Although death by neurologic criteria (brain death) is legally recognized throughout the United States, state laws and clinical practice vary concerning three key issues: (1) the medical standards used to determine death by neurologic criteria, (2) management of family objections before determination of death by neurologic criteria, and (3) management of religious objections to declaration of death by neurologic criteria. The American Academy of Neurology and other medical stakeholder organizations involved in the determination of death by neurologic criteria have undertaken concerted action to address variation in clinical practice in order to ensure the integrity of brain death determination. To complement this effort, state policymakers must revise legislation on the use of neurologic criteria to declare death. We review the legal history and current laws regarding neurologic criteria to declare death and offer proposed revisions to the Uniform Determination of Death Act (UDDA) and the rationale for these recommendations.

The health care industry has moved at a rapid pace away from paper records to an electronic platform across almost all sectors — much of it at the encouragement and insistence of the federal government. Such rapid expansion has increased exponentially the risk to individuals in the privacy of their data and, increasingly, to their physical well-being when medical records are inaccessible through ransomware attacks. Recognizing the unique and critical nature of medical records, the United States Congress established the Health Care Industry Cybersecurity Task Force under the Cybersecurity Information Sharing Act of 2015 for the purpose of reviewing cybersecurity risks within the health care industry and identifying who will lead and coordinate efforts to address such risks among the various agencies. The Task Force has since issued a report setting forth six high-level imperatives that the health care industry needs to achieve in order to combat cybersecurity, and, notably, many of the vulnerabilities plaguing the industry identified in the Report as requiring correction are not necessarily related to specific flaws in the current cybersecurity framework, but rather susceptibilities presented by the infrastructure and associated regulatory regime that has evolved over the last few decades over the health care industry generally. That is, the current health care infrastructure by its nature exacerbates cybersecurity risk. Between a lack of information sharing of industry threats, risks, and mitigations, disparate leadership and governance goals for cybersecurity, the confluence and contradiction of existing federal and state laws, fragmentation in the fee-for-service delivery system, lack of care coordination, and disparate resources across and among sectors, the industry suffers from heightened cyber risk. Solutions that are reactive to problems within the current infrastructure will likely have little long term impact toward reducing cybersecurity vulnerabilities because they do not address the underlying system challenges. All of these confluences causes one to wonder whether if in fact the current health care delivery infrastructure is a contributing factor to the incidents of cybersecurity attacks and the exorbitant costs associated with resolving data breaches, should Congress look not just to curb breach incidents, but to address root cause systematic challenges in the health industry infrastructure that create increased exposure of cybersecurity threats? This article argues that cybersecurity risks will continue to be heightened and more costly to the health care industry as compared to other industries unless and until some general system redesign is achieved that allows for (1) greater sharing of resources among industry participants to ensure the same protections are implemented at all levels of the industry, which can be strengthened through greater interoperability of systems across the health care industry; and (2) increased focus and attention on the importance of cybersecurity issues as a priority among system reforms.

This paper examines the practice implications of various state policies that provide publicly funded prenatal care to undocumented immigrants for health care workers who see undocumented patients. Data were collected through in-depth interviews with purposively sampled health care workers at safety net clinics in California, Maryland, Nebraska, and New York. Health care workers were asked about the process through which undocumented patients receive prenatal care in their health center and the ethical tensions and frustrations they encounter when providing or facilitating this care under policy restrictions. Respondents discussed several professional practice norms as well as the ethical tensions they encountered when policy or institutional constraints prevented them from living up to professional norms. Using Nancy Berlinger's “workarounds” framework, this paper examines health care workers' responses to the misalignment of their professional norms and the policy restrictions in their state. These findings suggest that the prenatal policies in each state raise ethical and professional challenges for the health care workers who implement them.

Validation of a biomarker-based medical product development tool or clinical test is an evidentiary process that must be tailored to the proposed use. Appropriate data and analyses are needed to demonstrate that the biomarker meets analytical and clinical performance criteria consistent with favorable benefit: risk balance.

The use of biomarkers holds great promise for the development of new therapeutics and the acceleration of clinical research. However, biomarkers must be validated — a complex and costly endeavor. Importantly, biomarker validation is meaningfully shaped by economic and policy-driven incentives.

Global Cumulative Treatment Analysis (GCTA) is a novel clinical research model combining expert knowledge, and treatment coordination based upon global information-gain, to treat every patient optimally while efficiently searching the vast space that is the realm of cancer research.

Although data sharing platforms host diverse data types the features of these platforms are well-suited to facilitating biomarker research. Given the current state of biomarker discovery, an innovative paradigm to accelerate biomarker discovery is to utilize platforms such as Vivli to leverage researchers' abilities to integrate certain classes of biomarkers.

Immunization plays a crucial role in global health security, preventing public health emergencies of international concern and protecting individuals from infectious disease outbreaks, yet these critical public health benefits are dependent on immunization law. Where public health law has become central to preventing, detecting, and responding to infectious disease, public health law reform is seen as necessary to implement the Global Health Security Agenda (GHSA). This article examines national immunization laws as a basis to implement the GHSA and promote the public's health, analyzing the scope and content of these laws to prevent infectious disease across Sub-Saharan Africa. Undertaking policy surveillance of national immunization laws in 20 Sub-Saharan African countries, this study: (1) developed a legal framework to map the legal attributes relevant to immunization; (2) created an assessment tool to determine the presence of these attributes under national immunization law; and (3) applied this assessment tool to code national legal landscapes. An analysis of these coded laws highlights legal attributes that govern vaccine requirements, supply chains, vaccine administration standards, and medicines quality and manufacturer liability. Based upon this international policy surveillance, it will be crucial to undertake legal epidemiology research across countries, examining the influence of immunization law on vaccination rates and disease outbreaks.

Cochrane has developed a linked data infrastructure to make the evidence and data from its rich repositories more discoverable to facilitate evidence-based health decision-making. These annotated resources can enhance the study and understanding of biomarkers and surrogate endpoints.

Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

Biomarkers can be powerful tools to guide diagnosis, treatment, and research. However, prudent use of biomarkers requires formal validation efforts. Although the data needed for biomarker validation has traditionally been hard to access, new research initiatives can ease this process.

The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

In the Winter 2017 edition of JLME, Dr. Carson outlined an economic approach to the epidemiology of HIV transmission within the gay community, with a special emphasis on mobile apps. His conclusion is that HIV transmission amongst the gay community constitutes a collective action problem, which is resolved by the social norm of using a condom. This article critiques Dr. Carson's approach from an economic perspective. By utilizing classic law and economic theory, this article will argue that HIV transmission may not, in fact, constitute a collective action problem in economic terms, and that instead condom use as a method of disease protection in theory can arise from purely rational, market driven actions. To do so, it borrows from transactional theory of information asymmetry to show the potential to alert counterparts as to serostatus. This conclusion provides an important supplement to Carson: rather than social norms being the core driver in condom usage to prevent HIV, instead condom use may arise solely as a result of rational, private decision making arising from market signaling. The article then critiques its own findings to demonstrate that it is unclear whether Carson's argument or the argument in this paper is, indeed, correct — which may represent a limitation in the analytical techniques advanced.