This essay celebrates the BU Health Law Program upon its 70th anniversary, offering reflections on the founders of the program, Fran Miller, George Annas, and Wendy Mariner (“FGW,” endearingly), and their contributions to the field.

Current faculty offer reflections, including: Several speak to scholarly research, including Elizabeth McCuskey on health care finance, Aziza Ahmed on human rights, Dionne Lomax on antitrust, Christopher Robertson on trust, and Kathy Zeiler on the marketplace. Other contributors speak to the student experience, with Dianne McCarthy on mentorship, Laura Stephens on demanding excellence, Michael Ulrich on teaching, and Larry Vernaglia on merging law and public health. On FGW’s broader impacts, Nicole Huberfeld speaks to the translation of research to reach new audiences, and Kevin Outterson writes about FGW’s pivotal roles in establishing the health law field and the institutions that now define it.

Together these pieces testify to the astounding contributions of these scholar-teacher-leaders across many domains and dimensions of health law. While their contributions are countless and immeasurable, these reflections offer a start.

Since 1984, the U.S. Preventive Services Task Force (USPSTF) has issued recommendations to the public regarding preventive health services. The recommendations have substantially benefited public health. With the passage of the Affordable Care Act in 2010, recommendations assigned the highest ratings (A and B) must be covered by most private health insurers without consumer cost-sharing. This statutory requirement has been challenged in Braidwood Management Inc. v. Becerra, a case centered on the plaintiffs’ argument that USPSTF members are officers of the United States but were not appointed in accordance with the Appointments Clause of the Constitution. The Appointments Clause requires that principal officers of the United States must be appointed by the President and confirmed by the Senate. This article contends that members of the USPSTF are not principal officers of the United States, but instead serve as advisors to Congress in making preventive health recommendations. Congress established the coverage policy, not the USPSTF members. On this basis, the defendants should prevail in the case, but if they do not, the court should apply severability to permit the Secretary of Health and Human Services to directly oversee the USPSTF in the assignment of ratings for preventive health recommendations. The important work of the USPSTF should not be abridged.

This piece takes as a given that we are stuck with our fragmented, inefficient, multi-payor health care system for at least the short run. It then analyzes the deficiencies of three payment mechanisms whereby regulators (including Congress) have invited private sector providers to help ameliorate perceived problems. The first concerns an inadequate supply of nursing home beds in the early ‘70s, the next focuses on Medicare Advantage as a supposedly superior cost containment alternative to traditional Medicare, and the final one involves the ‘devil’s bargain’ struck with the pharmaceutical industry to get prescription drug coverage added to Medicare. All three teach the same lesson: the government needs to be more vigilant not to give away the store when it invites the private sector in.

For almost a century, the Supreme Court has not invalidated a law using the nondelegation doctrine. Recognizing that Congress seldom has expertise to address the ever-increasing complexities of society, the Court has long held that Congress can legislate broadly and seek help from federal agencies to fill up the details. Accordingly, courts defer to Congress’s delegation choices, as long as it lays down an intelligible principle to guide the agencies entrusted with implementing legislation. Under that approach, the Court has upheld broad delegations of authority to federal agencies. This approach has been the bedrock of meaningful agency action, especially in health policy in which agencies must leverage their expertise to respond to highly technical issues, emergencies, advances in technology, and the need to address health disparities. While this deferential approach has guided the courts and Congress for decades, delegation is increasingly under attack. Braidwood Management, Inc. v. Becerra, which challenges the Affordable Care Act’s preventive services requirement, exemplifies nondelegation-based attacks on agency authority. With several members of the Supreme Court signaling interest in revisiting the current deferential delegation standard, Braidwood likely provides an opportunity for the Supreme Court to do so. Reinvigorating the nondelegation doctrine — coupled with the major questions doctrine and rolling back of Chevron deference — will hurt U.S. health policy. It will not only constrain how agencies work, but also aggrandize the courts and limit how Congress may achieve legislative goals.

The celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the “Center”) provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 19581 and that continues to make headlines more than sixty–six years later — organ transplantation. Transplantation is useful as an illustration of the joint fields of health law, bioethics, and human rights. It is a field that grew with us from infancy to maturity during the time of the Center’s growth and that illustrates how several related disciplines — most notably law and medical sciences — are essential to the development of organ transplantation. Additionally, organ transplantation and experiments involving organ transplantation have produced some of the most spectacular cases of human experimentation. Because of both the novelty and human drama these experiments involve, I will use some of them as examples of the pivotal health law and bioethics work the Center engages in. These examples, and others that will be touched on, lead me to conclude that there is no field that matches the life and death drama of health law, especially in the human organ transplantation field. This selective history of health law at the Center, including the definition of death and the limits of surrogate consent, suggest that the legal and bioethical issues brought to us by innovative organ transplantation surgery are unlikely to be exhausted any time soon.

The Affordable Care Act’s preventive services mandate requires private insurance plans to serve public health goals. But the employers that facilitate access to insurance for more than half the population hold political views and economic interests that may run counter to public interests. And now, in the name of for-profit employers’ religious rights, the courts are eroding the legal foundations of privately financed public health. Religious objections to the preventive services mandate — of which Braidwood Management, Inc. v. Becerra is just the most recent high-profile example — have become a site of opposition to public health. Courts have radically revised standards for religious exemption, adopting an individualistic frame that discounts population-level effects. Recent decisions could invite free exercise claims that go to the heart of securing population health through the workplace.

Current political divisions are destabilizing existing laws affecting the health field. Major changes in the field of health law have one thing in common: changes in who holds political power ‒ Congress and state legislatures, governors, presidents, judges, and agency officials. The laws that structure financial, economic, educational, and health care systems, environmental conditions, and civil society are primarily the product of elections that populate our political institutions. These structural determinants of health in turn create laws that influence how ‒ and how well ‒ we live and whether our society functions fairly under the rule of law. Thus, who gets elected matters a great deal to the health and safety of Americans. At the same time, changes in health laws resulting from elections may reveal shifts in the structures underlying our legal and economic systems and whether those shifts support or weaken principles of justice and the rule of law.

The 2023 Texas federal district court decision Braidwood Management, Inc. vs. Becerra enjoined the enforcement of the Affordable Care Act’s preventive care mandate, which requires “first-dollar” insurance coverage for a range of preventive measures, including pre-exposure prophylaxis (PrEP), an HIV prophylactic drug. Most scholars have analyzed the case with respect to the conflict between public health goals and the Religious Freedom Restoration Act (RFRA). This Article suggests another reading of the Braidwood decision in light of a broader socio-legal phenomenon I call preventive health stigma. Stereotypes attach to the underlying medical condition that a given measure is aimed at preventing, or to the actual preventive measure resulting in stigmatization. Preventive health stigma penetrated the Braidwood decision through the case’s focus on PrEP users’ signaled prurient behavior instead of the drug’s proven health benefits. After offering a novel reading of the Braidwood decision, this Article also shows how preventive health stigma surfaces in the legal treatment of other preventive measures, such as abortion pills, masking, and vaccines. Understanding how stigma attaches to preventive medicine constitutes an important step in understanding how law and prejudice can undermine health reform.

In 2023, Henrietta Lacks’ family won a settlement from Thermo Fisher Scientific on the grounds that the company had been “unjustly enriched” by the sale of products developed with Henrietta’s cells. Given that hundreds of thousands of people have tissue stored in the United States, this article explores how today’s patients might fare if they similarly sued professionals and companies that undertake unauthorized research on or commercialization of their tissue on the grounds of conversion, unjust enrichment, lack of informed consent, breach of fiduciary duty and, where government entities are involved, Fourteenth Amendment claims. The article notes that the practices that were subsequently seen as unethical in Henrietta Lacks’ care continue in some health care institutions today. It also analyzes how research and commercialization without consent can lead to a lack of trust in the research enterprise and the unwillingness of people to participate in research.

The burgeoning wellness industry attracts a lot of practitioners who are largely unregulated. This “wild west” of wellness creates uncertainty for insurers, employers, consumers, and practitioners as to: (1) what services and items wellness practitioners can offer; (2) whether those practitioners are qualified; and (3) whether they behave in an ethical manner. Some guideposts for these wellness stakeholders would be welcome and may reduce consumer harm. Guideposts for wellness is especially crucial in a time when the Braidwood Management, Inc. v. Becerra case threatens the delivery of preventive care services in the health care sector. As we have learned from the health care sector, the state licensure scheme is confining and not conducive to national practice, particularly in the wake of virtual platform technologies. Thus, instead of state licensure, this article proposes a private Standard Development Organization (SDO) scheme that can create and enforce standards within the wellness industry.

In 1974, the Center for Law and Health Sciences at the Boston University School of Law provided legal background papers on informed consent to research to the newly created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Sciences. These papers were written by George J. Annas, the Center’s Director, as well as Barbara F. Katz and I, who were staff attorneys at the time. These papers can be found in the appendices to the Commission reports1 and in our book Informed Consent to Human Experimentation: The Subject’s Dilemma,2 in which we present a refined version of those papers. This project introduced me to the world of human research ethics and the complexities of protecting the rights and welfare of research subjects.3 Over the past fifty years, I have sat on Institutional Review Boards (IRBs), been a member of the FDA’s Pediatric Research Advisory Board, and engaged in varying activities related to human subject protection. During this time, I took for granted that consent forms were the best method for ensuring that subjects were thoroughly informed about all aspects of the proposed research. Like many IRB members, I spent considerable time reviewing, editing, and debating with other IRB members about the precise wording of these forms.

Braidwood Management, Inc. v. Becerra threatens the nationwide enforceability of the preventive care mandate of the Affordable Care Act (ACA) with respect to a variety of preventive health care services. The success of this lawsuit could have devastating repercussions. Not only would many current guidelines of the U.S. Preventive Services Task Force (USPSTF) be affected, but future preventive care recommendations would be as well, to the detriment of achieving health equity goals. This Article posits that the loss of guaranteed free preventive care could threaten current and future health equity gains. If preventive care is no longer offered without cost-sharing, research shows that many people, especially those with lower socioeconomic status, will not access the care. This decrease in access to recommended screenings and other preventive services would likely decrease uptake, over time impacting the stage at which diseases such as cancer are diagnosed, making late-stage diagnoses with poorer prognoses more common, and increasing transmission of other conditions such as HIV. At the population level, decreased access to free preventive care could hinder efforts to reduce entrenched inequalities associated with these conditions.

Moreover, these effects will be amplified as insured people lose access to preventive care recommendations that evolve in response to new research findings. In the years since the ACA’s passage, the USPSTF has brought a health equity lens to each step of its recommendation process, including how it chooses preventive services to study, how it designs and conducts its research plan, and its approach to issuing recommendations along with calls for more research. Although some have argued that the resulting shift in the USPSTF’s recommendations has not happened fast enough, the way in which the USPSTF structures its evidentiary reviews — with a focus on high-level literature reviews of medical studies — suggests that over time, as individual studies continue to examine the effectiveness of interventions in different populations and publish their results, the shift will become more dramatic and the resulting recommendations will be more effective at combating health care disparities. If Braidwood is successful, no-cost insurance coverage for these more responsive recommended services could be undermined.

This Article explores the potential impact Braidwood could have on existing and anticipated advances in preventive care through a focus on two life-threatening conditions: cancer and HIV. Both cancer and HIV preventive care recommendations have undergone significant changes since the implementation of the preventive care mandate. While the resulting recommendations remain imperfect, the Article shows the important and evolving relationship between these recommendations and efforts to overcome pervasive and entrenched disparities in health outcomes related to these conditions. If Braidwood is upheld, ongoing efforts to reduce disparities in cancer and HIV will be stymied.

Fifty years ago, George J. Annas and Joseph Healey introduced the concept of a “patient rights advocate” in their seminal 1974 article published in the Vanderbilt Law Review. Annas expanded this vision in the ACLU Handbook, The Rights of Hospitalized Patients, later broadening its scope to all medical settings. This essay traces the evolution of patient advocacy, highlighting pivotal milestones: the advent of cancer navigators, the rise of the patient safety movement, the establishment of patient advocacy organizations, the development of Patient Advocate Offices in hospitals, and the emergence of independent advocates with board certification. It also examines the impact of advocacy on healthcare outcomes, costs, and patient-provider satisfaction, and explores future directions for this vital and growing profession.

The preventive services at the center of Braidwood Management, Inc. v. Becerra contribute to reducing inequities in life expectancy in the United States. Critical preventive are currently fully covered by insurance as preventive care under the Affordable Care Act. Reducing affordable access to such screenings and medicines is most likely to impact those with lower incomes and less education, and contribute to widening existing inequities in health outcomes.

Recent research has identified a large and growing mortality gap between those with and without college degrees. On average, individuals without college degrees are likely to die about 8.5 years earlier than those with such degrees. In recent decades, cancer death rates fell nearly two times faster among the college educated. Mortality from heart disease fell by nearly two-thirds among those with college degrees but by less than one-third for all others.

Disparities in life expectancy in the United States reflect the uneven progress against the leading causes of death among different populations. The Braidwood decision, if upheld, will raise the costs to patients for interventions that have contributed to recent gains in life expectancy. This Article analyzes the impact of Braidwood on preventive health interventions in the context of growing life expectancy gaps within the United States.

The Supreme Court’s decision 2024 in Loper Bright Enterprises v. Raimondo to overturn the Chevron doctrine, which required Federal Courts to defer to agency interpretations of ambiguous laws, along with other decisions challenging the decisions of regulatory agencies, marks a significant shift in healthcare regulatory oversight and compliance. This article takes this shift as an opportunity to examine the evolution of healthcare compliance education in U.S. law schools and consider how it should evolve to meet new demands. Through analysis of existing J.D. programs, master’s degrees, and certificate programs in healthcare compliance, the article explores how law schools are already adapting to meet industry demands while distinguishing between programs designed for licensed attorneys and those for non-lawyer compliance professionals. The article highlights the role of external accreditation by the Compliance Certification Board (CCB) and clarifies the distinction between “certification” awarded through examination and “educational certificates” awarded by institutions. In light of the ironically almost total lack of regulatory attention to these programs from the Council on Legal Education that sets standards for law school J.D. programs, the article advocates for greater transparency in program outcomes and improved data collection regarding graduate career trajectories. It also addresses an often forgotten population, lawyers interested in changing practice areas at different stages of their careers. It concludes with recommendations for law schools to enhance their role in preparing both lawyers and compliance professionals for a post-Chevron regulatory environment, emphasizing the need for better tracking of program effectiveness and graduate outcomes to inform curriculum development and career pathways in healthcare compliance.

Experiential learning opportunities are recognized to help students put classroom discussions into practice, build new peer networks, and challenge their own preconceptions about the roles of global structures and systems to advance health and wellbeing. After a pandemic-related hiatus, the University of Southern California Institute on Inequalities in Global Health returned to Geneva, Switzerland with students for two weeks at the time of the 2024 World Health Assembly to learn and engage with how global health governance plays out on an international stage. We brought eleven passionate and engaged USC Master’s in Public Health (MPH) students whose interests covered a range of issues, including child and maternal nutrition, sexual and reproductive health and rights in conflict settings, mental health, and noncommunicable diseases, among many other topics. We spent two weeks meeting with inter-governmental organizations, international advocacy organizations, United Nations agencies, and joint funded programs, and our students built their own event schedule during the World Health Assembly to cover the health topics they were most interested in pursuing. Our aim was to have students engage with the complex interplay of health, law, and rights, and to see in real time how research and education inform policy, on local, national and global levels. As instructors and coordinators, we are convinced that the role of experiential learning has never been more important or influential. Multilateralism is under attack, and rights regressions are rampant. We found that fostering honest, content driven conversations with our organizational partners, and then having intense follow-up with our students, resulted in new perspectives– personally and professionally – which is likely to serve the work of the students in global health for the years to come. When the distance between classroom readings and the actual people steering global health can be bridged, university courses that center experiential learning offer the opportunity for emerging health leaders to truly understand the structures and systems in place, and better imagine their own roles in the fight for the right to health.

Braidwood Management, Inc. v. Becerra challenges the Affordable Care Act free preventive coverage guarantee. Community health centers serve over 30 million residents of medically underserved urban and rural communities. Their limited federal grant funding makes them reliant on insurance revenue for their operations, Medicaid and subsidized marketplace coverage in particular, both of which are implicated by the case. To understand these implications, we developed an analytic model that crosswalks the preventive services potentially affected by Braidwood and the preventive care that all health centers must furnish. Of the 193 preventive services now covered under the guarantee, only forty-eight would survive were the Braidwood plaintiffs to prevail. In underserved communities, health centers are a principal source of the nearly 150 affected services, as evidenced by the care they are required to furnish under federal law, the quality metrics they are expected to meet, and the health diagnoses and treatments identified in federal performance reporting requirements. Thus, the impact on access, quality, patient health, and health center finances and care capability will likely be substantial.

Currently, the Affordable Care Act helps to provide inexpensive preventive care services to adolescents (10–19 years old) by preventing insurance companies from implementing cost-sharing measures. Some of these services can fall under the realm of mental health preventive care such as anxiety and depression testing. The lack of cost to a patient and their family encourages doctors to offer these services to their young patients. Furthermore, this Affordable Care Act provision - fosters doctor-patient communication because it normalizes mental health services as part of well-being. However, Braidwood Management Inc. v. Becerra threatens to have far reaching implications for preventive care policy and to disrupt health communication efforts to promote positive mental health. This Article uses structuration theory and a conceptual framework of adolescent development to examine the potential ramifications of cost-sharing on adolescent health. The implications of this change in cost-sharing include constraining doctors’ communication behavior in primary care settings and stunting healthy adolescent development. Ultimately, if the Braidwood decision is upheld, it may pose a challenge to a doctor’s ability to communicate with their young patient about mental health.

Over the past twenty-five years, the Center for Health Law, Ethics, and Human Rights (CLER) has been a leader in torture treatment, advocacy, and education. In 1998, the Boston Center for Refugee Health and Human Rights (BCRHHR) was founded to provide holistic treatment to asylum seekers who have been tortured by their governments and justifiably feared further persecution if they returned to their countries. Seeking justice is an important part of healing for survivors, and BCRHHR clinicians work closely with immigration attorneys to document clinical evidence of torture to support asylum applications. Following the September 11 attacks in 2001, it was revealed that the U.S. government tortured captives and committed other war crimes. CLER scholars examined how doctors and lawyers worked with the Central Intelligence Agency (CIA) to rationalize and sanitize torture, providing legal immunity for perpetrators. My colleagues and I at CLER assumed a national leadership role in opposing practices that constitute torture, as well as cruel, inhumane, and degrading treatment. These practices included the force-feeding of hunger strikers, the Rendition, Detention, and Interrogation (RDI) program (a covert operation involving disappearances, extrajudicial detentions, and torture of suspects in the so-called “War on Terror”), the use of lawyers and physicians to justify these actions, and U.S. policies that authorized torture. We met with military officials of the Department of Defense (DOD) and hosted a meeting with international experts to brainstorm solutions. We evaluated the devastating effects of the U.S. torture program on detainees and testified in the military commission’s pretrial hearings for a detainee accused of terrorism.

Doctors and lawyers at the CLER have focused on understanding contemporary torture and the relevance of the Nuremberg Doctors’ Trial which condemned Nazi doctors for torturing prisoners. The CLER continues to promote the importance of International Human Rights Law.