Law Commons^™

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

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 TRIPS compulsory …

Telemedicine Scams, Katrice B. Copeland

Journal Articles

Telemedicine emerged as a lifeline during the COVID-10 pandemic. Although the technology existed long before the pandemic, its use was limited due to strict government regulations that limited reimbursement for telemedicine visits. In response to the pandemic, the Government waiver many of its restrictions for the duration of the Public Health Emergency. These changes fueled the growth of telemedicine.

The problem, however, is that telemedicine makes it easier to conduct fraud on a larger scale because without in-person visits, medical providers can reach many more beneficiaries in a short period of time. Thus, the size and scale of typical health …

Nothing Generic About It: Promoting Therapeutic Access By Overcoming Regulatory And Legal Barriers To A Robust Generic Medical Device Market, Megan S. Wright, Zachary Shapiro, Adam Pan, Keturah James, Joseph Fins

Journal Articles

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the …

Covid-19 Business Interruption Insurance Losses: The Cases For And Against Coverage, Christopher French

Journal Articles

The financial consequences of the government-ordered shutdowns of businesses across America to mitigate the COVID-19 health crisis are enormous. Estimates indicate that small businesses have lost $255 to $431 billion per month and more than 44 million workers have been laid off. When businesses have requested reimbursement of their business interruption losses from their insurers under business interruption policies, their insurers have denied the claims. The insurance industry also has announced that business interruption policies do not cover pandemic losses, so they intend to fight COVID-19 claims “tooth and nail.” More than 450 lawsuits throughout the country already have been …

Dementia, Autonomy, And Supported Healthcare Decisionmaking, Megan S. Wright

Journal Articles

Healthcare providers often rely on surrogates to decide on behalf of their patients with dementia who are deemed incapable of exercising autonomy. There is a longstanding debate about the appropriate standard of surrogate healthcare decisionmaking for these patients. Many influential scholars argue that the precedent autonomy of the person with dementia should be respected, and healthcare decision-making laws generally reflect this principle. These laws direct surrogate decisionmakers to follow instructions in living wills or to decide on the basis of the wishes and values of the person before the onset of dementia.But other prominent scholars have questioned whether surrogates should …

Liquid Gold, Katrice Bridges Copeland

Journal Articles

According to federal health and census data, addiction treatment was a $21 billion business in 2003. By 2020, it is expected to double to $42 billion. The opioid crisis has fueled the growth of the industry by increasing the demand for residential drug treatment programs. Astronomical growth of an industry, however, often invites bad actors.

Bad actors have swarmed the residential drug treatment industry. One category of bad actors includes patient brokers, who recruit drug addicts with health insurance to residential drug treatment centers for sizeable kickbacks. Another category of bad actors are the owners and operators of treatment centers …

End Of Life And Autonomy: The Case For Relational Nudges In End-Of-Life Decision-Making Law And Policy, Megan S. Wright

Journal Articles

Autonomy is a central principle in many areas of health law. In the case of end-of-life decision-making law and policy, however, the principle of autonomy requires revision. On the whole, law conceptualizes autonomy at the end of life as an individual making private, personal decisions based solely on their interests and values, and independent of others. But ordinary people understand autonomous decisionmaking at the end of life differently, in a way that acknowledges the importance of their interpersonal relationships. Social science research has documented that strengthening relationships with others, sharing responsibility in the decision-making process with healthcare providers, and taking …

Improving Outcomes In Child Poverty And Wellness In Appalachia In The "New Normal" Era: Infusing Empathy Into Law, Jill C. Engle

Journal Articles

No abstract provided.

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.

The Rules Of Maternity, Dara Purvis

Journal Articles

A diverse body of laws and regulations speaking to reproductive rights, healthcare, criminal punishment of drug use, termination of parental rights, and more creates the rules of maternity. These rules are guidance provided both obliquely and explicitly by the law's coercive power telling women both how to and who should mother. Rule one begins in pregnancy, with the message that "your body is your child's vessel." During pregnancy, women are counselled that doctor knows best. After the child's birth, the mother remains responsible for the people who enter a child's life, leading to rule 3: "mothers must always protect." …

Expectant Fathers, Abortion, And Embryos, Dara Purvis

Journal Articles

One thread of abortion criticism, arguing that gender equality requires that men be allowed to terminate legal parental status and obligations, has reinforced the stereotype of men as uninterested in fatherhood. As courts facing disputes over stored pre-embryos weigh the equities of allowing implantation of the pre-embryos, this same gender stereotype has been increasingly incorporated into a legal balancing test, leading to troubling implications for ART and family law.

Effectuating Change In The Regulation Of Hiv Vaccines, Scott M. Engstrom

Scott M Engstrom

HIV has been at the forefront in politics, medicine, and law since its discovery in 1981. Over thirty years have passed since the virus began a wave of fear made worse by a sensationalist media. Though much of the uproar has dulled, the lasting effects on the American Psyche have remained as the AIDS death toll has risen. Although the medical community has made significant progress in managing the infection through complex drug cocktails, prevention remains the most effective tool in the fight against AIDS. However, the old aphorism “an ounce of prevention is worth a pound of cure” has …

Filial Support Laws In The Modern Era: Domestic And International Comparison Of Enforcement Practices For Laws Requiring Adult Children To Support Indigent Parents, Katherine C. Pearson

Journal Articles

Family responsibility and support laws have a long but mixed history. When first enacted, policy makers used such laws to declare an official policy that family members should support each other, rather than draw upon public resources. This article tracks modern developments with filial support laws that purport to obligate adult children to financially assist their parents, if indigent or needy. The author diagrams filial support laws that have survived in the 21st Century and compares core components in the United States (including Puerto Rico) and post-Soviet Union Ukraine. While the laws are often similar in wording and declared intent, …

Ru-486; Safe? Effective? Banned! Why Would The Food And Drug Administration Ban A Drug With Such Potential?, Mark A. Hernandez

Penn State International Law Review

No abstract provided.

Assessing Universal Access To Health Care: An Analysis Of Legal Principle And Economic Feasibility, Carlo V. Diflorio

Penn State International Law Review

No abstract provided.

Abortion Law Reform: The Nexus Between Abortion And The Role Of Women In The German Democratic Republic And The Federal Republic Of Germany, Elizabeth J. Kapo

Penn State International Law Review

No abstract provided.

Socialized Medicine: An Analysis Of Bureaucratic Inefficiency, John J. Moran

Penn State International Law Review

In analyzing the health care systems of Great Britain and Canada, this Comment examines the policies and reasons behind the passing of legislation which led to the advent of socialized medicine in these two nations. In addition, a discussion of the operation of these socialized health systems illustrates the turmoil and complexity associated with government medicine, and the need for subsequent legislative reforms. As this Comment reveals, these socialized systems, where overriding political objectives create further misallocation of resources and decreased quality of care, fail to provide a viable solution to American health concerns. Instead, reforms should be undertaken within …