at times distinct and at times overlapping. Development of a legal framework for a CIE requires attention to clearly articulated data flows, detailed use cases, strong legal agreements and policy considerations. CIEs typically rely on an individual’s express consent to share their information, requiring careful evaluation of applicable laws and regulations and promotion of community trust and equity. And because many participants in a CIE are HIPAA covered entities, functions of the CIE must fit within HIPAA’s regulatory framework. This article examines in depth two components of a sound legal framework—consent models and HIPAA compliance—identifying considerations and lessons learned to support lawful and ethical information sharing through a CIE.
Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial federal actions involving sensitive data. Jurisdictional concerns about compliance, security, and misuse underscore the need for governance frameworks that prioritize clarity, reciprocity, and accountability. Coercive approaches risk deepening fragmentation and undermining collaborative governance. Ultimately, modernization efforts will fail without supporting trust as the cornerstone of public health data governance. This article examines legal variation, transactional friction, and evolving jurisdictional perspectives to illuminate the critical role of trust in shaping the future of public health data systems.
This commentary suggests that the meaning and content of dignity is bound to the broader question of who is said to have personhood and sovereignty, and thus protection and rights under the law, and who is excluded from our legal community.
Tribal nations possess the inherent sovereign authority to protect the health and welfare of their people. Without equitable access to public health data, Tribal nations cannot fulfill this essential governmental duty. Federal, state, and local public health agencies must implement Tribal data sovereignty principles to support the exchange and protection of Tribal public health data. The adoption of Tribal data-sharing agreements can provide a framework for strengthening Tribal data sovereignty and recognizing a Tribe’s inherent right to collect and manage their data.
This article reports new legal data on state syringe services program (SSP) and drug paraphernalia laws in the United States. Scientific legal mapping methods were used to develop a longitudinal legal dataset capturing state-level SSP and drug paraphernalia laws in effect from January 1, 2010, through June 1, 2024. During that period, the number of states with a legal mechanism allowing for syringe distribution from SSPs nearly doubled. However, legal barriers to SSP operations remain in many states.
Prevailing wisdom suggests that sentencing guidelines may constrain judicial discretion and hinder individualised justice; however, our cross-jurisdictional analysis indicates that they might actually better protect these principles than unrestricted discretion. Utilising two large-scale datasets from England and Wales, and Hong Kong, we examine sentences for burglary, assault, and drug trafficking. The results reveal a paradox: guidelines in England and Wales contributed to greater consistency in retributive proportionality and enhanced consideration of personal mitigating factors. Conversely, Hong Kong’s discretionary approach resulted in inconsistent application of sentencing considerations and personal mitigating factors. Both systems prioritised procedural efficiency, with guilty pleas markedly reducing sentences across various offences. These findings challenge the ‘bias effect’ critique by demonstrating that well-structured guidelines can safeguard individualised justice better than unfettered discretion can. The study offers robust empirical evidence for institutional design in criminal justice systems.
In response to the article So You Think You Know Who’s the “Legally Authorized Representative”: Clinical Research Hits a Snag, this invited commentary draws attention to the practical realities that are overlooked in the paper’s examination of enrolling research participants without decisional capacity to provide their own consent. In such scenarios, the participant’s Legally Authorized Representative (LAR) is co-enrolled to consent on the participant’s behalf. Implementation of a research-based LAR is a two-part process that involves identifying the LAR according to legal hierarchy and performing a capacity assessment to determine whether the prospective participant requires an LAR. The paper makes several comparisons between standard care and research approaches to these decisions, most of which the author deems inadequate for clinical research contexts, and suggests that navigating this process may pose “unexpected legal and ethical hazards” for researchers. By offering a practitioner’s perspective in this commentary, I hope to bring clarity to this argument by explaining from direct experience how LAR implementation includes much greater collaboration and thought partnership between researchers and IRBs than the author gives credit for.
Although “law” is the primary common ground in law and society scholarship, many of us are trained in other, complementary academic disciplines, which give us unique perspectives into the interaction between law and society. How can we employ these perspectives in ways that help us effectively speak to our various disciplinary audiences? In this short essay, I draw from my own experiences navigating professional life in the academy to explore how my engagement with law and society scholarship has helped me navigate scholarly life between law and anthropology.
The Irish Supreme Court’s decision in Kelly v UCD1 is a significant ruling on judicial bias and disqualification. It is the first case to consider the implications of familial connections between judges and law firms representing parties since the Judicial Conduct Committee published its Guidelines on Judicial Conduct and Ethics in 2022.2 The case clarifies the legal test for objective bias, delineates its boundaries, and addresses the role of judicial conduct guidelines in disqualification decisions. It also has broader implications for other common law jurisdictions, particularly England & Wales, where similar issues of judicial propriety and public confidence in impartial adjudication arise.
Commenting on Cargill’s article, this Commentary examines how gene therapy research is regulated in the United States and how oversight of the field has developed. It discusses recent applications of gene therapy technologies and their implications for oversight, and of the impact of ordered cuts to NIH-funded research on gene therapy developments more broadly. Ultimately, it underscores the need for adaptive oversight frameworks for research involving emerging biotechnologies that balance scientific innovation, safety, and ethical considerations, and for effective public engagement on the acceptable use of these technologies, notwithstanding the discontinuation of NIH’s advisory mechanism established for this purpose.
Political pressures and institutional constraints have shaped a reactionary regulatory system that unduly preferences industry interests over public health. Breaking the reactive cycles that have long shaped device regulation will involve more than standard technical or incremental reforms. Congress would instead need to revisit more foundational values of device regulation to better align policy with the interests of patients and public health.
The data is clear: Earth’s temperature is on the rise, with the 10 most recent years being the hottest on record. Extreme heat is the number one weather-related killer in the United States. Laws and policies to protect individuals from the health hazards of extreme heat exposure are being contemplated across the nation at the federal, state, and local level. This paper aims to address the realities of extreme heat exposure and community needs during extreme heat. First, it will define important terms relevant to heat as used in climate science, occupational health, public health, and other fields. Second, it will describe heat exposure and needed protections for vulnerable populations, such as communities located in urban heat islands, those experiencing direct heat exposure in the workplace and those who lack access to cooling equipment at home. Last, the paper will explore law and policy approaches to address the health impacts of extreme heat, including a focused discussion of two different areas of the country: Florida and New York City.
This paper explores the interplay between intellectual property and gender in modern design law and practice, with a focus on the New Zealand Designs Act 1953 and references to Australian, United Kingdom and European Union law. It highlights how law and practice favour technical, utilitarian design principles (that coded masculine), but neglect the dynamic, sensory and affective (embodied and emotive) aspects of designs (that coded feminine). Through its focus on the technical, design law and practice ignore the socio-legal reality that the dynamic, sensory and affective are often central to a design’s success. The paper frames the foregoing in standpoint theory and affect. It challenges the focus on that which can be reduced to technical-based representation and the perception that this creates an objective master copy. The paper calls for a reassessment of what design law protects and how it protects it, to better align the system with the socio-legal realities of design creation and use.