RESUMEN
Concerns about genetic discrimination (GD) often surface when discussing research and innovation in genetics. Over recent decades, countries around the world have attempted to address GD using various policy measures. In this article, we survey these approaches and provide a critical commentary on their advantages and disadvantages. Our examination begins with regions featuring extensive policy-making activities (North America and Europe), followed by regions with moderate policy-making activities (Australia, Asia, and South America) and regions with minimal policy-making activities (the Middle East and Africa). Our analysis then turns to emerging issues regarding genetic testing and GD, including the expansion of multiomics sciences and direct-to-consumer genetic tests outside the health context. We additionally survey the shortcomings of current normative approaches addressing GD. Finally, we conclude by highlighting the evolving nature of GD and the need for more innovative policy-making in this area.
Asunto(s)
Privacidad Genética/legislación & jurisprudencia , Pruebas Genéticas/legislación & jurisprudencia , Genómica/ética , Genómica/legislación & jurisprudencia , Política Pública , Humanos , Legislación Médica , PrejuicioRESUMEN
Importance: Philanthropy is an increasingly important source of support for health care institutions. There is little empirical evidence to inform ethical guidelines. Objective: To assess public attitudes regarding specific practices used by health care institutions to encourage philanthropic donations from grateful patients. Design, Setting, and Participants: Using the Ipsos KnowledgePanel, a probability-based sample representative of the US population, a survey solicited opinions from a primary cohort representing the general population and 3 supplemental cohorts (with high income, cancer, and with heart disease, respectively). Exposures: Web-based questionnaire. Main Outcomes and Measures: Descriptive analyses (with percentages weighted to make the sample demographically representative of the US population) evaluated respondents' attitudes regarding the acceptability of strategies hospitals may use to identify, solicit, and thank donors; perceptions of the effect of physicians discussing donations with their patients; and opinions regarding gift use and stewardship. Results: Of 831 individuals targeted for the general population sample, 513 (62%) completed surveys, of whom 246 (48.0%) were women and 345 (67.3%) non-Hispanic white. In the weighted sample, 47.0% (95% CI, 42.3%-51.7%) responded that physicians giving patient names to hospital fundraising staff after asking patients' permission was definitely or probably acceptable; 8.5% (95% CI, 5.7%-11.2%) endorsed referring without asking permission. Of the participants, 79.5% (95% CI, 75.6%-83.4%) reported it acceptable for physicians to talk to patients about donating if patients have brought it up; 14.2% (95% CI, 10.9%-17.6%) reported it acceptable when patients have not brought it up; 9.9% (95% CI, 7.1%-12.8%) accepted hospital development staff performing wealth screening using publicly available data to identify patients capable of large donations. Of the participants, 83.2% (95% CI, 79.5%-86.9%) agreed that physicians talking with their patients about donating may interfere with the patient-physician relationship. For a hypothetical patient who donated $1 million, 50.1% (95% CI, 45.4%-54.7%) indicated it would be acceptable for the hospital to show thanks by providing nicer hospital rooms, 26.0% (95% CI, 21.9%-30.1%) by providing expedited appointments, and 19.8% (95% CI, 16.1%-23.5%) by providing physicians' cell phone numbers. Conclusions and Relevance: In this survey study of participants drawn from the general US population, a substantial proportion did not endorse legally allowable approaches for identifying, engaging, and thanking patient-donors.
Asunto(s)
Actitud Frente a la Salud , Obtención de Fondos/métodos , Donaciones , Hospitales , Pacientes/psicología , Rol del Médico/psicología , Adulto , Distribución por Edad , Anciano , Estudios de Cohortes , Economía Hospitalaria , Femenino , Obtención de Fondos/ética , Donaciones/ética , Cardiopatías , Hospitales/ética , Humanos , Renta , Masculino , Persona de Mediana Edad , Neoplasias , Pacientes/estadística & datos numéricos , Probabilidad , Distribución por Sexo , Factores Socioeconómicos , Encuestas y Cuestionarios/estadística & datos numéricos , Estados Unidos , Adulto JovenAsunto(s)
Confidencialidad/legislación & jurisprudencia , Health Insurance Portability and Accountability Act , Registros de Salud Personal , Privacidad/legislación & jurisprudencia , Europa (Continente) , Unión Europea , Health Insurance Portability and Accountability Act/historia , Health Insurance Portability and Accountability Act/legislación & jurisprudencia , Historia del Siglo XX , Humanos , Legislación como Asunto , Mercadotecnía , Estados UnidosRESUMEN
In this commentary article, I will identify and examine a variety of themes that arise in narratives written by 12 physician authors that detail their experiences with grateful patient fundraising. Grateful patient fundraising serves an important role in health care philanthropy. Donations by grateful patients offer practical benefits to society and altruistic giving can personally benefit donors and family members; however, solicitation of donations by physicians raises a number of legal and ethical issues including, concerns about equity and health information confidentiality. To prevent eroding or distorting the physician-patient relationship, physicians involved in grateful patient fundraising must adhere to ethical guidelines and recommendations.
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Obtención de Fondos , Médicos , Humanos , Principios Morales , Narración , Relaciones Médico-PacienteRESUMEN
This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail below, the voluminous and diverse data collected by some independent scientists who use mobile applications to conduct health research may be at risk for unregulated privacy and security breaches, leading to dignitary, psychological, and economic harms for which participants have few legally enforceable rights or remedies under current federal law. Federal lawmakers may wish to consider enacting new legislation that would require otherwise unregulated health data holders to implement reasonable data privacy, security, and breach notification measures.
Asunto(s)
Confidencialidad/legislación & jurisprudencia , Recolección de Datos/métodos , Aplicaciones Móviles/legislación & jurisprudencia , Investigación/legislación & jurisprudencia , Telemedicina/legislación & jurisprudencia , Confidencialidad/normas , Regulación Gubernamental , Health Insurance Portability and Accountability Act , Humanos , Aplicaciones Móviles/normas , Investigación/normas , Investigadores/clasificación , Telemedicina/normas , Estados UnidosRESUMEN
This article focuses on state privacy, security, and data breach regulation of mobile-app mediated health research, concentrating in particular on research studies conducted or participated in by independent scientists, citizen scientists, and patient researchers. Prior scholarship addressing these issues tends to focus on the lack of application of the HIPAA Privacy and Security Rules and other sources of federal regulation. One article, however, mentions state law as a possible source of privacy and security protections for individuals in the particular context of mobile app-mediated health research. This Article builds on this prior scholarship by: (1) assessing state data protection statutes that are potentially applicable to mobile app-mediated health researchers; and (2) suggesting statutory amendments that could better protect the privacy and security of mobile health research data. As discussed in more detail below, all fifty states and the District of Columbia have potentially applicable data breach notification statutes that require the notification of data subjects of certain informational breaches in certain contexts. In addition, more than two-thirds of jurisdictions have potentially applicable data security statutes and almost one-third of jurisdictions have potentially applicable data privacy statutes. Because all jurisdictions have data breach notification statutes, these statutes will be assessed first.
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Ciencia Ciudadana/métodos , Seguridad Computacional/legislación & jurisprudencia , Confidencialidad/legislación & jurisprudencia , Notificación Obligatoria , Aplicaciones Móviles/legislación & jurisprudencia , Investigación/legislación & jurisprudencia , Regulación Gubernamental , Humanos , Investigadores/clasificación , Gobierno Estatal , Estados UnidosRESUMEN
This article assesses the protections provided by state research laws for participants in mobile application (mobile app) mediated health research conducted by independent scientists, citizen scientists, and patient researchers. Prior scholarship in this area focuses on the lack of application of: (1) federal regulations governing research conducted or funded by one of sixteen signatory federal departments and agencies (the Common Rule); and (2) separate federal regulations promulgated by the Food and Drug Administration applicable to research conducted in anticipation of a submission to the FDA for approval of a drug or medical device. This article builds on this prior scholarship by carefully examining state research laws and suggesting ways in which these laws could be improved to better protect participants of mobile appmediated research conducted by independent scientists, citizen scientists, and patient researchers.
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Ciencia Ciudadana/métodos , Experimentación Humana/legislación & jurisprudencia , Aplicaciones Móviles/legislación & jurisprudencia , Investigación/legislación & jurisprudencia , Regulación Gubernamental , Humanos , Investigadores/clasificación , Gobierno Estatal , Estados UnidosRESUMEN
Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.
Asunto(s)
Investigación Biomédica/legislación & jurisprudencia , Computadoras de Mano , Ética en Investigación , Aplicaciones Móviles , Políticas , Telemedicina , Investigación Biomédica/tendencias , Guías como Asunto , Humanos , Investigadores/clasificación , Estados UnidosRESUMEN
In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the legal focus has shifted to the states. Signaling a new direction in state data privacy and consumer protection law, the California Consumer Privacy Act establishes important rights and protections for California residents with regard to the collection, use, disclosure, and sale of their personal information. The CCPA is certain to spur similar legislation and to affect national and international businesses that collect data from California's residents. Understanding the new law is important for all data-driven industries, including health care.
Asunto(s)
Confidencialidad/legislación & jurisprudencia , Recolección de Datos/métodos , Difusión de la Información/legislación & jurisprudencia , Sistemas de Registros Médicos Computarizados/legislación & jurisprudencia , Defensa del Paciente/legislación & jurisprudencia , Privacidad/legislación & jurisprudencia , California , Gobierno Federal , Regulación Gubernamental , Health Insurance Portability and Accountability Act , Humanos , Estados UnidosRESUMEN
Federal regulations governing human subjects research do not address key questions raised by incidental neuroimaging findings, including the scope of a researcher's disclosure with respect to the possibility of incidental findings and the question whether a researcher has an affirmative legal cuty to seek, detect, and report incidental findings. The scope of researcher duties may, however, be mapped with reference to common law doctrine, including fiduciary, tort, contract, and bailment theories of liability.
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Investigación Biomédica/legislación & jurisprudencia , Revelación/legislación & jurisprudencia , Hallazgos Incidentales , Sujetos de Investigación/legislación & jurisprudencia , Investigación Biomédica/ética , Encéfalo/patología , Diagnóstico por Imagen , Revelación/ética , Humanos , Consentimiento Informado/ética , Neurociencias/ética , Neurociencias/métodos , Relaciones Investigador-Sujeto/ética , Estados UnidosRESUMEN
Under the umbrella of the burgeoning neurotransdisciplines, scholars are using the principles and research methodologies of their primary and secondary fields to examine developments in neuroimaging, neuromodulation and psychopharmacology. The path for advanced scholarship at the intersection of law and neuroscience may clear if work across the disciplines is collected and reviewed and outstanding and debated issues are identified and clarified. In this article, I organize, examine and refine a narrow class of the burgeoning neurotransdiscipline scholarship; that is, scholarship at the interface of law and functional magnetic resonance imaging (fMRI).