Journal of law and health最新文献

An ethical advancement of scientific knowledge demands a delicate equilibrium between benefits and harms, in particular in health-related research. When applying and advancing scientific knowledge or technologies, Article 4 of UNESCO's Universal Declaration on Bioethics and Human Rights, ethically justifiable research requires maximizing direct and indirect benefits and minimizing possible harms. The National Institution of Health [NIH] Data Sharing Policy and Implementation Guidance similarly states that data necessary for drawing valid conclusions and advancing medical research should be made as widely and freely available as possible (in order to share the benefits) while safeguarding the privacy of participants from potentially harmful disclosure of sensitive information. This paper discusses the challenges in the maximization of research benefit and the minimization of potential harms in the unique context of health-related research in Big Data from multiple sources, which are differently protected by the law. Part I frames the ethical dilemma by discussing potential benefits and harms, showing the constant misalignment in health-related research in Big Data from multiple sources, between the benefits in the use of confidential information for scientific purposes and the value in keeping confidentiality. Part II addresses existing regulations, including their nature and legal coverage. It highlights the prevailing challenges when combining data from multiple sources that are differently protected by the law. Part III compares different requirements for consent or authorization to use persons' health information for research. It focuses on the difficulty of existing regulation to ensure those requirements when using multiple sources of data. Part IV investigates whether exemptions from the authorization requirement could prevail in the context of information that exceeds the protection of HIPAA and the Protection of Human Subjects Regulations. In Part V the paper proposes a solution of a statistical nature, using the method of synthetic data to balance conflicting considerations. Part VI shows how the use of synthetic data can overcome some of the ethical challenges.

This Note analyzes the flaws in the NCAA's current accidental injury health coverage policies for student-athletes and suggests ways to remedy the issues that plague student-athletes incurring serious injuries that may not be covered under current policies. Part I of this Note outlines the history of the NCAA and the policies relevant to the issues with accidental injury coverage currently in place. Part II looks at the significance of these coverage gaps in today's world of modern medicine and technology as well as the impact they have on the everyday life of college athletes. Part III suggests solutions to bridge the gaps in accidental injury coverage for the physical and financial futures of these student-athletes.

This article evaluates two proposals that the Organs Directive along with the commission's Action Plan 2009-2015 can be viewed as a form of hybrid governance. The Organs Directive is the first legally-binding supranational risk regulation devised in the field of organ donation and transplantation. The Directive is modelled on the earlier Directive dealing with blood, tissue, and cells. The Action Plan, which is soft law, will complement the Directive. The Directive and Action Plan requires additional administration procedures from the Member States with the EU Commission regularly monitoring the implementation of the work programme to ensure it is manageable for them. Before probing the Directive, the Impact Assessment (IA) undertaken by the EU Commission on organ donations, which is used to determine the rationale behind the adoption of the stringent Directive with the Action Plan, will be examined. The social, economic, and health impacts of the four regulatory options available to the Commission will be considered. The Directive and the Action Plan, which are finally adopted, will be discussed in detail, before the arguments are placed highlighting the fact that the Directive and Action Plan display a mode of hybrid governance. Next, the advantages and disadvantages of hybrid governance are laid out and conclusions are drawn as to whether the hybrid model was the best form of action in EU healthcare. In the conclusion, the article proposes the emergence of an "integrated model" within the Organs Directive, which is based on the fusion of the three governance structures: the OMC, comitology, and agencies.

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify the issue are explained. Part II then explores more details about the problem of heroin use--explaining what the drug is, what an overdose looks like, and how fentanyl-laced heroin is contributing to the problem. Similar to the pain medication description, there is a discussion on steps the government has taken thus far to combat the opiate issue. Finally, Part II introduces a United States Supreme Court case, National Federation of Independent Business v. Sebelius. In Part III, there is an in-depth analysis of why the state government solutions for dealing with the opioid epidemic have not worked thus far. This Note argues that, because even the strides that states like Ohio have taken have not solved the problem, Congress should mandate that all rehabilitation facilities accept health insurance and that all health insurance companies cover the cost of rehabilitation for opiate and opioid addiction. Analysis of the Commerce Clause, the Necessary and Proper Clause, and the Taxing Clause show that Congress has the authority to make such demands.

Through our work in youth advocacy as, respectively, legal and public health professionals, we are all too aware of the high levels of health care fragmentation experienced during pregnancy and postpartum by poor, young mothers of color. Meredith Matone's research highlights the heightened risk of fragmentation for girls with histories of child welfare involvement. For example, she found that 66.7% of young mothers who had resided in out-of-home placements and who had taken antipsychotic medication prior to becoming pregnant failed to fill prescriptions for antipsychotics in their first postpartum year. Put another way, two-thirds of these vulnerable young mothers--a far higher proportion than young mothers without histories of child welfare involvement--were not getting the treatment that they needed to care for themselves and their children. The very real consequences of this phenomenon can be seen in the experiences of Jesse Krohn's clients, several of whom have their stories told here. Treatment discontinuity, particularly during the transition to parenthood, places mothers at risk for poor health outcomes and maladaptive parenting approaches; threatens the health and safety of infants; and triggers child welfare involvement. This article explores the negative consequences and root causes of treatment discontinuity, as well as particularized population vulnerabilities for treatment discontinuity including, as noted, involvement with child welfare. It will also provide public health and child welfare policy solutions for reducing treatment discontinuity and improving mental and physical health outcomes for new mothers and infants. The population of mothers at highest risk for postpartum treatment gaps is not small: more than 40% of Medicaid-financed births to young women aged 15 to 24 occurred in mothers who had a childhood relationship to the child welfare system. It is unacceptable to be aware of the pervasiveness of this problem, particularly among intersectionally vulnerable women, and not deploy a targeted and evidence-based preventative and remedial response.

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan's proposal includes both measures. Taiwan's patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The scope of patentees who may benefit from the mechanism is larger than what is required. In addition, the system requires a generic drug company to notify the patentee at the time of filing the drug application if the generic drug company asserts invalidity or non-infringement which the generic drug company must prove. Furthermore, the health authority is allowed to stay the issuance of a generic drug permit while the patentee is suing the generic drug company in the court.

The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont's Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National Standard with the requirements of Vermont's Act 120 and concludes that Vermont's labeling law offered a better safeguard for consumer sovereignty because it included a larger range of products and required a label that immediately relayed disclosures to consumers.

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science's potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs--Recombinant DNA, in vitro fertilization, Cloning, Stem Cells--to better analyze how Congress is, and should, regulate this exciting and promising science.

The 2014 Toledo, Ohio tap water ban has, at least temporarily, put a spotlight on United States water supplies. Consequently, many Americans have begun to take a closer look at the quality of the fresh water bodies being used to supply tap water to their homes. Therefore, this Note analyzes the problems currently threatening the lakes, rivers, and other surface waters that are the source of fresh drinking water for huge populations in the United States. Part II examines the problem of nutrient pollution and explains the harmful effects it has on human health. Part III provides an overview of the current laws governing nutrient pollution and tap water quality. Part IV analyzes the source of the problem and demonstrates that agriculture is largely responsible. Lastly, Part V suggests that the problem of nutrient pollution can be resolved through a reinterpretation of the Clean Water Act's definition of a point source.