Law Commons^™

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …