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5.
Rev Med Suisse ; 16(681): 307-309, 2020 Feb 12.
Artigo em Francês | MEDLINE | ID: mdl-32049451

RESUMO

Switzerland has a high rate of legal measures of constraint by international standard. Beside the incorporation of legal, medical and economic elements, the physician may be asked on what it means to be a care giver and to be free, because his decision could private his patient of a fundamental human right. The deprivation of freedom for purposes of assistance is helpful in some clinical situations but remains a controversial issue. We have to do our due diligence when assessing the patient, notably his capacity of discernment, and discuss with him and his relatives other treatments without legal constraint. The advance directives and the joint plan of crisis should be tools to increase patients' autonomy and to decrease the coercive measures.


Assuntos
Coerção , Tomada de Decisões , Hospitais Psiquiátricos , Direitos do Paciente/legislação & jurisprudência , Diretivas Antecipadas , Humanos , Transferência de Pacientes/legislação & jurisprudência , Médicos/psicologia , Suíça
6.
Neurology ; 94(7): 306-310, 2020 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-31969466

RESUMO

Stroke is the second leading cause of death worldwide and a leading cause of adult disability worldwide. More than a third of individuals presenting with strokes are estimated to have a preexisting disability. Despite unprecedented advances in stroke research and clinical practice over the past decade, approaches to acute stroke care for persons with preexisting disability have received scant attention. Current standards of research and clinical practice are influenced by an underexplored range of biases that may hinder acute stroke care for persons with disability. These trends may exacerbate unequal health outcomes by rendering novel stroke therapies inaccessible to many persons with disabilities. Here, we explore the underpinnings and implications of biases involving persons with disability in stroke research and practice. Recent insights from bioethics, disability rights, and health law are explained and critically evaluated in the context of prevailing research and clinical practices. Allowing disability to drive decisions to withhold acute stroke interventions may perpetuate disparate health outcomes and undermine ethically resilient stroke care. Advocacy for inclusion of persons with disability in future stroke trials can improve equity in stroke care delivery.


Assuntos
Assistência à Saúde/ética , Pessoas com Deficiência , Acidente Vascular Cerebral/terapia , Temas Bioéticos , Tomada de Decisão Clínica/ética , Ensaios Clínicos como Assunto , Assistência à Saúde/legislação & jurisprudência , Pessoas com Deficiência/legislação & jurisprudência , Pessoas com Deficiência/reabilitação , Disparidades em Assistência à Saúde , Humanos , Direitos do Paciente/ética , Direitos do Paciente/legislação & jurisprudência
8.
Rev. derecho genoma hum ; (51): 61-76, jul.-dic. 2019.
Artigo em Inglês | IBECS | ID: ibc-192372

RESUMO

On December 27, 2018, Law No. 13,787 was enacted in Brazil, regulating the electronic health record and establishing rules for its digitization and use. While already in force, the new Law refers to the General Data Protection Law - LGPD (Law No. 13,709 of August, 14, 2018, as amended by Law No. 13,853 of July 08, 2019), which will only come into effect in August 2020. In analyzing the documentary dimension of the right to health in the Brazilian regulation, this text proposes to analyze two issues: Could the electronic health record mean risk of leakage or misuse of patients' data in violation of their rights of personality? If the information is online, how could it be prevented from being accessed out of clinical objectives thus constituting a violation of the patient's personality rights?


El 27 de diciembre de 2018 se promulgó en Brasil la Ley Núm. 13.787, que regula la historia clínica electrónica y establece normas para su digitalización y uso. Si bien ya está vigente, la nueva Ley se refiere a la Ley General de Protección de Datos - LGPD (Ley Núm. 13.709 de 14 de agosto de 2018, modificada por la Ley Núm. 13.853 del 8 de julio de 2019), que sólo entrará en vigor en agosto de 2020. Al analizar la dimensión documental del derecho a la salud en la regulación brasileña, este trabajo propone analizar dos cuestiones: ¿Podría el historial médico electrónico significar un riesgo de uso indebido de los datos de los pacientes en violación de sus derechos de personalidad? Si la información está en línea, ¿cómo se puede evitar que se acceda a ella desde objetivos clínicos, lo que constituye una violación de los derechos de la personalidad del paciente?


Assuntos
Humanos , Sistemas Computadorizados de Registros Médicos/ética , Sistemas Computadorizados de Registros Médicos/legislação & jurisprudência , Direitos do Paciente/ética , Direitos do Paciente/legislação & jurisprudência , Privacidade/legislação & jurisprudência , Brasil
11.
Rom J Morphol Embryol ; 60(2): 729-735, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31658352

RESUMO

PURPOSE: The purpose of the present article is to discuss the ethical challenges of the European Union (EU) health legislation framing the patients' rights and the cross-border healthcare (CBHC). BACKGROUND: The paper reviews the EU main legislation in the field, namely the Directive 2011∕24∕EU (CBHC Directive) of the European Parliament and of the Council of 9 March 2011, on the application of patients' rights in CBHC. CONTENT: The aim of the study is to analyze the patients' rights and the CBHC, enhancing the healthcare support and coordination under this regulatory framework. An exploratory and descriptive analysis will be conducted based on these legal provisions by focusing the ethical choices, the ethical duty, the ethical reasons and the patients' rights. An introductory literature overview will be provided and an analysis of the recent data reports published by the European Commission (EC) on the application of the CBHC Directive will be detailed. Therefore, six main themes emerged: (i) the protection of the patients' rights; (ii) the examination of the ethical challenges to address the EU public health issues; (iii) the monitoring of the data reports on the operation of the CBHC Directive; (iv) the reimbursement of costs of CBHC; (v) the European reference networks (ERNs); (vi) the eHealth network and the health technology assessment (HTA). CONCLUSIONS: The paper reviews the existing legal framework aimed to support the Member States (MS) in achieving a harmonized implementation of the CBHC Directive. Hence, particular ethical issues will be developed under this regulatory framework.


Assuntos
União Europeia/organização & administração , Política de Saúde/legislação & jurisprudência , Direitos do Paciente/legislação & jurisprudência , Humanos
12.
Australas J Ageing ; 38 Suppl 2: 90-97, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31496062

RESUMO

OBJECTIVE: Examine policies of aged care organisations relating to healthcare and lifestyle decision-making. METHODS: Seven aged care organisations submitted policy documents. Policies were analysed using the Australian Law Reform Commission (ALRC) "Decision-Making Principles" as a framework. Senior staff (N = 9) with policy development roles participated in follow-up interviews. RESULTS: The structure and content of policy documents varied significantly between organisations. Most acknowledged the need to support the rights of care recipients in decision-making; however, the nature of this support was often unclear. Interview themes included factors relating to "organisational contexts" "policy development and implementation" and "ethical challenges." An overarching theme among high-performing organisations was "proactive response aimed at pre-empting decision-making dilemmas". We provide recommendations for policy development, including a self-assessment audit tool. CONCLUSION: Aged care provider organisations may need to review policies in the areas of healthcare and lifestyle decision-making to meet current best practice principles.


Assuntos
Comportamento de Escolha , Demência/terapia , Geriatria/legislação & jurisprudência , Serviços de Saúde para Idosos/legislação & jurisprudência , Estilo de Vida , Cultura Organizacional , Participação do Paciente/legislação & jurisprudência , Direitos do Paciente/legislação & jurisprudência , Formulação de Políticas , Acreditação/legislação & jurisprudência , Austrália , Demência/diagnóstico , Demência/psicologia , Geriatria/organização & administração , Serviços de Saúde para Idosos/organização & administração , Humanos , Autonomia Pessoal
13.
SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. Impr.) ; 45(5): 303-310, jul.-ago. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-188087

RESUMO

OBJETIVO: La Ley 4/2017 de Derechos y Garantías de las Personas en el Proceso de Morir de la Comunidad de Madrid regula el ejercicio de los derechos de la persona durante el proceso de su muerte. El objetivo principal de este estudio fue medir los conocimientos y preferencias sobre sedación paliativa (SP), eutanasia, suicidio médicamente asistido (SMA) y adecuación del esfuerzo terapéutico (AET). Materiales y métodos: Se diseñó un cuestionario para recoger conocimientos sobre definición y legalidad de los recursos detallados y preferencias o disposición al uso propio o para un familiar. Contestaron 192 asistentes a las Jornadas de Cuidados Paliativos (octubre 2017). RESULTADOS: Del total, 160 (83,3%) eran mujeres, con media de 39 años (DT = 15,8). El 68,2% (131) no conocían la existencia de la Ley. La definición con mayor tasa de acierto fue SP (89,1%; 171) y la de menor AET (50,5%; 97). Sobre legalidad, el más acertado fue eutanasia (94,8%; 182) y el menos AET (63,5%; 122). SP fue considerado el recurso más adecuado (93,2%; 179) y el de mayor disposición de uso tanto en familiares (91,7%; 176) como para ellos mismos (90,6%; 174). SMA fue el menos adecuado (34,4%; 66), y al que menos recurrirían en caso de final de vida de un familiar (29,7%; 57) y de sí mismos (33,3%; 64). CONCLUSIONES: Existe mayor conocimiento de la condición de legalidad o ilegalidad de cada recurso que de la definición de los términos. El uso del SMA y la eutanasia se desaprueba. Se ha de incidir en el esclarecimiento del significado de AET y aclarar la confusión con otras medidas como SP y SMA


OBJECTIVE: The Law (4/2017) on rights and guarantees of persons in the process of dying in Community of Madrid regulates the exercise of the rights of the person during this process. The main objective of this study was to determine the knowledge and preferences about palliative sedation (PS), euthanasia, physician-assisted suicide (PAS), and adequacy of the therapeutic effort (ATE). MATERIALS AND METHODS: A questionnaire was designed to collect knowledge about definition and legality of detailed resources, and disposition for themselves or for a relative. The questionnaire was completed by a total of 192 palliative care Conference attendees (October 2017). RESULTS: Of those that completed the questionnaire, 160 (83.3%) were women, and the mean age was of 39 years (SD = 15.8). More than two-thirds (131; 68.2%) did not know that the law existed. The definition with the highest rate of knowledge was on PS (89.1%; 171) and the lowest was ATE (50.5%; 97). On legality, the most successful was euthanasia (94.8%; 182) and the lowest was ATE (63.5%; 122). PS was considered the most appropriate resource (93.2%; 179), and the greater willingness of use in both relatives (91.7%; 176) as well as by themselves (90.6%; 174). PAS was the least suitable (34.4%; 66), and that less might resort in case of end-of-life of a relative (29.7%; 57), and themselves (33.3%; 64). CONCLUSIONS: There is a greater awareness of the condition of legality or illegality of each resource than of the definition of the terms. The use of the PAS and euthanasia is disapproved. It is important to clarify the meaning of ATE, and clarify its confusion with other measures such as PS and PAS


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde/estatística & dados numéricos , Direitos do Paciente/legislação & jurisprudência , Assistência Terminal/métodos , Atitude do Pessoal de Saúde , Atitude Frente a Morte , Eutanásia/legislação & jurisprudência , Eutanásia/psicologia , Cuidados Paliativos/legislação & jurisprudência , Cuidados Paliativos/psicologia , Suicídio Assistido/legislação & jurisprudência , Suicídio Assistido/psicologia , Inquéritos e Questionários , Assistência Terminal/legislação & jurisprudência , Espanha
14.
Ann Ist Super Sanita ; 55(2): 179-185, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31264641

RESUMO

BACKGROUND: Nowadays one of the most critical aspects of innovative cell-based therapies is the unregulated industry, as it is becoming a competitor of the regulated system. Many private clinics, worldwide, advertise and offer cell-based interventions treatments directly to the consumer and this poses a risk to both vulnerable patients and health systems. Several countries have implemented Compassionate Use Programmes (CUP) that provide patients with medicines that have not yet completed the approval pathway, in the event that no reasonable alternative exists. Recently, in the public discourse, compassionate use has been increasingly associated with a patient's right to try. Thus, the aim of this study was to assess public knowledge of the clinical trials process with specific reference to innovative stem cell treatments, and trust in the institutions responsible for regulatory activities. We also asked people about their "right" to use unregulated therapies. METHODS: We developed an ad hoc questionnaire on three main areas of concern and administered it to 300 people in the patient waiting room at an Italian university hospital. RESULTS: Our findings suggest that people have a good knowledge of the clinical trials process and trust in healthcare institutions. Nonetheless, one person in two believes it is a right to use unregulated therapies. CONCLUSIONS: We stress the need, in the age of cellular therapies, for a commitment to support vulnerable patients and to strengthen awareness among the public about the substantial boundary that differentiates experimental therapies from unproven therapies. There should not be a "right to try" something that is unsafe but rather approved treatments and in line with good clinical practice. The trend, which emerged on this issue from our study, is quite different, confirming the urgent need to improve health information so that it is as complete as possible.


Assuntos
Ensaios de Uso Compassivo , Direitos do Paciente , Direito à Saúde , Transplante de Células-Tronco , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos como Assunto , Ensaios de Uso Compassivo/ética , Ensaios de Uso Compassivo/legislação & jurisprudência , Cultura , União Europeia , Feminino , Humanos , Itália , Masculino , Turismo Médico , Pessoa de Meia-Idade , Direitos do Paciente/ética , Direitos do Paciente/legislação & jurisprudência , Segurança do Paciente , Direito à Saúde/ética , Direito à Saúde/legislação & jurisprudência , Risco , Transplante de Células-Tronco/ética , Transplante de Células-Tronco/legislação & jurisprudência , Terapias em Estudo/ética , Confiança , Estados Unidos , Adulto Jovem
15.
Rev. argent. salud publica ; 39(9): 31-34, Julio 2019.
Artigo em Espanhol | LILACS, BINACIS, ARGMSAL | ID: biblio-1007196

RESUMO

OBJETIVO: revisar el desarrollo de las políticas públicas y el marco legal en Argentina para garantizar el acceso a la interrupción legal del embarazo (ILE) sobre la base de los derechos sexuales y los derechos reproductivos. MÉTODOS: Se revisaron las leyes y jurisprudencia que establecen el marco legal para el acceso a la interrupción legal del embarazo, documentos técnicos oficiales y otros materiales bibliográficos que hacen referencia a dicho marco legal. RESULTADOS: Los resultados del análisis bibliográfico mostraron que Argentina cuenta con un marco legal, encabezado por el Código Penal de la Nación (CPN), que permite la ILE por las siguientes causales: peligro para la salud o la vida de la persona gestante o embarazo como producto de violación. El Fallo F., A. L. de la Corte Suprema de Justicia de la Nación estableció una lectura aclaratoria del CPN, propiciando las políticas públicas que garanticen el derecho a la ILE. CONCLUSIONES: Por un lado, a pesar del marco legal vigente en Argentina, todavía se presentan barreras para el acceso a la ILE; por el otro, es necesario reforzar las políticas públicas destinadas a garantizar dicho acceso, lo que implica seguir capacitando a los equipos de salud y continuar con la tarea de gestión de la Dirección de Salud Sexual y Reproductiva de la Secretaría de Gobierno de Salud de la Nación, junto con los ministerios provinciales.


Assuntos
Humanos , Feminino , Gravidez , Política Pública , Aborto Legal/legislação & jurisprudência , Direitos Sexuais e Reprodutivos/legislação & jurisprudência , Argentina , Saúde Pública , Direitos do Paciente/legislação & jurisprudência
16.
Health Hum Rights ; 21(1): 141-147, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31239622

RESUMO

The Philippine community internship program, originally created to supplement the country's thinning health workforce while providing training to student doctors, poses a legal and ethical challenge for medical interns. Inherent characteristics of the program-such as financial disparities and burdens, the lack of supervision by senior doctors, the competence of student doctors, and short rotation times-can predispose interns to cause harm to the patients and communities they serve. As currently designed, the internship program has the capacity to leave interns unsupervised, at risk of legal ramifications, constantly questioning the correctness of their interventions, and perpetually straddling conflicting role virtues. By failing to ensure that the community internship program has appropriate safeguards in place, the government not only jeopardizes the welfare of interns but also threatens the quality and continuity of care that patients and communities receive, potentially violating their right to the highest attainable standard of health. One medical school recently started a novel internship program that could address the issues mentioned.


Assuntos
Competência Clínica/normas , Internato e Residência/normas , Direitos do Paciente , Estudantes de Medicina , Educação de Graduação em Medicina/normas , Humanos , Direitos do Paciente/legislação & jurisprudência , Filipinas , População Rural , Estudantes de Medicina/legislação & jurisprudência
17.
Int J Equity Health ; 18(1): 26, 2019 06 03.
Artigo em Inglês | MEDLINE | ID: mdl-31155007

RESUMO

BACKGROUND: The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that "prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process". However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. METHODS: Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. RESULTS: The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients' rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. CONCLUSION: The countries of Latin America and South Korea, currently, do not have laws that address patients' rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.


Assuntos
Ensaios Clínicos como Assunto , Continuidade da Assistência ao Paciente/economia , Humanos , América Latina , Direitos do Paciente/legislação & jurisprudência , República da Coreia
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