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What Congress's Repeal Efforts Can Teach Us About Regulatory Reform, Cary Coglianese, Gabriel Scheffler 2017 University of Pennsylvania Law School

What Congress's Repeal Efforts Can Teach Us About Regulatory Reform, Cary Coglianese, Gabriel Scheffler

Faculty Scholarship

Major legislative actions during the early part of the 115th Congress have undermined the central argument for regulatory reform measures such as the REINS Act, a bill that would require congressional approval of all new major regulations. Proponents of the REINS Act argue that it would make the federal regulatory system more democratic by shifting responsibility for regulatory decisions away from unelected bureaucrats and toward the people’s representatives in Congress. But separate legislative actions in the opening of the 115th Congress only call this argument into question. Congress’s most significant initiatives during this period — its derailed attempts to ...


Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard 2017 Temple University

Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard

Cleveland State Law Review

Depression is a common sequela of head trauma. Approximately half of all individuals with a cranial injury will experience depression within the first year, regardless of the severity of the injury. The ailment is characterized clinically as a mood disorder, often associated with intense feelings of sadness. However, depression is more complex than mood disorders, as many mental and bodily complaints—such as insomnia, fatigue, anxiety, appetite changes, aches and pains, and lack of interest in previously enjoyable activities—are associated with depression. These intense feelings, particularly when combined with despair and hopelessness, can lead to suicide, a dreaded potential ...


Suffrage For People With Intellectual Disabilities And Mental Illness: Observations On A Civic Controversy, Charles Kopel 2017 New York University Law School

Suffrage For People With Intellectual Disabilities And Mental Illness: Observations On A Civic Controversy, Charles Kopel

Yale Journal of Health Policy, Law, and Ethics

Most electoral democracies, including forty-three states in the United States,
deny people the right to vote on the basis of intellectual disability or mental illness. Scholars in several fields have addressed these disenfranchisements, including legal scholars who analyze their validity under U.S. constitutional law and international-human-rights law, philosophers and political scientists who analyze their validity under democratic theory, and mental-health
researchers who analyze their relationship to scientific categories.


Regulatory Disruption And Arbitrage In Health-Care Data Protection, Nicolas P. Terry 2017 Indiana University Robert H. McKinney School of Law

Regulatory Disruption And Arbitrage In Health-Care Data Protection, Nicolas P. Terry

Yale Journal of Health Policy, Law, and Ethics

This article explains how the structure of U.S. health-care data protection
(specifically its sectoral and downstream properties) has led to a chronically uneven policy environment for different types of health-care data. It examines claims for health-care data protection exceptionalism and competing demands such as data liquidity. In conclusion, the article takes the position that health­ care-data exceptionalism remains a valid imperative and that even current concerns about data liquidity can be accommodated in an exceptional protective model. However, re-calibrating our protection of health-care data residing outside of the traditional health-care domain is challenging, currently even
politically impossible.


Revisiting Incentive-Based Contracts, Wendy Netter Epstein 2017 DePaul University College of Law

Revisiting Incentive-Based Contracts, Wendy Netter Epstein

Yale Journal of Health Policy, Law, and Ethics

Incentive-based pay is rational, intuitive, and popular. Agency theory tells us
that a principal seeking to align its incentives with an agent's should be able to simply pay the agent to achieve the principal's desired results. Indeed, this strategy has long been used across diverse industries-from executive compensation to education, professional sports to public service-but with mixed results. Now a new convert to incentive compensation has appeared on the
scene: the United States' behemoth health-care industry. In many ways, the incentive mismatch story is the same. Insurance companies and employers are concerned about constraining the cost of care ...


Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, And A Path Forward, Emily A. Largent, Holly Fernandez Lynch 2017 Harvard Law School

Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, And A Path Forward, Emily A. Largent, Holly Fernandez Lynch

Yale Journal of Health Policy, Law, and Ethics

The practice of offering payment to individuals in exchange for their
participation in clinical research is widespread and longstanding. Nevertheless, such payment remains the source of substantial debate, in particular about whether or the extent to which offers of payment coerce and/or unduly induce individuals to participate. Yet, the various laws, regulations, and ethical guidelines that govern the conduct of human subjects research offer
relatively little in the way of specific guidance regarding what makes a payment offer ethically acceptable-or not. Moreover, there is a lack of definitional agreement regarding what the terms coercion and undue inducement mean in ...


The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid 2017 University of Miami Law School

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common ...


Mental Health Crisis In Maryland: A Lack Of Hospital Beds For The Mentally Ill Presents Maryland Legislature With Concerns About The Legality And Practicality Of Detainment, Ryan D. Konstanzer 2017 Notre Dame Law School

Mental Health Crisis In Maryland: A Lack Of Hospital Beds For The Mentally Ill Presents Maryland Legislature With Concerns About The Legality And Practicality Of Detainment, Ryan D. Konstanzer

Journal of Legislation

No abstract provided.


The Constitutionality Of Restrictions On Recreational Cannabis Advertising: Balancing Public Health And Freedom Of Expression, Melanie L. McPhail 2017 The University of Western Ontairo

The Constitutionality Of Restrictions On Recreational Cannabis Advertising: Balancing Public Health And Freedom Of Expression, Melanie L. Mcphail

Electronic Thesis and Dissertation Repository

On April 20, 2016, Health Minister Jane Philpott announced that legislation legalizing recreational marijuana would be introduced in Spring 2017, with the goal of keeping marijuana out of the hands of children and profit out of the hands of criminals. Bill C-45, An Act Respecting Cannabis passed the second reading in the House of Commons, and contains restrictions on advertising cannabis, with a few exceptions. Advertising is recognized as a protected form of expression under the Charter of Rights and Freedoms, so if the government infringes on this right, they must be able to prove that it is justified in ...


Hiv And The Ada: What Is A Direct Threat?, Dawn-Marie Harmon 2017 University of Maine School of Law

Hiv And The Ada: What Is A Direct Threat?, Dawn-Marie Harmon

Maine Law Review

Anne, a surgical technician at a local hospital, recently learned that she was HIV-positive. She works in the emergency room and, as a part of her job, she hands surgical instruments to doctors performing emergency surgery. It is a fast paced and unpredictable environment. Her hands often come in contact with sharp instruments. Although Anne has never put her hands into a patient's body cavity, there is a remote possibility that she may need to do so in the future. There is always a possibility, however small, that she will cut herself and come into blood-to-blood contact with a ...


Regulating Black-Box Medicine, W. Nicholson Price II 2017 University of Michigan Law School

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 ...


Pipeline Trends - December 2017, Nicole M. Trask, Sage Bagwell 2017 University of Massachusetts Medical School

Pipeline Trends - December 2017, Nicole M. Trask, Sage Bagwell

Commonwealth Medicine Publications

Pipeline Trends is produced by UMass Medical School’s Clinical Pharmacy Services and is distributed annually. This edition provides a comprehensive overview of:

  • Promising New Agents
  • Projected Generic Entry
  • Investigational Indications
  • FDA Updates
  • Industry Trends


Public Health Law As Administrative Law: Example Lessons, Edward P. Richards 2017 Selected Works

Public Health Law As Administrative Law: Example Lessons, Edward P. Richards

Edward P. Richards

No abstract provided.


Reforming Prison Policy To Improve Women-Specific Health And Sanitary Care Conditions Of Prisons In Ethiopia, Behailu T. Weldeyohannes 2017 College of William & Mary Law School

Reforming Prison Policy To Improve Women-Specific Health And Sanitary Care Conditions Of Prisons In Ethiopia, Behailu T. Weldeyohannes

William & Mary Journal of Women and the Law

No abstract provided.


Healthcare And Its Impact On Nurses: The United States Vs. The United Kingdom, Alexandria Colovos 2017 Western Kentucky University

Healthcare And Its Impact On Nurses: The United States Vs. The United Kingdom, Alexandria Colovos

Honors College Capstone Experience/Thesis Projects

Currently, in the United States, the topic of healthcare reform is in the back of everyone’s mind. What will come of our healthcare system? Will the cost of healthcare decrease? Will patients have better access to care? With this Capstone Experience/Thesis, I wanted to explore the differences between the current healthcare system that we have in the United States, to the nearly seventy-year-old National Health Service (NHS) in the United Kingdom, which provides healthcare to all. The NHS is free at the point of care and is funded by taxation. To understand if such a system would work ...


Foro: Las Enfermedades Huérfanas Y La Eutanasia.®, Daniel Fernando Gómez Tamayo 2017 Selected Works

Foro: Las Enfermedades Huérfanas Y La Eutanasia.®, Daniel Fernando Gómez Tamayo

Daniel Fernando Gómez Tamayo. PhD

Foro: Las enfermedades huérfanas y la eutanasia: Es preocupante que los mayores casos reportados de contagio por vih/sida hayan ocurrido en Africa: que fue una colonia de los Ingleses, y peor aún que las víctimas hayan sido descendientes de la raza y la cultura africana; entonces , las preguntas para el ente investigador son: ¿el vih se puede considerar como  un arma biológica, o, es una bacteria eutanásica y asesina individual, o es un virus de destrucción masiva? ¿por que razón la prueba de diagnóstico del vih/sida se llama elisa? ¿cómo se explica la trasmisión del virus desde la ...


Catholic Health Care And The Diocesan Bishop, Rev. John J. Coughlin, O.F.M. 2017 St. John's University School of Law

Catholic Health Care And The Diocesan Bishop, Rev. John J. Coughlin, O.F.M.

The Catholic Lawyer

No abstract provided.


Employer-Mandated Vaccination Policies: Different Employers, New Vaccines, And Hidden Risks, Teri Dobbins Baxter 2017 University of Tennessee College of Law

Employer-Mandated Vaccination Policies: Different Employers, New Vaccines, And Hidden Risks, Teri Dobbins Baxter

Utah Law Review

Although debates about access to healthcare and healthcare financing have been in the headlines for years, attention has only sporadically focused on new and resurgent health challenges in the form of outbreaks of contagious diseases. One obvious weapon in the fight against outbreaks is vaccination. Many vaccines have been proven safe and highly effective, but vaccine opponents have been vocal and influential; even some who work in healthcare facilities distrust vaccines. The tension between employees who distrust vaccines and employers who want to encourage or require vaccination has led many healthcare policy and legal scholars to explore the legal and ...


Law Library Blog (November 2017): Legal Beagle's Blog Archive, Roger Williams University School of Law 2017 Roger Williams University

Law Library Blog (November 2017): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.


The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah 2017 University of Michigan Law School

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications and Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to ...


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