Health Law Commons^™

A "Common" Proposal, Stacey A. Tovino

Scholarly Works

The Federal Policy for the Protection of Human Subjects (the “Common Rule”) is codified in separate regulations by seventeen federal departments and agencies, including the Department of Health and Human Services (HHS). HHS’s version of the Common Rule currently contains a basic policy for the protection of all human subjects, codified at Subpart A of the Common Rule, as well as special provisions governing human subjects research involving three sets of vulnerable populations, including pregnant women, fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D). This Article proposes that HHS amend the Common Rule to add ...

Gone Too Far: Federal Regulation Of Health Care Attorneys, Stacey A. Tovino

Scholarly Works

Outside health care counsel frequently obtain medical records, billing records, health insurance claims records, and other records containing individually identifiable health information in the course of representing health industry clients in medical malpractice, licensure, certification, accreditation, fraud and abuse, peer review, and other civil, criminal, and administrative health law matters. This Article is the first to argue that state rules of professional conduct, not federal health information confidentiality regulations, should govern outside health care counsel’s use and disclosure of confidential client information, and that outside counsel should be excepted from direct federal regulation under the HIPAA Privacy Rule.

Conflicts Of Interest In Medicine, Research, And Law: A Comparison, Stacey A. Tovino

Scholarly Works

Several of the remarks and articles presented in this symposium have addressed conflicts of interest arising during the provision of legal counsel to individuals who are elderly, including specific conflicts of interest implicated by estate planning, retirement planning, and long-term care planning. Topics examined thus far include conflicts of interest with respect to the application of rules of confidentiality within state rules of professional conduct to elderly clients with impaired decision-making capacity; conflicts of interest involving representative payees for Social Security benefits; conflicts of interest in distributions when parents enter into marriages that are unprotected by law; and conflicts of ...

Bedside Bureaucrats: Why Medicare Reform Hasn't Worked, Nicholas Bagley

Articles

Notwithstanding its obvious importance, Medicare is almost invisible in the legal literature. Part of the reason is that administrative law scholars typically train their attention on the sources of external control over agencies’ exercise of the vast discretion that Congress so often delegates to them. Medicare’s administrators, however, wield considerably less policy discretion than the agencies that feature prominently in the legal commentary. Traditional administrative law thus yields slim insight into Medicare’s operation. But questions about external control do not—or at least they should not—exhaust the field. An old and often disregarded tradition in administrative law ...

Compliance In The Ether: Cloud Computing, Data Security And Business Regulation, J. Nicholas Hoover

Journal of Business & Technology Law

No abstract provided.

Dependence On Cyberscribes - Issues In E-Security, Thomas R. Mclean, Alexander B. Mclean

Journal of Business & Technology Law

No abstract provided.

Disability Insurance In California, Jan Mark Dudman

Pepperdine Law Review

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Ryan G. Vacca

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three ...

Whose Pregnancy Is It Anyway? The Intrusion Of Abortion-Related Informed Consent Laws And Compelled Medical Treatment On The Doctor-Pregnant Patient Relationship, Jennifer Jascoll

Student Scholarship

No abstract provided.

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to ...

Family And Medical Leave Act Of 1993 - A Practical Analysis, Gerald L. Maatman Jr., Andrew J. Boling

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to ...

Equality Standards For Health Insurance Coverage: Will The Mental Health Parity And Addiction Equity Act End The Discrimination?, Ellen Weber

Golden Gate University Law Review

Congress enacted the Mental Health Parity and Addiction Equity Act in 2008 to end discriminatory health insurance coverage for persons with mental health and substance use disorders in large employer health plans. Adopting a comprehensive regulatory approach akin to that of other civil rights laws, the Parity Act requires “equity” in all plan features, including cost-sharing, durational limits and, most critically, the plan management practices that are used to deny many families medically necessary behavioral health care. Beginning in 2014, all health plans regulated by the Affordable Care Act must also comply with parity standards, effectively ending the second-class insurance ...

Workers Compensation: Presenting Medical Evidence In Heart Cases, Gerald J. Haas, Lowell A. Reed Jr, Irvin Stander

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

The Case Of Baby Andrew, Peter Singer, Helga Kuhse

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

The Devil (And Drugs) In The Details: Portugal's Focus On Public Health As A Model For Decriminalization Of Drugs In Mexico, Kellen Russoniello

Yale Journal of Health Policy, Law, and Ethics

It is a crisp morning in November of 2000, on the outskirts of the capital city. A man sits on the side of the road with a needle in his hand. Several individuals nearby make their home on the street. Some lay unconscious on the cold ground, some prepare to inject themselves with drugs, and still others wait for the droves of customers to pour into the area for their supply. It is an area characterized by rampant drug use, crime, and disease. Many of the people wandering these streets are infected with HIV, hepatitis, or tuberculosis. Rundown shacks and ...

Tipping The Scale: A Place For Childhood Obesity In The Evolving Legal Framework Of Child Abuse And Neglect, Shauneen M. Garrahan, Andrew W. Eichner

Yale Journal of Health Policy, Law, and Ethics

In 2009, a South Carolina mother named Jerri Gray was charged with criminally neglecting her fourteen-year-old son, Alexander Draper. The State removed her son from her custody and placed him in foster care. Even as of August 2011, two years later, Gray's charges were still pending and Draper remained with his aunt.

It is a well-known and sobering reality that child protective systems across the United States often must separate children from their abusive or neglectful parents in order to protect them from the harm inevitably caused by this type of home environment. Yet, in Ms. Gray's case ...

The Right To Be Fat, Yofi Tirosh

Yale Journal of Health Policy, Law, and Ethics

Why say "Inside every fat person there is a thin person waiting to get out." For me, it's more like "Inside every fat person there is an even fatter person waiting get out."'

In its now famous paragraph from Planned Parenthood of Southeastern Pennsylvania v. Casey, the Supreme Court tried to delineate the scope of liberty that the Constitution guarantees:

Our law affords constitutional protection to personal decisions relating to marriage, procreation, contraception, family relationships, child rearing, and education. . . . These matters, involving the most intimate and personal choices a person may make in a lifetime, choices central to personal ...

Pliva V. Mensing: Generic Consumers' Unfortunate Hand, Stacy B. Lee

Yale Journal of Health Policy, Law, and Ethics

The United States Supreme Court held in PLIVA v. Mensing that federal preemption immunizes generic drug manufacturers from liability for state law failure-to-warn claims. As a result, consumers harmed by a mislabeled generic drug will be unable to bring actions against generic manufacturers under state law. The Court confessed that the resulting federal drug-labeling scheme dealt consumers an "unfortunate hand." By removing generic manufacturers' duty to improve the adequacy of their products' warning labels, the Supreme Court calls into question the safety of generic drugs.

This Article explores the unfortunate hand that PLIVA dealt generic drug consumers and proposes a ...

Administrative Remedies In The Field Of Toxic Torts, Janet L. Heller

Journal of the National Association of Administrative Law Judiciary

No abstract provided.