Telehealth has the potential to address health disparities, but not without deliberate choices about how to implement it. To support vulnerable patients, health policy leaders must pursue creative solutions such as public-private partnerships, broadband infrastructure, and value-based payment. Without these initiatives or others like them, health disparities are likely to persist despite telehealth’s tantalizing potential.

There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did it was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy to those who oppose abortion. Abortion should be criminalized, yes, but with these exceptions carved out. This shibboleth has found its way not only in the public position taken by many Pro-Life politicians, but also in legislation across several U.S. states, and even the Hyde Amendment, which prohibits federal funding for abortion, makes an exception for these kinds of abortions

More than 24,000 patients await organ transplants and the number is increasing yearly. Living donors are an important source of transplant organs. In this paper, I argue that we can morally justify allowing children to serve as donors. Yet, I also argue that their participation must be restricted in order to prevent their exploitation.

The paper is divided into six sections. In the first section, I show why the traditional principles of personal autonomy and beneficence are not adequate morally to justify the participation of children in the nontherapeutic role of organ donor. Next, I argue that the moral justification of the child’s participation must be based on the intimate family relationship which permits activities that would be unacceptable in the public domain. In the third section, I argue that family autonomy ought to be limited by the principle of respect for persons. In the fourth section, I propose five principles to guide the participation of children as organ donors. In section five, I discuss the role of the child in the decision-making process. In section six, I critically examine the criteria for equity in donor selection.

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Preemption is a substantial threat to achieving racial equity. Since 2011, states have increasingly preempted local governments from enacting policies that can improve health and reduce racial inequities such as increasing minimum wage and requiring paid leave.

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. Bacterial diseases that in prior years were relatively easy and cheap to cure are now proving exceedingly difficult and expensive to treat because resistant strains have developed. A number of measures can be implemented in order to minimize the problem of antibiotic resistance. Conservation efforts on the use of antibiotics, educational campaigns about hygienic behavior, “cycling efforts” of antibiotics, efforts to stamp out misuse of antibiotics (of both the over- and under-use kind), and efforts to monitor and share information about the spread of resistant strains are examples of such measures. It is instructive to think of these measures as belonging to the “demand-side conservation response” to the problem of antibiotic resistance.

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies (product selection), and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to pain management generally.

All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA). CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence.

The term, “bioethics” was coined in 1970 by American cancerologist V. R. Potter. In the few decades since, the field of bioethics has emerged as an important discipline. The field has attained a remarkable degree of public recognition in a relatively short period of time. The “right to die” cases such as In re Quinlan placed bioethical issues on the front pages. Although the discipline is of recent vintage, the past quarter century has witnessed a flurry of scholarly activity, creating a substantial body of bioethical literature. Moreover, the bioethics movement has manifested itself in institutional expressions. Universities and medical schools have added courses in bioethics to their curricula. In 1974, federal legislation and regulations mandated that federal grantees conducting human subjects research establish institutional review boards to safeguard subjects’ welfare, and even absent a legislative mandate numerous hospitals created ethics committees. Centers and institutes, devoted exclusively to the study of bioethical issues, have been founded.

Clinical ethics, like the broader field of bioethics from which it emerged, is at a critical crossroads in its development, with conflicting paths ahead. It can either claim its distinctive place in the clinical arena, insisting unapologetically on certain minimal standards of professional training, practice and competence, addressing head on debates about various models of and methodological approaches to consultation, and establishing a shared vision of the purpose and meaning of the enterprise of clinical ethics itself. Or, it can devolve into a hobby that untrained, albeit interested, and generally well intentioned individuals can dabble in for fun or even profit, as they see fit, and without regard to the deep history and rich disciplinary roots of the field, the serious debates in the academic literature of bioethics, the foundational case histories and legal theories, or even any sense of professional accountability.

Informed consent is the single most important concept for understanding decision-making capacity. There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. This is a classic example of medicalization. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to normalize capacity assessment.

Returning the locus of capacity assessment to the attending, the primary care doctor, and even to ethics consultation in today's environment will require a substantial effort to undo a strong but illusory impression of capacity assessment. Hospital attorneys as well as clinical ethicists with a sophisticated understanding of health law can be in the vanguard of this reorientation.

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 discusses recent changes to state legal frameworks for mandatory vaccination in the context of school and healthcare worker vaccination. It then discusses state laws that allow pharmacists the authority to vaccinate.

Some form of assisted dying (voluntary euthanasia and/or assisted suicide) is lawful in the Netherlands, Belgium, Oregon, and Switzerland. In order for individual instances of assisted dying to be lawful in these jurisdictions, a valid request must precede the provision of assistance to die. Non-adherence to the criteria for valid requests for assisted dying may be a trigger for civil and/or criminal liability, as well as regulatory sanctions where the assistor is a medical professional.

In this article, we review the criteria and evidence in respect of requests for assisted dying in the Netherlands, Belgium, Oregon, and Switzerland. Our aim is to establish whether individuals who receive assisted dying do so on the basis of valid requests.

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access.

The health care industry will be a large customer of big data while predictive analytics already underlie important health care and public health initiatives. Yet big data are not benign. For example, data brokers, the businesses that buy, process, and sell “big data” are performing an end-run around health data protection by creating data “proxies” outside of HIPAA-protected space. From 2012-14 various branches of the federal government published five major reports on privacy. All five were in favor of increased regulation of data brokers. However, their recommendations for legislative or regulatory intervention were quite diverse. This essay describes the various proposals and offers a critical synthesis.

The goal of my comments regarding the case study of Eve Hyde — presented in the introduction of this symposium — is not first and foremost to resolve the conflict between individual autonomy and medical paternalism regarding non-consensual psychiatric treatment. Instead, the goal is to step back far enough from what is generally accepted as the morally appropriate basis for non-consensual psychiatric treatment, including involuntary hospitalization and medication, and to ask very basic questions about when patients may permissibly be treated without their consent. My goal, in short, is Socratic — to explore aspects of what we take for granted in order better to determine whether we ought to take them for granted. Commentators routinely urge that it is morally permissible forcibly to treat psychiatric patients, such as Eve Hyde, in order to preserve the patient’s best interests and restore the patient’s autonomy. Such arguments typically specify duties of beneficence toward others, while appreciating personal autonomy as a positive value to be weighed against other factors.

The presence of the Tuskegee Syphilis Study was palpable at the June 16, 2005, Food and Drug Administration’s (FDA) Advisory Committee meeting on BiDil, a heart medication from the pharmaceutical company NitroMed that sought approval as the first race-specific drug. So ubiquitous is the restless and unsettled spirit of Tuskegee that it continues to hover over the African American public and the biomedical research/health care provider communities more than three and a half decades after the actual study “died.” No one invoked the word “Tuskegee” in that dimly lit meeting room as BiDil gained the Advisory Committee’s approval. Yet its power was exerted even when it was not named. The FDA Committee’s chairman, Cleveland Clinic cardiology chief Steven Nissen, acknowledged this after the committee met: “We were putting [Tuskegee]…to rest.”

Physically and intellectually, man is not the same as a million years ago. This “improvement” in humans has occurred over a period of time and not as a result of any outside biotechnical intervention. So, the question is what is the need now? The fine line between what can be done technically and what should be done morally is the reason for biomedical ethics. What is the nature of man, and what is his relationship with his creator and his environment? Whose interest (man, God, and environment) are we as scientists and physicians to guard? What are the rights of the unborn, and who protects those rights? While seeking medical treatment for infertility and reconstructive surgery for a malformation or genetic manipulation for a genetic disease might perhaps be appropriate and recommended, is it also appropriate to create a super healthy, super human with genetic manipulation? If so, then are we embarking on the path of ethnic cleansing of humans of lesser ability, and is it appropriate to discriminate? In this paper, such questions and concerns are discussed from an Islamic perspective.