Researchers, as well as individuals and institutions that oversee their conduct, sometimes have conflicts of interest that weaken or render ineffective efforts to protect human research subjects. This article analyzes United States and international standards used to address conflicts of interest and reviews evidence regarding compliance. It finds current standards are insufficient and recommends that the federal government and international organizations adopt stronger legal standards that require resolving most significant conflicts of interest and specifying how to manage conflicts of interest not resolved.

Foods and beverages marketed for infants, babies, and toddlers through 3 years of age is a $7 billion industry in the United States, incorporating a wide range of products, including infant formula and other types of drinks, foods, and snacks. The World Health Organization (“WHO”) found that mothers “are often inundated with incorrect and biased information” from direct advertising, health claims on products, information packs from sales representatives, and the distribution of samples of infant formula and “educational materials” by infant formula manufacturers. To address these problematic practices, in 1981, the WHO established the International Code of Marketing of Breast-milk Substitutes (the “Code”) to end the inappropriate marketing of infant formula and other food and drinks intended for children up to age two. In 2016, WHO expanded the definition of breastmilk substitutes to include milk and milk products specifically marketed for feeding infants and young children up to age three. However, the United States is one of a minority of countries that has not passed any legislation or regulation to implement the Code. Furthermore, U.S. regulation and enforcement actions have not kept pace with the introduction of new products and product categories and the profusion of labeling and marketing claims questionably implying nutritional and developmental benefits from these products.

Beginning on inauguration day, President Trump has attempted an executive repeal of the Affordable Care Act. In doing so, he has tested the limits of presidential power. He has challenged the force of institutional and non-institutional constraints. And, ironically, he has helped boost public support for the ACA's central features. The first two sections of this article respectively consider the use of the President's tools to advance and to subvert health reform. The final two sections consider the forces constraining the administration's attempted executive repeal. I argue that the most important institutional constraint, thus far, is found in multifaceted actions by states – and not only blue states. I also highlight the force of public voices. Personal stories, public opinion, and 2018 election results – bolstered by presidential messaging – reflect growing support for government-grounded options and statutory coverage protections. Indeed, in a polarized time, “refine and revise” seems poised to supplant “repeal and replace” as the conservative focus countering liberal pressure for a common option grounded in Medicare.

Every day, companies collect health information from customers and analyze it for commercial purposes. This poses a significant threat to privacy, particularly as the Fourth Amendment protection of this deeply personal information is limited. Generally, law enforcement officers do not need probable cause and a warrant to access these private health information databases; only a subpoena is required, and sometimes nothing at all. The Fourth Amendment protections for health information may, however, have changed after the Supreme Court's 2018 decision in Carpenter v. United States, which held that the Fourth Amendment protects people from warrantless searches of historical cell-site location information possessed by their cell phone providers. The Court explained that, because of the nature of historical cell-site location information, individuals retain a reasonable expectation of privacy despite the information being in the possession of a third party. In reaching its holding, the Supreme Court considered the type of data, the uniqueness of cell-site location information, the impact of technological advancement on privacy, the voluntariness of the disclosure, and the property rights associated with the records. Many of these factors could support heightened Fourth Amendment protection for health information. This Article argues that Carpenter v. United States provides additional protections for future searches of health information in private databases.

States struggle to maintain a facade of sovereignty against the large-scale migration of immigrants and asylum seekers, who are trying to find their way into the receiving societies. Increased borders control, reinforced socio-legal boundaries and detention facilities are some of the constant efforts' states employ to quell the immigration of asylum seekers and control their presence. Disciplinary power often appears in a centralized form, such as borders and immigration systems, but also in decentralized, dispersed forms, ranging from medical practices, media and market influences, as well as many others, which were termed by Foucault as biopower. This force - which in its broad meaning describes deliberate attempts to interfere with the essential human existence and manage all spheres of life - is defined by Foucault as a ‘political power [that] had assigned itself the task of administering life’. Biopower is employed to manage, regulate and govern lives, produce obedience, and subordinate individuals and communities to disciplinary practices. The control over lives should be understood comprehensively, so that includes ‘a life of the city…political life, economic life…’ as well as ‘the management of … money … information, communication, water, sheep, grain …’. Accordingly, we argue that food is a form of biopower, an apparatus utilized to control and govern asylum-seekers. We posit that the state uses food to monitor the individuals' well-being, the community life, and affect the social existence. In this article, “food” refers to the role sustenance plays in providing nutrition and reinforcing socio-cultural values.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the “democratic deficit” to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability.

The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

Informed consent matters — so does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, this article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and reached without coercion. We suggest that the information provided must address the nature of the procedure — including benefits to the child, benefits to society, and risks. Parents should have their concerns and misconceptions addressed. The information needs to be accessible and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. These two countries are similar in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, there are meaningful differences in their vaccine policies and the current structures of their informed consent processes, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the processes used to obtain informed consent.

In the 21st century the opportunity for the public to comment to an administrative agency typically means an invitation to go to a website, type words into a box, and hit send. Many advocacy groups provide templates for people to submit a statement in support or opposition to specific proposals. However, standardized comments do not capture the voice of Medicaid. They do not share people's personal experiences and insights. This article describes how consumer advocates in Kentucky devised a strategy, their Secret Sauce, to help consumers participate in the public comment process that is now required for Section 1115 Medicaid demonstration waiver applications. It shows how advocates can help real people's voices be heard in the public comment process, not through templates but through a process that assists people to tell their own stories in their own words. This is Medicaid's voice, the stories of real people who rely on Medicaid. Medicaid's voice can help policy makers understand the real-life impact of policy choices they make. It can also provide relevant evidence for courts reviewing the Secretary's grant of a Section 1115 waiver. Medicaid's voice can also help build political momentum, bringing those who rely on Medicaid to the polls and into the political conversation about the future of Medicaid.

On January 8, 2019, shortly after his inauguration, California's Governor Gavin Newsom announced a proposal to provide health coverage to undocumented immigrants up to age 26. That same day, New York Mayor Bill de Blasio offered a $100 million plan to cover 600,000 uninsured New Yorkers, regardless of immigration status. These proposals from public officials on opposite sides of the continent stood in stark contrast to the Trump Administration's demand for a wall at the southern border, and its proposed public charge regulations that are expected to lead millions of lawfully present immigrants and their families to forego health insurance.