Health Law and Policy Commons^™

The Scramble To Promote Egg Donation Through A More Protective Regulatory Regime, Jacob Radecki

Chicago-Kent Law Review

Egg “donation” is a burgeoning industry in the United States. Fertility clinics capitalize on financially needy college students by advertising substantial financial benefits; particularly gifted women may receive thousands of dollars for selling their eggs. Rosy advertisements portray a well-paying procedure that also helps bring a child to a loving parent. Yet these descriptions mask significant potential harms. With respect to known problems, hormone regimens may cause ovarian hyper-stimulation syndrome, which in the most severe cases can lead to infertility. In terms of unknown risks, anecdotal evidence suggests that the long-term side effects of egg extraction may include cancer. The …

‘The Greatest Wealth Is Health’: Patient Protected Health Information In The Hands Of Hackers, 31 J. Marshall J. Info. Tech. & Privacy L. 657 (2015), Samantha Singer

UIC John Marshall Journal of Information Technology & Privacy Law

This comment will analyze the specific requirements and stages that EPs/EHs must comply with in order to receive its Medicare and Medicaid incentives, how EHR technologies are being implemented, how EHR technologies are affecting patients' privacy with regard to hacking a patient‟s PHI, and what EHR technology vendors and EPs/EHs should be doing to improve patient privacy and security to prevent hacking and other breaches.

Part I of this comment will address hacking of PHI. Part II will analyze the security measures that EHR vendors must currently incorporate into EHR technology and how the lack of required security measures impacts …

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

The Fda And The Rise Of The Empowered Patient, Lewis Grossman

Contributions to Books

No abstract provided.

Panel 3: Chronic Pain, Psychogenic Pain, And Emotion, Robert Dinerstein

Scholarly Articles in Law Reviews & Journals

No abstract provided.

"Do No Harm": A Comparative Analysis Of Legal Barriers To Corporate Clinical Telemedicine Providers In The United States, Australia, And Canada, Ian R. Landgreen

Georgia Journal of International & Comparative Law

No abstract provided.

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

Ironic Simplicity: Why Shaken Baby Syndrome Misdiagnoses Should Result In Automatic Reimbursement For The Wrongly Accused, Jay Simmons

Seattle University Law Review

Shaken baby syndrome (SBS)’s shortcomings include the debatable science behind SBS theory and diagnosis—the questioning of which has grown more vociferous—and the arguably biased, discriminatory treatment of the accused. Professor Deborah Tuerkheimer notes that the evolving SBS skepticism and contentious debate has resulted in "chaos" in many SBS adjudications and within the medical and biomechanical fields, with the same SBS proponents and opponents continually crusading for and clashing over their beliefs. The issues surrounding the medical and biomechanical components of SBS diagnoses have been repeatedly examined and discussed, and are not the focus of this Note. This Note recounts those …

Who's Virus Is It Anyway? How The World Health Organization Can Protect Against Claims Of "Viral Sovereignty", Jason Carter

Georgia Journal of International & Comparative Law

No abstract provided.

Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii

IP Theory

The manufacturing side of the pharmaceutical industry has been neglected in innovation theory and policy, with the unfortunate result of stagnant manufacturing techniques driving major problems for the healthcare system. This innovation failure has roots in ineffective intellectual property incentives and high regulatory hurdles to innovative change. Changes in pure regulation or intellectual property incentives have significant potential to help the innovation deficit, but are not the only possibility for change. A relatively minor regulatory change could harness the powerful dynamics of pioneer/generic competition surrounding generic drug market entry. If pioneer firms were permitted to make label claims committing to …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Addressing The Ethical Challenges In Genetic Testing And Sequencing Of Children, Ellen Wright Clayton, Laurence B. Mccullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf

Vanderbilt Law School Faculty Publications

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recom-mendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium’s PediatricsWorking Group compared these recommendations, focusing on operational and ethical issues specific to decision making forchildren. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locusof decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict or come to different butcompatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways.AAP/ACMG analyzes risks and benefits …

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

No abstract provided.

Uncle Sam Knows What’S In Your Medicine Cabinet: The Security And Privacy Protection Of Health Records Under The Hitech Act, 30 J. Marshall J. Info. Tech. & Privacy L. 667 (2014), Ranjit Janardhanan

UIC John Marshall Journal of Information Technology & Privacy Law

No abstract provided.

Using Egg Freezing To Extend The Biological Clock: Fertility Insurance Or False Hope?, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen

UIC Review of Intellectual Property Law

This paper examines public health law in the context of prospect theory, the leading behavioral account of risk aversion and risk-seeking. The paper first demonstrates how international environmental law can be mapped along prospect theory’s risk-seeking axis. It then completes this picture of prospect theory by examining National Federation of Independent Business v. Sebelius, which upheld the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Although Sebelius upheld the PPACA as an exercise of the federal government’s taxing authority, it reasoned that a directive aimed at uninsured individuals to buy health insurance lay beyond the power of Congress …

A Scientific Approach To Intellectual Property And Health: Innovation, Access, And A Forgotten Corner Of The Universal Declaration Of Human Rights, 13 J. Marshall Rev. Intell. Prop. L. 794 (2014), Adam Houston

UIC Review of Intellectual Property Law

For years, there has been vigorous debate over the relationship between intellectual property and health, especially in the context of pharmaceutical patents. Despite numerous attempts to strike a balance between innovation and access, however, few have looked to Article 27 of the Universal Declaration of Human Rights for guidance. Article 27, and its further elaboration and codification under Article 15 of the International Covenant on Economic, Social, and Cultural Rights, explicitly address this balance by pairing the right of everyone “to share in scientific advancement and its benefits” with a similarly universal right of authors to “material interests resulting” from …

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

All Faculty Scholarship

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

The Battle Over The Embryo: How West Virginia Should Legally Define The Embryo And Regulate Embryo Adoption, Alyssa Lechmanik

West Virginia Law Review

No abstract provided.

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

All Faculty Scholarship

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

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

Journal of Business & Technology Law

No abstract provided.

Parent In Life, Stranger At Law: Addressing The Inequality And Inconsistency Of Parentage Rights Of Same-Sex Parents, 46 J. Marshall L. Rev. 867 (2013), Paul Coogan

UIC Law Review

No abstract provided.

Applying Bioethics In The 21st Century: Principlism Or Situationism?, George P. Smith Ii

Scholarly Articles

After an examination of the four cardinal bioethical principles which define Principlism — autonomy, beneficence, non maleficence and justice — an explication of Joseph Fletcher’s theory of Situationism is undertaken.

The conclusion of this Article is that when an ethical dilemma arises and is “tested” as to its moral efficacy, rather than judge the acts in question in order to determine whether they are in conformance with one of the four bioethical principles, it is more humane and practical to determine the ethical propriety of questioned conduct by use of a situation ethic which in fact is more sensitive. This …

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

Journal of Business & Technology Law

No abstract provided.

The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely

Other Publications

The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?

The Mobile Health Revolution?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.

This Article evaluates mobile health and its many ambitions. …

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

Pepperdine Law Review

No abstract provided.

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.