Law Commons^™

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 …

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 …

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 …

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’ …

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. …

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 …

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 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 …

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, …

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 …

Comparative Effectiveness Research As Choice Architecture: The Behavioral Law And Economics Solution To The Health Care Cost Crisis, Russell Korobkin

Michigan Law Review

With the Patient Protection and Affordable Care Act (“ACA”) set to dramatically increase access to medical care, the problem of rising costs will move center stage in health law and policy discussions. “Consumer directed health care” proposals, which provide patients with financial incentives to equate marginal costs and benefits of care at the point of treatment, demand more decisionmaking ability from consumers than is plausible due to bounded rationality. Proposals that seek to change the incentives of health care providers threaten to create conflicts of interest between doctors and patients. New approaches are desperately needed. This Article proposes a government-facilitated …

An Insurance Structure To Encourage Investment In Preventative Health Care, Nicholas Georgakopoulos

University of Michigan Journal of Law Reform

The incentives for investments in Americans' health are poorly aligned. Health insurers are not sufficiently motivated to invest for the long term. The structure of health insurance does not compensate insurers for investments in lasting health, such as measures preventing chronic disease. If an American changes insurers, the new insurer reaps the benefits of the good health the prior insurer's investment produced. This Essay explores insurers' incentives to invest in health, illustrates how those incentives fail, explores possible improvements, and shows that subsequent insurers should have an obligation to compensate the prior insurer for the averted expenses of expected diseases …

Satmed: Legal Aspects Of The Physical Layer Of Satellite Telemedicine, Stephen Rooke

Michigan Journal of International Law

In 2003, Paul Hunt, the U.N. Commission on Human Rights' Special Rapporteur on the Right to Health, presented a report on the global availability of health care. Special Rapporteur Hunt argued that states are obligated to implement a right to health. Included in this right is the obligation "to ensure that no international agreement or policy adversely impacts upon the right to health, and that .. . international organizations take due account of the right to health, as well as the obligation of international assistance and cooperation, in all policy-making matters." One area Hunt left unexplored in his report was …

Family Caregiving And The Law Of Succession: A Proposal, Thomas P. Gallanis, Josephine Gittler

University of Michigan Journal of Law Reform

As the American population ages, the need for long-term care, already great, will become even greater. Some of this care is paid for by government programs, such as Medicaid, and by individual long-term care insurance policies. But the combination of the public fisc and private insurance are, and will continue to be, insufficient to pay for all of the care our seniors and adults with disabilities need. The provision of care in a family residence by one or more family members is an important component of our health care delivery system and must be supported and encouraged by public policy …

When Coercion Lacks Care: Competency To Make Medical Treatment Decisions And Parens Patriae Civil Commitments, Dora W. Klein

University of Michigan Journal of Law Reform

The subject of this Article is people who have been civilly committed under a state's parens patriae authority to care for those who are unable to care for themselves. These are people who, because of a mental illness, are a danger to themselves. Even after they have been determined to be so disabled by their mental illness that they cannot care for themselves, many are nonetheless found to be competent to refuse medical treatment. Competency to make medical treatment decisions generally requires only a capacity to understand a proposed treatment, not an actual or rational understanding of that treatment. This …

The Tangled Thicket Of Health Care Reform: The Judicial System In Action, Gene Magidenko

University of Michigan Journal of Law Reform Caveat

On March 23, 2010, after a lengthy political debate on health care reform, President Barack Obama signed the Patient Protection and Affordable Care Act (PPACA) into law. A week later, he signed the Health Care and Education Reconciliation Act of 2010, which amended certain provisions of PPACA. But far from ending the intense national debate on the issue, these enactments opened a new front of battle in the federal courts that will almost certainly make its way to the United States Supreme Court. Much of this litigation focuses on § 1501 of PPACA, which contains the controversial individual mandate requiring …

Access To Medicaid: Recognizing Rights To Ensure Access To Care And Services, Colleen Nicholson

University of Michigan Journal of Law Reform Caveat

The Supreme Court has defined Medicaid as “a cooperative federal-state program through which the Federal Government provides financial assistance to States so that they may furnish medical care to needy individuals.” In June 2012, the Court found the Patient Protection and Affordable Care Act’s (PPACA) Medicaid expansion unconstitutional. The Court took issue with the threat to withhold all of a state’s Medicaid funding if they did not comply with the expansion, finding it coercive and a fundamental shift in the Medicaid paradigm. However, Medicaid in its current form may not always be effective at providing beneficiaries with timely access to …

Abortion And Informed Consent: How Biased Counseling Laws Mandate Violations Of Medical Ethics, Ian Vandewalker

Michigan Journal of Gender & Law

If we slightly change the facts of the story about the discouraging doctor, it becomes a story that happens every day. Abortion patients face attempts to discourage them from terminating their pregnancies like those the imaginary doctor used, as well as others-and state laws mandate these attempts. While the law of every state requires health care professionals to secure the informed consent of the patient before any medical intervention, over half of the states place additional requirements on legally effective informed consent for abortion. These laws sometimes include features that have ethical problems, such as giving patients deceptive information. Unique …

Re-Thinking Health Insurance, Hans Biebl

University of Michigan Journal of Law Reform Caveat

In May 2009, while promoting the legislation that would become the Patient Protection and Affordable Care Act (PPACA), President Obama said that rising health care costs threatened the balance sheets of both the federal government and private enterprise. He noted that any increase in health care spending consumes funds that “companies could be using to innovate and to grow, making it harder for them to compete around the world.” Despite the rancorous debate that surrounded this health care legislation and which culminated with the Supreme Court’s decision in National Federation of Independent Businesses, the PPACA was not a radical piece …

Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn

Michigan Journal of Race and Law

With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …

Augmenting Advocacy: Giving Voice To The Medical-Legal Partnership Model In Medicaid Proceedings And Beyond, Marybeth Musumeci

University of Michigan Journal of Law Reform

The denial of Medicaid coverage for augmentative communication devices, despite an existing legal framework that mandates the opposite result, raises fundamental questions about what independence means for people with disabilities. This situation, compounded by the barriers in the Medicaid administrative appeal process encountered by such beneficiaries, invites new approaches to the delivery of civil legal services, such as medical-legal partnerships (MLPs). MLPs are formalized arrangements that bring lawyers into a healthcare setting to provide specialist consultations when patients experience legal problems that affect health. While there is an emerging scholarship on MLPs, this Article offers the first in-depth analysis of …

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

Finding A Cure In The Courts: A Private Right Of Action For Disparate Impact In Health Care, Sarah G. Steege

Michigan Journal of Race and Law

There is no comprehensive civil rights statute in health care comparable to the Fair Housing Act, Title VII, and similar laws that have made other aspects of society more equal. After Congress passed the Civil Rights Act of 1964, Title VI served this purpose for suits based on race, color, and national origin for almost four decades. Since the Supreme Court's 2001 ruling in Alexander v. Sandoval, however, there has been no private right of action for disparate impact claims under Title VI, and civil rights enforcement in health care has suffered as a result. Congress has passed new legislation …

Crisis On Campus: Student Access To Health Care, Bryan A. Liang

University of Michigan Journal of Law Reform

College-aged adults are an overrepresented group in the uninsured population of the United States, and traditionally underserved minorities are disproportionately affected. Students with private health insurance are often functionally uninsured as well, since most schools refuse to accept this traditionally elite calling card on campus. Consequently, the large uninsured and functionally uninsured populations often rely on school-sponsored health insurance plans for access to care. These plans have uneven coverage, limited benefits, exclusions and high co-pays and deductibles, and provide little health care security for their beneficiaries. Further, schools and insurance companies have profited substantially from these student plans, raising the …

There Is A Time To Keep Silent And A Time To Speak, The Hard Part Is Knowing Which Is Which: Striking The Balance Between Privacy Protection And The Flow Of Health Care Information, Daniel J. Gilman, James C. Cooper

Michigan Telecommunications & Technology Law Review

Health information technology (HIT) has become a signal element of federal health policy, especially as the recently enacted American Recovery and Reinvestment Act of 2009 (Recovery Act or ARRA) comprises numerous provisions related to HIT and commits tens of billions of dollars to its development and adoption. These provisions charge various agencies of the federal government with both general and specific HIT-related implementation tasks including, inter alia, providing funding for HIT in various contexts: the implementation of interoperable HIT, HIT-related infrastructure, and HIT-related training and research. The Recovery Act also contains various regulatory provisions pertaining to HIT. Provisions of the …

Risky Ventures: The Impact Of Irs Health Care Joint Venture Policy, Roger P. Meyers

University of Michigan Journal of Law Reform

IRS oversight of joint ventures between exempt and for-profit organizations has undergone substantial change over the past thirty years. This change has important consequences for the health care industry, where joint ventures have grown increasingly common. In the face of unclear guidance and aggressive enforcement of exemption-policing tools such as the private benefit doctrine and the control test, a hospital risks revocation of its tax-exempt status, or liability for unrelated business income tax, when it engages in a joint venture directly. It may be able to eliminate this risk by operating the same joint venture through a for-profit subsidiary; however, …

Giving In To Baby Markets: Regulation Without Prohibition, Sonia M. Suter

Michigan Journal of Gender & Law

The commodification of reproductive material evokes different responses. Some argue that the sale of reproductive material should be prohibited. Others argue in favor of unfettered baby markets on principle or to achieve broad-scale access to reproductive technologies. In this Article, the author responds to the emergence of baby markets with great skepticism, but reluctant acceptance. Drawing on a relational conception of autonomy and self-definition, she argues that commodification of reproductive material is intrinsically harmful. Moreover, such commodification poses a number of consequential harms. Nevertheless, in spite of these concerns, the author "gives in" to baby markets, which is to say …

Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman

Michigan Journal of Gender & Law

In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …

Consumer-Directed Health Care And The Chronically Ill, John V. Jacobi

University of Michigan Journal of Law Reform

Insurance plans with consumer-controlled spending accounts are advocated as tools for reducing health costs and empowering consumers. This Article describes their recent development and argues that they are likely to fail. Instead of focusing on the small number of consumers with chronic illnesses who account for the bulk of health spending they focus on the majority of relatively well consumers. This Article proposes market-based and regulatory changes focused on high-cost patients. To best serve cost and quality goals, health finance responsibility should be divided between consumers and their employers for predictable and routine costs, and government for chronic and catastrophic …

Liberty, Justice, And Insurance For All: Re-Imagining The Employment-Based Health Insurance System, Carolyn V. Juárez

University of Michigan Journal of Law Reform

This Note examines the history of employment-based health insurance and the inherent historical limitations that have led to an erosion of health insurance coverage. Based on a review of several studies, this Note argues that the number of uninsured Americans has reached crisis proportions. State reform efforts, legislative proposals, and other proposed solutions have failed to repair the system. Nonetheless, this Note argues that employment-based health care is integral to the structure of national health care. Furthermore, health insurance coverage can be increased by combining employment-based health care with three reforms: large employer mandates, refundable tax credits, and purchasing pools. …