Health Law and Policy Commons^™

Designing Development Programs For Non-Traditional Antibacterial Agents, John H. Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan J. Darrow, Kevin Outterson

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits …

Medical Board Of California, Mason Bettencourt, Betsy Gopinath

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Heather Morse, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, John Lacrosse, John Mysliwiec, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Dental Board Of California, Helene E. Mayer, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

The Kids Are Not Alright: Leveraging Existing Health Law To Attack The Opioid Crisis Upstream, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The opioid crisis is now a nationwide epidemic, ravaging both rural and urban communities. The public health and economic consequences are staggering; recent estimates suggest the epidemic has contracted the U.S. labor market by over one million jobs and cost the nation billions of dollars. To tackle the crisis, scholars and health policy initiatives have focused primarily on downstream solutions designed to help those who are already in the throes of addiction. For example, the major initiative announced by the U.S. Surgeon General promotes the dissemination of naloxone, which helps save lives during opioid overdoses.

This Article argues that the …

Due Process Supreme Court Appellate Division Second Department

Touro Law Review

No abstract provided.

Due Process Supreme Court Appellate Division

Touro Law Review

No abstract provided.

Off With Their Heads! How China's Controversial Human Head-Transplant Procedure Exceeds The Parameters Of International Ethical Standards In Human Experimentation, Deena Agamy

Georgia Journal of International & Comparative Law

No abstract provided.

Tacos, Tequila, And Tainted Alcohol? An Examination Of The Tainted Alcohol Problem In Mexico And What It Means For The American Tourist, Tammy Le

Georgia Journal of International & Comparative Law

No abstract provided.

Drowsy Driving Considerations In Non-Commercial Drivers For The Sleep Physician, Ann Marie Marciarille, Anand Bhat, David Ingram, Damien Stevens

Faculty Works

The sleep physician faces many challenges in the assessment of drowsy driving. The following article reviews current clinical evaluation methods and legal considerations at the state level in the United States.

Preparing Physicians To Contend With The Problem Of Dual Loyalty, Holly G. Atkinson

Publications and Research

Dual loyalty is defined as, particularly as it pertains to the field of medicine, a conflict or potential conflict between a healthcare professional’s simul- taneous obligations–expressed or implied–to a patient and to a third party. Dual loyalty situations often compromise physicians’ ethical behavior, lead- ing them to participate, either knowingly or unknowingly, in human rights violations perpetrated by a third party, often the state. Classic dual loyalty situations include the participation of physicians in state-sanctioned torture or the death penalty. However, there are a number of other dual loyalty scenarios that arise routinely in clinical practice in both closed institutions …

Emtala & Psychiatric Patients, Alexander Martell

DePaul Journal of Health Care Law

No abstract provided.

The Enigma Of Home Health Care: Initiatives To Combat Endemic Fraud And Improve Quality Care, Alec Deborin

DePaul Journal of Health Care Law

No abstract provided.

Conflict Of Interest In The Pharmaceutical Sector: A Guide For Public Management, Marc A. Rodwin

DePaul Journal of Health Care Law

No abstract provided.

Expanding Medication Assisted Treatment Is Not The Answer: Flaws In The Substance Abuse Treatment Paradigm, Katherine Drabiak

DePaul Journal of Health Care Law

No abstract provided.

A Systems Thinking Approach To Health Care Reform In The United States, Peter G. Gulick Jr

DePaul Journal of Health Care Law

No abstract provided.

Canada's Assisted Human Reproduction Act: Pragmatic Reforms In Support Of Research, Tania M. Bubela, Erika Kleiderman, Zubin Master, Ubaka Ogbogu, Vardit Ravitsky, Amy Zarzeczny, Bartha Maria Knoppers

Office of the Provost

Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints …

The Two Most Important Questions For Ethical Public Health, John Coggon, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health ethics is a distinct and established field, and it is important that its approaches and rationales are understood widely in the public health community. Such understanding includes the capacity to identify and combine principled and practical concerns in public health. In this paper, we present a background to the ideas that motivate public health ethics as a field of research and practice, and rationalize these through a critical ethico-legal approach to analysis. Two essential points of inquiry are identified and formulated to allow philosophical and practical agendas regarding public health to be combined. These come through asking the …

Mid-Atlantic Ethics Committee Newsletter, Summer 2019

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Newsletter, Summer 2019

Newsletter

No abstract provided.

Moving Beyond Medical Debt, Brook E. Gotberg, Michael D. Sousa

Faculty Publications

In recent years it has become clear that medical costs are imposing severe financial burdens on American families, sometimes to the point that bankruptcy becomes the only escape from crippling debt. When evaluating the well-established connection between outstanding medical debt and consumer bankruptcy, most existing empirical studies attempt to quantify the percentage of consumer bankruptcies that are "caused" by unmanageable medical indebtedness. This Article addresses what we believe to be a more significant line of empirical inquiry, namely, the connection between health insurance coverage and consumer bankruptcy as a more precise measurement of how national health insurance programs may or …

The Regulation Of Complementary And Alternative Medicine (Cam) In South Carolina, What Is Happening And What Needs To Change, Anna C. Smith

South Carolina Law Review

No abstract provided.

Pharmaceutical Industry Funding To Patient-Advocacy Organization: A Cross-National Comparison Of Disclosure Codes And Regulation, Laura Karas, Robin Feldman, Bai Ge, So Yeon Kang, Gerard F. Anderson

Articles

Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industry. Congressional investigations, academic publications, and news articles have endeavored to reveal the extent of drug and device industry influence on health care actors. In response, several nations, including the United States, have passed legislation mandating disclosure of drug company payments to physicians. In the United States, …

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous; …

J Mich Dent Assoc July 2019

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA’s 6,200+ members across the state. No publication reaches more Michigan dentists! This month's issue presents the 2019 MDA Award winners, outgoing MDA president Dr. Deb Peters' presidential address, and the 2019 MDA Annual Session in words and photos.

Pertanggungjawaban Hukum Pidana Terhadap Pelanggaran Rahasia Medis, Ridwan -

Jurnal Hukum & Pembangunan

Medical secrets are the patient's rights. This medical secret is a moral obligation based on moral norms derived from Hippocrates' oath. This secret is also known in various professions including advocates, religious scholars and priests, notaries and so on, but the medical profession is the oldest profession that is obliged to keep medical secrets. Maintaining the secret of medicine is an obligation for the medical profession in carrying out its duties and practices as a respect for human dignity. Medical secrets are regulated in international law, especially the law on human rights, Declaration of Human Rights and the 1945 Indonesian …

A Public Health Approach To Gun Violence, Legally Speaking, Michael Ulrich

Faculty Scholarship

The call for a public health approach to gun violence has largely ignored what role the nascent Second Amendment jurisprudence will play in hindering change. Given the state interest for infringing on Second Amendment rights is nearly always public safety, public health law doctrine provides an apt framework for analysis.

From Fitbits To Pacemakers: Protecting Consumer Privacy And Security In The Healthtech Age, Justin Evans, Katelyn Ringrose

Et Cetera

As wearable and analytics technology continues to be aggressively adopted, there is a congruent rise in data collection from wearable healthtech devices. This unprecedented rise in data collection poses massive privacy and security issues. This note addresses the benefits of IoT healthcare wearables and implants, as well as identifies where the privacy and security of data accrued by such devices could be improved. In an effort to better encapsulate the issue surrounding wearable device data collection, the authors analyze the many benefits of wearable healthcare devices, as well as look into the false sense of trust consumers have in the …