Volume 71, Number 6 – March 2022

Articles

Governing by Algorithm? No Noise and (Potentially) Less Bias
Cass R. Sunstein
PDF

As intuitive statisticians, human beings suffer from identifiable biases—cognitive and otherwise. Human beings can also be “noisy” in the sense that their judgments show unwanted variability. As a result, public institutions, including those that consist of administrative prosecutors and adjudicators, can be biased, noisy, or both. Both bias and noise produce errors. Algorithms eliminate noise, and that is important; to the extent that they do so, they prevent unequal treatment and reduce errors. In addition, algorithms do not use mental shortcuts; they rely on statistical predictors, which means that they can counteract or even eliminate cognitive biases. At the same time, the use of algorithms by administrative agencies raises many legitimate questions and doubts. Among other things, algorithms can encode or perpetuate discrimination, perhaps because their inputs are based on discrimination, or perhaps because what they are asked to predict is infected by discrimination. But if the goal is to eliminate discrimination, properly constructed algorithms nonetheless have a great deal of promise for administrative agencies.

Automating FDA Regulation
Mason Marks
PDF

In the twentieth century, the Food and Drug Administration (“FDA”) rose to prominence as a respected scientific agency. By the middle of the century, it transformed the U.S. medical marketplace from an unregulated haven for dangerous products and false claims to a respected exemplar of public health. More recently, the FDA’s objectivity has increasingly been questioned. Critics argue the agency has become overly political and too accommodating to industry while lowering its standards for safety and efficacy. The FDA’s accelerated pathways for product testing and approval are partly to blame. They require lower-quality evidence, such as surrogate endpoints, and shift the FDA’s focus from premarket clinical trials toward postmarket surveillance, requiring less evidence up front while promising enhanced scrutiny on the back end. To further streamline product testing and approval, the FDA is adopting outputs from computer models, enhanced by artificial intelligence (“AI”), as surrogates for direct evidence of safety and efficacy.

This Article analyzes how the FDA uses computer models and simulations to save resources, reduce costs, infer product safety and efficacy, and make regulatory decisions. To test medical products, the FDA assembles cohorts of virtual humans and conducts digital clinical trials. Using molecular modeling, it simulates how substances interact with cellular targets to predict adverse effects and determine how drugs should be regulated. Though legal scholars have commented on the role of AI as a medical product that is regulated by the FDA, they have largely overlooked the role of AI as a medical product regulator. Modeling and simulation could eventually reduce the exposure of volunteers to risks and help protect the public. However, these technologies lower safety and efficacy standards and may erode public trust in the FDA while undermining its transparency, accountability, objectivity, and legitimacy. Bias in computer models and simulations may prioritize efficiency and speed over other values such as maximizing safety, equity, and public health. By analyzing FDA guidance documents and industry and agency simulation standards, this Article offers recommendations for safer and more equitable automation of FDA regulation.

Algorithm v. Algorithm
Cary Coglianese & Alicia Lai
PDF

Critics raise alarm bells about governmental use of digital algorithms, charging that they are too complex, inscrutable, and prone to bias. A realistic assessment of digital algorithms, though, must acknowledge that government is already driven by algorithms of arguably greater complexity and potential for abuse: the algorithms implicit in human decision-making. The human brain operates algorithmically through complex neural networks. And when humans make collective decisions, they operate via algorithms too—those reflected in legislative, judicial, and administrative processes. Yet these human algorithms undeniably fail and are far from transparent. On an individual level, human decision-making suffers from memory limitations, fatigue, cognitive biases, and racial prejudices, among other problems. On an organizational level, humans succumb to groupthink and free riding, along with other collective dysfunctionalities. As a result, human decisions will in some cases prove far more problematic than their digital counterparts. Digital algorithms, such as machine learning, can improve governmental performance by facilitating outcomes that are more accurate, timely, and consistent. Still, when deciding whether to deploy digital algorithms to perform tasks currently completed by humans, public officials should proceed with care on a case-by-case basis. They should consider both whether a particular use would satisfy the basic preconditions for successful machine learning and whether it would in fact lead to demonstrable improvements over the status quo. The question about the future of public administration is not whether digital algorithms are perfect. Rather, it is a question about what will work better: human algorithms or digital ones.

Empathy in the Digital Administrative State
Sofia Ranchordás
PDF

Humans make mistakes. Humans make mistakes especially while filling out tax returns, benefit applications, and other government forms, which are often tainted with complex language, requirements, and short deadlines. However, the unique human feature of forgiving these mistakes is disappearing with the digitalization of government services and the automation of government decision-making. While the role of empathy has long been controversial in law, empathic measures have helped public authorities balance administrative values with citizens’ needs and deliver fair and legitimate decisions. The empathy of public servants has been particularly important for vulnerable citizens (for example, disabled individuals, seniors, and underrepresented minorities). When empathy is threatened in the digital administrative state, vulnerable citizens are at risk of not being able to exercise their rights because they cannot engage with digital bureaucracy.

This Article argues that empathy, which in this context is the ability to relate to others and understand a situation from multiple perspectives, is a key value of administrative law deserving of legal protection in the digital administrative state. Empathy can contribute to the advancement of procedural due process, the promotion of equal treatment, and the legitimacy of automation. The concept of administrative empathy does not aim to create arrays of exceptions, nor imbue law with emotions and individualized justice. Instead, this concept suggests avenues for humanizing digital government and automated decision-making through a more complete understanding of citizens’ needs. This Article explores the role of empathy in the digital administrative state at two levels: First, it argues that empathy can be a partial response to some of the shortcomings of digital bureaucracy. At this level, administrative empathy acknowledges that citizens have different skills and needs, and this requires the redesign of pre-filled application forms, government platforms, algorithms, as well as assistance. Second, empathy should also operate ex post as a humanizing measure which can help ensure that administrative mistakes made in good faith can be forgiven under limited circumstances, and vulnerable individuals are given second chances to exercise their rights.

Drawing on comparative examples of empathic measures employed in the United States, the Netherlands, Estonia, and France, this Article’s contribution is twofold: first, it offers an interdisciplinary reflection on the role of empathy in administrative law and public administration for the digital age, and second, it operationalizes the concept of administrative empathy. These goals combine to advance the position of vulnerable citizens in the administrative state.

Modeling Through
Ryan Calo
PDF

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 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 that stand to enhance policymaking. Computer-aided modeling holds promise in delivering on the broader goals of forecasting and systems analysis developed in the 1970s, arming policymakers with the means to anticipate the impacts of state intervention along several lines—to model, instead of muddle. A few policymakers have already dipped a toe into these waters, others are being told that the water is warm.

The prospect that economic, physical, and even social forces could be modeled by machines confronts policymakers with a paradox. Society may expect policymakers to avail themselves of techniques already usefully deployed in other sectors, especially where statutes or executive orders require the agency to anticipate the impact of new rules on particular values. At the same time, “modeling through” holds novel perils that policymakers may be ill equipped to address. Concerns include privacy, brittleness, and automation bias, all of which law and technology scholars are keenly aware. They also include the extension and deepening of the quantifying turn in governance, a process that obscures normative judgments and recognizes only that which the machines can see. The water may be warm, but there are sharks in it.

These tensions are not new. And there is danger in hewing to the status quo. As modeling through gains traction, however, policymakers, constituents, and academic critics must remain vigilant. This being early days, American society is uniquely positioned to shape the transition from muddling to modeling.

Volume 71, Number 6 – March 2022

Articles

Governing by Algorithm? No Noise and (Potentially) Less Bias
Cass R. Sunstein
PDF

As intuitive statisticians, human beings suffer from identifiable biases—cognitive and otherwise. Human beings can also be “noisy” in the sense that their judgments show unwanted variability. As a result, public institutions, including those that consist of administrative prosecutors and adjudicators, can be biased, noisy, or both. Both bias and noise produce errors. Algorithms eliminate noise, and that is important; to the extent that they do so, they prevent unequal treatment and reduce errors. In addition, algorithms do not use mental shortcuts; they rely on statistical predictors, which means that they can counteract or even eliminate cognitive biases. At the same time, the use of algorithms by administrative agencies raises many legitimate questions and doubts. Among other things, algorithms can encode or perpetuate discrimination, perhaps because their inputs are based on discrimination, or perhaps because what they are asked to predict is infected by discrimination. But if the goal is to eliminate discrimination, properly constructed algorithms nonetheless have a great deal of promise for administrative agencies.

Automating FDA Regulation
Mason Marks
PDF

In the twentieth century, the Food and Drug Administration (“FDA”) rose to prominence as a respected scientific agency. By the middle of the century, it transformed the U.S. medical marketplace from an unregulated haven for dangerous products and false claims to a respected exemplar of public health. More recently, the FDA’s objectivity has increasingly been questioned. Critics argue the agency has become overly political and too accommodating to industry while lowering its standards for safety and efficacy. The FDA’s accelerated pathways for product testing and approval are partly to blame. They require lower-quality evidence, such as surrogate endpoints, and shift the FDA’s focus from premarket clinical trials toward postmarket surveillance, requiring less evidence up front while promising enhanced scrutiny on the back end. To further streamline product testing and approval, the FDA is adopting outputs from computer models, enhanced by artificial intelligence (“AI”), as surrogates for direct evidence of safety and efficacy.

This Article analyzes how the FDA uses computer models and simulations to save resources, reduce costs, infer product safety and efficacy, and make regulatory decisions. To test medical products, the FDA assembles cohorts of virtual humans and conducts digital clinical trials. Using molecular modeling, it simulates how substances interact with cellular targets to predict adverse effects and determine how drugs should be regulated. Though legal scholars have commented on the role of AI as a medical product that is regulated by the FDA, they have largely overlooked the role of AI as a medical product regulator. Modeling and simulation could eventually reduce the exposure of volunteers to risks and help protect the public. However, these technologies lower safety and efficacy standards and may erode public trust in the FDA while undermining its transparency, accountability, objectivity, and legitimacy. Bias in computer models and simulations may prioritize efficiency and speed over other values such as maximizing safety, equity, and public health. By analyzing FDA guidance documents and industry and agency simulation standards, this Article offers recommendations for safer and more equitable automation of FDA regulation.

Algorithm v. Algorithm
Cary Coglianese & Alicia Lai
PDF

Critics raise alarm bells about governmental use of digital algorithms, charging that they are too complex, inscrutable, and prone to bias. A realistic assessment of digital algorithms, though, must acknowledge that government is already driven by algorithms of arguably greater complexity and potential for abuse: the algorithms implicit in human decision-making. The human brain operates algorithmically through complex neural networks. And when humans make collective decisions, they operate via algorithms too—those reflected in legislative, judicial, and administrative processes. Yet these human algorithms undeniably fail and are far from transparent. On an individual level, human decision-making suffers from memory limitations, fatigue, cognitive biases, and racial prejudices, among other problems. On an organizational level, humans succumb to groupthink and free riding, along with other collective dysfunctionalities. As a result, human decisions will in some cases prove far more problematic than their digital counterparts. Digital algorithms, such as machine learning, can improve governmental performance by facilitating outcomes that are more accurate, timely, and consistent. Still, when deciding whether to deploy digital algorithms to perform tasks currently completed by humans, public officials should proceed with care on a case-by-case basis. They should consider both whether a particular use would satisfy the basic preconditions for successful machine learning and whether it would in fact lead to demonstrable improvements over the status quo. The question about the future of public administration is not whether digital algorithms are perfect. Rather, it is a question about what will work better: human algorithms or digital ones.

Empathy in the Digital Administrative State
Sofia Ranchordás
PDF

Humans make mistakes. Humans make mistakes especially while filling out tax returns, benefit applications, and other government forms, which are often tainted with complex language, requirements, and short deadlines. However, the unique human feature of forgiving these mistakes is disappearing with the digitalization of government services and the automation of government decision-making. While the role of empathy has long been controversial in law, empathic measures have helped public authorities balance administrative values with citizens’ needs and deliver fair and legitimate decisions. The empathy of public servants has been particularly important for vulnerable citizens (for example, disabled individuals, seniors, and underrepresented minorities). When empathy is threatened in the digital administrative state, vulnerable citizens are at risk of not being able to exercise their rights because they cannot engage with digital bureaucracy.

This Article argues that empathy, which in this context is the ability to relate to others and understand a situation from multiple perspectives, is a key value of administrative law deserving of legal protection in the digital administrative state. Empathy can contribute to the advancement of procedural due process, the promotion of equal treatment, and the legitimacy of automation. The concept of administrative empathy does not aim to create arrays of exceptions, nor imbue law with emotions and individualized justice. Instead, this concept suggests avenues for humanizing digital government and automated decision-making through a more complete understanding of citizens’ needs. This Article explores the role of empathy in the digital administrative state at two levels: First, it argues that empathy can be a partial response to some of the shortcomings of digital bureaucracy. At this level, administrative empathy acknowledges that citizens have different skills and needs, and this requires the redesign of pre-filled application forms, government platforms, algorithms, as well as assistance. Second, empathy should also operate ex post as a humanizing measure which can help ensure that administrative mistakes made in good faith can be forgiven under limited circumstances, and vulnerable individuals are given second chances to exercise their rights.

Drawing on comparative examples of empathic measures employed in the United States, the Netherlands, Estonia, and France, this Article’s contribution is twofold: first, it offers an interdisciplinary reflection on the role of empathy in administrative law and public administration for the digital age, and second, it operationalizes the concept of administrative empathy. These goals combine to advance the position of vulnerable citizens in the administrative state.

Modeling Through
Ryan Calo
PDF

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 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 that stand to enhance policymaking. Computer-aided modeling holds promise in delivering on the broader goals of forecasting and systems analysis developed in the 1970s, arming policymakers with the means to anticipate the impacts of state intervention along several lines—to model, instead of muddle. A few policymakers have already dipped a toe into these waters, others are being told that the water is warm.

The prospect that economic, physical, and even social forces could be modeled by machines confronts policymakers with a paradox. Society may expect policymakers to avail themselves of techniques already usefully deployed in other sectors, especially where statutes or executive orders require the agency to anticipate the impact of new rules on particular values. At the same time, “modeling through” holds novel perils that policymakers may be ill equipped to address. Concerns include privacy, brittleness, and automation bias, all of which law and technology scholars are keenly aware. They also include the extension and deepening of the quantifying turn in governance, a process that obscures normative judgments and recognizes only that which the machines can see. The water may be warm, but there are sharks in it.

These tensions are not new. And there is danger in hewing to the status quo. As modeling through gains traction, however, policymakers, constituents, and academic critics must remain vigilant. This being early days, American society is uniquely positioned to shape the transition from muddling to modeling.