Health Law and Policy Commons^™

California V. Texas: Brief For Jonathan H. Adler, Nicholas Bagley, Abbe R. Gluck, And Ilya Somin As Amici Curiae Supporting Petitioner, Nicholas Bagley

Appellate Briefs

Amici are experts in constitutional law, legislation, statutory interpretation, and administrative law. They disagree on many legal and policy questions concerning the Affordable Care Act (“ACA”), Pub. L. No. 111-148, 124 Stat. 119 (2010), including many questions about how to interpret it and whether the plaintiff States have standing in the present case. Yet they agree on this: even assuming the insurance mandate is unconstitutional, it is severable from the other provisions of the ACA. Any contrary conclusion would be inconsistent with settled law and Congress’s clearly expressed intent. Amici respectfully submit this amicus brief to explain this point.<\p>

Amici’s …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

Articles

As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.

The Coronavirus And The Risks To The Elderly In Long-Term Care, William Gardner, David States, Nicholas Bagley

Articles

The elderly in long-term care (LTC) and their caregiving staff are at elevated risk from COVID-19. Outbreaks in LTC facilities can threaten the health care system. COVID-19 suppression should focus on testing and infection control at LTC facilities. Policies should also be developed to ensure that LTC facilities remain adequately staffed and that infection control protocols are closely followed. Family will not be able to visit LTC facilities, increasing isolation and vulnerability to abuse and neglect. To protect residents and staff, supervision of LTC facilities should remain a priority during the pandemic.

Healthy Data Protection, Lothar Determann

Michigan Technology Law Review

Modern medicine is evolving at a tremendous speed. On a daily basis, we learn about new treatments, drugs, medical devices, and diagnoses. Both established technology companies and start-ups focus on health-related products and services in competition with traditional healthcare businesses. Telemedicine and electronic health records have the potential to improve the effectiveness of treatments significantly. Progress in the medical field depends above all on data, specifically health information. Physicians, researchers, and developers need health information to help patients by improving diagnoses, customizing treatments and finding new cures.

Yet law and policymakers are currently more focused on the fact that health …

Redefining Reproductive Rights And Justice, Leah Litman

Michigan Law Review

Review of Reproductive Rights and Justice Stories edited by Melissa Murray, Katherine Shaw, and Reva B. Siegel.

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

The Ncaa's Special Relationship With Student-Athletes As A Theory Of Liability For Concussion-Related Injuries, Tezira Abe

Michigan Law Review

The National Collegiate Athletic Association (NCAA) is the primary governing body of college athletics. Although the NCAA proclaims to protect student-athletes, an examination of its practices suggests that the organization has a troubling history of ignoring the harmful effects of concussions. Over one hundred years after the NCAA was established, and seventy years after the NCAA itself knew of the potential effects of concussions, the organization has done little to reduce the occurrence of concussions or to alleviate the potential effects that stem from repeated hits to the head. This Note argues for recognizing a special relationship between the NCAA …

May Hospitals Withhold Ventilators From Covid-19 Patients With Pre-Existing Disabilities? Notes On The Law And Ethics Of Disability-Based Medical Rationing, Samuel R. Bagenstos

Law & Economics Working Papers

Thanks to the coronavirus pandemic, the threat of medical rationing is now clear and present. Hospitals faced with a crush of patients must now seriously confront questions of how to allocate scarce resources—notably life-saving ventilators—at a time of severe shortage. In their protocols for addressing this situation, hospitals and state agencies often employ explicitly disability-based distinctions. For example, Alabama’s crisis standards of care provide that “people with severe or profound intellectual disability ‘are unlikely candidates for ventilator support.’” This essay, written as this crisis unfolds, argues that disability-based distinctions like these violate the law. The Americans with Disabilities Act, the …

Trump V. Commonwealth Of Pennsylvania: Brief For Nicholas Bagley And Samuel L. Bray As Amici Curiae Supporting Petitioners, Nicholas Bagley

Appellate Briefs

Amici curiae are professors of law who have expertise that bears directly on one of the questions before this Court: Whether the court of appeals erred in affirming a nationwide preliminary injunction barring implementation of the final rules challenged by respondents.<\p>

This case squarely raises the propriety of an accelerating trend in the lower federal courts issuing injunctions that extend beyond the parties to bar enforcement of a challenged federal law or policy across the Nation. These injunctions are variously called "national," "universal," or "nationwide." They are inconsistent with the proper role of the federal courts in our constitutional structure …

The Hidden Disability Consensus In The 2020 Campaign, Harold A. Pollack, Samuel R. Bagenstos

Articles

At this writing, the final results of the Iowa caucuses remain unreported. No one yet knows which candidates did well and which did poorly. We do know that health policy is a defining cleavage between left and liberal Democrats this primary season. Much of the press coverage will naturally focus on the implications of this vote for Democrats’ commitment to an incremental public option or a full-throated single-payer plan.

Olmstead V. L.C.: The Supreme Court Case, Samuel R. Bagenstos, Irv Gornstein, Michael Gottesman, Jennifer Mathis

Articles

You have an incredible luxury here at Georgetown Law. You have faculty who are engaged in the world like two of my colleagues on this panel. To my immediate left is Professor Michael Gottesman (Georgetown University Law Center) who argued the case on behalf of Lois and Elaine, and to my next far left, Professor Irv Gornstein (Georgetown University Law Center) who argued the case on behalf of the United States. Between them is Jennifer Mathis (The Bazelon Center for Mental Health Law) who has spent, I think, most of her career at the Bazelon Center litigating, and organizing, and …

Is Obamacare Really Unconstitutional?, Nicholas Bagley

Articles

On December 18, 2019, just 3 days after the close of open enrollment on the exchanges and on the same day the House of Representatives impeached President Donald Trump, a conservative appeals court handed the President a major victory in his crusade against the Affordable Care Act (ACA). Over a stern dissent, the U.S. Court of Appeals for the Fifth Circuit declared that the law’s individual mandate is unconstitutional and that the entire rest of the law might therefore be invalid.

Prescription Restriction: Why Birth Control Must Be Over-The-Counter In The United States, Susannah Iles

Michigan Journal of Gender & Law

This Note argues that it is harmful and unnecessary to require women to obtain prescriptions for access to hormonal birth control. Requiring a prescription is necessarily a barrier to access which hurts women and hamstrings the ability to dictate their own reproductive plans. It is also an irrational regulation in light of the relative safety of hormonal birth control pills, particularly progestin-only formulations, compared to other drugs readily available on the shelves.

Leading medical organizations, including the American College of Obstetrics and Gynecologists, advocate for over-the-counter access to hormonal birth control. While acknowledging that not every woman will have positive …

Executive Power And The Aca, Nicholas Bagley

Book Chapters

As with any law of its complexity and ambition, the Affordable Care Act (ACA) vests in the sitting president broad implementation discretion. The law is not a blank check: in many ways both large and small, the ACA shapes and constrains the exercise of executive power. But Congress has neither the institutional resources nor the attention span to micromanage the rollout of a massive health program. It has no choice but to delegate.

Naturally, both President Obama and President Trump have drawn on their authority to tailor the ACA to their policy preferences. Neither president, however, has been able to …

Regulatory Responses To Medical Machine Learning, Timo Minssen, Sara Gerke, Mateo Aboy, W. Nicholson Price Ii, Glenn Cohen

Articles

Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML).MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and …

The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos

Articles

Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …

June Medical Services L.L.C. V. Gee: Brief For Constitutional Law Scholars Ashutosh Bhagwat, Lee C. Bollinger, Erwin Chemerinsky, Michael C. Dorf, Daniel Farber, Joanna L. Grossman, Pamela S. Karlan, Leah Litman, Martha Minow, Jane S. Schacter, Suzanna Sherry, Geoffrey R. Stone, David A. Strauss, Laurence H. Tribe, And Mary Ziegler As Amici Curiae Supporting Petitioners, Leah Litman

Appellate Briefs

Amici are constitutional law scholars who teach and write in the field of constitutional law, including as it relates to regulation of abortion, and who have a shared interest in identifying the proper standards of review. This brief sets forth Amici's considered understanding of the framework governing abortion regulation, as established by the decisions of this Court, and how to preserve the undue burden test as established in this Court's precedents over the last two decades. It also explains why the decision below, if permitted to stand, would threaten the uniformity and supremacy of federal law.

Louisiana's Act 620 requires …

Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

Articles

Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …

Medical Ai And Contextual Bias, W. Nicholson Price Ii

Articles

Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human experts — to identify malignancies as well as trained radiologists, to diagnose diabetic retinopathy as well as board-certified ophthalmologists, or to recommend tumor-specific courses of treatment as well as top-ranked oncologists — then those algorithms could be deployed in medical settings where human experts are not available, and patients could benefit. But there is a problem with this vision. Privacy law, malpractice, insurance reimbursement, and FDA approval standards all encourage developers …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, Will Nicholson Price Ii

Articles

Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its own challenges, and an understanding of the four roles …

Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii

Book Chapters

Biobanks represent an opportunity for the use of big data to drive translational medicine. Precision medicine demands data to shape treatments to individual patient characteristics; large datasets can also suggest new uses for old drugs or relationships between previously unlinked conditions. But these tasks can be stymied when data are siloed in different datasets, smaller biobanks, or completely proprietary private resources. This hampers not only analysis of the data themselves, but also efforts to translate data-based insights into actionable recommendations and to transfer the discovered technology into a commercialization pipeline. Cross-project technological innovation, development, and validation are all more difficult …

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

The Cost Of Novelty, W. Nicholson Price Ii

Law & Economics Working Papers

Patent law tries to spur the development of new, better, innovative technology. But it focuses much more on “new” than “better” — and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not …

Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman

Articles

A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, including how to ensure high-quality performance by medical AI, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its …

Constitutional Cohesion And The Right To Public Health, James G. Hodge Jr., Daniel Aaron, Haley R. Augur, Ashley Cheff, Joseph Daval, Drew Hensley

University of Michigan Journal of Law Reform

Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally are realities of our existing constitutional infrastructure. In essence, there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and malfeasance). Structural …

Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii

Other Publications

Artificial intelligence (AI) is rapidly entering health care and serving major roles, from automating drudgery and routine tasks in medical practice to managing patients and medical resources. As developers create AI systems to take on these tasks, several risks and challenges emerge, including the risk of injuries to patients from AI system errors, the risk to patient privacy of data acquisition and AI inference, and more. Potential solutions are complex but involve investment in infrastructure for high-quality, representative data; collaborative oversight by both the Food and Drug Administration and other health-care actors; and changes to medical education that will prepare …

Health Care Ai: Law, Regulation, And Policy., W. Nicholson Price Ii

Book Chapters

As discussed in previous chapters, artificial intelligence (AI) has the potential to be involved in almost all aspects of the health care industry. The legal landscape for health care AI is complex; AI systems with different intended uses, audiences, and use environments face different requirements at state, federal, and international levels. A full accounting of these legal requirements, or of the policy questions involved, is far beyond the scope of this chapter. Additionally, the legal and regulatory framework for AI in health care continues to evolve, given the nascent stage of the industry.

In this chapter, we offer an overview …

Privacy In The Age Of Medical Big Data, W. Nicholson Price Ii, I. Glenn Cohen

Articles

Big data has become the ubiquitous watch word of medical innovation. The rapid development of machine-learning techniques and artificial intelligence in particular has promised to revolutionize medical practice from the allocation of resources to the diagnosis of complex diseases. But with big data comes big risks and challenges, among them significant questions about patient privacy. Here, we outline the legal and ethical challenges big data brings to patient privacy. We discuss, among other topics, how best to conceive of health privacy; the importance of equity, consent, and patient governance in data collection; discrimination in data uses; and how to handle …

Shadow Health Records Meet New Data Privacy Laws, W. Nicholson Price Ii, Margot E. Kaminski, Timo Minssen, Kayte Spector-Bagdady

Articles

Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information, they are often subject to data privacy regulation. But amid a flood of new forms of health data, some third parties have figured out ways to avoid some data privacy laws, developing what we call “shadow health records”—collections of health data outside the health system that provide detailed pictures of individual health—that allow both innovative research and commercial targeting despite data privacy rules. Now that space …