Law Commons^™

Modernizing The Emergency Medical Treatment And Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Katharine Van Tassel

This Article will propose a very simple, two-step way to modernize EMTALA [Emergency Medical Treatment and Active Labor Act (1986)] to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access.

This solution also works across systems to resolve the conflict between the tort, licensure and hospital peer review systems that all discourage evidence-based treatment …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Harmonizing The Affordable Care Act With The Three Main National Systems For Healthcare Quality Improvement: The Tort, Licensure, And Hospital Peer Review Hearing Systems, Katharine Van Tassel

Katharine Van Tassel

.. [W]hile the ACA [Affordable Care Act] has at least some provisions addressing the need to make changes in the medical malpractice and licensure systems to encourage the use of evidence-based standards of care, the ACA completely ignores the hospital peer review system. This article makes specific suggestions for how to revise all three major systems [the tort, licensure, and hospital peer review] so that they can work in tandem with federal law to encourage physicians to adopt [an] evidence-based model of medical practice in order to improve healthcare quality, cost, and access. This article starts by explaining the difference …

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Blacklisted: The Constitutionality Of The Federal System For Publishing Reports Of "Bad" Doctors In The National Practitioner Data Bank, Katharine Van Tassel

Katharine Van Tassel

In order to highlight the problems with the NPDB [National Practitioner Data Bank], this Article compares physician blacklisting with other forms of blacklisting. For example, both physician and sexual predator blacklisting programs have the same goals: allowing the public to engage in self-protection by preventing “predators” from traveling to new locations to prey on a new group of unsuspecting victims. And both sexual predators and physicians suffer similar stigmatization as the result of the “badge of infamy” that comes with being blacklisted. But this is where the similarities end. Accused sex offenders get all of the trappings of due process …

Using Clinical Practice Guidelines And Knowledge Translation Theory To Cure The Negative Impact Of The National Hospital Peer Review Hearing System On Healthcare Quality, Cost, And Access, Katharine Van Tassel

Katharine Van Tassel

This Article starts with a history of the growth of hospital peer review and then examines the merits of the rationales that motivated the passage of the Health Care Quality Improvement Act of 1986 ('HCQIA'), which catapulted peer review into the national system that exists today. The Article next explains how the peer review hearing process works and how HCQIA turns private hospitals into small, individual quasi-regulatory agencies. The Article goes on to critique the 'bad apples' approach taken by hospital peer review in light of the growing body of empirical research that supports a systems improvement approach to dealing …

Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel

Katharine Van Tassel

This Article proposes a solution to the problems associated with the current use of vague standards in peer review. This Article will examine the proposal that medical staffs switch from ad hoc judicial decision-making to rule-making. This switch will allow medical staffs to abandon the troublesome practice of applying vague 'standard of care' measures ex post facto. In its stead, express contractual terminology could be adopted, such as 'expectations of performance,' which incorporates specifically chosen and uniquely tailored clinical practice guidelines ('CPGs') directly into the medical staff by-laws. Describing the expectations of physician performance in express contractual terms enables physicians …

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 …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …