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This Special Communication discusses the essential elements of designing and implementing informed consent practices for psychedelic medicine. Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings. Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses whether the federal EMTALA act requires that hospitals provide abortions when needed to protect the health of the pregnant person, even if prohibited by state law. [ABSTRACT FROM AUTHOR]

In this Viewpoint, the authors refute recent suggestions that the US Food and Drug Administration (FDA) is not accountable for its decisions, pointing out the legal, legislative, and executive checks and balances on the agency. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the Alabama Supreme Court's opinion on in vitro fertilization and how it plays into a larger push for fetal and embryonic personhood. [ABSTRACT FROM AUTHOR]

This Viewpoint examines current state-level approaches to addressing the increased incidence of violence against health care workers, as well as how laws are adapting to protect health care personnel. [ABSTRACT FROM AUTHOR]

This Viewpoint reviews how the recent US Supreme Court decision regarding affirmative action affects extant medical school admission policies seeking to enhance diversity of the national medical student body and its derivative national health care workforce. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the maternal mortality crisis in the US, the need for an extension of Medicaid postpartum coverage, and the residual challenges across the US related to maternal health. [ABSTRACT FROM AUTHOR]

The article discusses the challenges of building a diverse health care workforce following the US Supreme Court decision against affirmative action. Topics include the impact of the UC Davis Scale on applicants, the advantages and disadvantages related to family income in the medical school admission process, and the broader goal of decreasing health disparities through a more equitable physician selection process.

This Viewpoint explains the history of the Comstock Act, its use by those seeking to restrict abortion, and why it threatens abortion access in the US. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses how regulators across the world should approach the legal and ethical challenges, including privacy, device regulation, competition, intellectual property rights, cybersecurity, and liability, raised by the medical use of large language models. [ABSTRACT FROM AUTHOR]

This Viewpoint reviews California's recently proposed CalRx initiative to manufacture biosimilar insulin, highlights challenges facing the initiative, and suggests ways in which, if successful, the initiative could serve as a model for state-managed development of drugs other than insulin, reduce drug prices, and provide other benefits. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the controversy surrounding the FDA's efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the new Colorado law prohibiting anonymous gamete donation and other debates over reproductive technologies and secrecy. [ABSTRACT FROM AUTHOR]

This Viewpoint examines the murky legal treatment of various health-related wearable or other general wellness products for patients, physicians, and manufacturers, and recommends solutions. [ABSTRACT FROM AUTHOR]

This Viewpoint from several legal experts explains the ruling in Dobbs v Jackson Women's Health Organization and what it means for physicians, public health, and society. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the potential ramifications for assisted reproductive technologies, such as in vitro fertilization, if the Supreme Court overturns Roe v Wade. [ABSTRACT FROM AUTHOR]

This Viewpoint reviews the regulatory oversight of laboratory-developed tests, discusses its recent policy permutations, and explores potential future considerations. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the recent US Supreme Court ruling on SB8, the Texas law that prohibits abortion after 6 weeks of gestational age, and the effect the ruling could have on other constitutional rights. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the definitions of medical devices and low-risk general wellness products and examines the difficulties the difference between these types of products pose for regulation, consumer understanding, physician use and interpretation, privacy, reimbursement, and equity. [ABSTRACT FROM AUTHOR]

This Viewpoint reviews the leading objectives of the pandemic preparedness proposal, discusses the outcome of comparable past federal efforts, and emphasizes the imperative of intragovernmental coordination. [ABSTRACT FROM AUTHOR]

This Viewpoint examines the coverage gap in health insurance in the US and its potential redress by enhancing federal outreach to the uninsured, rendering permanent the health insurance benefits of the American Rescue Plan Act, and establishing a federal health insurance program for low-income adults in states that did not expand their Medicaid programs. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses SB8, the recent law passed in Texas that essentially prohibits abortion after 6 weeks of gestational age, and the effect this will have on persons seeking pregnancy termination as well as the future of constitutional protection of abortion services. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses ethical considerations and use of patents for human germline editing in the context of a recent World Health Organization report and release of several auxiliary documents exploring international governance tools for human genome engineering. [ABSTRACT FROM AUTHOR]

This Viewpoint revisits the Open Payments Program, mandated by the Sunshine Act, and discusses alleged violations by device and pharmaceutical manufacturers and the future enforcement of the program. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses elements of the American Rescue Plan Act of 2021 that bolster the Patient Protection and Affordable Care Act (ACA) and describes their potential implications and uncertainties. [ABSTRACT FROM AUTHOR]

This Viewpoint describes legislation aiming to criminalize medical care for transgender youth and explains why these bills are harmful and potentially unlawful. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses digital health passes (DHPs) that would grant access to work, entertainment, shopping, and travel with confirmation of COVID-19 immunity, and the scientific, legal, ethical, and equity considerations that must be worked through for DHPs to be considered effective and fair. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the recent special fraud alert issued by the DHHS Office of Inspector General (OIG) regarding industry-sponsored speaker programs, including the OIG's recommendations and their implications. [ABSTRACT FROM AUTHOR]

This Viewpoint reviews the creation of the US Interstate Medical Licensure Compact (IMLC), which facilitates licensure for physicians who wish to practice in multiple states with the aim of increasing access to care for patients in underserved areas and emphasizes its growing importance to states and physicians given more widespread use of telemedicine. [ABSTRACT FROM AUTHOR]

This Viewpoint summarizes the report of the International Commission on the Clinical Use of Human Germline Genome Editing sponsored by the US National Academy of Medicine and the UK Royal Society, enumerating technical, regulatory, and ethical standards that need to be met before HHGE can be used on human embryos. [ABSTRACT FROM AUTHOR]

This Viewpoint proposes legal and policy options for promoting universal face mask wearing in the US and, recognizing the limits of state-by-state implementation, proposes strengthening the authority, independence, and funding of the CDC to enact responses to this and future comparable public health emergencies. [ABSTRACT FROM AUTHOR]

This Viewpoint compares manual and digital strategies for coronavirus disease 2019 (COVID-19) contact tracing, describes how countries in Asia and Europe have used smartphone tracking, and discusses privacy and discrimination concerns and strategies for balancing public health and civil liberties in the US. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses the legal risks to health care workers and hospital systems from withdrawing or withholding ventilation from COVID-19 patients and cites a Maryland statute that offers legal immunity to clinicians making good faith decisions under emergency conditions as an example for other states to follow. [ABSTRACT FROM AUTHOR]

This section presents a reprint of the article "The Case for Remedial Germline Editing: The Long-term View," by Eli Y. Adashi and I. Glenn Cohen, which appeared on the "JAMA Health Forum" online journal. Topics discussed include the estimated global prevalence of heritable monogenic diseases, the capabilities and limitations of preimplantation genetic diagnosis (PGD) and remedial germline editing (RGE), and recent innovations on genome editing and its clinical applications.

This Viewpoint reviews the ethical and legal implications of using ambient intelligence, the use of artificial intelligence–based technologies to monitor health care and quality measures like handwashing and patient falls in health care setting. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the cost-effectiveness of prolonged mechanical ventilation in patients 80 years of age and older in the intensive care unit (ICU).Design: A retrospective review of consecutive ICU patients requiring 3 or more days of mechanical ventilation. Cost-effectiveness analysis was performed by assessing incremental hospital charges from hospital billing records; charges were then related to years of life saved. A telephone survey was used to follow up hospital survivors for a minimum of 4 years after discharge.Setting: A 20-bed medical-surgical ICU in a 420-bed, tertiary-care community teaching hospital.Patients: The study included all patients aged 80 years or older taken from a comprehensive database of all patients admitted to the ICU requiring mechanical ventilation from April 1, 1985, through October 31, 1987 (n = 512). Of 59 potential candidates, 45 were found to have complete billing records and were the subject of further analysis.Results: Of the 45 patients in the group under analysis, 10 survived to leave the hospital. Of these, two were alive and one could not be located at the time of follow-up. The charge per year of life saved is estimated to between $51,854 and $75,090 in 1985-1987 dollars. Of 22 patients whose age in years plus duration of mechanical ventilation in days totaled 100 or greater, only two survived hospitalization and neither was alive at follow-up. The cost per year of life saved in this subset of patients was $1181,308 in 1985-1987 dollars. One of these patients was discharged to a nursing home and died there 4.5 years later, after multiple hospital readmissions. The other patient died at home 2 months after hospital discharge.Conclusion: Based on hospital charges and life expectancy, the cost-effectiveness of prolonged mechanical ventilation in ICU patients age 80 years and over was poor in our population when the combination of age and duration of mechanical ventilation exceeded 100. Further studies using this type of analysis may prove valuable in both clinical and administrative decision-making processes. [ABSTRACT FROM AUTHOR]

Objective: --Diarrhea is an important cause of death among young children in both developing and developed countries, but little is known about diarrheal death among adults. In this study, we examined trends in diarrheal deaths among all age groups in the United States.Design/setting/participants: --We reviewed national mortality data complied by the National Center for Health Statistics, Hyattsville, Md, which consists of information from all death certificates filed in the United States for the period 1979 through 1987. A death for which diarrhea was listed as an immediate or underlying cause was considered a "diarrheal death" and included in the analysis.Results: --We found that 28,538 persons died of diarrhea cited as either an immediate or the underlying cause of death during the 9-year period. A majority of diarrheal deaths occurred among the elderly (older than 74 years of age, 51%), followed by adults 55 to 74 years of age (27%), and young children (younger than 5 years of age, 11%). For the elderly, adjusted risk factors for dying of diarrhea included being white, female, and residing in a long-term care facility. Only the elderly and young children had clear, distinct winter peaks of diarrheal deaths, suggesting that the diarrhea may, in part, be infectious in origin.Conclusion: --For the elderly, more directed studies of those at risk, such as nursing home residents, are needed to determine if oral rehydration therapy, vaccines, or other preventive measures might benefit this population. [ABSTRACT FROM AUTHOR]