Law Commons^™

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 …

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 …

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 …

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 …

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 …

Abortion Talk, Clare Huntington

Michigan Law Review

Review of Carol Sanger's About Abortion: Terminating Pregnancy in Twenty-First-Century America.

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 …

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then examines the federal agency initiatives undertaken in …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen

Michigan Law Review

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers’ …

Are Medicaid Work Requirements Legal?, Nicholas Bagley

Articles

On January 12, 2018, the Centers for Medicare & Medicaid Services (CMS) approved a waiver allowing Kentucky to impose a work requirement on some nondisabled Medicaid beneficiaries. Similar waivers are sure to follow. Supporters see work requirements as a spur to force the idle poor to work; opponents see the requirements as a covert means of withholding medical care from vulnerable people. Setting the policy debate aside, however, are work requirements legal?

Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley

Articles

In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …

The International Right To Health Care: A Legal And Moral Defense, Michael Da Silva

Michigan Journal of International Law

In the following, I outline the case against the international right to health care and explain why recognition of such a right is still necessary. The argument is explicitly limited to international human rights law and is primarily descriptive in nature, but I go on to explain the moral reasons to accept this account. Both the positive law and moral reasoning could be used in other health rights debates, but I do not attempt to make such claims here.

The structure of my work is as follows. I first outline three problems with recognizing an international right to health care. …

Medical Malpractice And Black-Box Medicine, W. Nicholson Price Ii

Book Chapters

The explosive proliferation of health data has combined with the rapid development of machine-learning algorithms to enable a new form of medicine: “black-box medicine.” In this phenomenon, algorithms troll through tremendous databases of health data to find patterns that can be used to guide care, whether by predicting unknown patient risks, selecting the right drug, suggesting a new use of an old drug, or triaging patients to preserve health resources. These decisions differ from previous data-based decisions because black-box medicine is, by its nature, opaque; that is, the bases for black-box decisions are unknown and unknowable.

Black-box medicine raises a …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii

Articles

Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting, and using those data. In the easy cases of coordinated care and stationary patients, the system works—sometimes. But when care is fragmented, fragmented data often result. Fragmented data create risks both to individual patients and to the system. For patients, fragmentation creates risks in care based on incomplete or incorrect information, and may also lead to privacy risks from a patched together system. For the system, data fragmentation hinders efforts to improve efficiency …

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …