Law Commons^™

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 …

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 …

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 …

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 …

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 …

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. …

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 …

World Trade And The Environment: The Cafe Case, Eric Phillips

Michigan Journal of International Law

This Note examines the CAFE case in the context of the debate over trade and the environment. It argues that the panel decision has aspects that support the notion that the international trading system can be compatible with efforts to protect the environment, and also has aspects that demonstrate that these do indeed clash, limiting efforts to protect the environment. Part I of this Note describes the CAFE law and places it in the context of domestic and international efforts to prevent global warming. Part II examines the panel's decision, arguing that the panel acted well within the scope of …

Telecommunications In Transition: Unbundling, Reintegration, And Competition, David J. Teece

Michigan Telecommunications & Technology Law Review

The world economy is experiencing a technological revolution, fueled by rapid advances in microelectronics, optics, and computer science, that in the 1990s and beyond will dramatically change the way people everywhere communicate, learn, and access information and entertainment. This technological revolution has been underway for about a decade. The emergence of a fully-interactive communications network, sometimes referred to as the "Information Superhighway," is now upon us. This highway, made possible by fiber optics and the convergence of several different technologies, is capable of delivering a plethora of new interactive entertainment, informational, and instructional services that are powerful and user-friendly. The …

U.S. Government Control Over The Export Of Scientific Research And Other Technical Data: Holes In The Sieve, Robert Greenspoon

Michigan Journal of International Law

In Part I, I establish the backdrop for answering the question by describing the kinds of scientific data that might be subject to security classification and export licensing. In Part II, I outline briefly who chooses what should be restricted and who enforces these restrictions. In Part III, I describe several situations in which the federal government has vigorously enforced controls over the dissemination of scientific information. I also analyze two recent cases involving computer software that I believe analogize directly to the scientific endeavor. Finally, in Part IV, I explain why First Amendment barriers, the growth of the Internet …

International Regulation And Control Of The Production And Use Of Chemicals And Pesticides: Perspectives For A Convention, Hans-Wolfgang Micklitz

Michigan Journal of International Law

A wide variety of instruments and mechanisms for the regulation and control of chemicals and pesticides is already available internationally. What is missing is an analysis that attempts to systematize the different approaches, to create transparency, to define where they overlap, and to discover prospective deficiencies and shortcomings. In order to accomplish this task, this article covers legally binding rules as well as recommendations and codes - the international soft law. The overall purpose is to outline a framework for future international regulation of chemicals and pesticides and to propose an international convention as a possible solution.

What Process Is Due? Courts And Science-Policy Disputes, Gregory B. Heller

Michigan Law Review

A Review of What Process is Due? Courts and Science-Policy Disputes by David M. O'Brien

Federal Agency Treatment Of Uncertainty In Environmental Impact Statements Under The Ceq's Amended Nepa Regulation § 1502.22: Worst Case Analysis Or Risk Threshold, Charles F. Weiss

Michigan Law Review

This Note traces the judicial and administrative treatment of uncertainty under NEPA and supports the CEQ's replacement of worst case analysis with a qualitative probability threshold. Part I discusses the development of reasonableness standards in NEPA common law to define agency obligations prior to promulgation of the worst case analysis regulation. Part II reviews the worst case analysis regulation and its judicial construction. Finally, Part III outlines the amended regulation, which replaces worst case analysis with a probability threshold employing the rule of reason to limit EIS discussion to environmental effects shown through credible scientific evidence to be reasonably foreseeable. …

Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

Part I of this Article describes some of the risks and benefits of newly emerging agricultural biotechnologies. After discussing, in Part II, the role of federal agencies in regulating agricultural biotechnologies, Part III of the Article proposes elements for an adequate regulatory regime. Part IV then measures the existing legal authorities, as implemented by the USDA and the EPA, against the ideal elements. Part V examines the willingness of these agencies to regulate. Finally, Part VI suggests changes that can be made in the current regulatory regime to bring about more effective regulation and to enhance public trust in regulatory …

Integrated Servies Digital Network: Issues And Options For The World's Future Communications Systems, A. M. Rutkowski

Michigan Journal of International Law

There has been virtually no public discussion of the significant public policy issues raised because of the intimidating nature of network engineering which forms the basis for nearly all the current dialogue. This paper discusses current ISDN developments, and sets forth an analytical framework within which these issues may be discussed.

Restrictions On Trade In Communication And Information Services, Geza Feketekuty, Jonathan David Aronson

Michigan Journal of International Law

Section one highlights some of the changes that the revolution in information exchange is producing. It also argues that transborder data flows could help facilitate international economic adjustment. Section two analyzes the types of reasons used to justify policy measures that inhibit the integration of the world communication network or prevent information from flowing across national borders. It also discusses the implication of restrictions on transborder data flows for the world trading system and for world economic growth. The final section discusses strategies for halting the proliferation of barriers to trade in communication and information services and for reducing existing …