Hasil untuk "Medical legislation"

Longmei Tian

As the right of patients to make autonomous decisions about life-sustaining treatment has gained wider recognition, many countries have introduced legislation on living wills. Over the past two decades, mainland China has seen a gradual shift from voluntary advocacy by civil-society organizations to initial local legislation, culminating in the Shenzhen Special Economic Zone Medical Regulations (2023), the first statute to recognize the legal effect of living wills. Yet the emerging living will system continues to be hindered by multiple factors at both the legislative and implementation stages. This article identifies three main challenges: vague statutory definitions of key concepts; the lack of supporting mechanisms, particularly for registration and revocation; and tensions between the practice of living wills and traditional cultural understandings of death and filial piety. On this basis, it proposes reforms to clarify in legislation the qualifications of parties eligible to execute living wills and the scope of their application, to establish a unified and accessible registration–revocation system, and to reinterpret the normative foundations of the living will system in light of local cultural values. The analysis aims to provide a roadmap for strengthening institutional safeguards for patients' medical autonomy in China and to offer comparative insights for other developing countries considering similar legislation.

A. V. Semenov, S. S. Smirnova, I. A. Egorov et al.

In the context of the COVID-19 pandemic, the problem of biological safety of patients and staff of medical organizations has reached a new level. The peculiarities of the functioning of infectious diseases hospitals for the treatment of patients with COVID-19 led to the formation of an artificial ecosystem in which conditions for the active circulation of viral and bacterial pathogens were formed. The aim of the study was to analyze monitoring data on compliance with sanitary legislation requirements in infectious disease hospitals of the Russian Federation where patients with COVID-19 are treated over a two-year period. Materials and methods. A retrospective epidemiological analysis of the Microsoft Office Excel database with a volume of 8.73 MB was carried out, based on the results of weekly monitoring of compliance with sanitary legislation in infectious diseases hospitals for the treatment of COVID-19 patients in the Russian Federation in the system report.gsen.ru for the period from week 42 of 2021 to week 42 of 2023. The analysis includes information on compliance with the requirements of sanitary legislation in 614 infectious diseases hospitals for the treatment of COVID-19 patients with a total bed capacity of 37,270, including 5,961 in intensive care units. Results and discussion. The inspection of infectious diseases hospitals by the Rospotrebnadzor bodies was carried out mainly within the framework of sanitary and epidemiological investigations. The main violations of sanitary legislation related to disinfection (27.7 %), provision of personnel with personal protective equipment (13.4 %) and separation of flows of varying degrees of epidemiological significance (12.3 %). The level of contamination of hospital facilities in infectious diseases hospitals with SARS-CoV-2 and opportunistic micro-flora was 0.3 % and 0.6 %, respectively. The opportunistic micro-flora isolated from the biological material of patients and from the objects of the hospital environment of infectious hospitals was comparable to each other, and represented by the families Staphylococcus, Enterobacterales (Klebsiella, Enterobacter, Escherichia coli) and gram-negative non-fermenting bacteria (Acinetobacter baumanii, Pseudomonas aeruginosa). Thus, in the context of the pandemic and the increased burden on infectious diseases hospitals, conditions are formed that increase the risks of the spread of HAIs among staff and patients. The results of this study should be taken into account when conducting control and supervisory measures, epidemiological investigations and organizing training sessions to prepare medical organizations to work in conditions of mass spread of infectious diseases.

Fatihana Nasution, Aji Lukman Ibrahim

This study aims to determine the practice of implementing telemedicine in Indonesia and examine the legal formulation of telemedicine implementation to prevent malpractice risks to patients. The study employs a normative juridical method with a statutory and conceptual approach. Secondary data is utilised, including primary (legislation), secondary (literature reviews), and tertiary legal materials (dictionaries) relevant to telemedicine and its legal implications. The findings reveal that Indonesia currently lacks specific regulations governing telemedicine. The existing Health Minister Regulation Number 20 of 2019 is inadequate to comprehensively guide telemedicine practices in the country. As a result, the implementation of telemedicine carries significant legal risks. Based on established principles of medical practice, telemedicine poses malpractice risks because doctors do not physically examine patients. Furthermore, the current regulations fail to address the primary aspects of telemedicine comprehensively, exacerbating the risk of malpractice and creating legal uncertainty when malpractice occurs. To address these issues, it is crucial to develop specific telemedicine regulations. These regulations should define the doctor-patient relationship, outline the rights and obligations of all parties, ensure the protection of electronic medical records, establish criminal sanctions for violations, and create an independent supervisory body to oversee telemedicine practices.

Andrzej Grzybowski, Piotr Brona

Abstract Artificial intelligence (AI)-based medical devices are already commercially available in Europe. The regulations surrounding the introduction and use of medical AI devices in the European Union (EU) are different to those in the USA, and the specifics of European legislature in medical AI are not commonly known. European law classifies medical devices into four classes: I, IIa, IIb, and III, depending on the perceived risk level of the device. Medical devices are certified under independent nongovernment bodies, and some can even self-certify their compliance with EU standards. The European “open” approach is vastly different from the strict perspective of the FDA, as reflected by the number of available medical AI devices. The EU is currently in a transitory period between two regulations, further complicating the legislative landscape. The devices in question deal with extremely sensitive data, collecting, processing, and sending images and diagnoses over the internet. The EU approach puts a large burden of verifying the effectiveness and integrity of the AI device on the consumer, without giving consumers many tools to do that effectively. This highlights the need for effective legislation and oversight from governing bodies, as well as the need for understanding the legalities and limitations of AI devices for those implementing them in clinical practice.

Diana Yenifer Servellón Castellanos

La Antropología Forense aporta elementos que contribuyen para que las víctimas y sus familiares encuentren la verdad, la justicia, la memoria, la reparación y la reconciliación. El presente artículo tiene por objeto destacar la importancia de brindar soluciones a las familias de personas desaparecidas por causas delincuenciales, ambientales, migratorias, entre otras, y que no han recibido una justicia pronta. Supone un pequeño contexto sobre los avances que se han realizado en Honduras en la materia, y reflexiona sobre la importancia de crear con urgencia una ley de personas desaparecidas y un programa que incorpore la creación de los equipos de Antropología Forense y los apoyos internacionales necesarios para el reconocimiento de las víctimas.

Alisson Nohelia Lanza Duarte, Jackeline Alger, César Augusto Durán López

Antecedentes: Las autopsias son esenciales para investigar las enfermedades emergentes ya que contribuyen a comprender su fisiopatología y fundamentar el tratamiento. Objetivo: Describir las publicaciones sobre autopsias de casos COVID-19 en el marco de la pandemia, 2019-2020. Metodología: Revisión de alcance. Periodo: publicaciones de noviembre 2019 a diciembre 2020. Términos utilizados: autopsia, cambios post mortem, hallazgos incidentales, infecciones por coronavirus, en sujetos humanos, en español e inglés; en bases de datos Research4Life, PubMed, LILACS, Researchgate. Se utilizó el estándar PRISMA. El protocolo fue aprobado por Unidad de Investigación Científica (UIC) de la Facultad de Ciencias Médicas (FCM), Universidad Nacional Autónoma de Honduras (UNAH). Resultados: De un total de 320 artículos identificados, se seleccionaron 42, correspondientes a 582 autopsias, todos en el idioma inglés. De los 42 artículos, los dos países con más publicaciones fueron de Estados Unidos 16 y Alemania 5. En 27 el rango de autopsias reportadas fue 1-10. En 17 las medidas de bioseguridad implementadas no fueron consignadas y en 13 no fueron especificadas. En 19, no se describe si las autopsias fueron completas o parciales. Las autopsias completas se reportaron en 14 publicaciones, parciales en cinco y autopsias completas y parciales en cuatro. En 11 publicaciones no se describieron los hallazgos macroscópicos; en los 42 trabajos se examinaron los tejidos con microscopio óptico, en 28 se utilizaron marcadores inmunohistoquímicos y en 7 microscopio electrónico. El órgano descrito principalmente fue pulmón en 40 estudios. Conclusiones e implicaciones: Son necesarias más publicaciones reportando series de autopsias completas, retomar la importancia del estudio de todos los órganos y la determinación de las causas de muerte por COVID-19. A diciembre de 2020, en América Latina no se había publicado estudios sobre autopsias. Las implicaciones para el manejo de casos y políticas públicas demuestran que se debe invertir en la realización de autopsias incluyendo los estudios histopatológicos que se requieran.  

Renato Duro Dias, Mariana Lannes Lindenmeyer, Fabiane Simioni et al.

O presente artigo investigou o processo de naturalização das práticas de violência obstétrica e de constante silenciamento sofrido pelas mulheres. O estudo pretendeu verificar se a hegemonia do discurso dos profissionais de saúde interfere na percepção dos casos de violência obstétrica. A partir da perspectiva histórica sobre o tema, foi possível compreender a origem do debate e sua delimitação enquanto violência sofrida pelas mulheres na assistência ao parto ou ao abortamento. Em um segundo momento, evidenciada a problemática em torno das relações entre profissionais de saúde e pacientes, o estudo tratou da teoria política de Ernesto Laclau e de Chantal Mouffe, matriz teórica de análise dos fenômenos sociais e políticos. No presente caso, esta teoria compôs a análise sobre a formação do discurso hegemônico existente na área da saúde. Demonstrada tal hegemonia discursiva, demonstrou-se ainda a interferência dessa realidade na percepção dos casos de violência obstétrica. Por fim, analisou-se alternativas para a transformação do discurso em hegemonia.

Endro Tri Susdarwono

Abstract: Health is not a health un sick, since it is contextual, as society defines health differently, at least by four aspects: cultural pattern, the cultural standard of health changes over time, technology affecting people’s health, social inequality affecting people’s health. Poor and wealthy countries have their specific health issues. In poor countries, health problems are mostly famine, malaria, cholera/diaries, skin disease, and infection. Health problems are mostly caused by a bad environment, dirty water, and bad sanitation. Health problems in rich countries, especially in the US, are mostly heart attack stroke, and obesity. There are two approaches to health social policy: the prevention and the cure. Prevention is sometimes called the social well-being policy to increase people’s health conditions. Another understanding of prevention is social work, which has a broader meaning that social life does not only refer to health. While the cure is commonly understood as a “social health care system”, as noted by Johnson and Schwartz defined as a system generally responsible for sickness and disability. Why government shall develop health policy, create a mechanism for health care, and manage health prevention ?”. The first answer is that a healthy society is an assurance for national productivity, and therefore competitiveness. The second answer is that a healthy society generates additional disposable income. There is no single best way to develop health policy. There are many rooms and spaces to develop creative health policy. Keywords:       health, health social policy, healthy society, national productivity.     Abstrak: Kesehatan bukanlah kesehatan yang tidak sakit, karena itu bersifat kontekstual, sebagaimana masyarakat mendefinisikan kesehatan secara berbeda, setidaknya melalui empat aspek: pola budaya, standar budaya kesehatan yang berubah dari waktu ke waktu, teknologi mempengaruhi kesehatan masyarakat, ketimpangan sosial yang mempengaruhi kesehatan masyarakat. Negara miskin dan kaya memiliki masalah kesehatan khusus mereka sendiri. Di negara-negara miskin, masalah kesehatan paling banyak terjadi pada kelaparan, malaria, kolera / buku harian, penyakit kulit dan infeksi. Masalah kesehatan sebagian besar disebabkan oleh lingkungan yang buruk, air kotor dan sanitasi yang buruk. Masalah kesehatan di negara kaya, terutama di AS, kebanyakan adalah serangan jantung, stroke, dan obesitas. Ada dua pendekatan kebijakan sosial kesehatan: pencegahan dan pengobatan. Pencegahan terkadang disebut sebagai kebijakan kesejahteraan sosial yang bertujuan untuk meningkatkan kondisi kesehatan masyarakat. Pengertian lain dari pencegahan adalah pekerjaan sosial, yang memiliki arti lebih luas bahwa kehidupan sosial tidak hanya mengacu pada kesehatan. Sementara penyembuhan umumnya dipahami sebagai “sistem perawatan kesehatan sosial”, sebagaimana dicatat oleh Johnson dan Schwartz didefinisikan sebagai sistem yang secara umum bertanggung jawab atas penyakit dan kecacatan. Mengapa pemerintah harus mengembangkan kebijakan kesehatan, membuat mekanisme perawatan kesehatan, dan mengelola pencegahan kesehatan? ”. Jawaban pertama, masyarakat yang sehat merupakan jaminan bagi produktivitas nasional, dan oleh karena itu berdaya saing. Jawaban kedua adalah bahwa masyarakat yang sehat menghasilkan pendapatan tambahan. Tidak ada satu cara terbaik untuk mengembangkan kebijakan kesehatan. Ada banyak ruang dan ruang untuk mengembangkan kebijakan kesehatan kreatif. Kata kunci: kesehatan, kebijakan sosial kesehatan, masyarakat sehat, produktivitas nasional.

Gustavo Penacino, Facundo Zapata, Ixchel De la Luz Martínez et al.

Desde hace 15 años la Sociedad Latinoamericana de Genética Forense realiza un ejercicio de calidad, comparativo interlaboratorios teórico y práctico, cuyo objetivo principal es contribuir al fortalecimiento de los laboratorios de genética forense participantes. Se analizó el registro de resultados publicados en el portal web de la sociedad (http://www.slagf.org), encontrándose que el error promedio cuando se analizan STRs autosómicos es del 2,01% y de 2,28% para STRs del Cromosoma Y, a lo largo de estos años, también se observó una evolución de la metodología analítica utilizada, lo que se refleja en el número de errores detectados. Se requiere realizar un proceso de reorganización de los ejercicios de calidad para seguir contribuyendo al fortalecimiento de los laboratorios dedicados a la genética forense.

O. P. Oliynyk

Background. Mental disorders as a result of various forms of addictions and high criminogenicity of such persons has led to the need for a number of legislative changes in the field of jurisprudence (law), medicine and expertise. Materials and methods. Mental state of 661 examinees persons was studied. The presence of states of dependence on psychoactive substances and their impact on the ability to apprehend the sense of one’s actions and manage (ASAM) them and apprehend the sense of one’s actions (ASA) was studied. Objective: to develop a model of forensic psychiatric expert assessment of the ability of persons with states of dependence on the psychoactive substances to apprehent their actions and (or) manage them in accordance with existing legislation. Results and conclusions. It was established that 1.1% of examenees could not ASAM completely in criminal proceedings, 93.2% could ASAM, and 5.7% could not ASAM. In the civil process, with a retrospective definition of the mental state at the time of the conclusion of an agreement, an expert decision on the significant impact of psychoactive substances was made in 45% of cases, on the preservation of the ability to ASAM - 31.7%, of the inability to ASAM - 23.3%. This testifies to the non-use of expert practice in making decisions on "restraint locus standi” in the widespread use of the category of "limited capacity" in the civil process, which leads to an unjustified restriction of judges in choosing medical and legal measures for the prevention of repeated crimes by persons with states of dependence on psychoactive substances.

Chandrashekar Hongally, Madhumitha Nanditale Sripad, Raju Nadakuru et al.

Introduction: Mental Healthcare Act (MHCA) 2017 is an act passed to regulate and provide mental health care and services. The act considers psychiatrists as one of the main mental health providers. Liabilities are prescribed under various chapters of MHCA 2017. It is imperative for practitioners to be completely aware of and follow the rules as per MHCA 2017, now that the rules are already framed. Materials and Methods: A thorough review of MHCA 2017, Central Mental Health Rules, and State Mental Health Rules 2018 was done. In addition, related scientific articles were accessed in PubMed and Google Scholar using keywords such as mental health legislation, law, and mental health. Relevant articles were reviewed to arrive at suggestions. Observations: Important liabilities are around the domains of registration of professionals and institutions, maintenance of records, promoting the rights of the persons with mental illness during treatment, and following the provisions of MHCA 2017 during admission and discharge. Punishment for contravention of provisions of the Act or rules or regulations made thereunder is clear and stringent and may vary from fine to imprisonment. Suggestions: Mental Health Professionals should understand the provisions of MHCA 2017 along with the rules and regulations made under this act. Please maintain basic medical records of all outpatients and inpatients and basic report of psychological assessments and release it upon request by the patient or nominated representative.

Vicente Torres Zúniga

Actualmente se encuentran disponibles en internet una serie de herramientas digitales cómodas y de sencilla adquisición que permiten realizar análisis de muy alta calidad y confiabilidad, en relación a los métodos de análisis tradicionales o más difundidos en la literatura estándar, programas de cómputo para obtener parámetros y hasta realizar reconstrucciones virtuales. Sin embargo, tales herramientas requieren de mayor difusión entre la comunidad científico-forense, por lo que proponemos la utilización de Tracker –un software-libre, robusto y multiplataforma como herramienta para analizar videograbaciones de interés forense, en particular en hechos de tránsito. Para ello nos apoyamos en el estudio de una videograbación que muestra el atropellamiento de un peatón, quien es lanzado después de rodar sobre el cofre y parabrisas del vehículo. Explicamos cada una de las etapas del análisis hasta obtener la velocidad de impacto del vehículo: ~54 km/hr. Contrastamos esta información con un modelo virtual y con cinco ecuaciones teóricas, obteniendo una alta concordancia entre las cotas calculadas. Con el aumento cotidiano de videograbaciones y la popularización de los medios para observarlas, este software representa una herramienta adecuada para calcular parámetros físicos, pues permite la contrastación y el desarrollo de teorías en casos forenses particulares

Klaus Rose, Hans Kummer

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

I. P. Krynychna

The article studies the historical experience of reforming the health care system in Ukraine, which allow clearing up the basic problems of public administration. Thus, the health care legislation is characterized as a fragmentary and complex thing with common overlaps and vaguely defined areas of accountability of financial and material resources and a significant deficit of funding. In turn, there is an urgent need for a fundamental change in strategy of the state policy concerning the restructuring of the health care system, which would involve fundamentally new mechanisms of public administration that must be adapted to the specific social problems and opportunities, particularly in conditions of limited resources. It is determined that reforming the health care systems of the former Soviet Union countries has similar nature with Ukraine, namely: the lack of government funding, poor quality of medical care, high level of medical services payment by citizens, the low level of wages of health care employees, and, as a consequence, the limited availability of the population to qualitative health services. On the basis of the results of the analysis of existing and not solved problems of the health care system it is proved the necessity to introduce new mechanisms of control in this field: the development of a system of compulsory medical insurance; the combination of budget and insurance sources of financing the health care system; the growing funding for the health care system; the development of initial care; adjustment of the state guarantees, according to the state financial opportunities; increasing the wages of health care employees; search for new organizational forms of health care institutions; increase the efficiency of health care resources; privatization and improvement of the structure of the medical care system . Keywords: public administration, health care reform, health insurance, initial care, medical care, medical services, health care resources.

Damian Clarke

Introduction. This study audited the process of ethics approval for Master’s research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa.Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master’s proposal for the year 2010 was reviewed. Results. A total of 53 proposals for Master’s degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32) for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC)) to respond to each of the 53 proposals. Twenty-three studies (43.4%) received provisional approval on the first response, 2 proposals (3.8%) were rejected, and 28 proposals (52.8%) were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.

DALLARI, Sueli Gandolfi

No início das jornadas comemorativas do 10º aniversário de nossa Revista de Direito Sanitário lembramos — num editorial — um pouco da evolução internacional e brasileira dos estudos de Direito Sanitário. Hoje, quero chamar a atenção para a importância atual do tema no direito interno. Com efeito, após a convocação da audiência pública n. 4, realizada pelo Supremo Tribunal Federal para debater as questões relativas às demandas judiciais que objetivam prestações de saúde, pode-se afirmar que o Direito Sanitário passou a ser, efetivamente, uma disciplina jurídica reconhecida.

COMPARATO, Fábio Konder

Jurisprudência em perspectiva. Comentários.

Cristina Esteves Jordão, Poliana Reche Mêdola, Luciane Cruz Lopes et al.

O uso do placebo em pesquisa clínica desperta controvérsias especialmente em estudos envolvendo seres humanos. O propósito deste trabalho é analisar o emprego ético de grupo controle-placebo e a proteção dos sujeitos da pesquisa em estudos clínicos realizados no Brasil, desde a Resolução do Conselho Nacional de Saúde CNS 196/96. Fez-se revisão sistemática (1997 a 2006) nas bases de dados Lilacs, Medline e SciELO, de estudos clínicos realizados no país com o uso de placebo e analisou-se sua natureza e aceitação ética, tendo em vista as disposições da referida Resolução.

Marco Aurélio Antas Torronteguy

Resenha sobre a publicação "Propriedade intelectual e saúde pública" de Carlos María Correa (Fundação Boiteux, Florianópolis, 2007)

BALBINOT, Rachelle Amália Agostini

Resenha sobre a publicação "Les Grands Principes du Droit de la Santé",