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Articles 1 - 9 of 9
Full-Text Articles in Consumer Protection Law
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
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 …
The Missing Link: U.S. Regulation Of Consumer Cosmetic Products To Protect Human Health And The Environment, Valerie J. Watnick
The Missing Link: U.S. Regulation Of Consumer Cosmetic Products To Protect Human Health And The Environment, Valerie J. Watnick
Pace Environmental Law Review
This article explores these lax regulatory efforts and their connection to risk assessment, and proposes changes to our current toxics regulatory paradigm. Part I of this article explores our current regulatory approach for consumer cosmetics. Part II discusses the specific and dire concerns regarding chemicals that are suspected carcinogens and those suspected of disrupting the human endocrine system. The article argues in Part III that because the framework for our current regulation of consumer cosmetic products is not designed to be protective of human health, our regulatory paradigm must shift dramatically in the future if this is to become our …
Selective Contracting In Prescription Drugs: The Benefits Of Pharmacy Networks, Joanna Shepherd
Selective Contracting In Prescription Drugs: The Benefits Of Pharmacy Networks, Joanna Shepherd
Faculty Articles
Selective contracting in health care involves contractual arrangements among insurers and health care providers that give covered individuals a financial incentive to obtain health care from a limited panel of providers. Although selective contracting has been an important strategy of health insurance plans for decades, it has only recently expanded to prescription drug coverage. Drug plans now create pharmacy networks that channel customers to in-network pharmacies. Pharmacies compete to be part of the networks by offering discounts on the drugs they sell to covered customers and drug plans. Although networks can lower prescription drug costs for drug plans and consumers, …
Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank A. Pasquale, Tara Adams Ragone
Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank A. Pasquale, Tara Adams Ragone
Faculty Scholarship
This Article examines how new technologies generate privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is …
Access To Health Care As An Incentive For Healthy Behavior, Lindsay Wiley
Access To Health Care As An Incentive For Healthy Behavior, Lindsay Wiley
Articles in Law Reviews & Other Academic Journals
Hundreds of thousands of lives have been saved by vehicle safety standards. For many years, the auto industry fought the adoption of even the most basic standards tooth and nail, arguing that driver responsibility was the key to preventing auto accidents. In doing so, vehicle manufacturers "reinforceled] certain common sense ideas about traffic safety"-that drivers were responsible for car accidents and that vehicle design could not do much to make serious crashes survivable-"and suppressled] others." Auto insurers-who bear much of the economic cost of car crashes through a combination of first party and liability insurance-initially joined auto manufacturers in pushing …
Enlightened Regulatory Capture, David Thaw
Enlightened Regulatory Capture, David Thaw
Articles
Regulatory capture generally evokes negative images of private interests exerting excessive influence on government action to advance their own agendas at the expense of the public interest. There are some cases, however, where this conventional wisdom is exactly backwards. This Article explores the first verifiable case, taken from healthcare cybersecurity, where regulatory capture enabled regulators to harness private expertise to advance exclusively public goals. Comparing this example to other attempts at harnessing industry expertise reveals a set of characteristics under which regulatory capture can be used in the public interest. These include: 1) legislatively-mandated adoption of recommendations by an advisory …
Sugary Drinks, Happy Meals, Social Norms, And The Law, Lindsay Wiley
Sugary Drinks, Happy Meals, Social Norms, And The Law, Lindsay Wiley
Articles in Law Reviews & Other Academic Journals
What role should government play in discouraging harmful overconsumption? What modes of government intervention best strike the balance between effectiveness and political acceptability? It is well established that government has a legitimate interest in protecting the health and safety of the people, even from their own choices and actions. Furthermore, there is no fundamental right to sell or purchase particular services or products in particular configurations. The appropriate question, then, is not what government may do to prevent non- communicable diseases that are associated with individual behavior choices, but rather what government should do. This comment on David Friedman's Public …
"¿Qué Información Hay Que Facilitar Al Consumidor Cuando Adquiere Productos Alimenticios Por Internet O Mediante Otros Sistemas De Comunicación A Distancia?", Luis González Vaqué
"¿Qué Información Hay Que Facilitar Al Consumidor Cuando Adquiere Productos Alimenticios Por Internet O Mediante Otros Sistemas De Comunicación A Distancia?", Luis González Vaqué
Luis González Vaqué
Para garantizar la información alimentaria, es necesario tener en cuenta todas las formas de suministrar alimentos a los consumidores, como la venta de alimentos mediante técnicas de comunicación a distancia. Es evidente que cualquier alimento suministrado a través de la venta a distancia debe cumplir los mismos requisitos de información que los alimentos vendidos en los comercios; por lo tanto, el art. 14 del Reglamento nº 1169/2011 establece la información alimentaria obligatoria pertinente en tales casos y que también debe estar disponible antes de realizar la compra.