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.

“[T]he tissue or embryo is not the primary victim at all. The victims are the parents who have been deprived of the potential to conceive a child together.”1

The opioid crisis is one of the largest public health problems in the history of the United States. Prescription drug monitoring programs (“PDMPs”)—state databases containing the records of all prescriptions for controlled substances written in the state—have emerged as a means to track opioid prescribing and use. While PDMPs are typically used as a tool for physicians to inform their prescribing practices, many states also permit law enforcement to access PDMPs when investigating controlled substance distribution, often without prior judicial approval. Such law enforcement use of PDMPs raises serious questions of patient privacy. The Fourth Amendment protects individuals from unreasonable searches and seizures where they have a reasonable expectation of privacy and has been interpreted to require law enforcement have probable cause and a search warrant before infringing upon an individual’s reasonable expectation of privacy. Several courts have held that patients have no reasonable expectation of privacy, or a severely diminished expectation of privacy, in their prescription drug records held in PDMPs. As support, courts rely on the third-party doctrine because the information is disclosed to physicians and then held by the state; the highly regulated nature of the prescription drug industry; and the statutory framework of the Controlled Substances Act. Such analysis disregards patients’ expectation of privacy in their personal health information, the confidentiality in the physician-patient relationship, and the resulting patient incentives not to seek care. Therefore, this Article argues that law enforcement must have probable cause and a search warrant to access PDMPs because the exceptions to the Fourth Amendment’s probable cause and warrant requirements do not apply.

“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”

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.

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.

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.