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Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin Jan 2021

Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin

Vanderbilt Law School Faculty Publications

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these ...


Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans Jan 2020

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself (DIY) genomic ...


The Waiting Game: How States Can Solve The Organ-Donation Crisis, Meredith M. Havekost Mar 2019

The Waiting Game: How States Can Solve The Organ-Donation Crisis, Meredith M. Havekost

Vanderbilt Law Review

Thousands of patients in the United States live in limbo every day waiting for a lifesaving organ transplant, and the gap between the number of people who need a transplant and the number of available organs widens every year. Every state currently allows individuals to unilaterally indicate their intent to donate their organs upon death, but in practice, family members are frequently allowed to override the express intentions of decedents. In addition, the current U.S. "opt-in" system fails to reach its full potential because many eligible decedents never express their desires to become or not to become organ donors ...


Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg Jan 2019

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of ...


Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa Mar 2018

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more ...


Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel Mar 2018

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is ...


Should Regulatory Compliance Be A Goal Or A Constraint For Health Care Companies? Finding Effective Methods To Assure Compliance With The Federal Anti-Kickback Statute And The False Claims Act, Roni A. Elias Jan 2017

Should Regulatory Compliance Be A Goal Or A Constraint For Health Care Companies? Finding Effective Methods To Assure Compliance With The Federal Anti-Kickback Statute And The False Claims Act, Roni A. Elias

Florida A & M University Law Review

The stereotypical conception of compliance is reinforced by some of the fundamental assumptions about what the primary objectives of a corporation should be and about how a corporation should accomplish those objectives. According to the prevailing theory of corporate structure, a corporation exists for the sole purpose of earning profits for its shareholders, and all of its actions are to be directed toward that end. If compliance with the law is not an inherently profit making activity, it is to be treated as a constraint on the corporation's efficient operation. According to this view, compliance will generally be considered ...


The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson Jan 2017

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval ...


Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra Jan 2016

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.


Informed Consent As Compelled Professional Speech: Fictions, Facts, And Open Questions, Nadia N. Sawicki Jan 2016

Informed Consent As Compelled Professional Speech: Fictions, Facts, And Open Questions, Nadia N. Sawicki

Washington University Journal of Law & Policy

This article explores the relationship between a physician’s First Amendment right to free speech and state informed consent mandates. Sawicki details the convoluted jurisprudence surrounding consent mandates, focusing on one-sided and controversial subject matter that many states require physicians to disclose. Sawicki then offers a legal framework for how a physician-challenged consent mandate may pass through the court system based on existing Supreme Court jurisprudence.


Adverse Events: The Need For The United States And Japan To Reform Patient Safety, Rocco Giovanni Motto Jan 2016

Adverse Events: The Need For The United States And Japan To Reform Patient Safety, Rocco Giovanni Motto

Washington University Global Studies Law Review

After the Institute of Medicine released a report in 1999 a startling discovery was apparent: between 44,000 and 98,000 hospital patients in the United States died in 1997 as a result of an adverse event. An adverse event is an unfavorable event that is caused by a medical product rather than the primary condition of the patient. In other words, an adverse event describes any harm to a patient as a result of medical care. A later study estimated that between 220,000 and 440,000 hospital patients in the United States suffer from some type of adverse ...


Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra Jan 2015

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.


For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley Oct 2014

For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley

University of Michigan Journal of Law Reform Caveat

This football season, millions of Americans enjoying their favorite pastime might feel pangs of a guilty conscience. Years of scientific research into the long-term neurological effects of tackle football and a recent settlement between the National Football League (NFL) and thousands of retired NFL players have made football-related traumatic brain injuries (TBI) a topic of national conversation. Current and former NFL players and even President Obama have participated in the conversation, saying that they would hesitate to let their sons play the game for fear of possible brain injury. Because research has uncovered signs of permanent brain damage in players ...


Hodgson V. Minnesota: Chipping Away At Roe V. Wade In The Aftermath Of Webster, Selina K. Hewitt Nov 2012

Hodgson V. Minnesota: Chipping Away At Roe V. Wade In The Aftermath Of Webster, Selina K. Hewitt

Pepperdine Law Review

No abstract provided.


Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr. Nov 2012

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.


The Policy Against Federal Funding For Abortions Extends Into The Realm Of Free Speech After Rust V. Sullivan, Loye M. Barton Nov 2012

The Policy Against Federal Funding For Abortions Extends Into The Realm Of Free Speech After Rust V. Sullivan, Loye M. Barton

Pepperdine Law Review

No abstract provided.


The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano Oct 2012

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.


Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert Jan 2011

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners and policy-makers ...


Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez Jan 2011

Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the ...


The Money Blind: How To Stop Industry Bias In Biomedical Science, Without Violating The First Amendment, Christopher Robertson Jan 2011

The Money Blind: How To Stop Industry Bias In Biomedical Science, Without Violating The First Amendment, Christopher Robertson

Faculty Scholarship

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical ...


A Complete Property Right Amendment, John H. Ryskamp Oct 2006

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.


Drugged, Carl E. Schneider Jul 2006

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with ...


Dimensions Of Equality In Regulating Assisted Reproductive Technologies, Mary Crossley Jan 2005

Dimensions Of Equality In Regulating Assisted Reproductive Technologies, Mary Crossley

Articles

Although concerns about individual liberty and the nature and extent of reproductive freedom have tended to dominate discussions regarding the proliferation of and access to reproductive technologies, questions about the implications of assisted reproductive technologies (ARTs) for equality have also arisen. Despite the high number of invocations of equality in the literature regarding ARTs, to date little effort has been made to comprehensively examine the implications of ARTs for equality. This short Article seeks to highlight the variety of equality issues that ARTs present and to develop a framework for classifying different types of equality issues. Specifically, I suggest that ...


Internet Pharmacies: Why State Regulatory Solutions Are Not Enough, Linda C. Fentiman Oct 2004

Internet Pharmacies: Why State Regulatory Solutions Are Not Enough, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

Internet pharmacies are an economic and communications miracle--and a regulatory nightmare. It is estimated that Americans spent some $3.2 billion in 2003 on medications from the Internet, but Internet pharmacies permit consumers to evade long-standing regulatory protections, particularly those that rely on the oversight of drug prescribing and dispensing by licensed physicians and pharmacists.


Bioethics With A Human Face, Carl E. Schneider Oct 1994

Bioethics With A Human Face, Carl E. Schneider

Articles

This Article and the successor article I will shortly publish grow out of one reaction I have had to years of reading bioethical and legal literature. Let me begin by putting the point in its simplest, even crudest, form: That literature too often discusses the problems of health care in so disembodied and denatured a way that the patients and physicians, the family and friends, the dread and the disease are quite abstracted from the scene. The result is a literature that critically limits itself and that crucially oversimplifies the issues it confronts. There are, of course, reasons bioethical and ...


Governmental Regulation Of The Drug Industry, J. Mark Hiebert Jan 1970

Governmental Regulation Of The Drug Industry, J. Mark Hiebert

Cleveland State Law Review

In today's world of increased government participation in business, certain industries are frequently spotlighted for particular attention. The communications industry is one, the drug industry is another. In both cases the special attention is fitting, for the communications industry, like the drug industry, each in its own way, reaches the very fiber of American life. Each has the inherent capability of changing our political and social order. At any rate two points are basic: first, the drug industry directly affects the foundations of our society and therefore is a reasonable concern of government. Secondly, the drug industry has a ...


Characteristics And Constitutionality Of Medical Legislation, Harry B. Hutchins Jan 1909

Characteristics And Constitutionality Of Medical Legislation, Harry B. Hutchins

Articles

Right to practice medicine regulated by statute.--In the absence of a statute upon the subject, any person is at liberty to practice medicine or surgery or both. This is the common law. And yet in the absence of a statute the physician necessarily assumes certain responsibilities that grow out of his relation to those whom he treats. He is bound to bring to the discharge of his duties the learning, skill and diligence usually possessed and exercised by physicians similarly situated. In other words, while in the absence of statutory regulation, the door of the profession is open to ...