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Take It With A Grain (Or More) Of Salt: Why Industry-Backed Dietary Guidelines Fail Americans And How To Fix Them., Caroline Farrington 2022 University of Michigan Law School

Take It With A Grain (Or More) Of Salt: Why Industry-Backed Dietary Guidelines Fail Americans And How To Fix Them., Caroline Farrington

University of Michigan Journal of Law Reform

The U.S. Dietary Guidelines lack oversight and accountability. The result: Guidelines that reflect food industry interests instead of modern science. This deleterious guidance goes on to govern federally-subsidized food assistance programs and to influence dietary choices throughout the private sector and private life. Ultimately, the Guidelines significantly contribute to the endemic chronic disease they seek to address.

The Guidelines Advisory Committee is notoriously rife with conflicts of interest, and thus most Guidelines scholarship has focused on reforming the Committee. But the 2015 and 2020 Guidelines show that these reforms are insufficient and agency-level change is necessary. In 2015, the ...


Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler 2022 Northwestern University School of Law

Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler

University of Michigan Journal of Law Reform

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or ...


Big Data, Big Gap: Working Towards A Hipaa Framework That Covers Big Data, Ryan Mueller 2022 Indiana University Maurer School of Law

Big Data, Big Gap: Working Towards A Hipaa Framework That Covers Big Data, Ryan Mueller

Indiana Law Journal

One lasting impact of the Health Insurance Portability and Accountability Act (HIPAA) is the privacy protections it provides for our sensitive health information. In the era of Big Data, however, much of our health information exists outside the traditional doctor-patient dynamic. From wearable technology, to mobile applications, to social media and internet browsing, Big Data organizations collect swaths of data that shed light on sensitive health information. Big Data organizations largely fall outside of HIPAA’s current framework because of the stringent requirements for when the HIPAA protections apply, namely that the data must be held by a covered entity ...


Delayed & Denied: Recalibrating The Erisa Attorney's Fee Factors For Healthcare Claims, Katherine T. Vukadin 2022 Villanova University Charles Widger School of Law

Delayed & Denied: Recalibrating The Erisa Attorney's Fee Factors For Healthcare Claims, Katherine T. Vukadin

Villanova Law Review

No abstract provided.


Reclaiming The Right To Consent: Judicial Bypass Mechanism As A Way For Persons With Disabilities To Lawfully Consent To Sexual Activity In Ohio, Melissa S. Obodzinski 2022 Cleveland-Marshall College of Law

Reclaiming The Right To Consent: Judicial Bypass Mechanism As A Way For Persons With Disabilities To Lawfully Consent To Sexual Activity In Ohio, Melissa S. Obodzinski

Cleveland State Law Review

In Ohio, it is a criminal offense to engage in sexual conduct with another when his or her ability to consent is “substantially impaired” because of a mental or physical condition. There is no mechanism for persons with intellectual and/or developmental disabilities to receive judicial notice of whether their ability to consent is “substantially impaired” prior to criminal adjudication, nor is there a way for them to affirmatively prove that they have the capacity to consent to sexual activity. Thus, under Ohio law, intellectually and/or developmentally disabled individuals may be functionally and irrevocably barred from engaging in sexual ...


Presumptively Awful: How The Federal Government Is Failing To Protect The Constitutional Rights Of Those Adjudicated As Mentally Ill, As Illustrated By The § 922(G)(4) Circuit Split, Kaitlyn M. Rubcich 2022 Pepperdine University

Presumptively Awful: How The Federal Government Is Failing To Protect The Constitutional Rights Of Those Adjudicated As Mentally Ill, As Illustrated By The § 922(G)(4) Circuit Split, Kaitlyn M. Rubcich

Pepperdine Law Review

The Third, Sixth, and Ninth Circuits are split as to whether the 18 U.S.C. § 922(g)(4) federal firearms ban violates the Second Amendment rights of those who were once adjudicated as mentally ill but have since returned to good mental health. In Beers v. Attorney General, the Third Circuit applied its own unique framework and held that § 922(g)(4) is constitutional. Meanwhile, the Sixth Circuit applied intermediate scrutiny in Tyler v. Hillsdale County Sheriff’s Department and deemed the statute unconstitutional, while in Mai v. United States, the Ninth Circuit also applied intermediate scrutiny but held ...


The Federal Global Migration And Quarantine Network: A Report From The National Academies Of Sciences, Engineering, And Medicine, Lawrence O. Gostin, Georges C. Benjamin, Tequam Worku 2022 Georgetown University - Law Center - O'Neill Institute for National and Global Health Law

The Federal Global Migration And Quarantine Network: A Report From The National Academies Of Sciences, Engineering, And Medicine, Lawrence O. Gostin, Georges C. Benjamin, Tequam Worku

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic thrust the US Centers for Disease Control and Prevention (CDC) Division of Global Migration and Quarantine (DGMQ) into the epicenter of the national response. DGMQ is charged with preventing the importation of infectious diseases at land and sea borders and the spread of those diseases within the US. For more than 50 years, the agency’s comprehensive quarantine system, its regulatory powers, and scientific guidance has placed DGMQ at the forefront of emergency response. CDC requested the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess the performance of the DGMQ during the COVID-19 pandemic, covering ...


Physical Losses, Invisible Damages: Finding Coverage For Business Interruption Insurance Claims Sustained During The Covid-19 Pandemic, Mason Medeiros 2022 University of Minnesota Law School

Physical Losses, Invisible Damages: Finding Coverage For Business Interruption Insurance Claims Sustained During The Covid-19 Pandemic, Mason Medeiros

Minnesota Journal of Law, Science & Technology

No abstract provided.


Cafo’S Are A Public Health Crisis:The Creation Of Covid-19, Helena Masiello 2022 University of Miami School of Law

Cafo’S Are A Public Health Crisis:The Creation Of Covid-19, Helena Masiello

University of Miami Law Review

Concentrated Animal Feeding Operations (“CAFO’s”) are largely unregulated by State or Federal Laws in the United States. As a result of this lack of oversight, they are a breeding ground for deadly infectious diseases. The COVID-19 epidemic has demonstrated the threat that diseases pose to the United State like H1N1, SARS, and Ebola.
The USDA needs to regulate CAFOs under the mandate given to them by congress in the AHPA to ensure that they are not the epicenter of the next wave of deadly infectious diseases. Scientists have been warning about the disease potential of CAFOs for the last ...


The Implication Of Texas Abortion Law Sb8 On At-Risk Populations In Texas And Other States, Kelly Zielinski 2022 DePaul University College of Law

The Implication Of Texas Abortion Law Sb8 On At-Risk Populations In Texas And Other States, Kelly Zielinski

DePaul Journal of Health Care Law

When the United States Supreme Court didn’t strike down, SB8, Texas’ anti-abortion law, there was a shift in the legal landscape for women’s reproductive rights. The novel structure of the bill would undeniably lead to copycat bills being enacted by other states looking to restrict access to abortion and disproportionately affect at-risk populations in those states. To protect the most vulnerable populations, the government needs to enact laws that recognize abortion as healthcare. Roe v. Wade has been precedent for fifty and any limitations on the established law will have lasting impacts on generations to come. This comment ...


Manipulating The Prescription Drug Market: Spiking Prices, Inducing Demand, And Costs To The Public, Katherine Drabiak, J.D. 2022 University of South Florida College of Public Health

Manipulating The Prescription Drug Market: Spiking Prices, Inducing Demand, And Costs To The Public, Katherine Drabiak, J.D.

DePaul Journal of Health Care Law

In 2016, Mylan made headlines when it spiked the price of its EpiPen AutoInjector by 400%, raising the price from an average of $57 to $500. Critics called the price hike “outrageous, “brutal” and “corrupt.” Public outcries fueled a demand for a Congressional investigation, and Mylan negotiated a settlement with the United States Department of Justice over alleged violations of the False Claims Act. Although competition self-corrected and similar products entered the marketplace, this case – and other similar cases involving generic drugs and insulin – highlighted the skyrocketing costs of prescription drugs in the United States. In 2019, United States outpatient ...


Dental Support Organizations And The Corporate Practice Of Dentistry: Will Streamlining Create Legal Violations?, Angelina Campin 2022 DePaul University College of Law

Dental Support Organizations And The Corporate Practice Of Dentistry: Will Streamlining Create Legal Violations?, Angelina Campin

DePaul Journal of Health Care Law

The increased use of technology when searching for health care providers means that consumers of dental care are more concerned with efficiency in making appointments and paying bills, immediate access to information, clear pricing, and transparency when it comes to choosing a provider and a facility to visit. Keeping up with the increased demands for efficiency and technological advances presents a challenge to sole practitioner dentists, which is the standard dental practice model. Dental support organizations (“DSOs”) have seen an increase in popularity recently, especially over the last five to ten years, in part to meet both the needs of ...


Artificial Intelligence/ Machine Learning-Based Medical Devices: Regulatory And Patentability Challenges, May Lee 2022 Penn State Law

Artificial Intelligence/ Machine Learning-Based Medical Devices: Regulatory And Patentability Challenges, May Lee

Penn State Journal of Law & International Affairs

No abstract provided.


The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth 2022 Penn State Law

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Penn State Journal of Law & International Affairs

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to (1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or ...


A New Architecture For Global Health Emergency Preparedness And Response—The Imperative Of Equity, Lawrence O. Gostin 2022 Georgetown University - Law Center - O'Neill Institute for National and Global Health Law

A New Architecture For Global Health Emergency Preparedness And Response—The Imperative Of Equity, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Even before COVID-19 emerged in Wuhan, China, in December 2019, the prevailing global narrative was inequity—in health, income, race, and socioeconomic status. COVID-19 amplified all these inequities. Early in the pandemic, low-income countries were left without key medical resources, such as diagnostic tests, personal protective equipment, and ventilators. By 2021, inequitable vaccine distribution captured global attention and outrage. This year, high-income countries have bought the lion’s share of Paxlovid, a highly effective antiviral treatment. Vaccine inequities remain with only 16% of people in low-income countries having received at least 1 vaccine dose vs 80% of people across high-income ...


Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed 2022 HIPS, D.C.; Georgetown’s O’Neill Institute for National and Global Health Law

Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed

Michigan Journal of Gender & Law

Transgender youth are increasingly able to access gender-affirming healthcare. Because gender-affirming care such as hormone therapy is clinically shown to reduce gender dysphoria and ease physical and social transition, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary for the treatment of dysphoria. However, an important dimension of gender-affirming care remains under-insured and overpriced: fertility preservation (FP). Several studies indicate that hormone therapies and certain gender-affirming surgeries can have negative, long-term impacts on future fertility. Although these impacts can be mitigated through approved FP methods such as sperm cryopreservation and oocyte cryopreservation, such methods are rarely ...


Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke 2022 University of Michigan Law School

Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke

Michigan Journal of Gender & Law

Pregnant transgender people’s experiences vary: they may identify as male or non-binary and may seek gender-affirming medical care to different degrees. This variety in gender identities and bodies puts additional pressure on CJEU’s pregnancy discrimination case law—a case law that is, as this Article argues, already flawed. Building on a critique of the CJEU’s decision in Dekker, this Article discusses three alternative approaches to addressing pregnancy discrimination in EU law. The first two approaches are different ways of construing pregnancy discrimination as sex discrimination. First, the Article discusses a gender-stereotyping approach to direct sex discrimination, and ...


The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth 2022 Texas A&M University School of Law

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Student Scholarship

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to(1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or ...


Cost-Effectiveness Comes To America: The Promise And Perils Of Cost-Effective Analysis In Medication Coverage Decisions, Carl Coleman 2022 Seton Hall University School of Law

Cost-Effectiveness Comes To America: The Promise And Perils Of Cost-Effective Analysis In Medication Coverage Decisions, Carl Coleman

Georgia State University Law Review

In an effort to control rising drug costs, some health insurers have begun experimenting with methods to link decisions about coverage to the value added by medicines, including through the use of formal cost-effectiveness analysis (CEA). Increased interest in subjecting new drugs to rigorous economic analysis is a welcome development, as it offers the potential to minimize wasteful spending on drugs whose high prices are not justified by evidence of additional benefits produced. At the same time, CEA raises significant ethical issues, particularly when payers use it to limit access to drugs deemed to provide insufficient value for money. For ...


404 Provider Not Found: Contributions And Solutions To Inadequate Provider Networks For Behavioral Health Care, Travis Williams 2022 Georgia State University College of Law

404 Provider Not Found: Contributions And Solutions To Inadequate Provider Networks For Behavioral Health Care, Travis Williams

Georgia State University Law Review

Despite the efforts of policymakers, access to in-network behavioral health care services has continued to lag relative to other types of health care. Many psychiatrists, for example, do not accept insurance, limiting access to their services to only those individuals who can afford to pay out of pocket. Several factors contribute to insurance networks’ paucity of behavioral health care providers, including low insurance reimbursement for behavioral health care services, inadequate regulation and enforcement, provider shortages, and a lack of access to telehealth services. To maximize the utility of existing regulatory structures, states should take an outcome-oriented enforcement approach that principally ...


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