Law Commons^™

Ctr. For Biological Diversity V. United States Fish & Wildlife Serv., Ali Stapleton

Public Land & Resources Law Review

The Ninth Circuit Court of Appeals affirmed the District Court of Arizona’s decision to deny a proposed mining plan becuase the operations exceeded the boundaries of a valid mining claim. The issue the court addressed is whether a permanent occupancy of waste rock and tailings on land, absent the discovery of valuable minerals, is a reasonable use related to mining activities. The Ninth Circuit decision effectively prevented mining companies from amending the 1872 Mining Law on the administrative record. Motions for a rehearing and a rehearing en banc were denied.

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany Lee

All Faculty Scholarship

Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

Modeling Through, Ryan Calo

Articles

Theorists of justice have long imagined a decision-maker capable of acting wisely in every circumstance. Policymakers seldom live up to this ideal. They face well-understood limits, including an inability to anticipate the societal impacts of state intervention along a range of dimensions and values. Policymakers cannot see around corners or address societal problems at their roots. When it comes to regulation and policy-setting, policymakers are often forced, in the memorable words of political economist Charles Lindblom, to “muddle through” as best they can.

Powerful new affordances, from supercomputing to artificial intelligence, have arisen in the decades since Lindblom’s 1959 article …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

How The Administrative State Got To This Challenging Place, Peter L. Strauss

Faculty Scholarship

Written for a dispersed agrarian population using hand tools in a local economy, our Constitution now controls an American government orders of magnitude larger that has had to respond to profound changes in transportation, communication, technology, economy, and scientific understanding. How did our government get to this place? The agencies Congress has created to meet these changes now face profound new challenges: transition from the paper to the digital age; the increasing centralization in an opaque, political presidency of decisions that Congress has assigned to diverse, relatively expert and transparent bodies; the thickening, as well, of the political layer within …

Administrative Law In The Automated State, Cary Coglianese

All Faculty Scholarship

In the future, administrative agencies will rely increasingly on digital automation powered by machine learning algorithms. Can U.S. administrative law accommodate such a future? Not only might a highly automated state readily meet longstanding administrative law principles, but the responsible use of machine learning algorithms might perform even better than the status quo in terms of fulfilling administrative law’s core values of expert decision-making and democratic accountability. Algorithmic governance clearly promises more accurate, data-driven decisions. Moreover, due to their mathematical properties, algorithms might well prove to be more faithful agents of democratic institutions. Yet even if an automated state were …

A False Sense Of Security: How Congress And The Sec Are Dropping The Ball On Cryptocurrency, Tessa E. Shurr

Dickinson Law Review (2017-Present)

Today, companies use blockchain technology and digital assets for a variety of purposes. This Comment analyzes the digital token. If the Securities and Exchange Commission (SEC) views a digital token as a security, then the issuer of the digital token must comply with the registration and extensive disclosure requirements of federal securities laws.

To determine whether a digital asset is a security, the SEC relies on the test that the Supreme Court established in SEC v. W.J. Howey Co. Rather than enforcing a statute or agency rule, the SEC enforces securities laws by applying the Howey test on a fact-intensive …

Regulation Of Algorithmic Tools In The United States, Christopher S. Yoo, Alicia Lai

All Faculty Scholarship

Policymakers in the United States have just begun to address regulation of artificial intelligence technologies in recent years, gaining momentum through calls for additional research funding, piece-meal guidance, proposals, and legislation at all levels of government. This Article provides an overview of high-level federal initiatives for general artificial intelligence (AI) applications set forth by the U.S. president and responding agencies, early indications from the incoming Biden Administration, targeted federal initiatives for sector-specific AI applications, pending federal legislative proposals, and state and local initiatives. The regulation of the algorithmic ecosystem will continue to evolve as the United States continues to search …

The Automated Administrative State: A Crisis Of Legitimacy, Danielle K. Citron, Ryan Calo

Faculty Scholarship

The legitimacy of the administrative state is premised on our faith in agency expertise. Despite their extra-constitutional structure, administrative agencies have been on firm footing for a long time in reverence to their critical role in governing a complex, evolving society. They are delegated enormous power because they respond expertly and nimbly to evolving conditions.

In recent decades, state and federal agencies have embraced a novel mode of operation: automation. Agencies rely more and more on software and algorithms in carrying out their delegated responsibilities. The automated administrative state, however, is demonstrably riddled with concerns. Legal challenges regarding the denial …

Solenex Llc V. Jewell, F. Aaron Rains

Public Land & Resources Law Review

In Solenex LLC v. Jewell, the Secretary of the Interior cancelled a highly contentious oil and gas lease in Montana’s Badger-Two Medicine area, an environmentally sensitive and culturally significant area to the Blackfeet Tribe, nearly thirty years after the lease had been issued. Solenex, a Louisiana based oil and gas company and holder of the lease, brought this action to enjoin the cancellation. The District Court for the District of Columbia agreed with Solenex and found that the Secretary’s decision took an unreasonable amount of time and violated good-faith contractual obligations. On these grounds, the court found the Secretary’s …

Transparency And Algorithmic Governance, Cary Coglianese, David Lehr

All Faculty Scholarship

Machine-learning algorithms are improving and automating important functions in medicine, transportation, and business. Government officials have also started to take notice of the accuracy and speed that such algorithms provide, increasingly relying on them to aid with consequential public-sector functions, including tax administration, regulatory oversight, and benefits administration. Despite machine-learning algorithms’ superior predictive power over conventional analytic tools, algorithmic forecasts are difficult to understand and explain. Machine learning’s “black-box” nature has thus raised concern: Can algorithmic governance be squared with legal principles of governmental transparency? We analyze this question and conclude that machine-learning algorithms’ relative inscrutability does not pose a …

Center For Biological Diversity V. Zinke, Ryan Hickey

Public Land & Resources Law Review

The oft-cited “arbitrary and capricious” standard revived the Center for Biological Diversity’s most recent legal challenge in its decades-long quest to see arctic grayling listed under the Endangered Species Act. While this Ninth Circuit decision did not grant grayling ESA protections, it did require the United States Fish and Wildlife Service to reconsider its 2014 finding that listing grayling as threatened or endangered was unwarranted. In doing so, the court found “range,” as used in the ESA, vague while endorsing the FWS’s 2014 clarification of that term. Finally, this holding identified specific shortcomings of the challenged FWS finding, highlighting how …

Regulation By Database, Nathan Cortez

Faculty Journal Articles and Book Chapters

The federal government currently publishes 195,245 searchable databases online, a number of which include information about private parties that is negative or unflattering in some way. Federal agencies increasingly publish adverse data not just to inform the public or promote transparency, but to pursue regulatory ends ⎯ to change the underlying behavior being reported. Such "regulation by database" has become a preferred method of regulation in recent years, despite scant attention from policymakers, courts, or scholars on its appropriate uses and safeguards.

This Article, then, evaluates the aspirations and burdens of regulation by database. Based on case studies of six …

Common Carriage’S Domain, Christopher S. Yoo

All Faculty Scholarship

The judicial decision invalidating the Federal Communications Commission's first Open Internet Order has led advocates to embrace common carriage as the legal basis for network neutrality. In so doing, network neutrality proponents have overlooked the academic literature on common carriage as well as lessons from its implementation history. This Essay distills these learnings into five factors that play a key role in promoting common carriage's success: (1) commodity products, (2) simple interfaces, (3) stability and uniformity in the transmission technology, (4) full deployment of the transmission network, and (5) stable demand and market shares. Applying this framework to the Internet …

Entrepreneurial Administration, Philip J. Weiser

Publications

A core failing of today’s administrative state and modern administrative law scholarship is the lack of imagination as to how agencies should operate. On the conventional telling, public agencies follow specific grants of regulatory authority, use the traditional tools of notice-and-comment rulemaking and adjudication, and are checked by judicial review. In reality, however, effective administration depends on entrepreneurial leadership that spearheads policy experimentation and trial-and-error problem-solving, including the development of regulatory programs that use non-traditional tools.

Entrepreneurial administration takes place both at public agencies and private entities, each of which can address regulatory challenges and earn regulatory authority as a …

The Challenge Of Regulatory Excellence, Cary Coglianese

All Faculty Scholarship

Regulation is a high-stakes enterprise marked by tremendous challenges and relentless public pressure. Regulators are expected to protect the public from harms associated with economic activity and technological change without unduly impeding economic growth or efficiency. Regulators today also face new demands, such as adapting to rapidly changing and complex financial instruments, the emergence of the sharing economy, and the potential hazards of synthetic biology and other innovations. Faced with these challenges, regulators need a lodestar for what constitutes high-quality regulation and guidance on how to improve their organizations’ performance. In the book Achieving Regulatory Excellence, leading regulatory experts …

The Forgotten Core Of The Telecommunications Act Of 1996, Philip J. Weiser

Publications

No abstract provided.

Regulating Software When Everything Has Software, Paul Ohm, Blake Reid

Publications

This Article identifies a profound, ongoing shift in the modern administrative state: from the regulation of things to the regulation of code. This shift has and will continue to place previously isolated agencies in an increasing state of overlap, raising the likelihood of inconsistent regulations and putting seemingly disparate policy goals, like privacy, safety, environmental protection, and copyright enforcement, in tension. This Article explores this problem through a series of case studies and articulates a taxonomy of code regulations to help place hardware-turned-code rules in context. The Article considers the likely turf wars, regulatory thickets, and related dynamics that are …

Optimizing Government For An Optimizing Economy, Cary Coglianese

All Faculty Scholarship

Much entrepreneurial growth in the United States today emanates from technological advances that optimize through contextualization. Innovations as varied as Airbnb and Uber, fintech firms and precision medicine, are transforming major sectors in the economy by customizing goods and services as well as refining matches between available resources and interested buyers. The technological advances that make up the optimizing economy create new challenges for government oversight of the economy. Traditionally, government has overseen economic activity through general regulations that aim to treat all individuals equally; however, in the optimizing economy, business is moving in the direction of greater individualization, not …

Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley

Articles

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

Policy Tailors And The Rookie Regulator, Sarah Tran

Sarah Tran

Commentators have long lamented the lack of policy tailoring in the patent system. But unlike other administrative agencies, who regularly tailor regulatory policies to the needs of specific industries, the U.S. Patent and Trademark Office (“PTO”) was widely believed to lack the authority and institutional competence for such policymaking. This Article provides the first comprehensive analysis of recent legislative reforms to the PTO’s policymaking authority. It shows the reforms empower the PTO to have a larger say in patent policy than ever before. The big question is thus: to what extent is it good policy for a rookie regulator to …

On Capturing The Possible Significance Of Institutional Design And Ethos, Peter L. Strauss

Faculty Scholarship

At a recent conference, a new judge from one of the federal courts of appeal – for the United States, the front line in judicial control of administrative action-made a plea to the lawyers in attendance. Please, he urged, in briefing and arguing cases reviewing agency actions, help us judges to understand their broader contexts. So often, he complained, the briefs and arguments are limited to the particular small issues of the case. We get little sense of the broad context in which it arises – the agency responsibilities in their largest sense, the institutional issues that may be at …

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner

West Virginia Law Review

No abstract provided.

Scientific Expertise In Policymaking: The Case For Open Review And Patent Reform, Beth Simone Noveck

ExpressO

The Energy Research Advisory Board, the group of external scientific advisors that provided impartial expert advice to the Secretary of Energy since 1978, was disbanded this May. The Administration, like its predecessors, regularly replaces experts on agency advisory panels with ideologues and political allies. We are at the nadir of a historical progression since World War II away from trust in and use of scientific expertise in policymaking. This shift however, has not been countered with greater public participation. Instead, administrative law and theory have developed a model of the managerial administrative authority. The "expertocratic" agency relies on internal expertise …