Health Law and Policy Commons^™

Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez

Faculty Journal Articles and Book Chapters

For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices. The FDA will experiment with shifting its scrutiny from the pre-market to the post-market phase, shifting the locus of regulation from products to firms, and shifting from centralized government review to decentralized …

A Black Box For Patient Safety?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Technology now makes it possible to record surgical procedures with striking granularity. And new methods of artificial intelligence (A.I.) and machine learning allow data from surgeries to be used to identify and predict errors. These technologies are now being deployed, on a research basis, in hospitals around the world, including in U.S. hospitals. This Article evaluates whether such recordings – and whether subsequent software analyses of such recordings – are discoverable and admissible in U.S. courts in medical malpractice actions. I then argue for reformulating traditional "information policy" to accommodate the use of these new technologies without losing sight of …

Big Waiver Under Statutory Sabotage, Elizabeth Mccuskey

Faculty Scholarship

The Affordable Care Act's State Innovation waiver allows federal agencies to suspend the most controversial parts of the statute for states to pursue alternative paths, while keeping the federal funding provided by the statute. This "big waiver" provision has the potential to enable states to pursue transformative health reforms, while preserving the affordability and universal coverage aims of the federal statute. Big waivers like this one carry theoretical promise, which largely depends on the strength of the federal statute's baseline infrastructure. This Essay considers early implementation of the State Innovation waiver as a test for big waiver theory - and …

Us Military Medical Ethics In The War On Terror, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Military medical ethics has been challenged by the post-11 September 2001 ‘War on Terror’. Two recurrent questions are whether military physicians are officers first or physicians first, and whether military physicians need a separate code of ethics. In this article, we focus on how the War on Terror has affected the way we have addressed these questions since 2001. Two examples frame this discussion: the use of military physicians to force-feed hunger strikers held in Guantanamo Bay prison camp, and the uncertain fate of the Department of Defense’s report on ‘Ethical Guidelines and Practices for US Military …

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Tamar F. Barlam, Jake R. Morgan, Warren A. Kaplan, Kevin Outterson, Stephen I. Pelton

Faculty Scholarship

We compared antibiotic prescribing for children with and those without an underlying chronic condition associated with increased risk for invasive pneumococcal disease. Children with a chronic condition had significantly greater cumulative exposure to antibiotics and higher rates of prescriptions per person-year than those without a chronic condition; this population is at increased risk for the emergence of multidrug-resistant pathogens.

The Global Preclinical Antibacterial Pipeline, Ursula Theuretzbacher, Kevin Outterson, Aleks Engel, Anders Karlén

Faculty Scholarship

Antibacterial resistance is a great concern and requires global action. A critical question is whether enough new antibacterial drugs are being discovered and developed. A review of the clinical antibacterial drug pipeline was recently published, but comprehensive information about the global preclinical pipeline is unavailable. This Review focuses on discovery and preclinical development projects and has found, as of 1 May 2019, 407 antibacterial projects from 314 institutions. The focus is on Gram-negative pathogens, particularly bacteria on the WHO priority bacteria list. The preclinical pipeline is characterized by high levels of diversity and interesting scientific concepts, with 135 projects on …

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

Freezing The Future: Elective Egg Freezing And The Limits Of The Medical Expense Deduction, Tessa R. Davis

Kentucky Law Journal

No abstract provided.

Regulate Physician Restrictive Covenants To Improve Healthcare, Judy Ann Clausen

Kentucky Law Journal

No abstract provided.

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Financial Impact Of The Opioid Crisis On Local Government: Quantifying Costs For Litigation And Policymaking, Elizabeth Weeks

Scholarly Works

The opioids epidemic has had a significant impact on individuals and communities, including local governments responsible for serving and protecting those affected individuals. This is the first study of its kind to consider whether those local government costs are quantifiable, a question that has salience both for pending opioid litigation in federal and state courts and for local planning and budgeting decisions. This article first provides a detailed description of the opioid litigation landscape, including the federal multidistrict litigation (MDL) in Ohio, the Native American tribes’ actions, and various procedural and other hurdles that local government plaintiffs face in seeking …

Teaching Tomorrow’S Lawyers Through A (Semi-) Generalist, (Mostly-) Individual Client Poverty Law Clinic: Reflections On Five Years Of The Community Health Law Partnership, Jason A. Cade

Scholarly Works

Design options when starting a live-client clinic from scratch can be somewhat overwhelming. Should the clinic focus on systemic impact or individual representation? Appellate work or hearings? Should the clinic specialize or cover multiple legal issues? Another set of issues concerns how the clinic should find and accept its clients, and whether students should have a role in the intake process. The list of choices goes on. In this Essay, written for the Georgia Law Review’s Online Issue celebrating 50 years of clinics at the University of Georgia School of Law, I describe how I have navigated these and other …

Healthism In Tort Law, Elizabeth Weeks

Scholarly Works

This article draws on the author's recently published book, Healthism: Health Status Discrimination and the Law (with Jessica L. Roberts) (Cambridge University Press 2018), examining tort law doctrine and policy for examples of differential treatment of health status or behaviors. Just as scholars previously have drawn attention to discrimination based on race, sex, age, and other protected categories in tort law, the article urges similar examination of tort law's potential to discriminate against the unhealthy. The article discusses the potential for healthism in the reasonably prudent person standard of care, contributory negligence, assumption of the risk, noneconomic damages caps, impaired …

Knowledge Of Practicing Physicians About Their Legal Obligations When Caring For Patients With Disability, Nicole Agaronnik, Elizabeth Pendo, Julie Ressalam, Eric G. Campbell, Lisa Iezzoni

All Faculty Scholarship

doi: 10.1377/hlthaff.2018.05060 HEALTH AFFAIRS 38, NO. 4 (2019): 545–553

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Permitted Incentives For Workplace Wellness Plans Under The Ada And Gina: The Regulatory Gap, Elizabeth Pendo

Articles

Although workplace wellness plans have been around for decades, they have flourished under the Patient Protection and Affordable Care Act (“PPACA”) into a $6 billion-dollar industry. Under PPACA, a “wellness plan” is a program of health promotion or disease prevention offered by an employer that is designed to promote health or prevent disease and which meets the other applicable requirements of that subsection. Employers look to these programs to promote healthy lifestyles, improve the overall health of employees and beneficiaries, and reduce rising healthcare costs.

PPACA’s amendments to the Health Insurance Portability and Accountability Act (“HIPAA”) permit employers to offer …

Contemporary Aspects Of Female Genital Mutilation Prohibitions In The United States, Limor Ezioni

American University Journal of Gender, Social Policy & the Law

No abstract provided.

The Challenges And Implications Of Fiscal Health, Bruce D. Mcdonald Iii

South Carolina Journal of International Law and Business

No abstract provided.

Investigating Potentially Unlawful Death Under International Law: The 2016 Minnesota Protocol, Christof Heyns, Stuart Casey-Maslen, Toby Fisher, Sarah Knuckey, Thomas Probert, Morris Tidball-Binz

The International Lawyer

No abstract provided.

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.