Law Commons^™

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 …

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

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

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

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

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

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

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

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

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 …

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 …

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