This article describes implementation of a longitudinal curriculum in public health law, building on doctrinal coursework with skills-based coursework and opportunities for interdisciplinary, community-based engagement and service learning. It specifically describes development of a Policy Practicum, giving an example of how law students can learn policy skills and skills of effective community coalition work through a healthy homes partnership, highlighting areas where the curriculum can incorporate interdisciplinary education. It offers lessons learned during the curriculum-building process, and concludes with a more intensive service-learning strategy through the development of a Policy Lab.

Finding “common ground” to fix some of the policy problems with the ACA was never expected to be easy. How challenging depends on the election outcome. With split government or even same party control of the Congress and White House but without a supermajority in the Senate, fixing identifiable problems requires remedies that might garner bipartisan cooperation. Some potential strategies that might meet this requirement are described.

Newborn male circumcision is a minor surgical procedure that has generated significant controversy. Accumulating evidence supports significant health benefits, most notably reductions in urinary tract infections, acquisition of HIV and a number of other sexually transmitted infections, penile cancer, phimosis, paraphimosis, balanitis and lichen sclerosis. While circumcision, like any surgical procedure, has risks for complications, they occur in less than 1 in 500 infants circumcised and most are minor and require minimal intervention. The CDC and the American Academy of Pediatrics (AAP) believe that health benefits of circumcision outweigh the risks. For this reason, the AAP believes that parents should be allowed to make the decision concerning circumcision of their male infants after receiving non-biased information on health risks and health benefits.

While the possibility of enacting a sui generis Biobank Act has been debated in Germany at great length, as of yet the country has not implemented any biobankspecific legislation. Instead, oversight is available via a network of research and privacy laws, including those of the European Union. The Nationale Kohorte, Germany's large-scale, population-based epidemiological research biobank, is funded by the Federal Ministry of Education and Research, and there are currently 108 registered bio-banks throughout Germany. The current system, including the structure and study design of the Nationale Kohorte, privileges the protection of personal information even at the cost of socially desirable research; it remains to be seen if forthcoming legislation will shift this balance.

This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (“SUPPORT”). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the tradeoffs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”

Stem cell policy in the United States is an amalgam of federal and state policies. The scientific development of human pluripotent embryonic stem cells (ESCs) triggered a contentious national stem cell policy debate during the administration of President George W. Bush. The Bush “compromise” that allowed federal funding to study only a very limited number of ESC derived cell lines did not satisfy either the researchers or the patient advocates who saw great medical potential being stifled. Neither more restrictive legislation nor expansion of federal funding proved politically possible and the federal impasse opened the door for a variety of state-based experiments. In 2004, California became the largest and most influential state venture into stem cell research by passing “Prop 71,” a voter initiative that created a new stem cell agency and funded it with $3 billion. Several states followed suit with similar programs to protect the right of investigators to do stem cell research and in some cases to invest state funding in such projects. Other states devised legislation to restrict stem cell research and in five states, criminal penalties were included. Thus, the US stem cell policy is a patchwork of multiple, often conflicting, state and federal policies.

The foreskin is a complex structure that protects and moisturizes the head of the penis, and, being the most densely innervated and sensitive portion of the penis, is essential to providing the complete sexual response. Circumcision—the removal of this structure—is non-therapeutic, painful, irreversible surgery that also risks serious physical injury, psychological sequelae, and death. Men rarely volunteer for it, and increasingly circumcised men are expressing their resentment about it.

Circumcision is usually performed for religious, cultural and personal reasons. Early claims about its medical benefits have been proven false. The American Academy of Pediatrics and the Centers for Disease Prevention and Control have made many scientifically untenable claims promoting circumcision that run counter to the consensus of Western medical organizations.

Circumcision violates the cardinal principles of medical ethics, to respect autonomy (self-determination), to do good, to do no harm, and to be just. Without a clear medical indication, circumcision must be deferred until the child can provide his own fully informed consent.

In 2012, a German court held that circumcision constitutes criminal assault. Under existing United States law and international human rights declarations as well, circumcision already violates boys› absolute rights to equal protection, bodily integrity, autonomy, and freedom to choose their own religion. A physician has a legal duty to protect children from unnecessary interventions. Physicians who obtain parental permission through spurious claims or omissions, or rely on the American Academy of Pediatrics' position, also risk liability for misleading parents about circumcision.

This article outlines the author's experience designing and implementing an asynchronous online course. Designed as a complement to public health law externships at any location, the course addresses professionalism and strategic lawyering. The article further describes the author's fellowship journey, which emboldened her view that faculty must attempt to live the expectations we have for our students, and also declare our professional values, especially when teaching about policymaking which is fraught with values conflicts. It concludes with a call for others to pilot innovative teaching approaches to address both the crisis in legal education and pressing societal issues, thereby contributing to the health of our legal community.

Tracing the evolution of political conversations about health care spending and their relationship to the formation of policy is a valuable exercise. Health care spending is about science and ethics, markets and government, freedom and community. By the late 1980s the unique upward trajectory of post-Medicare U.S. health care spending had been established, recessions and tax cuts were eroding federal and state budgets, and efforts to harness market forces to serve policy goals were accelerating. From the initial writings on “managed competition,” through the failed Clinton health reform effort in the early 1990s, to the passage of the Affordable Care Act in 2010, the policy narrative of health spending acquired a superficial consistency. On closer examination, however, it becomes apparent that the cost problem has been repeatedly reframed in political discourse even during this relatively brief period. The clearest transition has been from a narrative centered on rationing necessary care to one committed to reducing wasteful care – although the role of accumulated law and regulation in perpetuating waste remains largely unrecognized and the recently articulated commitment to population health seems an imperfect proxy for explicitly developing social solidarity with respect to health and health care in the United States.

Biobank-based research is not specifically addressed in Indian statutory law and therefore Indian Council for Medical Research guidelines are the primary regulators of biobank research in India. The guidelines allow for broad consent and for any level of identification of specimens. Although privacy is a fundamental right under the Indian Constitution, courts have limited this right when it conflicts with other rights or with the public interest. Furthermore, there is no established privacy test or actionable privacy right in the common law of India. In order to facilitate biobank-based research, both of these lacunae should be addressed by statutory law specifically addressing biobanking and more directly addressing the accompanying privacy concerns. A biobank-specific law should be written with international guidelines in mind, but harmonization with other laws should not be attempted until after India has created a law addressing biobank research within the unique legal and cultural environment of India.

Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty.

The goal of this project was to expand an existing public health law curriculum to incorporate lessons on population health outcomes research, extra-legal advocacy, and the population health perspective. The project also created opportunities for students not only to read about and discuss concepts, but also to employ the lessons more practically through exercises and by writing white papers on public health law reform topics relevant to population health in Missouri. To do this, the project expanded an existing didactic course and created a new credit-bearing, experiential “Lab.”

Biobank-based research in Mexico is mostly governed by research and data protection laws. There is no direct mention of biobanks in either statutory or regulatory law besides a requirement that the Federal Ministry of Health and a Mexican institution devoted to scientific research approve the transfer of biological materials outside of Mexico for population genetics research purposes. Such requirements are the basis of Genomic Sovereignty in Mexico, but such requirements have not prevented international collaboration. In addition, Mexican law singles out genetic research in informed consent provisions, but it does not specify whether all biobank-based research is genetic research. In order to facilitate international collaboration on biobank-based research, Mexico should directly address biobanking in its laws, building on the research framework and data protection framework already in place.

Competition cannot stem the rise of health care expenditures because it leaves agency diffuse and transferred in part to the institutions of advanced capitalism, which excel in generating demand for their services. The United States should turn to state rate setting to concentrate purchasing power.

The management of children born with trisomy 18 is controversial, and both providers and parents often have differing opinions. Many parents choose to terminate the pregnancy while others go forward, making decisions based on their beliefs, understanding, and physician recommendations. Physicians are similarly divided regarding treatment of these children, as some feel that aggressive treatments are futile while others defer to the parents' wishes.

Interrupted aortic arch with ventricular septal defect in children with trisomy 18 presents an ethical dilemma that highlights the kinds of controversies in medical decision making facing physicians on a daily basis. Repair of interrupted aortic arch with ventricular septal defect poses a high risk to newborns with or without trisomy 18. Therefore, the option for surgery should be treated as with any routine informed consent process. Parents should be counseled about the risks, benefits, alternatives, and the likelihood of success both short and long term and be should offered a choice between surgery and palliative care.

Aggressive medical and surgical interventions have not been clearly demonstrated to improve survival in neonates with trisomy 18; there are no data that demonstrates improved quality of life for these children after these interventions; and these interventions are clearly associated with significant morbidity, resource allocation, and cost.

The Netherlands does not have any specific legislation pertaining to human biological materials and data collection by biobanks. Instead, these issues are governed by a patchwork of laws, codes of practices, and other ethical instruments, where special emphasis is given to the right to privacy and self-determination. While draft legislation for biobanking was scheduled to enter into force in 2007, as of mid-2015 such legislation was still under consideration, with the intent that it would focus particularly on individual self-determination, the interests of research, the use of bodily materials collected by biobanks for criminal law purposes, and dilemmas around results that are clinically relevant for biobank participants. Under the current framework, the amount of privacy protection afforded to data is linked to its level of identifiability. International sharing of personal data to non-EU/European Economic Area countries is allowed if these countries provide adequate protection.

This article reviews the primary avenues of judicial challenge to the ACA, focusing on those that have reached, or have the potential to reach, the Supreme Court. The review demonstrates how deep-seated public policy opposition can be expressed through litigation.

Lawyers are most often portrayed and understood to be zealous advocates for individual clients in adversarial litigation or zero-sum transactions. Law schools provide excellent preparation for this type of lawyer role, but lawyers' unique understanding of the law is also needed for systemic advocacy, policymaking, and legal education to solve the most difficult societal problems. An interdisciplinary public health law class is one way for law schools to provide students an opportunity to explore and develop these other professional identities.

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle.