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Widespread diagnostic and serological (antibody) testing is one key to mitigating the COVID-19 pandemic. While at first, the majority of COVID-19 diagnostic testing in the USA took place in healthcare settings, quickly a direct-to-consumer (DTC) testing market also emerged. In these DTC provision models, the test is initiated by a consumer and the sample collection occurs at home or in a commercial laboratory. Although the provision of DTC tests has potential benefits—such as expanding access to testing and reducing the risk of exposure for consumers and medical personnel—it also raises significant ethical and regulatory concerns. This article reviews these challenges and shows how they parallel and also diverge from prior concerns raised in the DTC health testing arena. The first part of this paper provides an overview of the landscape of diagnostic and serological tests for COVID-19, anticipating how provision models are likely to evolve in the future. The second part discusses five primary issues for DTC COVID-19 tests: test accuracy; potential misinterpretation of results; misleading claims and other misinformation; privacy concerns; and fair allocation of scarce resources. We conclude with recommendations for regulators and companies that aim to ensure ethically marketed DTC COVID-19 tests.

Neurotherapies for diagnostics and treatment-such as electroencephalography (EEG) neurofeedback, single-photon emission computerized tomography (SPECT) imaging for neuropsychiatric evaluation, and off-label/experimental uses of brain stimulation-are continuously being offered to the public outside mainstream healthcare settings. Because these neurotherapies share many key features of complementary and alternative medicine (CAM) techniques-and meet the definition of CAM as set out in Kaptchuk and Eisenberg-here we refer to them as "alternative neurotherapies." By explicitly linking these alternative neurotherapy practices under a common conceptual framework, this paper draws attention to, and critically considers, the cross-cutting ethical and legal issues related to the provision of these services. The first section of this paper provides an updated empirical overview of uses of SPECT neuropsychiatric evaluations, EEG neurofeedback, and experimental/off-label forms of brain stimulation. Next, drawing on CAM bioethics scholarship, we highlight the pertinent ethical issues in the alternative neurotherapy context, including the truthful representation of evidence base, marketing to vulnerable populations, potential harms, provider competency, and conflicts of interest. Finally, we consider the principal legal issues at stake for the provision of alternative neurotherapies in the U.S., namely those related to licensing and scope-of-practice considerations. We conclude with recommendations for future research in this domain.

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