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Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai 2017 Duke Law School

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the …


Proportionality Review In Administrative Law, Jud Mathews 2017 Penn State Dickinson Law

Proportionality Review In Administrative Law, Jud Mathews

Contributions to Books

At the most basic level, the principle of proportionality captures the common-sensical proposition that, when the government acts, the means it chooses should be well-adapted to achieve the ends it is pursuing. The proportionality principle is an admonition, as German administrative law scholar Fritz Fleiner famously wrote many decades ago, that “the police should not shoot at sparrows with cannons”. The use of proportionality review in constitutional and international law has received ample attention from scholars in recent years, but less has been said about proportionality’s role within administrative law. This piece suggest that we can understand the differences in …


Forces Of Federalism, Safety Nets, And Waivers, Edward H. Stiglitz 2017 Cornell Law School

Forces Of Federalism, Safety Nets, And Waivers, Edward H. Stiglitz

Cornell Law Faculty Publications

Inequality is the defining feature of our times. Many argue it calls for a policy response, yet the most obvious policy responses require legislative action. And if inequality is the defining feature of our times, partisan acrimony and gridlock are the defining features of the legislature. So being, it is worth considering what role administrative agencies, and administrative law, might play in ameliorating or exacerbating economic inequality. Here, I focus on American safety net programs, many of which are joint operations between federal administrative agencies and state governments. In this context, a central mode of bureaucratic policy innovation comes in …


Internal Administrative Law, Gillian E. Metzger, Kevin M. Stack 2017 Columbia Law School

Internal Administrative Law, Gillian E. Metzger, Kevin M. Stack

Faculty Scholarship

For years, administrative law has been identified as the external review of agency action, primarily by courts. Following in the footsteps of pioneering administrative law scholars, a growing body of recent scholarship has begun to attend to the role of internal norms and structures in controlling agency action. This Article offers a conceptual and historical account of these internal forces as internal administrative law. Internal administrative law consists of the internal directives, guidance, and organizational forms through which agencies structure the discretion of their employees and presidents control the workings of the executive branch. It is the critical means for …


On Health, Law, And Religion, Stacey A. Tovino 2017 University of Nevada, Las Vegas -- William S. Boyd School of Law

On Health, Law, And Religion, Stacey A. Tovino

Scholarly Works

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman's Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court's recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a wide …


Fair For Whom? Why Debt-Collection Lawsuits In St. Louis Violate The Procedural Due Process Rights Of Low-Income Communities, Aimee Constantineau 2017 American University Washington College of Law

Fair For Whom? Why Debt-Collection Lawsuits In St. Louis Violate The Procedural Due Process Rights Of Low-Income Communities, Aimee Constantineau

American University Law Review

No abstract provided.


2016 Survey Of Rhode Island Law: Cases And Public Laws Of Note, 2017 Roger Williams University

2016 Survey Of Rhode Island Law: Cases And Public Laws Of Note

Roger Williams University Law Review

No abstract provided.


The Triage And Treatment Of Healthcare Institutions In Distress: How To Involve State Regulators In Healthcare Bankruptcies And Receiverships, Brian P. Stern, Christopher J. Fragomeni 2017 R.I. Superior Court

The Triage And Treatment Of Healthcare Institutions In Distress: How To Involve State Regulators In Healthcare Bankruptcies And Receiverships, Brian P. Stern, Christopher J. Fragomeni

Roger Williams University Law Review

No abstract provided.


Agency Innovation In Vermont Yankee's White Space, Emily S. Bremer, Sharon B. Jacobs 2017 University of Wyoming College of Law

Agency Innovation In Vermont Yankee's White Space, Emily S. Bremer, Sharon B. Jacobs

Publications

The literature on “agency discretion” has, with a few notable exceptions, largely focused on substantive policy discretion, not procedural discretion. In this essay, we seek to refocus debate on the latter, which we argue is no less worthy of attention. We do so by defining the parameters of what we call Vermont Yankee’s “white space” — the scope of agency discretion to experiment with procedures within the boundaries established by law (and thus beyond the reach of the courts). Our goal is to begin a conversation about the dimensions of this procedural negative space, in which agencies are free …


Administrative Dissents, Sharon B. Jacobs 2017 University of Colorado Law School

Administrative Dissents, Sharon B. Jacobs

Publications

Commissioners, like judges, dissent. They do so at length, with vigor, and with persistence. Yet while separate judicial decisions are the subject of a rich literature, their administrative counterparts have long languished in obscurity. A closer look is warranted, however, because studying administrative dissent can enhance our understanding of internal agency operations as well as the relationships between agencies and other actors. This Article presents the results of an original review of separate statements at the Federal Energy Regulatory Commission and the Nuclear Regulatory Commission dating back four decades. It uses these findings to move beyond two common generalizations about …


Entrepreneurial Administration, Philip J. Weiser 2017 University of Colorado Law School

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 …


Irreconcilable Similarities: The Inconsistent Analysis Of 212(C) And 212(H) Waivers, Kate Aschenbrenner Rodriguez 2017 University of Oklahoma College of Law

Irreconcilable Similarities: The Inconsistent Analysis Of 212(C) And 212(H) Waivers, Kate Aschenbrenner Rodriguez

Oklahoma Law Review

No abstract provided.


Statutory Junk, David Schoenbrod 2017 New York Law School

Statutory Junk, David Schoenbrod

Articles & Chapters

Much as “space junk”—the debris that past space missions have left in earth’s orbit—can disable a current space mission, obsolete statutory commands that Congress has left on the books can keep an administrative agency from accomplishing its current mission. This statutory junk has proliferated in recent decades because Congress has shifted from giving agencies open-ended authority to commanding them in exacting detail, but often fails to revise these commands after changing circumstances have made the old commands perverse. Congress fails because, contrary to the suppositions of some law professors, this delegation allows legislators to shift blame to the agency for …


How Privacy Distorted Standing Law, Felix T. Wu 2017 Benjamin N. Cardozo School of Law

How Privacy Distorted Standing Law, Felix T. Wu

Articles

No abstract provided.


Localist Administrative Law, Nestor M. Davidson 2017 Fordham University School of Law

Localist Administrative Law, Nestor M. Davidson

Faculty Scholarship

To read the voluminous literature on administrative law is to inhabit a world focused almost exclusively on federal agencies. This myopic view, however, ignores the wide array of administrative bodies that make and implement policy at the local-government level. The administrative law that emerges from the vast subterranean regulatory state operating within cities, suburbs, towns, and counties has gone largely unexamined. Not only are scholars ignoring a key area of governance, but courts have similarly failed to develop an administrative jurisprudence that recognizes what is distinctive about local agencies. The underlying justifications for core administrative law doctrines at the federal …


Curial Deference In Singapore Public Law: Autochthonous Evolution To Buttress Good Governance And The Rule Of Law, Tan K. B. EUGENE 2017 Singapore Management University

Curial Deference In Singapore Public Law: Autochthonous Evolution To Buttress Good Governance And The Rule Of Law, Tan K. B. Eugene

Research Collection Yong Pung How School Of Law

Central to the separation of powers and the rule of law, judicial review empowers the courts to examine the exercise of discretionary power. While there is no general doctrine of deference, judical review in Singapore emphasises the green-light approach in facilitating good governance, and is sensitive to the political, socio-cultural and economic context. However, the jurisprudence also indicates a nuanced and robust approach to better regulate the decision-makers' latitude. A categorical approach towards justiciability is eschewed, and judicial scrutiny adopts varying intensities of review, taking into account the rights of the individual vis-a-vis the fair and just protection of governmental …


Addressing Bias In Administrative Environmental Decisions, Robert R. Kuehn 2017 Washington University in St. Louis School of Law

Addressing Bias In Administrative Environmental Decisions, Robert R. Kuehn

Scholarship@WashULaw

Allegations of bias in administrative environmental decisions are common and seemingly increasing because of the significant economic and political interests in many disputes. From high profile national oil spills to local land use matters, parties to environmental proceedings allege conflicts of interest, favoritism, prejudgment of outcomes, comingling of prosecutorial and adjudicatory functions, ex parte communications, and improper political influence. Where bias occurs, it can significantly impact the implementation and enforcement of environmental laws. Biased proceedings can undermine the goals of environmental laws by causing prejudiced decisions not grounded in law or fact, ultimately harming public health and the environment. The …


Is The U.S. Supreme Court Becoming Hostile To The Administrative State, Jeffrey Lubbers 2017 American University Washington College of Law

Is The U.S. Supreme Court Becoming Hostile To The Administrative State, Jeffrey Lubbers

Contributions to Books

Jeffrey S. Lubbers, Is the U.S. Supreme Court Becoming Hostile to the Administrative State?, prepared for the Administrative Law Discussion Forum held at the University of Luxembourg, July 1-2, 2015; published (with other papers) by Carolina Academic Press in Comparative Perspectives on Administrative Procedure Global Papers Series Volume III pp. 31-50 (Russell W. Weaver, et. al. eds 2017). Draft available at http://ssrn.com/abstract=2645036


Self-Driving Cars: On The Road To A New Regulatory Era, Brian A. Browne 2017 Case Western Reserve University School of Law

Self-Driving Cars: On The Road To A New Regulatory Era, Brian A. Browne

Journal of Law, Technology, & the Internet

"Self-driving cars shatter the schism between federal and state safety regulations for automobiles in the United States…. In Part I, this paper will define self-driving cars and their benefits, describe the imminent safety issues they present for regulatory agencies, and introduce the most commonly analyzed legal issues for self-driving cars. Part II will give background information on the United States regulates motor vehicles by first describing the federal government’s traditional role in regulating vehicle safety via NHTSA. Then, Part II will explain the preliminary actions NHTSA and several state governments have taken to preliminarily regulate self-driving cars. Part III will …


Executive Agreements Relying On Implied Statutory Authority: A Response To Bodansky And Spiro, David A. Wirth 2017 Vanderbilt University Law School

Executive Agreements Relying On Implied Statutory Authority: A Response To Bodansky And Spiro, David A. Wirth

Vanderbilt Journal of Transnational Law

Until recently, the law surrounding executive agreements has been a subject of attention from a relatively small number of academics concerned with foreign relations law, along with State Department lawyers who have a need to deploy the underlying concepts in concrete determinations. Then, with little advance warning, the Paris Agreement thrust legal doctrines surrounding executive agreements to center stage in public policy debates and in the popular press. President Donald Trump's campaign promise to "cancel" the Paris Agreement has drawn even more attention to the issue. Unfortunately, the result has been a great deal of confusion, often needlessly contributing to …


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