The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly-discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and presents novel informed consent and dual use challenges: human genome editing and gene drives in insects.

I begin with a discussion of so far disastrously unsuccessful attempts to regulate germline editing in humans, including a summary of the first application of germline genome editing in humans and its aftermath. I then turn to a discussion of setting ethical standards for a genomic technology that has not yet been deployed in nature—gene drives. Finally, I end by suggesting that human rights can and should be directly applicable to defining the ethics of genomic research.

Corporate influence is one of the most pressing issues in public health. It cuts across many of our most intractable problems—from obesity to the opioid epidemic. Companies develop close relationships with public health agencies, research universities, academic medical centers, professional societies, and patient advocacy organizations—often funding medical research and public health interventions intended to address the very challenges these corporations are creating or exacerbating. How we view relationships with industry, including how these relationships are framed in ethical discourse, shapes our legal and policy responses to them. In recent years, fueled in part by the opioid epidemic, the ethical framing of industry relationships has begun to evolve in significant ways. But legal and policy responses have not yet caught up. In this article, I develop a temporal account of corporate influence, and legal and policy responses to corporate influence. This account clarifies the limitations and adverse effects of conflicts of interest disclosure, especially when implemented as the sole legal or policy response. Disclosure can illuminate corporate influence—but policymakers cannot and should not rely on disclosure to eliminate corporate influence or its effects. Nor should we allow disclosure to crowd out structural and systemic responses to corporate influence—including sequestration of and separation from private-sector entities.

The issue of online prescribing through the use of telemedicine raises ethical concerns. In particular, several studies suggest a correlation between telemedicine and overprescribing. Meanwhile, new developments in the law also have the potential to significantly impact online prescribing using telemedicine. In the absence of concrete federal guidance and a continued delay in issuing required federal regulations, states have developed their own laws, which vary considerably, regarding the ability of physicians to engage in online prescribing through telemedicine. As legal developments open doors for physicians to prescribe through telemedicine, current evidence of overprescribing, although limited, suggests the need to carefully balance access to health care and quality of care in this context, especially when crafting innovative legislative responses.

This article attempts to explore this dynamic issue by closely evaluating the research on overprescribing involving telemedicine and the ethical issues surrounding online prescribing. It will continue by analyzing the current legal landscape for online prescribing for telemedicine at both the federal and state levels. Next, this article will examine ethics opinions offered by medical groups that touch this issue. Finally, this article will suggest several recommendations for law and policy moving forward by shedding light on the ethical issues surrounding telemedicine and online prescribing and how to strike a balance between access and quality of care.

Doctors have two ethical duties: to cure disease or ease suffering and, also, to do no harm. The ethical duty to “Do No Harm” has been used to justify two sides of a pendulum swing in the philosophy of opioid prescribing for pain. In the 1990s, it was invoked to expand prescribing, and more recently to justify dramatic reductions in prescription opioid use. In this Article, we explore whether prescribing opioids for pain presents challenges that differ from the ordinary mandate physicians face as they balance the call for action with the imperative to do no harm [DNH].

We argue that the treatment of pain differs in three important ways. First, the fact that pain is present and occurrent reduces uncertainty about the need for action, and thus strengthens the reasons to act. Second, while DNH applies to both physicians and policymakers, each has distinct duties: physicians have a duty to the individual patient; policymakers have a duty to society. As a result, harm from drug diversion should weigh little when clinicians decide how to treat individual patients. Public health officials, by contrast, rightly consider societal effects. However, in doing so, they must adopt policies that mitigate the ethical burdens placed on physicians, respect the testimony of patients in pain, and pay particular attention to how policy guidance is likely to be implemented by others. Finally, we address what duties are owed to patients who are currently taking opioid medication, given evidence that they are experiencing significant barriers in receiving healthcare. We argue that once treatment has been initiated, there are special duties to these patients.

“Big Data represents a challenge that points to the need for collective and political approaches to self-protection rather than solely individual, atomistic approaches.”

– Anita Allen, “Protecting One's Own Privacy in a Big Data Economy”

Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from (1) establishment of a healthcare relationship, (2) state licensure laws, and (3) reimbursement. We analyze these areas because of the legal ambiguities or inconsistencies they raise depending on the state, which seem to be hampering telehealth growth without necessarily improving quality of care. We propose several solutions for a more unified approach to telehealth regulation that incorporate core bioethics principles of doctor-patient relationship, competence, patient autonomy, as well as population-wide questions of resource allocation and access. Lawmakers should clarify that healthcare relationships may be established outside of in-person meetings, align licensure laws via an interstate compact or federal preemption, and expand Centers for Medicare and Medicaid plans to reimburse telehealth delivery in the home.

Patent rights are recognized as a property asset with an attendant right to exclude. However, recent policy developments highlight that the right to exclude is not inviolable. This paper explores two rapidly evolving exceptions to patent exclusivity, both of which take the form of compulsory licenses. First, under the international Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”), national governments can compel patent owners to out-license technology in service of greater good. These egalitarian compulsory licenses improve access to technology but undermine patent value. Second, compulsory licenses are increasingly relied upon as an equitable remedy in U.S. patent litigation. Typically referred to as “ongoing royalties,” these court-mandated compulsory licenses are a modern alternative to injunctions against adjudged infringers. TRIPS compulsory licenses and ongoing royalties arise under independent legal frameworks, but necessarily invoke parallel economic considerations. While the wisdom of each has been discussed at length by others, this paper explores principles of royalty determination employed in each context. Considering both frameworks, an analysis of where each succeeds and fails is provided, together with an exploration of optimized royalty frameworks.

Nondiscrimination rules—statutes, regulations, and soft law protections—are critical for reducing health and health care disparities. Although scholarship has interrogated how nondiscrimination rules affect behavior by discriminators, comparatively little has considered how protections can affect choices made by members of protected groups. A number of states and some interpretations of federal law protect people from discrimination on the basis of sexual orientation. This Article seeks to identify relationships between actual state law, perceived state law, and experiences of discrimination and medical mistrust. This Article reports the results of a national cross-sectional survey of over 3,000 men using Grindr to meet male partners. Participants scored comparable to chance in knowledge about state nondiscrimination protections, with “optimistic errors” (erroneous beliefs that one was protected) significantly more common than pessimistic errors. Perceptions of protection were significantly correlated with lower medical mistrust and greater uptake of care, as well as lower perceived barriers to disclosure and care-seeking. Actual state law protections, however, were significant predictors of having had discussions with providers that depended on disclosure of sexual behavior or orientation. Building on these results, this Article considers pathways by which nondiscrimination law may exert welcome mat (and “unwelcome mat”) effects.