Health Law and Policy Commons^™

From Myriad To Moderna: The Modern (Bio)Pharmaceutical Company, Ana Santos Rutschman

Faculty Publications

This Article examines the emergence of two modern pharmaceutical companies: Myriad and Moderna. After providing a brief background on each company, this Article contrasts them across the following areas: the technologies they have brought to market; their location; their start-up stages and the role that venture capital played in catalyzing their evolution from start-ups to large corporate structures; their relationships with other entities in the private sector, in academia and in the public sector; and their intellectual property and licensing strategies.

Byte By Byte: Breaking Down The Third-Party Doctrine And Reproductive Health Apps After Dobbs, Travis Handler

Oklahoma Law Review

No abstract provided.

Pro And Con Choice? Moral Equality, Neutrality, And Abortion Pill "Reversal", Melissa Ballengee Alexander

Oklahoma Law Review

No abstract provided.

Age And Saving Lives In Crisis Standards Of Care: A Multicenter Cohort Study Of Triage Score Prognostic Accuracy, Michael Hermsen, Patrick G. Lyons, Govind Persad, Alice F. Bewley, Chengsheng Mao, Kaveri Chhikara, Anoop Mayampurath, Matthew Churpek, Monica E. Peek, Yuan Luo, William F. Parker

Publications

No abstract provided.

Tribal Health Self-Determination: The Role Of Tribal Health Systems In Actualizing The Highest Attainable Standard Of Health For American Indians And Alaska Natives, Vanessa Ann Racehorse

Publications

In this Article, I explore the concept of Tribal self-determination in the context of systems that serve American Indian and Alaska Native communities. I investigate the vast health disparities that exist in Tribal communities, as well as the history and current legal framework for the provision of health care in Indian Country. Part of this discussion also provides information on the federal laws and policies that have fractured the traditional lifeways of Native communities and contributed to the disparate health outcomes that now exist. I also provide background on the fundamental federal laws and policies, particularly the Indian Self-Determination and …

Assessment Of Implementation And Enforcement Of Smoke-Free Laws And Policies Among Malaysian Smokers: A Mixed Method Approach, Gan Shiz Yee

Student Works (2020-2029)

Smokefree laws (SFL) and policies could deter smoking by strengthening anti-smoking norms, impacting cessation behaviour due to decreased social acceptability of smoking in public spaces. With socioeconomic status (SES) affecting smoking risk factors, disparities in health outcomes post-SFL implementation are likely. Furthermore, regional and international assessments show Malaysia’s poor performance due to ineffective smoking bans and enforcement. Local studies revealed inadequate SFL implementation and enforcement, leading to high secondhand smoke (SHS) exposure. Understanding these challenges and opportunities is crucial for improving policy implementation and enforcement to enhance public health outcomes. This study examined the association between SFL and quit intention …

Ghost Guns: A Case Study On The Tension Between Public Exigencies And Statutory Construction, Bradley Krause

Catholic University Law Review

Administrative agencies often navigate public policy issues while simultaneously handling complex and highly technical matters. When facing a public emergency, how should courts interpret these agencies’ authorizing statutes? What rules of thumb exist to guide the courts? This Comment answers these questions through a case study on ongoing litigation pertaining to a recent ATF (Bureau of Alcohol, Tobacco, and Firearms) regulation. The regulation, targeted towards ghost guns (also known as “privately manufactured firearms”), seeks to incorporate these weapons within pre-existing definitions in the ATF’s authorizing statute, the Gun Control Act of 1968 (GCA). In spite of challenges to the regulation, …

Is Hipaa Dead? How Recent Developments In Ftc Section 5 Enforcement May Impact Traditional Notions Of Health Privacy, Brian Patrick

University of Cincinnati Law Review

No abstract provided.

Dignity Defended, Privacy Preserved: A Call For Improved Legal Safeguards To Shield Victims Of Intimate Crimes From Public Scrutiny, Madeline E. Brown

University of Cincinnati Law Review

No abstract provided.

Why The Ostensible Agency Tort Doctrine Is Incoherent, Daniel Harris

University of Miami Business Law Review

One of the most perplexing areas of current tort law is the ostensible agency tort doctrine, which courts use to determine whether companies should be held liable for the negligence of their independent contractors. In most cases, liability under this doctrine requires proof the plaintiff detrimentally relied on a representation that the contractor was an employee of the defendant. However, in cases involving the negligence of independent contractor emergency room doctors, courts often hold hospitals liable under the ostensible agency tort doctrine without requiring such proof. Why does the doctrine take two inconsistent forms?

This Article argues that the law’s …

Transplantation And Immortality: A Selective History Of Boston University’S Center For Health Law, Ethics & Human Rights, George J. Annas

Faculty Scholarship

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 …

Disability Discrimination By Clinical Algorithm, Elizabeth Pendo, Jennifer D. Oliva

Articles

In response to America’s escalating drug poisoning crisis, the federal government has funded, incentivized, and mandated that states adopt and implement prescription drug monitoring programs (“PDMPs”) to electronically surveil controlled substances and other “drugs of concern.” State PDMPs utilize proprietary, predictive software platforms that deploy algorithms to determine whether a patient is at risk for drug misuse, drug diversion, doctor shopping, or substance use disorder. PDMPs have never been validated by a federal agency or peer review, yet states have mandated their use throughout the health care delivery system.

Research demonstrates that clinical overreliance on the risk scores generated by …

Under Observation: Wilson V. Inthachak Shows That Georgia’S Emergency Care Statute Still Lacks A Uniform Interpretation, Thomas S. Kiser

Mercer Law Review

This year, pro- and anti-tort reform forces met on the battleground of O.C.G.A. § 51-1-29.5(c), a statute that gives doctors increased protection from malpractice claims when they provide “emergency medical care in a hospital emergency department . . . .” When healthcare providers or hospitals are sued for negligence under these circumstances, the plaintiff must have clear and convincing evidence that the provider was grossly negligent, a greater hurdle than an ordinary medical malpractice plaintiff would need to overcome. While the statute is crystal clear in its purpose, Georgia courts have not reached a consensus regarding its application. Wilson v. …

Make America Healthy: Reducing High Pharmaceutical Prices Without Reducing Innovation, Srividhya Ragavan

Faculty Scholarship

Cost of medication in the United States has historically remained one of the highest in the world. The conundrum that the United States has faced in balancing innovation with affordability of life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with healthcare obligations. The result is an overflow of issues, which emphasize the need to delineate limits on innovation to balance pharmaceutical novelty with robust public health within the United States. This has increasingly shifted the focus of patent law into the realm of healthcare issues. Naturally, it leads to an inquiry about how best …

China, The Trips Waiver, And The Global Pandemic Response, Peter K. Yu

Faculty Scholarship

This chapter identifies three distinct reasons why China took a middle-of-the-road position in the debate on the COVID-19 TRIPS waiver at the WTO. It also recounts the country’s more assertive position in the run-up to the adoption of the Ministerial Decision on the waiver. Drawing eight lessons from the international debate on the waiver and the subsequent Ministerial Decision, the chapter offers insights into the future role China can or will play in future international policy debates at the intersection of intellectual property and public health, including during the next pandemic.

Advocacy Spotlight: Understanding The Mda's Role With Dental Insurance Reimbursement Rates, Daniel Miller D.D.S.

The Journal of the Michigan Dental Association

The Michigan Dental Association (MDA) is dedicated to advocating for members and advancing the dental profession. While federal laws prohibit the MDA from negotiating reimbursement rates with dental insurers, it provides significant support through education, advocacy, and resources.

Key initiatives include enhancing transparency in network leasing, endorsing PPO Negotiation Solutions to help practices optimize contracts, and offering educational programs on billing and coding. The MDA also facilitates peer networking and equips dentists with tools to navigate insurance challenges effectively.

Looking ahead, the MDA remains committed to empowering members through advocacy, guiding future dentists on contract literacy, and fostering a resilient …

Dentistry And The Law: Overlooked Purchase Agreement Terms, Daniel Schulte Jd

The Journal of the Michigan Dental Association

Selling a dental practice involves numerous legal, financial, and operational considerations. Assembling a team—including a lawyer, accountant, broker, and insurance professional—is crucial for ensuring a smooth transaction. While letters of intent are optional, they help define terms like exclusivity, due diligence, and confidentiality.

Purchase agreements, often drafted by the buyer’s lawyer, should detail asset allocation, tax implications, and handling of accounts receivable. Neglected areas such as work-in-process procedures and rework responsibilities must also be addressed to avoid disputes. Properly planning and negotiating these terms protects both buyer and seller, minimizing post-sale complications and ensuring a seamless transition of ownership.

J Mich Dent Assoc December 2024

The Journal of the Michigan Dental Association

Each month, The Journal of the Michigan Dental Association provides news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. It stands as the primary publication reaching Michigan dentists.

The December issue includes a timely cover feature on evidence supporting community water fluoridation, a clinical feature answering questions on patient dental records, a guest editorial on leadership by former MDA Journal Editor Dr. Bill Chase, and a Back Page article on how a personal touch makes a difference. We also provide our annual 2024 Author/Title Index and regular departments: The New Professional, …

The Case For Specialty Dockets: The Intersection Of Judicial Intervention, Psychiatric Hospitalization And Involuntary Commitments, Community-Based Services, And Public Safety, The Honorable Jacqueline S. Mcclenney

University of Richmond Law Review

Defendant Doe was diagnosed with a significant mental illness in 2015. His adult diagnosis of paranoid schizophrenia came after having been an adjudicated delinquent following multiple status offenses as a juvenile. Defendant Doe was placed into foster care as a result of his biological father’s incarceration and his mother’s unwillingness to seek treatment for her substance use disorder. Mother, father, and now adult Defendant Doe were all eligible for services and attempted to receive them through the local community services board (“CSB”).

Defendant Doe received psychiatric and supportive services through the CSB. Defendant Doe again entered the criminal justice system …

Silent Suffering: Demanding Individual Accountability For Sexual Assault Against Disabled Children In School Environments, Stephanie Flores

Journal of Law and Policy

Disabled children are among the most vulnerable in society, particularly in school environments where they depend on the actions and care of others for their safety. These children face significantly higher risks of sexual abuse than their non-disabled peers, and school officials' negligence can exacerbate this danger. Despite the prevalence of such cases, the Fifth Circuit's refusal to recognize school officials’ liability under the state-created danger doctrine, as seen in Fisher v. Moore, deprives disabled children of adequate legal recourse under 42 U.S.C. § 1983. The decision holds that school officials cannot be held personally liable for the peer-inflicted sexual …

Just Fix The Damn Payment System!, Frances H. Miller

Faculty Scholarship

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 …

Water Fluoridation: The Evidence Behind The Risk Of Fluoride Use, Margherita Fontana D.D.S., Ph.D., Carlos González-Cabezas D.D.S., M.S.D., Ph.D., Livia Tenuta D.D.S., M.Sc., Ph.D.

The Journal of the Michigan Dental Association

The debate surrounding fluoride use for caries control has intensified due to recent events, including a National Toxicology Program (NTP) report and a court ruling mandating EPA action on fluoride levels in tap water.

Despite concerns about fluoride's potential neurodevelopmental impact at high concentrations, current evidence shows no adverse effects at the recommended levels of 0.7 ppm in U.S. community water fluoridation programs. While studies in regions with endemic fluorosis suggest an association between high fluoride exposure and lower IQ, methodological limitations undermine causal conclusions.

Global and U.S. health authorities, including the WHO and ADA, reaffirm the safety and efficacy …

What You Must Know: Retention And Destruction Of Dental Records And Your Most-Asked Questions About Dental Records, Daniel Schulte Jd

The Journal of the Michigan Dental Association

An overview of the basic information about dental records, including retention and destruction, that you and your staff should be aware of, provided by MDA Legal Counsel Dan Schulte, J.D. Plus, for your reference, answers to the questions Michigan dental offices are asking about dental record retention, access, release, and destruction.

Dental records are vital for patient care, legal compliance, and professional practice management. Michigan law mandates retaining dental records for a minimum of 10 years, ensuring their confidentiality, accessibility, and integrity. Destruction of records less than 10 years old requires patient notification and authorization, while those over 10 years …

A One-Egg Wonder: Working To Cure Judicial Gender Bias And Increase Access To Pre-Embryos For Infertile Parties, Nicole Marks Kaufman

Cardozo Law Review

The first live birth of a child conceived from in vitro fertilization (“IVF”) happened in 1978. Today, over eight million children have been born through IVF procedures. The first dispute over the resulting pre-embryos was in 1990 when the Tennessee Supreme Court outlined a balancing approach with a presumption favoring non-use of the pre-embryos for courts to follow when resolving these matters. Numerous states have taken differing approaches—some have taken a contractual approach, others an approach requiring contemporaneous mutual consent before there can be a departure from the status quo, and very few state legislatures have directly addressed how to …

Health Law And Democracy, Wendy K. Mariner

Faculty Scholarship

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 …

Equitable Thriving: A Lifecourse Approach To Maternal And Child Health Justice, Yael Cannon

Georgetown Law Faculty Publications and Other Works

Black women are at least three times more likely to die due to a pregnancy-related cause than White women. Grave racial disparities also abound in severe maternal morbidity, or significant unexpected health consequences of labor and delivery. The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, eliminating the constitutional right to abortion, has only further restricted reproductive healthcare options and raised concerns that these disparities will grow even starker. Black, Indigenous, and Latine infants and children also experience unjust—and avoidable—health inequities. As a general matter, people of color are sicker across their lifespans and die younger in …

Where There's A Will, There's A Way: Abortion Litigation In The States, Catherine Dowd

Tennessee Journal of Race, Gender, & Social Justice

No abstract provided.

Dismantling The Dogma Of Dot: A Human Rights-Based Review Of Directly Observed Therapy For Tuberculosis, Brian Citro, Dr. Jennifer Furin, Rhea Lobo, Ingrid Schoeman, Timur Abdullaev, James Malar

Northwestern Journal of Human Rights

The global tuberculosis (TB) response is at a crossroads. In recent years, new ideas, technologies, and political commitments have reinvigorated the fight against this age-old disease that kills more people each year than HIV and malaria combined. But with key indicators just beginning to recover after moving in the wrong direction during the COVID-19 pandemic, hard-earned gains are at stake. In this rejuvenated yet challenging context, we critically review an idea and practice at the heart of the TB response—directly observed therapy or DOT. First, we explore DOT’s controversial method and history as a component of the World Health Organization’s …

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.