Law Commons^™

Humans In The Loop, Nicholson Price Ii, Rebecca Crootof, Margot Kaminski

Articles

From lethal drones to cancer diagnostics, humans are increasingly working with complex and artificially intelligent algorithms to make decisions which affect human lives, raising questions about how best to regulate these “human in the loop” systems. We make four contributions to the discourse.

First, contrary to the popular narrative, law is already profoundly and often problematically involved in governing human-in-the-loop systems: it regularly affects whether humans are retained in or removed from the loop. Second, we identify “the MABA-MABA trap,” which occurs when policymakers attempt to address concerns about algorithmic incapacities by inserting a human into decision making process. Regardless …

Distributed Governance Of Medical Ai, W. Nicholson Price Ii

Law & Economics Working Papers

Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human can notice, it can democratize expertise beyond the circle of highly specialized practitioners, like letting generalists diagnose diabetic degeneration of the retina. But AI doesn’t always work, and it doesn’t always work for everyone, and it doesn’t always work in every context. AI is likely to behave differently in well-resourced hospitals where it is developed than in poorly resourced frontline health environments where it might well make the biggest difference …

The Promise And Limits Of Lawfulness: Inequality, Law, And The Techlash, Salomé Viljoen

Articles

In response to widespread skepticism about the recent rise of “tech ethics”, many critics have called for legal reform instead. In contrast with the “ethics response”, critics consider the “lawfulness response” more capable of disciplining the excesses of the technology industry. In fact, both are simultaneously vulnerable to industry capture and capable of advancing a more democratic egalitarian agenda for the information economy. Both ethics and law offer a terrain of contestation, rather than a predetermined set of commitments by which to achieve more democratic and egalitarian technological production. In advancing this argument, the essay focuses on two misunderstandings common …

Taking It With You: Platform Barriers To Entry And The Limits Of Data Portability, Gabriel Nicholas

Michigan Technology Law Review

Policymakers are faced with a vexing problem: how to increase competition in a tech sector dominated by a few giants. One answer proposed and adopted by regulators in the United States and abroad is to require large platforms to allow consumers to move their data from one platform to another, an approach known as data portability. Facebook, Google, Apple, and other major tech companies have enthusiastically supported data portability through their own technical and political initiatives. Today, data portability has taken hold as one of the go-to solutions to address the tech industry’s competition concerns.

This Article argues that despite …

Regtech And Predictive Lawmaking: Closing The Reglag Between Prospective Regulated Activity And Regulation, John W. Bagby, Nizan G. Packin

Michigan Business & Entrepreneurial Law Review

Regulation chronically suffers significant delay starting at the detectable initiation of a “regulable activity” and culminating at effective regulatory response. Regulator reaction is impeded by various obstacles: (i) confusion in optimal level, form and choice of regulatory agency, (ii) political resistance to creating new regulatory agencies, (iii) lack of statutory authorization to address particular novel problems, (iv) jurisdictional competition among regulators, (v) Congressional disinclination to regulate given political conditions, and (vi) a lack of expertise, both substantive and procedural, to deploy successful counter-measures. Delay is rooted in several stubborn institutions, including libertarian ideals permeating both the U.S. legal system and …

Innovation In A Legal Vacuum: The Uncertain Legal Landscape For Shared Micro-Mobility, David Pimentel, Michael B. Lowry, Timothy W. Koglin, Ronald W. Pimentel

Journal of Law and Mobility

The last few years have seen an explosion in the number and size shared micro-mobility systems (“SMMS”) across the United States. Some of these systems have seen extraordinary success and the potential benefit of these systems to communities is considerable. However, SMMS have repeatedly ran into legal barriers that either prevent their implementation entirely, confuse and dissuade potential users, or otherwise limit SMMS’s potential positive impact.

This paper reflects a detailed study of state laws relating to SMMS and the platforms commonly used in these systems. The study uncovered many inconsistencies with micro-mobility laws across the country. Currently, many states …

Digital Market Perfection, Rory Van Loo

Michigan Law Review

Google’s, Apple’s, and other companies’ automated assistants are increasingly serving as personal shoppers. These digital intermediaries will save us time by purchasing grocery items, transferring bank accounts, and subscribing to cable. The literature has only begun to hint at the paradigm shift needed to navigate the legal risks and rewards of this coming era of automated commerce. This Article begins to fill that gap by surveying legal battles related to contract exit, data access, and deception that will determine the extent to which automated assistants are able to help consumers to search and switch, potentially bringing tremendous societal benefits. Whereas …

The Future Of Law And Mobility, Daniel A. Crane

Articles

With the launch of the new Journal of Law and Mobility, the University of Michigan is recognizing the transformative impact of new transportation and mobility technologies, from cars, to trucks, to pedestrians, to drones. The coming transition towards intelligent, automated, and connected mobility systems will transform not only the way people and goods move about, but also the way human safety, privacy, and security are protected, cities are organized, machines and people are connected, and the public and private spheres are defined.

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 …

Tiny Things With A Huge Impact: The International Regulation Of Nanomaterials, Dario Picecchi

Michigan Journal of Environmental & Administrative Law

Mounting evidence demonstrates that nanotechnology and nanomaterials impose severe environmental risks. To minimize these risks, the usage and handling of certain nanomaterials could be addressed under existing treaties such as the Rotterdam Convention, the Stockholm Convention, and the Basel Convention. However, even if existing treaties govern the handling of certain nanomaterials, no treaty effectively regulates all the specific challenges that nanomaterials pose to the global environment. Consequently, a completely new regulatory instrument is required. An international organization could take responsibility for developing and promoting such a nanospecific international legal framework. By incorporating the precautionary principle, a technology transfer, research cooperation, …

The Commodification Of Cryptocurrency, Neil Tiwari

Michigan Law Review

Cryptocurrencies are digital tokens built on blockchain technology. This allows for a product that is fully decentralized, with no need for a third-party intermediary like a government or financial institution. Cryptocurrency creators use initial coin offerings (ICOs) to raise capital to build their tokens. Cryptocurrency ICOs are problematic because they do not fit neatly within either of two traditional categories—securities or commodities. Each of these categories has their own regulatory agency: the SEC for securities and the CFTC for commodities. At first blush, ICOs seem to be a sale of securities subject to regulation by the SEC, but this is …

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 …

Lamarck Revisited: The Implications Of Epigenetics For Environmental Law, Michael P. Vandenbergh, David J. Vandenbergh, John G. Vandenbergh

Michigan Journal of Environmental & Administrative Law

For generations, a bedrock concept of biology was that genetic mutations are necessary to pass traits from one generation to the next, but new developments in genetics are challenging this fundamental assumption. A growing body of scientific evidence demonstrates that chemical alteration of the way a gene functions, whether through exposure to chemicals, foods or even traumatic experiences, may not only affect the exposed individual, but also the individual’s offspring for two generations or more. This interaction between genes and the environment, known as epigenetics, has revolutionized the understanding of how genes are expressed within an individual and how they …

Change In Regulation Is Necessary For Genetically Engineered Mosquitoes, Insung Hwang

Michigan Journal of Environmental & Administrative Law

Millions of genetically engineered (GE) mosquitoes could soon be released in Key West, Florida as an effort to eradicate wild mosquitoes that are transmitters of diseases such as malaria, dengue, and chikungunya. Both international and domestic regulations fail to provide effective regulatory schemes that can facilitate the application of this technology while ensuring all safety and environmental aspects are properly addressed. The Food and Drug Administration’s assertion of jurisdiction is based on its assessment that the GE mosquitoes are “animal drugs” under the Federal Food, Drug, and Cosmetic Act. This is especially troublesome because the end goal of using these …

Instrument Choice, Carbon Emissions, And Information, Michael Wara

Michigan Journal of Environmental & Administrative Law

This Article examines the consequences of a previously unrecognized difference between pollutant cap-and-trade schemes and pollution taxes. Implementation of cap-and-trade relies on a forecast of future emissions, while implementation of a pollution tax does not. Realistic policy designs using either regulatory instrument almost always involve a phase-in over time to avoid economic disruption. Cap-and-trade accomplishes this phase-in via a limit on emissions that falls gradually below the forecast of future pollutant emissions. Emissions taxation accomplishes the same via a gradually increasing levy on pollution. Because of the administrative complexity of establishing an emissions trading market, cap-and-trade programs typically require between …

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

Making Method Visible: Improving The Quality Of Science-Based Regulation, Pasky Pascual, Wendy Wagner, Elizabeth Fisher

Michigan Journal of Environmental & Administrative Law

Scientific inferences are theories about how the world works that scientists formulate based on their observations. One of the most difficult issues at the intersection of law and science is to determine whether the weight of evidence supports one scientific inference versus other competing interpretations of the observations. In administrative law, this difficulty is exacerbated by the behavior of both the courts and regulatory agencies. Agencies seldom achieve the requisite visibility that explains the analytical methods they use to reach their scientific inferences. Courts—because they appreciate neither the variety of inferential methods nor their epistemic foundations—do not demand this level …

Past Its Prime: Why The Clean Air Act Is In Need Of Modification, Levi Smith

University of Michigan Journal of Law Reform Caveat

The Clean Air Act (CAA) is the primary federal statute regulating the emission of air pollutants. First enacted in 1970, the CAA requires, inter alia, the federal government to establish air quality goals and states to develop implementation plans to achieve those goals. The most stringent requirements of the CAA are imposed on “new” or “modified” sources of pollution, such as sulfur dioxide, nitrous oxides, and particulate matter. Sources that were operating when the CAA was enacted are mostly exempt from regulation under the Act. Because of the substantial costs associated with the CAA standards, there is an incentive for …

High-Frequency Trading: Should Regulators Do More, Matt Prewitt

Michigan Telecommunications & Technology Law Review

High-Frequency Trading ("HFT") is a diverse set of algorithmic trading strategies characterized by fast order execution. Its importance in international markets has increased vastly in recent years. From a regulatory perspective, HFT presents difficult and partially unresolved questions. The difficulties stem partly from the fact that HFT encompasses a wide range of trading strategies, and partly from a dearth of unambiguous empirical findings about HFT's effects on markets. Yet certain important conclusions are broadly accepted. HFT can increase systemic risk by causing or exacerbating events like the "Flash Crash" of May 6, 2010. HFT can also enable market manipulators to …

Foreword: Rulemaking, Democracy, And Torrents Of E-Mail, Nina A. Mendelson

Articles

This Foreword is meant as an initial foray into the question of what agencies should do with mass public comments, particularly on broad questions of policy. Part I discusses the extent to which congressional control, presidential control, and agency procedures themselves can ensure that agency decisions are democratically responsive. In view of shortcomings in both congressional and presidential control, I underscore the need to focus closely on rulemaking procedures as a source of democratic responsiveness. The possibility that agencies may be systematically discounting certain public submissions raises difficulties, and I present some examples. Part II makes a preliminary case that …

Wireless Net Neutrality Regulation And The Problem With Pricing: An Empirical, Cautionary Tale, Babette E.L. Boliek

Michigan Telecommunications & Technology Law Review

I present here a unique empirical analysis of the consumer welfare benefits of prior regulation in the mobile telecommunications industry. In particular, I analyze the relative consumer benefits of state rate regulation and federal entry regulation. The institution of filing requirements and FTC review and approval of various consumer pricing regimes is highly analogous to the consumer price controls imposed by various state level public utility commissions in the past. Furthermore, the imposition of a zero-price rule is analogous to past rate regulation; in particular it is similar to past wholesale regulation with its underlying principles of open access and …

States, Markets, And Gatekeepers: Public-Private Regulatory Regimes In An Era Of Economic Globalization, Christopher M. Bruner

Michigan Journal of International Law

This Article illuminates the spectrum of international economic regimes through discussion of an under-theorized regulatory structure in which traditional distinctions between State and market, public and private power, hard and soft law, and international and domestic policy realms, essentially collapse-the "public-private gatekeeper."

Technology Wars: The Failure Of Democratic Discourse, Gregory N. Mandel

Michigan Telecommunications & Technology Law Review

Conflicts over the use and regulation of various technologies pervade public discourse and have dramatic implications for the public interest. Controversies over the regulation of genetically modified products, nuclear power, and nanotechnology, among others, provoke some of the most socially and politically volatile debates of our time. These technology conflicts extract a substantial price from society--they create costly inefficiencies, prevent society from optimally managing new technologies, consume vast resources, and retard technological growth. This Article develops a framework for understanding technology controversies, and consequently proposes new means for resolving or ameliorating a variety of seemingly intractable legal and regulatory standoffs. …

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Other Publications

It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …

The Least Of The Sentient Beings' And The Question Of Reduction, Refinement, And Replacement, Joseph Vining

Other Publications

The subject I was asked to think about with you today is raised by a very large change in the focus of biomedical research. In raw percentage terms, the animals involved in experimentation are now overwhelmingly rats and mice, and, perhaps because they are rats and mice, they are used in large numbers, numbers in thousands and tens of thousands at some institutions. Legal, ethical, and practical accommodation to this fact on the ground presents a host of questions. There are questions of the cost of care. There are questions of the training of veterinarians, principal investigators, and laboratory personnel. …

Carte Blanche For Cruelty: The Non-Enforcement Of The Animal Welfare Act, Katharine M. Swanson

University of Michigan Journal of Law Reform

This Note explores both the judicial and administrative underenforcement of the Animal Welfare Act in protecting the welfare of laboratory animals used for purposes of experimentation. Specifically, the Note suggests that judicial underenforcement is borne as a result of the difficulties of lodging a private cause of action under the Act or gaining standing under the alternative statutory scheme of the Administrative Procedure Act. It further suggests administrative underenforcement in describing the promulgated regulations of the Act as inadequate and the lack of self-policing mechanisms. Finally, the Note suggests some ways that enforcement can be made more effective in these …

Fda Approved? A Critique Of The Artificial Insemination Industry In The United States, Karen M. Ginsberg

University of Michigan Journal of Law Reform

Artificial insemination by donor is becoming an increasingly popular means to achieving parenthood. While the majority of couples use artificial insemination to overcome fertility problems, many recipients use artificial insemination to avoid passing a genetic disease to their children. However, case studies reveal the inherent dangers of artificial insemination, namely the lack of proper screening methods to avoid passing genetic diseases to children born by artificial insemination. State-by-state regulation, federal guidelines, and private adjudication have all proven to be inadequate methods of regulating the artificial insemination industry. Ginsberg proposes federal regulation as the only means of achieving a safe artificial …

Revitalizing Environmental Federalism, Daniel C. Esty

Michigan Law Review

Politicians from Speaker Newt Gingrich to President Bill Clinton, cheered on by academics such as Richard Revesz, are eagerly seeking to return authority over environmental regulation to the states. In the European Union, localist opponents of environmental decisionmaking in Brussels rally under the banner of "subsidiarity." And in debates over international trade liberalization, demands abound for the protection of "national sovereignty" in environmental regulation. All of these efforts presume that a decentralized approach to environmental policy will yield better results than more centralized programs. This presumption is misguided. While the character of some environmental concerns warrants a preference for local …