Health Law and Policy Commons^™

The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich

Notre Dame Journal on Emerging Technologies

Pharmaceutical manufacturers can delay the generic entry for a blockbuster drug. In order to keep the generic system on track, it is critical to expose the various avenues of generic delay. Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through …

A Sleeping Giant: Mhelath Applications, The Gdpr, And The Need For Federal Privacy Regulation In The United States, Kali Peeples

Notre Dame Journal on Emerging Technologies

An analysis of privacy regulation concerning mHealth apps is a multifaceted process that requires the examination of changes within not only the healthcare space but also the technological world, as well as the legislative history and intent of various nations.The main issue being addressed in this paper is whether the United States should create nationwide legislation that directly relates to mHealth data protection or continue with a self-regulatory method. Part I focuses on the development and rapid creation of mHealth apps within the past decade. Part II seeks to illustrate the distinct privacy concerns of mHealth apps by concentrating on …

The Code Of Life And Death, Braden R. Leach

Notre Dame Journal on Emerging Technologies

Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet. The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences. Unsurprisingly, voluntary guidance has not …

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

An Introduction To Personal Growth Bets: Using Contract Law To Lose Weight And Quit Smoking, Max Raskin, Jack Millman

Notre Dame Journal on Emerging Technologies

Self-improvement is hard. Whether losing weight or quitting smoking, individuals have a difficult time honoring their commitments, especially if the only person they are disappointing is themselves. In this Article, we introduce a new legal mechanism for incentivizing personal growth. We describe this mechanism as a personal growth contract, which allows an individual to make an enforceable agreement with either a counterparty or himself with the aim of self-improvement. We propose the use of smart contracts to help execute unilateral personal growth contracts. Our conclusion is that personal growth contracts should be presumptively legal, provided they do not violate some …

Rights And Remedies: Rental Housing For Low-Income Households In The United States, David Ray Papke, Mary Elise Papke

Marquette Benefits and Social Welfare Law Review

The state of rental housing for low-income households in the United States is deplorable. Unaffordable, unsanitary, and insecure, this housing violates the internationally recognized right of housing. While the United States has never formally recognized that right, the right guarantees not only a roof overhead but also affordability, habitability, and security of tenure. Policies and programs seeking to remedy the problems in rental housing might consciously address these aspects of rental housing. Policies and programs of this sort will not be enough to eliminate all problems, but they would alleviate a matter of great embarrassment, namely, the most affluent country …

The War On Drugs Or The War On Drug Users? Supervised Consumption Site In The United States As A Harm Reduction Strategy To Fight The Opioid Epidemic, Mary Crevello

Marquette Benefits and Social Welfare Law Review

Exploring the U.S. response to the opioid crisis, this study critically examines supervised consumption sites (SCSs) as a pragmatic approach. The historical framework of the "war on drugs" is scrutinized, highlighting its limitations and the necessity to shift from punitive measures towards more effective harm reduction strategies. Due to escalating opioid-related fatalities and inadequate harm reduction methods, the potential of SCSs is evaluated for short-term intervention. The Department of Justice's (DOJ) role in facilitating temporary measures to enable SCS operations is assessed, underscoring the urgency for a stable legislative framework to comprehensively address the crisis.

This research advocates for embracing …

All Dogs Are Emotional Support Animals: The Timely Need To Reconsider The Rights Of Renters To Have Dogs Under The Fair Housing Act, Leigh Cummings

Marquette Benefits and Social Welfare Law Review

The lack of pet-friendly housing options in the United States and the current web of property-owner-imposed restrictions unfairly prevents renters and lower-income individuals and families from benefitting from dog companionship. The recent confusion and stigma around the term “emotional support animal” has led to misinterpretation of the requirements of a reasonable accommodation request under the Fair Housing Act. Interpreting “assistance animal” under the Fair Housing Act as a blanket classification that applies to all dogs would reverse this current bias. Restrictions should promote responsible pet caretaking, not limit dog ownership. Considering recent heightened protections for dogs in other areas of …

A Major Question: Has Osha Missed Its Opportunity To Regulate Medical Residentduty Hours?, Anthony Anguille-Valles

Nevada Law Journal

Medical residents fall into a category of workers perpetually overlooked by the Occupational Safety and Health Administration (“OSHA”) due to their dual role as employee and trainee. Despite OSHA’s knowledge of the often life-threatening safety and health hazards medical residents face in the workplace pursuant to their uniquely arduous working conditions—most notably their duty hours—it has declined repetitiously to exercise its authority under the Occupational Safety and Health Act to intervene. While OSHA’s past failure to intervene should not hinder it from exercising its statutory authority to protect medical residents in the workplace today, SCOTUS’ recent efforts to curb administrative …

Staff Matters: Supporting Employees After A Maternity Leave, Jodi Schafer Sphr, Shrm-Scp

The Journal of the Michigan Dental Association

This article reviews federal law regarding employer obligations to new mothers, including the Fair Labor Standards Act and the Providing Urgent Maternal Protections for Nursing Mothers Act. The article contains suggestions for ways to support new mothers returning to work in a practice. This article is an installment of the MDA Journal’s monthly Staff Matters^® department.

Federalism, Leadership, And Covid-19: Evolving Lessons For The Public’S Health, Nicole Huberfeld

Faculty Scholarship

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law and much more. This collection provides a critical reflection on what changes the pandemic has already introduced, and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global 'stress test,' and explore how the US and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies …

J Mich Dent Assoc September 2023

The Journal of the Michigan Dental Association

Reports from the deans of Michigan’s two dental schools covering the past year’s activities serve as the dual cover stories for this issue. Other feature articles include a discussion of professionalism, a diagnostic challenge describing adenomatoid odontogenic tumor, and a memorial tribute to recently deceased MDA Executive Director Karen Burgess. Monthly departments include Dentistry and the Law, Staff Matters^® human resource guidance, MDA Services (endorsed programs), MDA Foundation, news updates in News You Need, and more.

How Are You Holding Up? The State Of Judges' Well-Being: A Report On The 2019 National Judicial, Terry A. Maroney, David X. Swenson, Joan Bibelhausen, David Marc

Vanderbilt Law School Faculty Publications

Judges have always faced significant stressors, including the burden of consequential decision-making, exposure to disturbing evidence, and isolation. While every judicial assignment has its own mix of concerns, challenge is a constant. Recurrent experiences of serious stressors place judges at risk of burn-out, secondary trauma, poor mental and physical health, and substance use disorders.

Historically, such issues have been addressed primarily in the context of judicial fitness - that is, only when individual judges were suffering to the degree that they could no longer competently perform their duties would the system respond, and then usually for the purpose of discipline …

Abolition And Environmental Justice, Allegra M. Mcleod

Georgetown Law Faculty Publications and Other Works

During the coronavirus pandemic, movements for penal abolition and racial justice achieved dramatic growth and increased visibility. While much public discussion of abolition has centered on the call to divest from criminal law enforcement, contemporary abolitionists also understand public safety in terms of building new life-sustaining institutions and collective structures that improve human well-being, linking penal divestment to environmental justice. In urging a reimagination of public safety, abolitionists envision much more than decriminalization or a reallocation of police functions to social service agencies or other alternatives to imprisonment and policing. Instead, for abolitionists, meaningful public safety requires, among other things, …

Health Care Fraud And The Erosion Of Trust, Katrice Bridges Copeland

Northwestern University Law Review

In health care, trust is a foundational concept. Patients must trust that their medical practitioners are competent to treat them. The trustworthiness of medical practitioners encourages patients to disclose intimate facts about their medical issues. Further, patients must trust health care providers to demonstrate impartial concern for the patients’ well-being, also known as fidelity. In providing care, the needs of the patients, rather than financial incentives, must drive medical practitioners. Without this trust, patients may not cooperate with diagnosis and treatment. In addition to trusting providers, care outcomes are better if patients trust the health care system as a whole. …

Covid-19 Pandemic’S Impact On Online Sex Advertising And Sex Trafficking, Coxen O. Julia, Vanessa Castro, Bridgette Carr, Glen Redin

Articles

Disruptive social events such as the COVID-19 pandemic can have a significant impact on sex trafficking and the working conditions of victims, yet these effects have been little understood. This paper examines the effect of the COVID-19 pandemic on sex trafficking in the United States, based on analysis of over one million sexual service advertisements from the online platform Rubratings.com, using indicators of third-party management as potential proxies for trafficking. Our results show that there have been measurable changes in online commercial sexual service advertising, both with and without third-party management indicators, in the United States, with a significant decrease …

Meet Our New Faculty: Jenn Oliva, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Professor Jenn Oliva joined Indiana Law earlier this summer as a professor of law and as Val Nolan Faculty Fellow. Prior to joining the IU Maurer Law faculty, Professor Oliva served as Professor of Law and Co-Director of the UCSF/UC Law Consortium on Law, Science & Health Policy at the University of California College of Law, San Francisco. She has also served as Associate Dean for Faculty Research & Development and Director of the Center for Health & Pharmaceutical Law at Seton Hall University School of Law where she was selected as the law school’s 2021 Professor of the Year …

Legal Needs And Health Outcomes For People With Cancer In Medical-Legal Partnership Programs: A Systematic Review, Allison B. Dowling, Caitlin Schille Jensen, Abigail Sweeney, C. Scott Dorris, Deborah F. Perry

HJA Scholarship

Medical-legal partnerships (MLPs) integrate lawyers into the medical team to address patients’ unmet legal needs that create barriers to good health and well-being (i.e., “health-harming legal needs”) and improve health outcomes. Given the growing popularity of MLP as an innovative healthcare model, this review has two objectives: to identify peer-reviewed literature measuring (1) cancer patients’ legal needs, and (2) outcomes for cancer patients after receiving MLP legal services. A systematic literature search was conducted in concordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for the period 2006- 2022. Four articles met the inclusion criteria for objective …

N Y State Dent J August-September 2023

The New York State Dental Journal

In the August-September 2023 issue, the reader will find the following feature articles:

• Iatrogenic Indirect Compression of the Inferior Alveolar Nerve by a Dental Implant
• Use of Dentoalveolar and Zygomatic Implants in Restoration of Maxillary Defect Following Fibula Free-flap Reconstruction Failure
• Flapless Approach to Dental Implant Surgery: To Use or Not to Use?

This issue includes regular columns with regional news impacting the New York membership including: editorial and perspectives columns, legal, association activities, component news, continuing education opportunities, and classifieds.

Don't Let The Sun Go Down On Same-Sex Parental Rights: How Relying On Mutual Consent At The Time Of Artificial Insemination And Childbirth Can Uphold Legal Parentage Of Separated Same-Sex Couples, Danielle M. Digrazia

Villanova Law Review (1956 - )

No abstract provided.

Navigating The Legal Landscape Of Mental Health In The Workplace: Insights For The Dental Practice, Gary Chamberlin Milr, Jd

The Journal of the Michigan Dental Association

Dealing with an employee’s mental health situation poses complex challenges for human resource professionals. Dental practices, typically run by busy dentists or administrative managers, often lack a human resource professional and the legal expertise needed to navigate the intricacies of employment laws pertaining to mental health disabilities. Moreover, mental health issues in the workplace are sensitive, private matters that intersect with disability and leave laws and are still associated with cultural stigmas despite evolving societal attitudes. This article provides specific scenarios that give insights into the legal issues when managing dental office employees with mental health conditions. Readers should address …

What Does Professionalism Mean To You? Part I, Michael G. Maihofer Dds

The Journal of the Michigan Dental Association

This commentary explores generational perspectives on professionalism in dentistry, focusing on how younger dentists perceive this concept. It highlights the changing dynamics in dentistry and questions whether professionalism remains relevant in a world where various practice models exist. Insights from young dentists shed light on their commitment to professionalism and its evolving definition, emphasizing the importance of caring for patients and maintaining high-quality care.

Hipaa Update: Conducting A Security Risk Analysis, Jennifer Cosey

The Journal of the Michigan Dental Association

The Health Insurance Portability and Accountability Act (HIPAA) Security Rule mandates periodic security risk analyses (SRA) to assess compliance. This analysis evaluates threats and vulnerabilities to electronic protected health information (EPHI) and considers all devices connected to a network. While the Security Rule is flexible, small organizations must still adhere to its standards. IT vendors and staff play a crucial role in implementing HIPAA safeguards. Threats and vulnerabilities must be identified to select appropriate safeguards for EPHI. These safeguards include administrative, physical, and technical measures. Addressable specifications should be implemented if reasonable, and documentation of decisions is essential. A Technical …

J Mich Dent Assoc August 2023

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story on new dentist’s perceptions of professionalism.
• A feature on legal considerations when addressing employee wellness.
• A feature on the meaning of wellness by ADA Trustee Dr. Brett Kessler.
• Practice guidance on conducting a HIPAA security risk analysis.
• Commentary “The New Golden Age of Dentistry.”
• Editorial and regular department articles on MDA Foundation …

Compassion: It’S Needed Now More Than Ever, Michelle C. Dziurgot Dds

The Journal of the Michigan Dental Association

This editorial emphasizes the pressing need for compassion in a world of conflict and division. It underscores the importance of compassion in global crises, politics, family dynamics, and the dental profession. MDA Editor Michelle C. Dziurgot encourages unity and understanding, advocating for compassion as a vital force in bridging divides.

The Global Health And Care Worker Compact: Evidence Base And Policy Considerations, Eric A. Friedman, Robert Bickford, Charles Bjork, James Campbell, Giorgio Cometto, Alexandra Finch, Catherine Kane, Sarah A. Wetter, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Background During the COVID-19 pandemic, and recognising the sacrifice of health and care workers alongside discrimination, violence, poor working conditions and other violations of their rights, health and safety, in 2021 the World Health Assembly requested WHO to develop a global health and care worker compact, building on existing normative documentation, to provide guidance to ‘protect health and care workers and safeguard their rights’.

Methods A review of existing international law and other normative documents was conducted. We manually searched five main sets of international instruments: (1) International Labour Organization conventions and recommendations; (2) WHO documents; (3) United Nations (UN) …

Prioritizing Regional Wildlife Conservation By Rejuvenating The Western Hemisphere Convention On Nature Protection, Shade Streeter, David Hunter, William Snape Iii

Sustainable Development Law & Policy

Last year, parties to the Convention on Biological Diversity (“CBD”), representing nearly every nation, signed a milestone agreement committing, among other things, to conserve thirty percent of Earth’s lands and oceans to stave off the rapid diminution of the planet’s biodiversity. Implementing these global commitments will require not only strong domestic measures, but also enhanced regional cooperation targeting the conservation of the region’s migratory wildlife and shared resources. Although the United States is the sole major holdout from the CBD, it can still reassert its leadership in regional wildlife conservation by rejuvenating the Convention on Nature Protection and Wildlife Preservation …

Unclos, Undrip & Tartupaluk: The Grim Tale Of Hans Isle And Graense, Christopher Mark Macneill

Sustainable Development Law & Policy

“Inuit have lived in the Arctic from time immemorial.” The Arctic, in the face of climate change, has become a hot spot for exploration, resource extraction, and increased shipping and scientific activity. “[The] Inuit . . . have had a common and shared use of the sea area and the adjacent coasts” among their own communities, and contemporaneously with the world. This vast circumpolar Inuit Arctic region includes land, sea, and ice stretching from eastern Russia (Chukotka region) across the Berring Strait, to Alaska, the Canadian Arctic, and Greenland, representing an Inuit homeland known as Nunaat. Hans Isle, a small …

The Great Climate Migration: A Critique Of Global Legal Standards Of Climate-Change Caused Harm, Mariah Stephens

Sustainable Development Law & Policy

Approximately 2.4 billion people, or about forty percent of the global population, live within sixty miles (one hundred kilometers) of a coastline. The United Nations (“U.N.”) determined that “a sea level rise of half a meter could displace 1.2 million people from low-lying islands in the Caribbean Sea and the Indian and Pacific Oceans, with that number almost doubling if the sea level rises by two metres.” The U.N. also reports that “sudden weather-related hazards” have internally displaced an annual average of 21.5 million people since 2008. Within the next few decades, this number is likely to continue to increase. …

The Future Of Crypto-Asset Mining: The Inflation Reduction Act And The Need For Uniform Federal Regulation, Liz Guinan

Sustainable Development Law & Policy

Crypto-asset mining is energy-intensive and environmentally harmful, presenting challenges and opportunities for federal, state and local governments, regulators, and society as a whole. As of December 2021, the United States has thirty-eight percent of the global crypto network hash rate, which is the total amount of computational power used to mine and process crypto transactions, making the United States the world’s largest crypto-asset mining industry. The total electricity consumption of crypto-asset mining in the United States is estimated to be around 121.36 terawatt-hours (“TWh”) per year, which is equivalent to the electricity consumption of approximately 10.9 million households in the …