Law Commons^™

The Hipaa Privacy Rule At Age 25: Privacy For Equitable Ai, Barbara J. Evans

UF Law Faculty Publications

This Article argues that unconsented access to data is not ethically problematic in and of itself. What has made it problematic is the weak framework of alternative protections that the Privacy Rule prescribes when data are used without individual consent. This Article proposes specific measures to strengthen those protections so that the pursuit of greater health care equity need not imply a loss of meaningful privacy standards.

Part I describes two competing visions of how to protect data privacy, examining the roots of ongoing discontent with the Privacy Rule and tracing policymakers’ original rationale for fashioning a major federal privacy …

Should Canada Adopt Managed Access Agreements In Canada For Expensive Drugs?, Melanie Mcphail, Tania M. Bubela

Office of the Provost

Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to be cost-effective (or may even be unsafe) or delaying the reimbursement of a drug that is cost-effective and offers clinical benefit to patients. Novel reimbursement decision models and frameworks, such as managed access agreements (MAAs), may address this decision challenge. Here, we provide a comprehensive overview of the legal limitations, considerations, and implications for adopting MAAs in Canadian jurisdictions. We begin with an overview of …

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

Ella P. Stewart And The Benefits Of Owning A Neighborhood Pharmacy, Randall K. Johnson

Faculty Works

This Essay is the first to explain how and why Ella P. Stewart, who was among the first Black women to earn a doctoral degree in Pharmacy, used her status as a small business owner to protect the limited set of legal rights that were available to African-Americans in the twentieth century. It also describes how Stewart’s early personal and professional experiences informed her subsequent public service career. Additionally, this Essay highlights the various ways that Stewart expanded the real freedoms that Black Americans enjoyed by guaranteeing they received a fair share of public goods or services. It concludes by …

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 …

Medical-Legal Partnership As A Model For Access To Justice, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The United States is plagued with a “justice gap” that leaves many Americans with unmet civil legal needs. Americans with low income do not receive the legal help they require for as many as 92% of their substantive civil legal problems. The justice gap requires many legal aid agencies to triage, becoming “emergency rooms” for clients with unmet legal needs. This national crisis calls for new innovations so that access to justice (A2J) can function more like primary care, promoting better use of resources and preventing legal crises that can cause long-lasting harm.

Medical-Legal Partnerships (MLPs) embed lawyers in healthcare …

Considerations In Selecting Venues For The American Thoracic Society International Conference: Balancing Competing Priorities Of The Society's Diverse Membership, Gregory P. Downey, M. Patricia Rivera, Lynn M. Schnapp, Irina Petrache, Jesse Roman, Karen J. Collishaw

Division of Pulmonary and Critical Care Medicine Faculty Papers

No abstract provided.

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

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, …

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price

Law & Economics Working Papers

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (IRA) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Advancing Equity In The Pandemic Treaty, Lawrence O. Gostin, Kevin A. Klock, Katherine Ginsbach, Sam F. Halabi, Taylor Hall-Debnam, Janelle Lewis, Vanessa S. Perlman, Katie Robinson

Georgetown Law Faculty Publications and Other Works

There is a broad consensus around equity’s importance. Even countries that hoarded supplies during the acute phase of COVID-19 seem to understand that the international community must find a means to ensure fairer allocation of medical resources when the next health crisis hits. But there has been little agreement about the concrete steps needed to operationalize fairer access and benefit sharing. That is, what are the workable mechanisms that could reduce the divide between richer and poorer populations? The World Health Assembly, the governing body of the World Health Organization, has appointed an Intergovernmental Negotiating Body to develop a pandemic …

Disaster Risk In The Carceral State, Saptarishi Bandopadhyay, Joshua R. Coene

Journal Articles

The overlap between prisoner vulnerability and disasters in the United States is undeniable. During 2020 and 2021, the United States endured a series of natural hazards such as wildfires, floods, and hurricanes, many of which exposed the country’s 2.1 million inmates to additional risks and compounded the danger posed by COVID-19. Yet policymakers and scholars are only beginning to appreciate the centrality and magnitude of disaster risk management for the millions of people currently held in penal institutions around the country. Unsurprisingly, the production of “lessons learned” documents that follow in the aftermath of disasters overlook how prisoner vulnerability is …

The Health Care Industry Is Ready For A Revolution: Its Privacy Laws Are Not, Erin Rutherford

Student Scholarship

This paper highlights the costs and benefits associated with the gathering, storing, analyzing, and digitizing of health information; examines current privacy laws and their inadequacies in the new and constantly changing digital health world; and then provides a proposal framework to balance encouraging innovation while protecting individual autonomy. The article specifically proceeds as follows. This paper first discusses of the evolution of the health industry, from paper records to the wide array of sources generating health information today. Next, it considers the benefits to the ever-increasing amount of health information, which, while considerable can often be in tension with privacy …

Pro-Choice Plans, Brendan S. Maher

Faculty Scholarship

After Dobbs v. Jackson Women’s Health Organization, the United States Constitution may no longer protect abortion, but a surprising federal statute does. That statute is called the Employee Retirement Income Security Act of 1974 (“ERISA”), and it has long been one of the most powerful preemptive statutes in the entire United States Code. ERISA regulates “employee benefit plans,” which are the vehicle by which approximately 155 million people receive their health insurance. Plans are thus a major private payer for health benefits—and therefore abortions. While many post-Dobbs anti-abortion laws directly bar abortion by making either the receipt or provision of …

Moving To Digitized Health Care: Why Hipaa Coverage Needs To Be Expanded

Connecticut Law Review

The rapid development of personal technology over the past few years has thrust health care online. Most people have used some form of health tracking apps, nutrition apps, or exercise and fitness apps. The expansion of telehealth services and apps during the COVID-19 pandemic accelerated the shift toward online health care. Digitized health care, whether accessed through a mobile app, a web site, or a telehealth service, provides a convenient and efficient means for people to access health care services. But this new access comes with a hidden cost: a risk of unauthorized use of private health information. This Comment …

Ballad Health: Understanding Appalachia’S Regional Healthcare Monopoly, Meredith A. Bailey

Baker Scholar Projects

The Ballad Health merger of 2018, which combined the now 21 hospitals in the region under one organization, has impacted the healthcare landscape in Northeast Tennessee and Southwest Virginia. Historically, Appalachia has had to persevere through primary physician shortages, a lack of specialty care, geographic obstacles to accessing healthcare, challenges related to substance abuse, and much more. Since the merger of Mountain States Health Alliance and Wellmont Health System, little research has been done to assess the perceived impact the aggregation of providers has had on the population it serves. This study utilizes an online survey to better understand the …

Vaccine Politics: Law And Inequality In The Pandemic Response To Covid-19, Matthew M. Kavanagh, Renu Singh

O'Neill Institute Papers

International mechanisms failed to achieve equitable distribution of COVID-19 vaccines—prolonging and deepening the pandemic. To understand why, we conduct process tracing of the first year of international policymaking on vaccine equity. We find that, in the absence of a single venue for global negotiation, two competing law and policy paradigms emerged. One focused on demand and voluntary action by states and firms, while the alternative focused on opening knowledge and expanding production through national and international law. While these could have been complementary, power inequalities between key actors kept the second paradigm from gaining traction on the global agenda. The …

Abortion Law In A Time Of Judicial Adventurism, Michael Boucai

Other Scholarship

No abstract provided.

Diverse Patients’ Attitudes Towards Artificial Intelligence (Ai) In Diagnosis, Christopher Robertson, Andrew Woods, Kelly Bergstrand, Jessica Findley, Cayley Balser, Marvin J. Slepian

Faculty Scholarship

Artificial intelligence (AI) has the potential to improve diagnostic accuracy. Yet people are often reluctant to trust automated systems, and some patient populations may be particularly distrusting. We sought to determine how diverse patient populations feel about the use of AI diagnostic tools, and whether framing and informing the choice affects uptake. To construct and pretest our materials, we conducted structured interviews with a diverse set of actual patients. We then conducted a pre-registered (osf.io/9y26x), randomized, blinded survey experiment in factorial design. A survey firm provided n = 2675 responses, oversampling minoritized populations. Clinical vignettes were randomly manipulated in eight …

A Game Theoretic Approach To Balance Privacy Risks And Familial Benefits, Ellen W. Clayton, Jia Guo, Murat Kantarcioglu, Et Al.

Vanderbilt Law School Faculty Publications

As recreational genomics continues to grow in its popularity, many people are afforded the opportunity to share their genomes in exchange for various services, including third-party interpretation (TPI) tools, to understand their predisposition to health problems and, based on genome similarity, to find extended family members. At the same time, these services have increasingly been reused by law enforcement to track down potential criminals through family members who disclose their genomic information. While it has been observed that many potential users shy away from such data sharing when they learn that their privacy cannot be assured, it remains unclear how …

Adolescent Use And Co-Use Of Tobacco And Cannabis In California: The Roles Of Local Policy And Density Of Tobacco, Vape, And Cannabis Retailers Around Schools, Georgiana Bostean, Anton M. Palma, Alison A. Padon, Erik Linstead, Joni Ricks-Oddie, Jason A. Douglas, Jennifer B. Unger

Sociology Faculty Articles and Research

Adolescent tobacco use (particularly vaping) and co-use of cannabis and tobacco have increased, leading some jurisdictions to implement policies intended to reduce youth access to these products; however, their impacts remain unclear. We examine associations between local policy, density of tobacco, vape, and cannabis retailers around schools, and adolescent use and co-use of tobacco/vape and cannabis.

We combined 2018 statewide California (US) data on: (a) jurisdiction-level policies related to tobacco and cannabis retail environments, (b) jurisdiction-level sociodemographic composition, (c) retailer locations (tobacco, vape, and cannabis shops), and (d) survey data on 534,176 middle and high school students (California Healthy Kids …

Center For Health & Homeland Security Newsletter, Spring 2023

Newsletter

No abstract provided.

House Bill 1316 & Senate Bill 0538: Paid Leave For Adoptive And Foster Parents, Lilia Zylstra, Caroline Shutley, Sydney Reyes, Evelyn Mankowski

Belmont University Research Symposium (BURS)

House Bill 1316 and its companion Senate Bill 0538 propose that employees of the state of Tennessee should be allotted up to 6 weeks paid leave if they become a foster parent to a minor or adopt a minor. To better understand HB 1316 and SB 0538 from a social work perspective, it is vital to examine how the proposed bill promotes the importance of human relationships, the dignity and worth of a person, and social justice—while also recognizing where the bill has room for growth. This study of HB1316 will provide an in-depth analysis of the bill from a …

Prosecuting Excessive Pricing Of Pharmaceuticals Under Competition Law: Evolutionary Development, Frederick M. Abbott

Scholarly Publications

Prosecution of pharmaceutical companies for excessive pricing of products under competition law is now a reality. As recently as a decade ago, such prosecutions were virtually nonexistent. That situation has changed dramatically as competition authorities in Europe and South Africa have pursued a significant number of such prosecutions and have levied substantial fines against the investigated parties. While the United States has traditionally led in policing the pharmaceutical market against anticompetitive misconduct, in this specific arena it has fallen behind, principally because federal courts so far have refused to acknowledge excessive pricing as a cause of action under Section 2 …

After Roe, After Dobbs, Angela Onwuachi-Willig

Shorter Faculty Works

Being able to control reproductive choices—having the ability to decide if and when to give birth and become a parent—is central to determining how one may build a life and future. For some, having control over their reproductive capacities could mean the difference between completing or not completing their education, taking advantage of a particular job opportunity or having to decline it, or moving or not moving to a different location. These decisions shape our economy and our society.

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany Lee

All Faculty Scholarship

Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

Jurisgenerative Tissues: Sociotechnical Imaginaries And The Legal Secretions Of 3d Bioprinting, Roxanne Mykitiuk, Joshua Shaw

Articles & Book Chapters

Three-dimensional ‘bioprinting’ is under development, which may produce living human organs and tissues to be surgically implanted in patients. Like tissue engineering and regenerative medicine generally, the process of bioprinting potentially disrupts experience of the human body by redefining understandings of, and becoming actualised in new practices and regimes in relation to, the body. The authors consider how these novel sociotechnical imaginaries may emerge, having regard to law’s contribution to, as well as its possible transformation by, the process of 3D bioprinting. The authors draw on Gilbert Simondon and corporeal, material feminists to account for these disruptions as ‘ontogenetic,’ in …

Pathogen Genomes As Global Public Goods (And Why They Should Not Be Patented), Jorge L. Contreras

Utah Law Faculty Scholarship

During past viral outbreaks, researchers rushed to patent genomic sequences of the viruses as they were discovered, leading to disputes and delays in research coordination. Yet similar disputes did not occur with respect to the genomic sequence of SARS-CoV-2, the virus responsible for COVID-19. With respect to COVID-19, global research collaboration occurred rapidly, leading to the identification of new variants, the ability to track the spread of the disease, and the development of vaccines and therapeutics in record time. The lack of patenting of SARS-CoV-2 is likely due the U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. …

Introduction: Access To Healthcare Symposium, Yvonne F. Lindgren

Faculty Works

The four Articles in this Access to Healthcare symposium edition address the different ways that the U.S. healthcare delivery system is failing marginalized communities, including individuals who are disabled, who are birthing, who are women of color or represent another marginalized group, or who live in poverty. The result is a rich conversation that uncovers the complex systems that contribute to unequal access to health care and unjust disparities in health outcomes in the United States.

The Global Health Architecture: Governance And International Institutions To Advance Population Health Worldwide, Lawrence O. Gostin, Eric A. Friedman, Alexandra Finch

Georgetown Law Faculty Publications and Other Works

Policy Points Global health institutions and instruments should be reformed to fully incorporate the principles of good health governance: the right to health, equity, inclusive participation, transparency, accountability, and global solidarity. New legal instruments, like International Health Regulations amendments and the pandemic treaty, should be grounded in these principles of sound governance. Equity should be embedded into the prevention of, preparedness for, response to, and recovery from catastrophic health threats, within and across nations and sectors. This includes the extant model of charitable contributions for access to medical resources giving way to a new model that empowers low- and middle-income …