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COVID-19 , Pandemias , Organización Mundial de la Salud , Humanos , COVID-19/epidemiología , SARS-CoV-2 , IncertidumbreRESUMEN
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.
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Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group. Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified. Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.
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Consenso , Alucinógenos , Humanos , Alucinógenos/uso terapéutico , Política de Salud , Consentimiento Informado/éticaRESUMEN
Congressional hearings and public reports have drawn attention to problems afflicting Medicare Advantage (MA), the privatized version of Medicare. Private plans became a staple of Medicare through the passage of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA). Congress passed this law during a furor of privatization, when think tanks and powerful financial interests emphasized the power of corporations' profit incentive to improve the efficiency and quality of social enterprise. Yet the surging criticism of MA suggests a misalignment between the financial interest of some MA plans and the well-being of their patient populations. The criticisms range from deceptive marketing, ghost networks, and patient cherry-picking to unethical prior authorization denials and defrauding the government. In total, MA plans cost the federal government 22% more per patient than if these patients in question were enrolled in traditional Medicare. Moreover, it is not clear that this additional funding is producing proportional benefits. These developments raise questions about the presence of a profit incentive in Medicare, and perhaps health care more broadly.
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Women's Health Research, barely 40-year-old in the United States has recently received an all-important boost from First Lady Jill Biden. The $100 million in question are bound to make a meaningful difference in this all-important arena. It was the view of the White House that "our nation must fundamentally change how we approach and fund women's health research." The White House expressed its hope that "congressional leaders, the private sector, research institutions, and philanthropy" will answer the call to "improve the health and lives of women throughout the nation."
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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.
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Artificial intelligence (AI)-enabled chatbots are increasingly being used to help people manage their mental health. Chatbots for mental health and particularly 'wellness' applications currently exist in a regulatory 'gray area'. Indeed, most generative AI-powered wellness apps will not be reviewed by health regulators. However, recent findings suggest that users of these apps sometimes use them to share mental health problems and even to seek support during crises, and that the apps sometimes respond in a manner that increases the risk of harm to the user, a challenge that the current US regulatory structure is not well equipped to address. In this Perspective, we discuss the regulatory landscape and potential health risks of AI-enabled wellness apps. Although we focus on the United States, there are similar challenges for regulators across the globe. We discuss the problems that arise when AI-based wellness apps cross into medical territory and the implications for app developers and regulatory bodies, and we outline outstanding priorities for the field.
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Inteligencia Artificial , Salud Mental , Aplicaciones Móviles , Humanos , Promoción de la Salud , Estados Unidos , TelemedicinaRESUMEN
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.
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Alucinógenos , Consentimiento Informado , Alucinógenos/administración & dosificación , Humanos , Consentimiento Informado/legislación & jurisprudencia , Estados Unidos , Trastornos Mentales/tratamiento farmacológicoRESUMEN
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.
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Política , Derechos Sexuales y Reproductivos , Niño , Humanos , Alabama , Estados Unidos , Derechos Sexuales y Reproductivos/legislación & jurisprudencia , Estructuras EmbrionariasRESUMEN
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.
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Personal de Salud , Violencia , Violencia Laboral , Humanos , Violencia/prevención & control , Violencia Laboral/prevención & control , Gobierno , Política PúblicaRESUMEN
Rapid advances in digital technology have expanded the availability of diagnostic tools beyond traditional medical settings. Previously confined to clinical environments, these many diagnostic capabilities are now accessible outside the clinic. This study utilized the Delphi method, a consensus-building approach, to develop recommendations for the development and deployment of these innovative technologies. The study findings present the 29 consensus-based recommendations generated through the Delphi process, providing valuable insights and guidance for stakeholders involved in the implementation and utilization of these novel diagnostic solutions. These recommendations serve as a roadmap for navigating the complexities of integrating digital diagnostics into healthcare practice outside traditional settings like hospitals and clinics.