In this issue, Zakout discusses European Union (EU) legal provisions for inclusion of patients of all types in clinical trials.1 Shee highlights the unfortunate failure to include adequate numbers of older adults and adults with disabilities in clinical trials of anti-cancer agents. We agree with her argument that this is an ethical issue as well as a scientific and clinical issue.

As increasing proportions of our global population age, transgender people are experiencing higher rates of dementia, and many are afraid to enter long-term care. Structural interventions such as advance directives may help mitigate fears around entering long-term care by managing specific anxieties that transgender people may have about dementia, loss of decision-making capacity, and discrimination in long-term care settings.

This exploratory study set out to pilot use of a Risk Innovation approach to support the development of advanced biopreservation technologies, and the societally beneficial development of advanced technologies more broadly. This is the first study to apply the Risk Innovation approach — which has previously been used to help individual organizations clarify areas of value and threats — to multiple entities involved in developing an emerging technology.

Advanced biopreservation technologies using subzero approaches such as supercooling, partial freezing, and vitrification with reanimating techniques including nanoparticle infusion and laser rewarming are rapidly emerging as technologies with potential to radically disrupt biomedicine, research, aquaculture, and conservation. These technologies could pause biological time and facilitate large-scale banking of biomedical products including organs, tissues, and cell therapies.

To evaluate how study characteristics and methodological aspects compare based on presence or absence of industry funding, Hughes et al. conducted a systematic survey of randomized controlled trials (RCTs) published in three major medical journals. The authors found industry-funded RCTs were more likely to be blinded, post results on a clinical trials registration database (ClinicalTrials.gov), and accrue high citation counts.1 Conversely, industry-funded trials had smaller sample sizes and more frequently used placebo as the comparator, used a surrogate as their primary outcome, and had positive results.

The exclusion of the elderly and people with disabilities from cancer clinical research without appropriate justification is discriminatory and is at odds with the ethos of EU principles, laws and research regulations. It further limits study generalizability. Several primary EU laws fronted by the European Charter prohibit engaging in disparate impact discrimination on the grounds of age and disability in all of EU tasks.

The end of the federal COVID-19 public health emergency (PHE) on May 11, 2023, marked a pivotal shift in the landscape of telehealth regulation in the US. Kwan, Jolin, and Shachar analyze the implications of this transition by exposing inconsistencies in access to care. We agree that we now face a “convoluted patchwork of permanent and temporary changes to telehealth law and policy.”1

Balancing on a tightrope twenty feet above the ground is outside the comfort zones of many health law professors. Being there forces you to consider in new ways yourself, your skills, and your surroundings. Fears arise, and yet you must still act. And you must trust that the person who offered you this opportunity cared about you and your well-being, and that they would ensure there was a way to get from where you began to the other side.

Few people in my memory have a name that more appropriately defines the life they have lived. “Charitable purpose” as defined in O.C.G.A. § 43-17-2 includes any charitable or benevolent purpose including health, education, or social welfare. Anyone who knew Charity Scott knows that she lived a life devoted to providing and improving the health of her community, the education of law students about health law and its use to improve the health of her community, and social welfare by addressing the socio-economic determinants of health. If she had not been assigned that name at birth, those of us who knew her could have easily assigned Charity as a nickname.

Our paper examines what is required to protect and promote effective public discussion and policy development in the current climate of divisive disagreement about many public policy questions. We use abortion as a case example precisely because it is morally fraught. We first consider the changes made by Dobbs, as well as those which led up to the Dobbs decision, accompany it, and follow from it.

This tribute compares Charity Scott to Fred Rogers, highlighting how Charity nurtured health law colleagues’ unique gifts and built community. Continuing the neighborhood theme, it highlights encouraging developments relating to health, housing, and place: Medicaid housing supports and potential reparations for redlining-related health inequities.

When skeletal dysplasias are suspected in the prenatal period, investigation, counseling, and management become especially challenging. By better understanding the complex forces at play and parental values, prenatal health care providers may improve the ways in which they counsel patients to improve the decision-making process under conditions of significant uncertainty, including in cases of prenatally suspected skeletal dysplasia.

This symposium Article describes how prison abolitionist arguments also support the hypothesis that a defining goal of health law should be the abolition of hospitals. Like prison abolitionism, the hospital abolition hypothesis can provide a constructive way to shift the focus of legal analysis from substantive dimensions (in health law — cost, quality, access, and equity) to the dimension of power.

Law Schools are now required to provide education to law students on bias, cross-cultural competency, and racism under ABA Standard 303(c). Law clinics, with their social justice orientation, have long taught about structural causes of bias and oppression and ways to intervene at system levels to prevent problems. Medical legal partnership (MLP) clinics have done so by employing concepts from social work and health science programs on structural competency. This article examines MLP and related curriculum to meet the ABA mandate.

In a “mixed bag” 2023-2024 session, the U.S. Supreme Court issued a series of decisions both favorable and antithetical to public health and safety. Taking on tough constitutional issues implicating gun control, misinformation, and homelessness, the Court also avoided substantive reviews in favor of procedural dismissals in key cases involving reproductive rights and government censorship.

Medical-legal partnerships (MLPs) support patients and clinicians by streamlining legal and medical care and helping identify and address a subset of social drivers of health (SDOH). Less is known on the effect of MLPs on the competency of residents regarding SDOH. The aim of this study was to identify how integration of an MLP into a pediatric residency training program affected residents’ experience understanding and addressing SDOH.

It was a great privilege to know Professor Charity Scott. I first met her when I was finishing Emory University’s joint law and public health program in the early 2000s, through the Office of General Counsel at the U.S. Centers for Disease Control (CDC), in the early days of CDC’s Public Health Law Program, now the Office of Public Health Law Services. In those days, introductions were generous and frequent for excited students beginning their careers, but meeting Professor Scott made an impression on me. She was the first and only female health law professor in the field that I had the opportunity to know in the early years of my career.

Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents.

The Covid-19 pandemic elevated global attention to the complex problem of allocating and disseminating newly approved vaccines. Following early calls for vaccine equity,1 global health leaders made progress but struggled to fully realize distribution goals.2 With respect to vaccination rates, low and middle income countries have not achieved full parity with high income countries.3 In this issue, Harmon, Kholina, and Graham follow longstanding critiques of market-based vaccine procurement to propose “legal and practical solutions for realizing a new access to vaccines environment”4 that will, they suggest, further the goal of global health justice.

As the federal government continues to expand upon and improve its data sharing policies over the past 20 years, complex challenges remain. Our interviews with U.S. academic genetic researchers (n=23) found that the burden, translation, industry limitations, and consent structure of data sharing remain major governance challenges.