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Articles 91 - 120 of 419
Full-Text Articles in Law
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
Michigan Telecommunications & Technology Law Review
Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …
Prisoners With Disabilities, Margo Schlanger
Prisoners With Disabilities, Margo Schlanger
Book Chapters
A majority of American prisoners have at least one disability. So how jails and prisons deal with those prisoners’ needs is central to institutional safety and humaneness, and to reentry success or failure. In this chapter, I explain what current law requires of prison and jail officials, focusing on statutory and constitutional law mandating non-discrimination, accommodation, integration, and treatment. Jails and prisons have been very slow to learn the most general lesson of these strictures, which is that officials must individualize their assessment of and response to prisoners with disabilities. In addition, I look past current law to additional policies …
Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley
Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley
Articles
Though congressional efforts to repeal and replace the Affordable Care Act (ACA) seem to have stalled, the Trump administration retains broad executive authority to reshape the health care landscape. Perhaps the most consequential choices that the administration will make pertain to Medicaid, which today covers more than 1 in 5 Americans. Much has been made of proposals to introduce work requirements or cost sharing to the program. But another decision of arguably greater long-term significance has been overlooked: whether to allow “partial expansions” pursuant to a state Medicaid waiver. Arkansas has already submitted a waiver request for a partial expansion, …
The Dubious Empirical And Legal Foundations Of Wellness Programs, Adrianna Mcintyre, Nicholas Bagley, Austin Frakt, Aaron Carroll
The Dubious Empirical And Legal Foundations Of Wellness Programs, Adrianna Mcintyre, Nicholas Bagley, Austin Frakt, Aaron Carroll
Articles
The article offers information on the dubious empirical and legal foundations of workplace wellness programs in the U.S. Topics discussed include enactment of Affordable Care Act for expanding the scope of incentives availas; analysis of financial incentives offered to the employees for encouraging their participation in wellness programs; and targeting incentives specifically toward individuals diagnosed with chronic diseases.
The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos
The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos
Articles
It seems that everybody loves workplace wellness programs. The Chamber of Commerce has firmly endorsed those progarms, as have other business groups. So has President Obama, and even liberal firebrands like former Senator Tom Harkin. And why not? After all, what's not to like about programs that encourage people to adopt healthy habits like exercise, nutritious eating, and quitting smoking? The proponents of these programs speak passionately, and with evident good intentions, about reducing the crushing burden that chronic disease places on individuals, families, communities, and the economy as a whole. What's not to like? Plenty. Workplace wellness programs are …
Federalism And The End Of Obamacare, Nicholas Bagley
Federalism And The End Of Obamacare, Nicholas Bagley
Articles
Federalism has become a watchword in the acrimonious debate over a possible replacement for the Affordable Care Act (ACA). Missing from that debate, however, is a theoretically grounded and empirically informed understanding of how best to allocate power between the federal government and the states. For health reform, the conventional arguments in favor of a national solution have little resonance: federal intervention will not avoid a race to the bottom, prevent externalities, or protect minority groups from state discrimination. Instead, federal action is necessary to overcome the states’ fiscal limitations: their inability to deficit-spend and the constraints that federal law …
A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider
A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider
Michigan Telecommunications & Technology Law Review
Human institutions and activities cannot avoid failures. Anxiety about them often provokes governments to try to prevent those failures. When that anxiety is vivid and urgent, government may do so without carefully asking whether regulation’s costs justify their benefits. Privacy and Accountability in Black Box Medicine admirably labors to bring discipline and rationality to thinking about an important development — the rise of “black-box medicine” — before it causes injuries regulation should have prevented and before it is impaired by improvident regulation. That is, Privacy and Accountability weighs the costs against the benefits of various forms of regulation across the …
Risk And Resilience In Health Data Infrastructure, Nicholson Price
Risk And Resilience In Health Data Infrastructure, Nicholson Price
Law & Economics Working Papers
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 …
Unduly Burdening Women’S Health: How Lower Courts Are Undermining Whole Woman’S Health V. Hellerstedt, Leah M. Litman
Unduly Burdening Women’S Health: How Lower Courts Are Undermining Whole Woman’S Health V. Hellerstedt, Leah M. Litman
Michigan Law Review Online
At the end of the Supreme Court’s 2016 Term, the Court issued its decision in Whole Woman’s Health v. Hellerstedt. One of the more closely watched cases of that Term, Hellerstedt asked whether the Supreme Court would adhere to its prior decision in Planned Parenthood v. Casey, which reaffirmed that women have a constitutionally protected right to decide to end a pregnancy.
The state of Texas had not formally requested that the Court revisit Casey or the earlier decision Casey had affirmed, Roe v. Wade, in Hellerstedt. But that was what Texas was, in effect, asking …
Contemporary Practice Of The United States Relating To International Law, Daugirdas Kristina, Julian Davis Mortenson
Contemporary Practice Of The United States Relating To International Law, Daugirdas Kristina, Julian Davis Mortenson
Articles
In this section: • Congress Overrides Obama’s Veto to Pass Justice Against Sponsors of Terrorism Act • U.S. Federal Court of Appeals Upholds United Nations’ Immunity in Case Related to Cholera in Haiti • U.S.-Russian Agreements on Syria Break Down as the Syrian Conflict Continues • Russia Suspends Bilateral Agreement with United States on Disposal of Weapons-Grade Plutonium • The United States Makes Payment to Family of Italian Killed in CIA Air Strike • United States Ratifies Hague Convention on the International Recovery of Child Support and Other Forms of Family Maintenance
The Fmla And Psychological Support: Courts Care About "Care" (And Employers Should, Too), Katherine Stallings Bailey
The Fmla And Psychological Support: Courts Care About "Care" (And Employers Should, Too), Katherine Stallings Bailey
Michigan Law Review
The Family and Medical Leave Act (“FMLA”) recognizes an employee’s right to take leave to care for a qualifying family member. In light of the Act’s remedial nature, the intended scope of the care provision is broad, but its definitional details are sparse. As a result of the attendant interpretive discretion afforded to courts, the Seventh Circuit announced its rejection of the requirement—first articulated by the Ninth Circuit—that care provided during travel be related to continuing medical treatment. A facial analysis of the resulting circuit split fails to appreciate the fundamental difference between the Seventh and Ninth Circuits’ considerations: the …
Regulating Secrecy, W. Nicholson Price Ii
Regulating Secrecy, W. Nicholson Price Ii
Articles
Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …
R-Egg-Ulation: A Call For Greater Regulation Of The Big Business Of Human Egg Harvesting, Danielle A. Vera
R-Egg-Ulation: A Call For Greater Regulation Of The Big Business Of Human Egg Harvesting, Danielle A. Vera
Michigan Journal of Gender & Law
When it comes to young healthy women “donating” their eggs, America has a regulation problem. This Note explains the science behind the harvesting of human eggs, focusing on potential egg donors, and describes the specific factors that make egg donation a unique type of transaction. It describes the current regulatory status of the assisted reproductive technology industry in the United States and highlights the ways in which this scheme fails to protect egg “donors.” This Note concludes with a call for comprehensive regulation of the assisted reproductive technology industry.
The Tax Definition Of "Medical Care:" A Critique Of The Startling Irs Arguments In O'Donnabhain V. Commissioner, Katherine Pratt
The Tax Definition Of "Medical Care:" A Critique Of The Startling Irs Arguments In O'Donnabhain V. Commissioner, Katherine Pratt
Michigan Journal of Gender & Law
This Article critiques the startling arguments made by the Internal Revenue Service (“IRS”) in O’Donnabhain v. Commissioner, a case in which the issue was whether a person diagnosed with gender identity disorder (“GID”) could take a federal tax deduction for the costs of male-to-female medical transition, including hormone treatment, genital surgery, and breast augmentation. Internal Revenue Code § 213 allows a deduction for the costs of “medical care,” which (1) includes costs incurred for “the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body,” but (2) generally …
Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley
Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley
Articles
Yet another bruising fight has erupted over health care reform. On September 9, 2016, the Obama administration offered to open settlement negotiations with health insurers that have sued the United States to recover billions of dollars that they claim they are owed. Congressional Republicans are incensed, believing that any settlement would illegally squander taxpayer dollars in a lastgasp effort to save the Affordable Care Act (ACA).
Black Health Matters: Disparities, Community Health, And Interest Convergence, Mary Crossley
Black Health Matters: Disparities, Community Health, And Interest Convergence, Mary Crossley
Michigan Journal of Race and Law
Health disparities represent a significant strand in the fabric of racial injustice in the United States, one that has proven exceptionally durable. Many millions of dollars have been invested in addressing racial disparities over the past three decades. Researchers have identified disparities, unpacked their causes, and tracked their trajectories, with only limited progress in narrowing the health gap between whites and racial and ethnic minorities. The implementation of the Affordable Care Act (ACA) and the movement toward value-based payment methods for health care may supply a new avenue for addressing disparities. This Article argues that the ACA’s requirement that tax-exempt …
Nfib V. Sebelius And The Individual Mandate: Thoughts On The Tax/Regulation Distinction, Kyle D. Logue
Nfib V. Sebelius And The Individual Mandate: Thoughts On The Tax/Regulation Distinction, Kyle D. Logue
Michigan Business & Entrepreneurial Law Review
When Chief Justice John Roberts wrote the opinion of the Court in National Federation of Independent Businesses v. Sebelius (NFIB) explaining the constitutionality of the Affordable Care Act’s (ACA) minimum essential coverage provision (sometimes referred to as the individual mandate), he reasoned that the mandate—or, more precisely, the enforcement provision that accompanied the mandate (the Shared Responsibility Payment or SRP)—could be understood as a tax on the failure to purchase health insurance. According to this view, the enactment of the mandate and its accompanying enforcement provisions fell within Congress’s virtually unlimited power to “lay and collect taxes.” This tax-based interpretation …
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Law & Economics Working Papers
Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …
Productivity And Affinity In The Age Of Dignity, Stephen Lee
Productivity And Affinity In The Age Of Dignity, Stephen Lee
Michigan Law Review
This Review proceeds as follows. Part I summarizes The Age of Dignity. Part II explains how this segment of immigrant workers challenges the productivity/affinity binary that dominates immigration law’s formal migration rules. Part III shows how this binary sets up dual migration streams, both of which could account for future flows of care workers. As Part III shows, the example of the eldercare industry nicely illustrates how the employment based and family-based migration systems simply represent two different ways of filling labor needs. I then conclude.
Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii
Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii
Articles
Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort
Articles
Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …
The Affordable Care Act, Experience Rating, And The Problem Of Non-Vaccination, Eric Esshaki
The Affordable Care Act, Experience Rating, And The Problem Of Non-Vaccination, Eric Esshaki
University of Michigan Journal of Law Reform Caveat
Polio, the whooping cough, and the mumps, among many other communicable diseases, were once prevalent in communities within the developed world and killed millions of people.1 The advent of vaccinations contained or eradicated several of these diseases.2 However, these diseases still exist in the environment3 and are making a comeback in the United States.4 Their persistence is directly attributable to the rising trend among parents refusing to vaccinate their children.5 One proposed solution to this problem is to hold parents liable in tort when others are harmed by their failure to vaccinate. Another proposed solution argues that parents should pay …
Shared Responsibility Regulation Model For Cross-Border Reproductive Transactions, Sharon Bassan
Shared Responsibility Regulation Model For Cross-Border Reproductive Transactions, Sharon Bassan
Michigan Journal of International Law
The term “cross-border reproductive transactions” refers to the movement of tens of thousands of people, who travel from one country to purchase reproductive services from suppliers in other countries, in order to have a child.2 It is estimated that between eleven and fourteen thousand patients in Europe alone engage in this practice annually.3 Historically, the phrase ‘medical tourism’ used to refer to the travel of patients from less-affluent countries seeking better healthcare in countries with superior healthcare standards. Today, the journey is just as likely to flow in the opposite direction, as patients travel from industrialized to less affluent countries …
Legal Limits And The Implementation Of The Affordable Care Act, Nicholas Bagley
Legal Limits And The Implementation Of The Affordable Care Act, Nicholas Bagley
Articles
Accusations of illegality have dogged the Obama Administration's efforts to implement the Affordable Care Act (ACA), the most ambitious piece of social legislation since the advent of Medicare and Medicaid. Some of the accusations have merit; indeed, it would be surprising if they did not. Even as the ACA's rollout has exposed unanticipated difficulties in the statutory design, congressional antipathy to health reform has precluded looking to the legislature to iron out those difficulties. To secure his principal achievement, President Obama has repeatedly tested the limits of executive authority in implementing the ACA. Six years after its enactment and two …
Privacy And Accountability In Black-Box Medicine, Roger Allan Ford, W. Nicholson Price Ii
Privacy And Accountability In Black-Box Medicine, Roger Allan Ford, W. Nicholson Price Ii
Michigan Telecommunications & Technology Law Review
Black-box medicine—the use of big data and sophisticated machine-learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, …
Transparency And The Supreme Court—Can Employers Refuse To Disclose How Much They Pay For Health Care?, Nicholas Bagley, Christopher Koller
Transparency And The Supreme Court—Can Employers Refuse To Disclose How Much They Pay For Health Care?, Nicholas Bagley, Christopher Koller
Articles
For decades, the prices that hospitals and physicians charge private insurers have been treated as trade secrets. Even though inflated prices are an enormous reason why health care is so much more expensive in the United States than in other countries, we have only a hazy picture of what those prices actually are.
Spending Medicare’S Dollars Wisely: Taking Aim At Hospitals’ Cultures Of Overtreatment, Jessica Mantel
Spending Medicare’S Dollars Wisely: Taking Aim At Hospitals’ Cultures Of Overtreatment, Jessica Mantel
University of Michigan Journal of Law Reform
With Medicare’s rising costs threatening the country’s fiscal health, policymakers have focused their attention on a primary cause of Medicare’s high price tag—the overtreatment of patients. Guided by professional norms that demand they do “everything possible” for their patients, physicians frequently order additional diagnostic tests, perform more procedures, utilize costly technologies, and provide more inpatient care. Much of this care, however, does not improve Medicare patients’ health, but only increases Medicare spending. Reducing the overtreatment of patients requires aligning physicians’ interests with the government’s goal of spending Medicare’s dollars wisely. Toward that end, recent Medicare payment reforms establish a range …
Three Words And The Future Of The Affordable Care Act, Nicholas Bagley
Three Words And The Future Of The Affordable Care Act, Nicholas Bagley
Articles
As an essential part of its effort to achieve near universal coverage, the Affordable Care Act (ACA) extends sizable tax credits to most people who buy insurance on the newly established health care exchanges. Yet several lawsuits have been filed challenging the availability of those tax credits in the thirty-four states that refused to set up their own exchanges. The lawsuits are premised on a strained interpretation of the ACA that, if accepted, would make a hash of other provisions of the statute and undermine its effort to extend coverage to the uninsured. The courts should reject this latest effort …
Medicine As A Public Calling, Nicholas Bagley
Medicine As A Public Calling, Nicholas Bagley
Michigan Law Review
The debate over how to tame private medical spending tends to pit advocates of government-provided insurance—a single-payer scheme—against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissiveness, however, rests on a failure to appreciate just how deeply the public utility model shaped health law in the twentieth century— and how it continues to shape health law today. Closer economic regulation of the medical industry may or may not …
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Articles
Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …