RESUMO
Patients and family members (N = 671) were surveyed in five Mid-Atlantic U.S. hospitals to ascertain the number and kinds of ethical concerns they are presently experiencing or have previously experienced while being sick or receiving medical care. Seventy percent of participants had at least one (range 0-14) type of ethical concern or question. The most commonly experienced concerns pertained to being unsure how to plan ahead or complete an advance directive (29.4%), being unsure whether someone in the family was able to make their own decisions (29.2%), deciding about limiting life-sustaining treatments (28.6%), wondering about disclosing personal medical information to others in the family (26.4%) and not being sure whether to undergo treatment because of cost (26.2%). Most were interested to some degree in getting help from ethics consultants in the future (76.6%). Given this prevalence, common concerns might usefully be addressed systematically, rather than exclusively on a case-by-case basis.
Assuntos
Família , Assistência Terminal , Humanos , Pacientes , Diretivas Antecipadas , IncertezaAssuntos
Sequência de Bases/genética , Eucariotos/genética , Animais , Biodiversidade , Genômica , HumanosRESUMO
The Earth BioGenome Project (EBP) is an audacious endeavor to obtain whole-genome sequences of representatives from all eukaryotic species on Earth. In addition to the project's technical and organizational challenges, it also faces complicated ethical, legal, and social issues. This paper, from members of the EBP's Ethical, Legal, and Social Issues (ELSI) Committee, catalogs these ELSI concerns arising from EBP. These include legal issues, such as sample collection and permitting; the applicability of international treaties, such as the Convention on Biological Diversity and the Nagoya Protocol; intellectual property; sample accessioning; and biosecurity and ethical issues, such as sampling from the territories of Indigenous peoples and local communities, the protection of endangered species, and cross-border collections, among several others. We also comment on the intersection of digital sequence information and data rights. More broadly, this list of ethical, legal, and social issues for large-scale genomic sequencing projects may be useful in the consideration of ethical frameworks for future projects. While we do not-and cannot-provide simple, overarching solutions for all the issues raised here, we conclude our perspective by beginning to chart a path forward for EBP's work.
Assuntos
Espécies em Perigo de Extinção/legislação & jurisprudência , Ética em Pesquisa , Genômica , Animais , Biosseguridade/ética , Biosseguridade/legislação & jurisprudência , Genômica/ética , Genômica/legislação & jurisprudência , HumanosRESUMO
Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC). We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
Assuntos
Participação da Comunidade , Disseminação de Informação , Informática Médica/normas , Participação dos Interessados , Humanos , ConfiançaRESUMO
Increasing our understanding of Earth's biodiversity and responsibly stewarding its resources are among the most crucial scientific and social challenges of the new millennium. These challenges require fundamental new knowledge of the organization, evolution, functions, and interactions among millions of the planet's organisms. Herein, we present a perspective on the Earth BioGenome Project (EBP), a moonshot for biology that aims to sequence, catalog, and characterize the genomes of all of Earth's eukaryotic biodiversity over a period of 10 years. The outcomes of the EBP will inform a broad range of major issues facing humanity, such as the impact of climate change on biodiversity, the conservation of endangered species and ecosystems, and the preservation and enhancement of ecosystem services. We describe hurdles that the project faces, including data-sharing policies that ensure a permanent, freely available resource for future scientific discovery while respecting access and benefit sharing guidelines of the Nagoya Protocol. We also describe scientific and organizational challenges in executing such an ambitious project, and the structure proposed to achieve the project's goals. The far-reaching potential benefits of creating an open digital repository of genomic information for life on Earth can be realized only by a coordinated international effort.
Assuntos
Biodiversidade , Espécies em Perigo de Extinção , Genoma , Sequenciamento de Nucleotídeos em Larga Escala , Planeta TerraRESUMO
National and international public-private partnerships, consortia, and government initiatives are underway to collect and share genomic, personal, and healthcare data on a massive scale. Ideally, these efforts will contribute to the creation of a medical information commons (MIC), a comprehensive data resource that is widely available for both research and clinical uses. Stakeholder participation is essential in clarifying goals, deepening understanding of areas of complexity, and addressing long-standing policy concerns such as privacy and security and data ownership. This article describes eight core principles proposed by a diverse group of expert stakeholders to guide the formation of a successful, sustainable MIC. These principles promote formation of an ethically sound, inclusive, participant-centric MIC and provide a framework for advancing the policy response to data-sharing opportunities and challenges.
Assuntos
Disseminação de Informação , Informática Médica , Humanos , Serviços de Informação , Informática Médica/éticaAssuntos
Sistemas de Informação/legislação & jurisprudência , Saúde Mental , Segurança Computacional/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Política de Saúde , Humanos , Internet , Aplicativos Móveis , Estados Unidos , United States Federal Trade Commission/organização & administração , United States Food and Drug Administration/organização & administraçãoRESUMO
Discussions surrounding patient engagement and empowerment often use the terms "patient" and "consumer" interchangeably. But do the two terms hold the same meaning, or is a "patient" a passive actor in the health care arena and a "consumer" an informed, rational decision-maker? Has there been a shift in our usage of the two terms that aligns with the increasing commercialization of health care in the U.S. or has the patient/consumer dynamic always been a part of the buying and selling of health care in the American system? Recent discussions of the issue exist in the popular press and in social media forums such as TEDMED, but few direct analyses of the ethical, legal, and policy ramifications of this possible shift in terminology are available in the academic literature. This paper analyzes our usage of the terms and any recent changes in the dynamic and discusses the ethical, legal, and policy implications of this simple terminology for the physicianpatient relationship.
Assuntos
Participação da Comunidade , Direitos do Paciente/ética , Autonomia Pessoal , Mercantilização , Humanos , Terminologia como Assunto , Estados UnidosRESUMO
Electronic health records and electronic health information exchange are essential to improving quality of care, reducing medical errors and health disparities, and advancing the delivery of patient-centered medical care. In the US correctional setting, these goals are critical because of the high numbers of Americans affected, yet the use of health information technology is quite limited. In this article, I describe the legal environment surrounding health information sharing in corrections by focusing on 2 key federal privacy laws: the Health Insurance Portability and Accountability Act of 1996 and the federal Confidentiality of Alcohol and Drug Abuse Patient Records laws. In addition, I review stakeholder concerns and describe possible ways forward that enable electronic exchange while ensuring protection of inmate information and legal compliance.
Assuntos
Confidencialidade , Registros Eletrônicos de Saúde/organização & administração , Health Insurance Portability and Accountability Act/organização & administração , Sistemas de Informação/organização & administração , Prisões/organização & administração , Segurança Computacional/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Health Insurance Portability and Accountability Act/legislação & jurisprudência , Humanos , Sistemas de Informação/legislação & jurisprudência , Prisões/legislação & jurisprudência , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Estados UnidosRESUMO
Large amounts of personal health data are being collected and made available through existing and emerging technological media and tools. While use of these data has significant potential to facilitate research, improve quality of care for individuals and populations, and reduce healthcare costs, many policy-related issues must be addressed before their full value can be realized. These include the need for widely agreed-on data stewardship principles and effective approaches to reduce or eliminate data silos and protect patient privacy. AMIA's 2012 Health Policy Meeting brought together healthcare academics, policy makers, and system stakeholders (including representatives of patient groups) to consider these topics and formulate recommendations. A review of a set of Proposed Principles of Health Data Use led to a set of findings and recommendations, including the assertions that the use of health data should be viewed as a public good and that achieving the broad benefits of this use will require understanding and support from patients.
Assuntos
Registros Eletrônicos de Saúde/normas , Política de Saúde , Confidencialidade/normas , Humanos , Disseminação de Informação , Política Organizacional , Acesso dos Pacientes aos Registros , Participação do Paciente , Sociedades Médicas , Estados UnidosRESUMO
We review the evolution of federal financing for child health care over the past 40 years. The Social Security Amendments of 1967 established the program of early and periodic screening, diagnosis and treatment (EPSDT) as a required Medicaid benefit. The EPSDT amendments directed agencies to cover "early and periodic" screening and diagnostic services to ascertain "defects" and "chronic conditions" in children, as well as health care and treatment needed to "correct or ameliorate" such defects and conditions discovered during the screening examinations. The 1997 enactment of the Children's Health Insurance Program (CHIP) shifted federal policy from the use of an early coverage standard to one that gives insurers much more discretion to define medical necessity and coverage exclusions. CHIP programs offer coverage that is narrower than the benefits available under Medicaid. The Affordable Care Act (ACA) requires significantly more classes of care to be covered than does CHIP but well below the level of coverage under Medicaid. Implementation of the ACA to date suggests that the US Department of Health and Human Services will only demand pediatric coverage pegged to the commercial insurance market standards, rather than Medicaid's unique pediatric coverage standard. Although EPSDT's emphasis on early, developmental, and ameliorative services might result in more comprehensive benefits for children, particularly those with special health needs, one might still describe the ACA coverage as providing a basic, minimal level of services from a distributive justice perspective. It may, however, vary from state to state. States have the authority to decide whether to use an EPSDT-style approach or to follow the more restrictive approach of commercial insurance plans. Advocacy at the state level will determine which approach different states take.
Assuntos
Serviços de Saúde da Criança/organização & administração , Política de Saúde , Cobertura do Seguro/organização & administração , Medicaid/organização & administração , Patient Protection and Affordable Care Act/organização & administração , Serviços Preventivos de Saúde/organização & administração , Criança , Proteção da Criança , Política de Saúde/economia , Política de Saúde/legislação & jurisprudência , Política de Saúde/tendências , Humanos , Estados UnidosAssuntos
Processamento Eletrônico de Dados/legislação & jurisprudência , Implementação de Plano de Saúde/legislação & jurisprudência , Disseminação de Informação/legislação & jurisprudência , Informática Médica/legislação & jurisprudência , Integração de Sistemas , American Recovery and Reinvestment Act/organização & administração , Aniversários e Eventos Especiais , Segurança Computacional/legislação & jurisprudência , Diagnóstico por Imagem , Regulamentação Governamental , Health Insurance Portability and Accountability Act/organização & administração , Humanos , Privacidade/legislação & jurisprudência , Telerradiologia , Estados UnidosAssuntos
Confidencialidade/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Processos Grupais , Experimentação Humana/legislação & jurisprudência , Privacidade/legislação & jurisprudência , Pesquisadores , Confiança , American Recovery and Reinvestment Act , Confidencialidade/ética , Confidencialidade/normas , Registros Eletrônicos de Saúde/ética , Experimentação Humana/ética , Experimentação Humana/normas , Humanos , Autonomia Pessoal , Pesquisadores/ética , Pesquisadores/legislação & jurisprudência , Sujeitos da Pesquisa , Manejo de Espécimes/ética , Estados UnidosAssuntos
Registros Eletrônicos de Saúde , Sistemas de Informação , Relações Médico-Paciente/ética , Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/legislação & jurisprudência , Registros Eletrônicos de Saúde/tendências , Humanos , Sistemas de Informação/ética , Sistemas de Informação/legislação & jurisprudência , Sistemas de Informação/tendências , Estados UnidosRESUMO
During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent's proper role in a health care environment in which electronic information sharing holds primary importance. This article discusses current implementation of the doctrine within health information exchange networks; the relationship between informed consent and privacy; the variety of ways that the concept is referenced in discussions of information sharing; and challenges that surround incorporation of the doctrine into the evolving HIT environment. The article concludes by reviewing the purpose behind the traditional obligation to obtain informed consent and the possibility of maintaining its relevance in the new environment.
Assuntos
Registros Eletrônicos de Saúde , Disseminação de Informação , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Registro Médico Coordenado , Humanos , Estados UnidosAssuntos
American Recovery and Reinvestment Act/organização & administração , Segurança Computacional/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Registros Eletrônicos de Saúde/legislação & jurisprudência , Prática de Saúde Pública/legislação & jurisprudência , Acesso à Informação/legislação & jurisprudência , Comércio/legislação & jurisprudência , Coleta de Dados/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Privacidade/legislação & jurisprudência , Estados UnidosAssuntos
Definição da Elegibilidade/legislação & jurisprudência , Privacidade Genética/economia , Testes Genéticos/economia , Planos de Assistência de Saúde para Empregados/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Seleção Tendenciosa de Seguro , Prática de Saúde Pública/legislação & jurisprudência , Employee Retirement Income Security Act , Privacidade Genética/legislação & jurisprudência , Testes Genéticos/legislação & jurisprudência , Health Insurance Portability and Accountability Act , Humanos , Aplicação da Lei , Preconceito , Previdência Social/legislação & jurisprudência , Impostos/legislação & jurisprudência , Estados UnidosRESUMO
The widespread adoption of health information technology (HIT) has been recognized as both a necessary element of health reform and a required building block of a modern, high performing health care system.