Hasil untuk "Medical legislation"

J. Asarnow, Michelle Rozenman, Jessica Wiblin et al.

Ana Estela Haddad, Deise Garrido, Leonardo Shibata et al.

Este artigo analisou a evolução da regulação da telessaúde no Brasil, com ênfase na sua incorporação às políticas públicas por meio do Programa SUS Digital, iniciativa coordenada pela Secretaria de Informação e Saúde Digital do Ministério da Saúde. Trata-se de uma revisão narrativa, elaborada por meio da análise normativa de instrumentos legais e infralegais, incluindo leis, decretos, portarias ministeriais e resoluções dos conselhos profissionais da área da saúde. O estudo organiza a trajetória da telessaúde em três grandes fases: iniciativas-piloto e primeiros marcos legais; institucionalização progressiva com apoio de programas ministeriais; e consolidação normativa com a Lei n. 14.510/2022, que autoriza a prática da telessaúde em caráter permanente. Argumenta-se que a pandemia da covid-19 foi um catalisador para mudanças normativas e operacionais, viabilizando o uso ampliado da telessaúde em todos os níveis de atenção. Os resultados alinham-se a investigações anteriores que destacam o papel da telessaúde na ampliação do acesso e na qualificação do cuidado, especialmente em regiões remotas. A criação da Secretaria de Informação e Saúde Digital e o lançamento do Programa SUS Digital marcam uma nova fase, na qual a telessaúde é inserida em uma estratégia mais ampla de transformação digital do Sistema Único de Saúde. Os dados corroboram estudos que apontam a necessidade de ações coordenadas, investimento contínuo em infraestrutura, formação profissional e governança digital. As evidências sugerem que o avanço da legislação de telessaúde é compatível com as diretrizes internacionais e pode contribuir para maior equidade no cuidado em saúde.

Muireann Quigley, Laura Downey, Zaina Mahmoud et al.

The United Kingdom’s Medicines and Medical Devices Act (MMD Act) 2021 received royal assent on 11 February 2021. In its passage through parliament, as well as in the accompanying Explanatory Notes, the Act was framed by the government as a necessary post-Brexit bill. Yet prior to this, it was widely presumed that existing statutory instruments, enacted in 2019 to address medical devices regulation in anticipation of a ‘No Deal Brexit’, would provide the United Kingdom (UK) with the necessary legal framework through the transition period and beyond. The European Union (EU) exit legislation included provisions aimed at aligning domestic law with the new EU Medical Devices Regulation (EU MDR) and In Vitro Devices Regulation (EU IVDR) (which were initially due to be implemented during the EU exit transition period). However, just over a year later, at the end of 2020, while the 2021 Act was in the final stages of its parliamentary journey, legislation was introduced that reversed the provisions of the domestic medical device regulations concerning alignment for Great Britain (GB: England, Wales, and Scotland). The result is that the UK now has a dual system of regulation, with Northern Ireland (NI) being governed by the new EU MDR and EU IVDR and GB by older pre-Brexit (yet still EU-derived) law. This article is an attempt to analyse the complex situation now in existence regarding the regulation of medical devices in the UK. To this end, we focus on three main issues. First, we examine the difficulties and challenges presented by the dual system of regulation between NI and GB, highlighting the potentially far-reaching consequences of regulatory divergence between different UK jurisdictions. Second, we ask whether, in the rush to new legislation in 2021, opportunities to properly reform the approach to medical devices were missed. Finally, we look to the future, focusing on the recent Medicine and Healthcare products Regulatory Agency Consultation on the future of medical devices regulation in the UK and the challenges and opportunities that remain.

Izabela Rojek, Dariusz Mikołajewski, Ewa Dostatni et al.

Three-dimensional-printed medical devices are a separate group of medical devices necessary for the development of personalized medicine. The present article discusses a modern and specific group of medical devices and exoskeletons, which aims to present our own experiences in the selection of materials, design, artificial-intelligence optimization, production, and testing of several generations of various upper limb exoskeletons when considering the Medical Devices Regulation (MDR) and the ISO 13485 and ISO 10993 standards. Work is underway to maintain the methodological rigor inherent in medical devices and to develop new business models to achieve cost-effectiveness so that inadequate legislation does not stop the development of this group of technologies (3D scanning, 3D printing, and reverse engineering) in the healthcare system. The gap between research and engineering practice and clinical 3D printing should be bridged as quickly and as carefully as possible. This measure will ensure the transfer of proven solutions into clinical practice. The growing maturity of 3D printing technology will increasingly impact everyday clinical practice, so it is necessary to prepare medical specialists and strategic and organizational changes to realize the correct implementation based on the needs of patients and clinicians.

Zheng Jiang, Xin Yang, Fei Chen et al.

BackgroundIn the information era, patients can easily be misled by inaccurate internet content, thus making not well-informed decisions about medical issues. Adenoid hypertrophy, one of the most common causes of chronic upper airway obstruction in children and adolescents, may lead to serious complications, including sleep apnea and craniofacial change. There have been no critical studies about the quality of websites on adenoid hypertrophy, posing a challenge for users without a medical background to determine which website offers more reliable information. Moreover, the blockage of access to internet search tools such as Google, Yahoo, and others has created an isolated internet environment for the enormous user population in mainland China. Differences in internet legislation, the commercial environment, and culture are also likely to result in varied quality of online health information inside and outside mainland China. To date, no study has compared the quality difference between mainland Chinese and English websites. ObjectiveThe aims of this study were to (1) analyze the quality of websites about adenoid hypertrophy accessible by patients, (2) investigate the quality differences between Chinese and English websites, (3) determine which type of website (eg, government-sponsored, health care provider) is more reliable in terms of medical information, and (4) determine whether the blockage of foreign websites is hindering users’ accessibility to better-quality websites in mainland China. MethodsThe first 100 websites (excluding advertisements) displayed on the top three search engines worldwide and in mainland China for the key search term “enlarged adenoids” were collected as the data source. The websites were evaluated based on accessibility, accountability, interactivity, structure, and content quality (accuracy, content coverage, and objectivity). Cohen κ was calculated, and one-way ANOVA and the Kruskal-Wallis test were performed to compare the results between groups and subgroups. ResultsThe mean score for the content quality of English websites was significantly higher than that of Chinese websites (6.16 vs 4.94, P=.03 for Google, Bing, and Yahoo; 6.16 vs 4.16, P<.001 for Baidu, Sougou, and Bing China). Chinese users who are not influenced by the Internet Censorship System are more likely to access higher-quality online medical information (4.94 vs 4.16, P=.02). In within-group Student-Newman-Keuls q posthoc analysis, professional organization and government-sponsored websites were generally of better quality than other websites for both Chinese and English websites (P<.05). ConclusionsGenerally, the English websites on adenoid hypertrophy are of better quality than Chinese websites; thus, Chinese users residing outside of the Chinese mainland are less influenced by inaccurate online medical information.

F. Azraf, M. Chtibi, F. Laboudi et al.

Introduction For many years, the question of the announcement of the diagnosis in psychiatry has been controversial. It is the starting point of a management allowing access to psychoeducation and to the patient’s recovery. In the case of schizophrenia, the cognitive impairment and the stigmatizing nature of the pathology jeopardize the announcement of the diagnosis. However, recommendations and legislation emphasize the need to inform the patient about his or her pathology. In Morocco, the law n° 131-13 of February 19, 2015 relating to the practice of medicine has made information about the diagnosis to patients an obligation for doctors and a right for patients Objectives The interest of our work is to try to evaluate the current state of this practice, its ethics and its representations among psychiatrists. Methods This is a descriptive study on the announcement of the diagnosis of schizophrenia in a population of psychiatrists. The data collection was carried out by a questionnaire including: Socio-demographic and professional data, opinion on practice and training concerning diagnostic announcement in psychiatry, physicians’ representations concerning announcement: frequency, opinion on the importance of this practice. Results 31 participants responded to our questionnaire. More than 9 out of 10 participants would not benefit from training on diagnostic announcement. Only 22.6% of physicians reported being very or somewhat familiar with medical information laws and their content regarding the regulation of diagnostic announcement. All participants considered schizophrenia to be the most difficult pathology to announce, followed by personality disorders and bipolar disorder. 74.2 of the participants considered it “rather” or “completely” essential to inform the patient of his or her psychiatric diagnosis. 77.4% of the participants considered it necessary to announce the diagnosis of schizophrenia and 80.7 often or systematically announce this diagnosis. Three situations considered appropriate to announce a diagnosis of schizophrenia: 74.2% announce it in general when the patient or the family asks for information about the diagnosis, 42% advise the patient when he/she mentions schizophrenia on his/her own. The patient’s functional inability to understand the diagnosis (77.4%) and the fear of negative clinical and therapeutic repercussions (41.9 and 38.7 respectively) were reported to deter physicians from making the announcement. More than half of the participants (64.5%) thought that the announcement of the diagnosis improved therapeutic compliance. Conversely, 35.5% considered that the announcement had no impact on therapeutic compliance. Conclusions The announcement of the diagnosis of schizophrenia remains today a complex and evolving subject. Even if great progress has been made to inform patients as well as possible, practices remain disparate from one doctor to another and this information is not well traced. Disclosure of Interest None Declared

Julia Brassolotto, Alessandro Manduca-Barone, Paige Zurbrigg

Medical assistance in dying (MAiD) was legalized in Canada in 2016. Canadians’ opinions on the service are nuanced, particularly as the legislation changes over time. In this paper, we outline findings from our review of representations of MAiD in Canadian news media texts since its legalization. These stories reflect the concerns, priorities, and experiences of key stakeholders and function pedagogically, shaping public opinion about MAiD. We discuss this review of Canadian news media on MAiD, provide examples of four key themes we identified (vulnerability, autonomy, dignity, and human rights), and discuss their implications for health policy and equity. Though key stakeholders share the values of autonomy, dignity, and human rights, they appeal to them in diverse ways, sometimes with conflicting policy demands. These representations offer a useful gauge of how views about MAiD continue to shift alongside changes in federal legislation. These stories can influence related policies, respond to the powerful voices that shape MAiD legislation, and have the potential to change national conversations. Our analysis adds to the existing body of scholarship on MAiD by examining post-Bill C-7 news media, identifying related health equity issues and tensions, and discussing potential impacts of MAiD’s representations in news media.

David Schneeberger, Karl Stöger, Andreas Holzinger

Valeria Herdea, Raluca Ghionaru, Claudiu N. Lungu et al.

<b>Background</b>: According to WHO, infectious disease control can be achieved if the vaccine coverage (VC) exceeds 90%. In recent years there has been a declining trend in VC which could lead to the recurrence of infectious diseases. <b>Objectives</b>: The study analyzed the determinants of VC and of parental decisions regarding immunization in children aged 0–1 year monitored during two high-risk epidemiological periods (the measles epidemic and the COVID-19 pandemic period). <b>Methods</b>: A retrospective observational cohort study-data regarding vaccination of children younger than 1 year of age during the periods January 2019–June 2019 (measles epidemic) and January 2020–June 2020 (COVID-19 pandemic) were analyzed. 2.850 children from 2019 and 2.823 children from 2020 were enrolled. Family physicians interacted with 2840 parents or legal guardians in 2019 and with 2800 parents or legal guardians in 2020, during the infants’ consults providing medical information and answer to their questions and worries regarding their immunization. Data on immunization schedules on the determinants of parents’ decisions regarding vaccination were evaluated. <b>Results</b>: During 2019–2020, VC has followed a declining trend for each type of vaccine included in the Romanian National Immunization Program; the most affected were infants aged 9–12 months during both periods: in 9-month aged infants, the MMR vaccine VC was 67.49% in 2019 vs. 59.04% in 2020 (<i>p</i> < 0.004). In the 12 months aged infants, the MMR VC was 64.29% in 2019 vs. 55.88% in 2020 (<i>p</i> < 0.005). For the Hexavalent vaccine administered at the age of 11 months, the VC was 71.59% in 2019 vs. 62.08% in 2020 (<i>p</i> < 0.001). The determinants of parents’ decisions regarding vaccination included parental hesitance 2019—25% vs. 2020—35%, fear on side effects 2019—32% vs. 2020—45%, vaccination denial 2019—7% vs. 2020—10%. Conclusion: We found a declining trend in the VC in Romania during the epidemic and pandemic periods. The decrease in VC for MMR generated a major risk for new measles outbreaks Permanent awareness educational campaigns regarding infectious disease risk are needed, accompanied by the empowerment of primary care and the emergence of an immunization management program based on national regulatory legislation.

Gjoshe Stefkov, Ivana Cvetkovikj Karanfilova, Veronika Stoilkovska Gjorgievska et al.

Cannabis is gaining increasing attention due to the high pharmacological potential and updated legislation authorizing multiple uses. The development of time- and cost-efficient analytical methods is of crucial importance for phytocannabinoid profiling. This review aims to capture the versatility of analytical methods for phytocannabinoid profiling of cannabis and cannabis-based products in the past four decades (1980–2021). The thorough overview of more than 220 scientific papers reporting different analytical techniques for phytocannabinoid profiling points out their respective advantages and drawbacks in terms of their complexity, duration, selectivity, sensitivity and robustness for their specific application, along with the most widely used sample preparation strategies. In particular, chromatographic and spectroscopic methods, are presented and discussed. Acquired knowledge of phytocannabinoid profile became extremely relevant and further enhanced chemotaxonomic classification, cultivation set-ups examination, association of medical and adverse health effects with potency and/or interplay of certain phytocannabinoids and other active constituents, quality control (QC), and stability studies, as well as development and harmonization of global quality standards. Further improvement in phytocannabinoid profiling should be focused on untargeted analysis using orthogonal analytical methods, which, joined with cheminformatics approaches for compound identification and MSLs, would lead to the identification of a multitude of new phytocannabinoids.

Mariela Contreras, Gracia M. Pineda , Ana Romero et al.

Introducción: El rol de la mujer en el área científica ha crecido con el paso de los años, pero aún persiste una gran brecha de género en ciencia. Para conocer y manejar esa brecha, es necesario hacer un mapeo de la situación de las mujeres investigadoras en Honduras. Objetivo: Describir la participación y contribuciones de las investigadoras hondureñas en la producción científica nacional según su perfil en Google Académico. Metodología: Se usó Power BI para analizar las variables sexo, institución, índice H, número de citaciones, número de publicaciones, año de la primera publicación, y áreas de investigación registradas en su perfil, utilizando la versión 2 del Ranking de Investigadores Hondureños según su Perfil de Google Académico disponible en https://bit.ly/38s6YuT, el cual es un registro depurado. Resultados: El 35% de todos los perfiles eran de mujeres, 41% vinculadas a las ciencias médicas y de la salud y en su mayoría (92%), afiliadas a universidades. Pese al creciente número de mujeres investigadoras registradas en Google Académico, el crecimiento no es simétrico respecto a los hombres. Solamente el 3.1% de las investigadoras tenía un índice H que supera los dos dígitos. Conclusión: A pesar de los avances, se mantiene la inequidad de género entre investigadores hondureños según la data de Google Académico. Se requiere de políticas públicas e institucionales, para corregir esa brecha.

Joshua D. Brown, B. Costales, Sascha van Boemmel-Wegmann et al.

Use of medical marijuana is increasing in the United States and older adults are the fastest growing user group. There is little information about the characteristics and outcomes related to medical marijuana use. This study is a descriptive analysis of older adults (aged ≥50 years old) who were early adopters of a medical marijuana program in the U.S. state of Florida. Per state legislation, initial and follow-up treatment plans were submitted to the University of Florida College of Pharmacy. Data collection included demographics, clinical history, medical conditions, substance use history, prescription history, and health status. Follow-up treatment plans noted changes in the chief complaint and actions taken since the initial visit. Of the state’s 7548 registered users between August 2016 and July 2017, N = 4447 (58.9%) were older adults. Patients utilized cannabidiol (CBD)-only preparations (45%), preparations that had both tetrahydrocannabinol (THC) and CBD (33.3%) or were recorded to use both CBD-only and THC + CBD products (21.7%). The chief complaints indicating medical cannabis treatment were musculoskeletal disorders and spasms (48.4%) and chronic pain (45.4%). Among other prescription medications, patients utilized antidepressants (23.8%), anxiolytics and benzodiazepines (23.5%), opioids (28.6%), and cardiovascular agents (27.9%). Among all drug classes with potential sedating effects, 44.8% of the cohort were exposed to at least one. Patients with follow-up visits (27.5%) exhibited marked improvement as assessed by the authorizing physicians. However, the patient registry lacked detailed records and linkable information to other data resources to achieve complete follow up in order to assess safety or efficacy. Future improvements to registries are needed to more adequately capture patient information to fill knowledge gaps related to the safety and effectiveness of medical marijuana, particularly in the older adult population.

Alma López, Miguel Betancourt, Eduardo Casas et al.

Plain language summary The emergence of ART in humans has been an important tool for the treatment of infertility. It is reported that one in four couples in developing countries has fertility problems. In 2009, the International Committee for Monitoring Assisted Reproductive Technology (ICMART) established ART as "all treatments or procedures involving in vitro manipulation of oocytes, sperm or embryos for the purpose of establishing a pregnancy". The number of treatments performed in Latin America has been increasing, and Mexico is the third country with the most assisted reproduction cycles performed in the region. However, Mexico lacks a national regulation for human assisted reproduction. This has caused Mexico to become a medical tourism paradise, which increases the possibility of abuses, fraud, and clinical risks. In addition, it allows each institution offering assisted reproduction services, whether public or private, to establish arbitrary requirements for inclusion. Thus, the emergence of a regulation that allows a safe clinical practice based on ethics, which will also make this reproductive tool available to any social group, is a social need. Therefore, the aim of this review was to examine the existing legislation that regulates human assisted reproduction practices in Mexico, but also to examine the legal analysis of the policies, laws, and regulations in use in some countries in Latin America, North America, and Europe, as well as highlighting the importance of working on the establishment of regulations that allow for safe and ethically based clinical practices.

Gemayel Lee, Brittany Grovey, T. Furnish et al.

A. Fraser, E. Butchart, P. Szymański et al.

To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device. Defining its content, however, has been delegated to implementing legislation, which is now being considered. From a clinical perspective, it is imperative that all evidence reviewed by notified bodies and regulatory authorities is disclosed-with the exception, if justified, only of technical specifications that are considered confidential or manufacturing details that are protected as intellectual property-and public access to this evidence must be guaranteed by EU law. From ethical and other perspectives, there are no grounds for less clinical evidence being available to health-care professionals about the medical devices that they use than is already available for new pharmaceutical products. Full transparency is needed; without it, informed decisions relating to the use of new medical devices will remain impossible.

Leticia Rubio Lamia, Juan Suárez, Ignacio Santos et al.

Justificación: La autopsia es el procedimiento fundamental para determinar las causas de muerte, provee información crítica para ser correlacionada con la clínica, epidemiología y fisiopatolología de enfermedades con altas tasas de mortandad. Los hallazgos patológicos de las autopsias deben confirmar el diagnóstico clínico y determinar los efectos del tratamiento para fundamentar terapias eficaces. La infección por SARS-Cov-2 al tratarse de una enfermedad nueva con implicaciones sin precedentes para la humanidad, ha generado múltiples trabajos científicos para entenderla desde diferentes puntos de vista. Objetivos: Los propósitos de la revisión fueron: analizar la literatura disponible sobre autopsias de pacientes con infección por SARS-CoV-2, identificar los principales hallazgos patológicos reportados y determinar las condiciones técnicas en que se hicieron esos procedimientos. Metodología: Se utilizaron los buscadores bibliográficos (PubMed, Google Scholar, Dialnet, Scielo), usando las palabras Autopsia, Postmortem y COVID-19, para localizar la literatura sobre las autopsias de pacientes con infección por SARS-CoV-2. Resultados: Se obtuvieron 16 artículos científicos que cumplieron los criterios de búsqueda, en siete se reportaron 83 autopsias de 54 varones y 16 mujeres, con edad promedio de 60,91 años. El análisis anatomopatológico se enfocó especialmente en los pulmones, que macroscópicamente estaban pesados por edema y congestión. Microscópicamente había daño alveolar difuso (membranas hialinas o de organización con angiogénesis y microtrombos) e infiltración linfocitaria intersticial. En 18 autopsias también analizaron otros órganos como corazón, hígado, riñón y bazo. Conclusión: A pesar del incremento de trabajos de investigación sobre la enfermedad, Covid-19 los estudios basados en autopsia son muy escasos y limitados. Un aumento en el número de autopsias realizadas a los fallecidos por COVID-19 proveería mayor conocimiento de las características de la enfermedad, la causa de la muerte, la extensión de la misma y efectos del tratamiento.

Richard Bales, Christopher Elko

Since the initial response to the Covid-19 labor crisis, the United States has faced a series of issues that raise questions as to the success of the initial measures taken, as well as the potential need for future legislation. Just as the United States took a piecemeal approach to shutting down, it has taken the same approach to reopening. With political pressure mounting to reopen the economy in full, parts of the U.S. are in medical crisis and many legal issues remain to be addressed.

Rezky Ami Cahyaharnita

Medical records are made in writing, complete and clear or electronically. Medical records are the basis of medical services to patients. Paper medical records increase the amount of paper waste in Indonesia. A national e-health strategy is a comprehensive approach to efforts in the national health sector. Electronic medical records are more effective because of better time management. The formulation of the problem in this article covers the reasons, criteria, and implementation of electronic medical records. The research method used is descriptive qualitative research with a statute approach. The criteria for a good electronic medical record are integrated data from various sources, data collected at the service point, and supporting service providers in decision making. The expected electronic medical record is to be integrated with the health service facility information system program without neglecting the confidentiality aspect. Therefore, the government needs to make regulations on the technical implementation of electronic medical records.

T. Gibson, S. Herring, J. Kutcher et al.

Nikolaos I. Spanoudakis, E. Constantinou, A. Koumi et al.