Health Law and Policy Commons^™

Legal Malpractice In Washington: Use Of The Rules Of Professional Conduct, Angelo Tadrous

Seattle University Law Review

Legal malpractice claims are difficult to prove. They are difficult to prove because many jurisdictions require that a plaintiff prove that, but for the lawyer’s misconduct, the client would have fared better. Thus, in a malpractice suit, a plaintiff must try a case within a case. Despite this difficulty, many jurisdictions prohibit the use of the Rules of Professional Conduct when litigating a malpractice case. Washington State is one of these jurisdictions. The Washington Supreme Court held in Hizey v. Carpenter that the Rules of Professional Conduct may not be referred to during trial. This Note argues that this prohibition …

Beyond The Ban: Chhaupadi Abolition And The Governance Of Menstrual Autonomy In Western Nepal, Nikita Paudel

Master in Public Policy Theses

This thesis examines how two decades of efforts to abolish chhaupadi have shaped the everyday conditions under which women and girls experience menstruation in western Nepal. Chhaupadi, commonly understood as menstrual seclusion, has been addressed through Supreme Court directives, national policy, criminal law, municipal implementation instruments, hut demolition campaigns, public health programming, and rights-based advocacy. Yet the practice has persisted, adapted, and in some cases moved into less visible spaces. Rather than treating this as a simple gap between law and practice, this thesis asks how abolition efforts themselves have become part of the regulatory regime through which menstruation is …

Dental Professionalism In A Changing World: Challenges & Opportunities, Robert P. Iovino, Dds, Ma Dds, Ma

Journal of the American College of Dentists

This manuscript examines the erosion of traditional dental professionalism amid rising educational costs, declining membership in professional associations, and the growing influence of corporate ownership and private equity in dentistry. Drawing perspectives from economics, sociology, philosophy, law, and ethics, it traces the historical development of professional licensure and its role in safeguarding clinical autonomy, ethical integrity, and public trust. The analysis highlights how deregulation and profit-driven practice models challenge the profession’s social contract. The manuscript argues that preserving strong civic institutions, restrictive licensure standards, and humanities-informed education is essential to sustaining dentistry as a learned profession rather than a commodified …

Is Being A Shareholder ‘In Name Only’ A Problem?, Daniel Schulte Jd

The Journal of the Michigan Dental Association

This column addresses the legal risks for Michigan dentists entering "shareholder in name only" agreements with non-dentist entities. Michigan law requires dental practices to be owned by licensed dentists to ensure professional control over public healthcare. Arrangements where management companies or manufacturers can reclaim stock for a nominal fee effectively strip the dentist of true ownership. This lack of control can lead to ethical conflicts, such as pressure to sell specific appliances regardless of professional judgment. Engaging in such schemes may endanger a dentist's license by thwarting state laws intended to protect clinical independence.

Ethical Sourcing In The Context Of Health Data Supply Chain Management: A Value Sensitive Design Approach, Camille Nebeker Edd, Ms, Ellen Wright Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Abstract

Objective

The Bridge2AI program is establishing rules of practice for creating ethically sourced health data repositories to support the effective use of ML/AI in biomedical and behavioral research. Given the initially undefined nature of ethically sourced data, this work concurrently developed definitions and guidelines alongside repository creation, grounded in a practical, operational framework.

Materials and Methods

A Value Sensitive Design (VSD) approach was used to explore ethical tensions across stages of health data repository development. The conceptual investigation drew from supply chain management (SCM) processes to (1) identify actors who would interact with or be affected by the data …

Whose Burden, Whose Benefit? Revisiting Ethical Trade-Offs In The Who Guidelines On Scaling Up Mass Azithromycin Administration, Maple Goh, A. M. Viens, Safura Abdool Karim, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

Author summary

• New evidence suggests that mass drug administration of azithromycin (MDAA) can significantly reduce childhood mortality in high-burden, low-resource settings, yet the World Health Organization’s (WHO) 2020 guidelines take a cautious approach due to concerns about antimicrobial resistance (AMR).
• While the WHO guidelines cite ethical principles, they insufficiently address key considerations, such as intergenerational justice, equitable burden sharing, and the structural determinants of health that shape infectious disease vulnerability.
• Global AMR policy often prioritizes conservation over access in ways that disproportionately burden low-income countries, despite high-income countries also bearing significant responsibility for the emergence and spread of AMR.
• A …

The Ethics Of Industry-Funded Speakers’ Bureaus—How They Disseminate Innovation And Could Corrupt Medicine, Jennifer E. Miller, Christopher Robertson

Faculty Scholarship

It is often said that a business without marketing is dead. But when a medical product is marketed irresponsibly, it is patients who may pay with their lives. In this context, Wieberdink et al¹ examine participation in industry-sponsored speakers’ bureaus by academic clinical faculty, conceptualizing the practice as a form of conflicted and irresponsible pharmaceutical marketing. Reviewing 129 US allopathic medical school conflict-of-interest (COI) policies, they found that less than 40% prohibit industry speakers’ bureau participation outright, while 19% impose conditional restrictions, such as requiring that faculty retain control over presentation content. Wieberdink et al¹ advocate for a …

Re-Imagining Tomorrow: A Technology, Innovation Law, And Ethics Symposium On Addictive Technology And Children, Margaret Chon

Seattle University Law Review

In this Foreword, Professor Margaret Chon introduces Seattle University's Technology, Innovation Law, and Ethics (TILE) program, the 2024 TILE Symposium, and Dr. Gaia Bernstein’s Unwired: Gaining Control Over Addictive Technologies.

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

The Intersection Of Regulation, Quality Care Delivery, And Ethics And Compliance: Look Carefully Before Crossing!, David R. Hoffman, Ilene Warner-Maron

Saint Louis University Journal of Health Law & Policy

Quality and compliant care delivery in nursing homes remains elusive. Four main interests are currently misaligned, thereby putting nursing home residents at risk of harm. Without a clearly defined commitment to quality and compliant care and alignment of these interests, nursing home residents will remain vulnerable to severe harm.

The first key interest concerns nursing home ownership and management. Currently, over seventy percent of nursing homes are owned by for-profit entities. Previous ownership models, including non-profit, religious-based, and county-owned facilities, have largely closed or transitioned to for-profit entities. The shift in ownership significantly impacts quality and compliant care delivery. Unfortunately, …

Ethical Issues In Pandemic Prevention, Preparedness, And Response, Govind Persad

Publications

Pandemic policies raise complex ethical challenges, as well as scientific and technical ones. This chapter examines four critical areas where ethical analysis is essential for effective pandemic prevention, preparedness, and response: spending decisions, clinical research, restrictions on rights and freedoms, and fair allocation of scarce medical resources.

Spending on pandemic prevention, preparedness, and response often involves trade-offs with other societal priorities, such as education, infrastructure, and environment. Navigating these trade-offs requires careful consideration of opportunity costs and distributional impacts.

Rights and freedoms can likewise present difficult trade-offs when pandemic policies restrict individual liberties, requiring clear goals and proportionate responses that …

Ethical Considerations In Qualitative Research After Dobbs, Sabrina Singh

Pace Law Review

The verdict in the Dobbs case will undoubtedly have an impact on the United States research enterprise for years to come. Since the landmark decision was handed down by the high court, researchers have warned of the impacts that the decision will have on clinical research. However, there is less discussion about how qualitative researchers will be impacted by this decision. Oftentimes, qualitative researchers are asking their participants to be vulnerable and to let researchers be privy to intimate and/or confidential details about their lives. In exchange for such access, researchers need to ensure the protection of their participants and …

Introduction—Bioethics After Dobbs, James Toomey

Pace Law Review

No abstract provided.

The Shared Ethical Framework To Allocate Scarce Medical Resources: A Lesson From Covid-19, Ezekiel J. Emanuel, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, …

Developing Ethics And Equity Principles, Terms And Engagement Tools, Ellen W. Clayton, Rachele Hendricks-Sturrup, Shilo Anders, Et Al.

Vanderbilt Law School Faculty Publications

Background:

Artificial intelligence (AI) and machine learning (ML) technology design and development continues to be rapid, despite major limitations in its current form as a practice and discipline to address all sociohumanitarian issues and complexities. From these limitations emerges an imperative to strengthen AI and ML literacy in underserved communities and build a more diverse AI and ML design and development workforce engaged in health research.

Objective:

AI and ML has the potential to account for and assess a variety of factors that contribute to health and disease and to improve prevention, diagnosis, and therapy. Here, we describe recent activities …

The Human Role In Artificial Intelligence, Christopher J. Smiley Dds

The Journal of the Michigan Dental Association

The success of AI requires human involvement to ensure that it is used safely and effectively. Transparency, collaboration, and standardization are necessary.

Concordance Of International Regulation Of Pediatric Health Research, Ellen W. Clayton, Mark A. Rothstein Jd, Et Al.

Vanderbilt Law School Faculty Publications

International, multi-site, pediatric health research has shown great promise by vastly increasing the amount and heterogeneity of biospecimens and clinical records. However, considerable impediments are created by the significant costs and delays associated with obtaining regulatory approval in numerous countries, which is often complicated by varying and sometimes opaque research ethics standards and procedures. Although it is unlikely that the global community could reach consensus on a single set of research ethics policies and procedures, voluntary policy pronouncements by countries agreeing to defer to the approval of research ethics bodies in other countries might be a way forward.

Deference is …

Protect Your Patients And Yourself: The Complete And Honest Medical History, Mitchell Gardiner Dmd

The Journal of the Michigan Dental Association

This feature article emphasizes the critical role of obtaining a complete and honest medical history in dental practice. Reflecting on the evolution of clinicians' diligence since dental school, the article underscores the potential risks associated with inadequate medical histories. The legal and ethical responsibilities in gathering comprehensive patient information are highlighted, emphasizing the impact on patient well-being and the dentist's vulnerability to legal challenges. The complexities of patients' truthfulness, especially regarding sensitive topics, are discussed, urging clinicians to establish trust for accurate disclosures. The article concludes with practical recommendations, stressing the ongoing need for thorough medical history reviews and the …

Risk Tradeoffs And Equitable Decision-Making In The Covid-19 Pandemic, Lawrence O. Gostin, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Since the start of the Covid-19 pandemic, societies have faced agonizing decisions about whether to close schools, shutter businesses, delay nonemergency health care, restrict travel, and authorize the use of emergency Covid-19 countermeasures under limited scientific understanding. Measures to control the spread of COVID-19 have disrupted our health, educational, and economic systems, tarnished our mental health, and took away our cherished time with family and friends. Conflicting advice from health agencies on the utility of public health measures left us wondering, was it all worth it? We still do not have all the answers to guide us through difficult risk-risk …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

Kidney, Money, And The Shī‘Ah Implementation Of The Rule Of Necessity, Zahra Takhshid

Sturm College of Law: Faculty Scholarship

In the U.S., over 43,000 people die every year waiting for a kidney. In Iran, however, monetary incentives have eliminated such a waitlist. Iran is the only country in the world with an unrelated living kidney donor program that has allowed for monetary incentives in the form of an altruistic gift, which has become known as “the Iranian Model.” Nevertheless, the legal details of the system remain vague and scholars both in and outside of Iran continue to debate the nature of the system. Does the Iranian system consider kidneys a commodity? Can you legally buy a kidney in Iran? …

Covid-19 And Digital Contact Tracing: Regulating The Future Of Public Health Surveillance, Divya Ramjee, Pollyanna Sanderson, Imran Malek

Cardozo Law Review de•novo

Digital surveillance tools are at the forefront of potential public health response strategies for the COVID-19 pandemic. The United States is in desperate need of a national-level contact tracing and exposure notification strategy to supplement traditional public health response efforts. This article addresses data privacy and security concerns, as well as epidemiological considerations, when developing digital contact tracing and exposure notification tools. It is both feasible and prudent that the United States establish a federal network for public health surveillance aided by digital tools, especially considering that waves of COVID-19 are expected to continue well into 2021 and while the …

Bioethics: Ethical Considerations Of Ventilator Triage During A Pandemic, Susannah J. Gleason, William J. Keegan

Georgia State University Law Review

In the midst of the COVID-19 pandemic, hospitals across the country faced unprecedented volumes of patients seeking treatment related to the respiratory complications of the virus. As a result, states were forced to reassess existing scarce resource allocation guidelines to appropriately accommodate the high demand. This Peach Sheet analyzes the ethical considerations implicated in enacting and following these guidelines when treating patients, specifically in the context of ventilator triage in response to the COVID-19 pandemic.

Equitable Allocation Of Covid-19 Vaccines: An Analysis Of The Initial Allocation Plans Of Cdc's Jurisdictions With Implications For Disparate Impact Monitoring, Harald Schmidt, Rebecca Weintraub, Michelle A. Williams, Alison Buttenheim, Emily Sadecki, Helen Wu, Lawrence O. Gostin, Angela A. Shen

Georgetown Law Faculty Publications and Other Works

Major global and national vaccine allocation guidelines urge planners to allocate vaccines in ways that recognize, and ideally reduce, existing societal inequities within countries. However, allocation plans of the US will be determined individually by each of the CDC’s 64 jurisdictions (states, the District of Columbia, five cities, and territories). We analyzed whether jurisdictions have incorporated novel approaches to reduce inequity, based on plans published by the CDC in early November 2020 (63 summaries [98% of all jurisdictions] and 47 full guidance documents [73% of all, including all 50 states]).

Eighteen states adopted a novel proposal to use a disadvantage …

Video; Health Law & Ethics 2020, Kathy Cerminara, Jonathan Kroner Law Office, Mcdermott Will & Emery Llp, Lubell & Rosen, Gerald M. Morris

NSU Law Seminar Series

This program will focus on the current climate of health law and the necessary steps used through federal practice to adjust to the ever-changing atmosphere of new legislation. Attendees will learn about the various paths within the practice, about emerging new laws, outreach and training, and how to become involved in the federal practice of health law. The presenters will explain what you need to get started, what different types of experiences and exposure might be helpful in entering the field and instruct you on maintaining ethics by knowing and following the Federal Rules of Civil Procedure and Model Rules …

Is It Lawful And Ethical To Prioritize Racial Minorities For Covid-19 Vaccines?, Harald Schmidt, Lawrence O. Gostin, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in …

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

Genome Editing 2020: Ethics And Human Rights In Germline Editing In Humans And Gene Drives In Mosquitoes, George J. Annas

Faculty Scholarship

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and …

Setting Priorities Fairly In Response To Covid-19: Identifying Overlapping Consensus And Reasonable Disagreement, David Wasserman, Govind C. Persad, Joseph Millum

Sturm College of Law: Faculty Scholarship

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; …