Hasil untuk "Medical legislation"

ON MARCH 8 and 9, hearings on the School Health Services Bill (S. 1290) were held before the sub-committee on health of the Senate Committee on Labor and Public Welfare. Those who testified on this legislation appeared in the following order: Senator Leverett Saltonstall, sponsor of the bill; Mr. Oscar R. Ewing, Federal Security Administrator; Dr. Martha Eliot, Associate Chief of the U. S. Children's Bureau; Dr. Reginald Atwater, Executive Secretary of the American Public Health Association; Dr. James R. Miller, Board of Trustees of the American Medical Association; Dr. Vlado A. Getting, speaking as President of the Association of State and Territorial Health Officers; Dr. John P. Hubbard, speaking as Director of the Study of Child Health Services; and Mr. Clyde A. Erwin, National Council of Chief State School Officers. When this legislation was reviewed in this column in the February issue of Pediatrics, attention was called to the fact that two controversial points would undoubtedly receive attention in hearings before the Senate Committee. These two points are: (1) division of responsibility between health and educational authorities and (2) the inclusion in the bill of two words "and treatment" which provide for medical services related to the correction of defects discovered during the course of school examinations. Controversy over the division of responsibility between health and education authorities failed to reach solution prior to the date of these hearings. Educational authorities maintained that a bill related to school programs should give greater recognition to educational agencies. Public health authorities, on the other hand, protested that since this was proposed as a health measure, it should be administered primarily by official health agencies. Mr. Ewing, whose agency includes the Office of Education as well as the U. S. Public Health Service and the U. S. Children's Bureau, introduced amendments to S. 1290, the results of which were to place much more emphasis on health education and physical education than the sponsor intended.

J. Siegel, James E. Daily, Demetrius Perry et al.

Importance Psychedelic drugs are becoming accessible in the US through a patchwork of state legislative reforms. This shift necessitates consensus on treatment models, education and guidance for health care professionals, and planning for implementation and regulation. Objective To assess trends in psychedelics legislative reform and legalization in the US to provide guidance to health care professionals, policy makers, and the public. Evidence Review Data were compiled from legislative databases (BillTrack50, LexisNexis, and Ballotpedia) from January 1, 2019, to September 28, 2022. Legislation was identified by searching for terms related to psychedelics (eg, psilocybin, MDMA, peyote, mescaline, ibogaine, LSD, ayahuasca, and DMT). Bills were coded by an attorney along 2 axes: which psychedelic drugs would be affected and in what ways (eg, decriminalization, funding for medical research, and right to try). To explore drivers and rates of legislative reform, data were compared with other state indices including 2020 presidential voting margins and marijuana legislative reform. Findings Twenty-five states have considered 74 bills (69 legislative initiatives, 5 ballot measures); 10 bills were enacted, and 32 were still active. The number of psychedelic reform bills introduced during each calendar year increased steadily from 5 in 2019 to 6 in 2020, 27 in 2021, and 36 in 2022. Nearly all bills specified psilocybin (67 [90%]), and many also included MDMA (3,4-methylenedioxy-methamphetamine; 27 [36%]). While bills varied in their framework, most (43 [58%]) proposed decriminalization, of which few delineated medical oversight (10 of 43 [23%]) or training and/or licensure requirements (15 of 43 [35%]). In general, bills contained less regulatory guidance than the enacted Oregon Measure 109. While early legislative efforts occurred in liberal states, the margin between liberal and conservative states has decreased over time (although the difference was not significant), suggesting that psychedelic drug reform is becoming a bipartisan issue. In addition, an analytic model based on marijuana legalization projected that a majority of states will legalize psychedelics by 2034 to 2037. Conclusions and Relevance Legislative reform for psychedelic drugs has been proceeding in a rapid, patchwork fashion in the US. Further consideration should be given to key health care issues such as establishing (1) standards for drugs procured outside the medical establishment, (2) licensure criteria for prescribers and therapists, (3) clinical and billing infrastructure, (4) potential contraindications, and (5) use in special populations like youths, older adults, and pregnant individuals.

Sarah Mroz, S. Dierickx, L. Deliens et al.

Assisted dying practices, which include euthanasia and physician-assisted suicide (PAS), have expanded significantly around the world over the past 20 years. Euthanasia refers to the act of intentionally ending the life of a patient by a health care practitioner through medical means at that patient's explicit request while PAS involves the provision or prescribing of drugs by a health care practitioner for a patient to end their own life. The growing global aging population accompanied by higher levels of chronic disease and protracted illnesses have sharpened the focus on end of life issues and societal and legislative debates continue to address related moral and ethical complexities. Assisted dying practices are now legal in 18 jurisdictions, increasing the number of people with access to euthanasia and/or physician-assisted suicide (PAS) to over 200 million. New legislation is being crafted or considered in Portugal, Spain and 16 US states. Germany has recently overturned a ban on assisted dying services and New Zealand will put legalization of euthanasia to a vote in 2020. Assisted dying practice characteristics differ and there is also considerable variation in the terminology and labels used for assisted dying, which can add to the confusion and controversy around the practices. Frequency of use also varies greatly by jurisdiction, though a consistent increase has been seen in European countries including Belgium, the Netherlands and Switzerland as well as some jurisdictions with long-standing physician assisted dying laws, such as Oregon and Washington. All assisted dying legislation includes substantive and procedural requirements, such as minimum age, waiting period, health condition, physician consultation and reporting procedure, however, some are extensive and detailed while others are more limited. As access to assisted dying expands in new and existing jurisdictions, research must also expand to diligently examine the impact on patients, specifically among vulnerable populations, as well as on health care practitioners, health care systems and communities. This article will provide a thorough investigation, or 'status quaestionis' of the terminology, evolution and current legislative picture of assisted dying practices around the globe and contribute to the ongoing ethical, regulatory and practice debate, which have become increasingly important considerations for medical practice, end-of-life care and public health.

P. J. Maas, J. V. Delden, L. Pijnenborg et al.

Muhammad Usman Akbar, Måns Larsson, Ida Blystad et al.

Large annotated datasets are required for training deep learning models, but in medical imaging data sharing is often complicated due to ethics, anonymization and data protection legislation. Generative AI models, such as generative adversarial networks (GANs) and diffusion models, can today produce very realistic synthetic images, and can potentially facilitate data sharing. However, in order to share synthetic medical images it must first be demonstrated that they can be used for training different networks with acceptable performance. Here, we therefore comprehensively evaluate four GANs (progressive GAN, StyleGAN 1–3) and a diffusion model for the task of brain tumor segmentation (using two segmentation networks, U-Net and a Swin transformer). Our results show that segmentation networks trained on synthetic images reach Dice scores that are 80%–90% of Dice scores when training with real images, but that memorization of the training images can be a problem for diffusion models if the original dataset is too small. Our conclusion is that sharing synthetic medical images is a viable option to sharing real images, but that further work is required. The trained generative models and the generated synthetic images are shared on AIDA data hub.

Sophie Mitra

Marina de Almeida Magalhães, Mário César Scheffer

O conceito de “emergência”, no campo do direito, está atrelado ao reconhecimento institucional da ocorrência de situações que, por sua urgência e/ou particularidade, justifiquem a atuação excepcional da administração pública. Este estudo buscou, a partir de levantamento e da análise documental de normas, descrever como se dava a regulação do conceito de Emergências de Saúde Pública, no ordenamento jurídico brasileiro antes da pandemia da covid-19. No plano teórico, sugerimos que o modelo emergencial adotado é o da acomodação, sob o qual são estabelecidos limites e diretrizes prévios para a atuação excepcional, mas garantindo margem de flexibilidade suficiente para permitir derrogações normativas temporárias. No plano empírico, o estudo compilou as normas que regulam a atuação da administração pública em emergências de saúde, na forma de competências, poderes e prerrogativas excepcionais. As disposições encontradas são majoritariamente voltadas à flexibilização das regras de organização administrativa do Estado e, no geral, estavam alinhadas às recomendações da literatura e da Organização Mundial da Saúde. Contudo, este aparato regulatório não foi capaz de evitar os trágicos resultados do enfrentamento da covid-19 no Brasil, tendo sofrido diversas alterações a partir das normas excepcionais publicadas ao longo da emergência. Esse cenário sugere a importância, para o curto e médio prazo, de uma agenda de reformulação do modelo emergencial adotado no ordenamento brasileiro.

Saad Liaqat, Humaira Farman, Sabra Bibi et al.

A medical device is defined as “any an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent” and “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals”. Objective: The objective of this systematic review was to outline the steps and necessary requirements needed for approval and legislation of new medical devices. Methods:  Two databases; PubMed and Google Scholar were electronically searched for articles published from year 2011 to 2021. The following MeSH (Medical Subjects Headings) terms; “new medical devices”, “Regulatory Bodies”, “Approval Medical Devices”, “Pre-market Post-market Approval” along with Boolean operators AND, OR and NOT were used to search for the articles. Results: It is evident from our study that risks associated with new medical and dental devices are being taken seriously by the governments of different countries and intensive work is done to minimize the risks and maximize the benefits of them. Conclusions: It is safe to say that we are entering a new era of safe medical practice along with new and better devices being available for the public. The reforms being made will help not only the hospitals and patients but will also assist the manufacturers in understanding the mechanisms involved in clearing their products for the approval. It will lead to advancement and reshaping healthcare system to combat many challenges faced by it and promote and protect the public health.

Etyn Ariyani Susilowati, Wardah Yuspin, Absori Absori

Abstract: Humans are social creatures, namely creatures that require interaction with other humans. Interaction between humans is not only communication but involves all aspects of life, including the legal aspect. Based on law number 36 of 2014 concerning health workers, it is anyone who devotes himself to the health sector and has knowledge and/or skills through education in the health sector which for certain types requires the authority to carry out health efforts. The purpose of this study was to determine the level of compliance of medical personnel in the implementation of informed consent. In addition, medical personnel understand the role of informed consent in preventing lawsuits and medical disputes. The research method used is a non-doctrinal research method, namely the questionnaire method, direct interviews with medical personnel, and medical record documents, especially informed consent sheets. Problem formulation: 1. How is the compliance of medical personnel with the implementation of informed consent? 2. What is the role of Informed Consent in Medical Dispute Prevention efforts? 3. What is the concept of implementing informed consent in order to prevent medical disputes? The results of the study: "Medical Personnel Compliance with the Implementation of Informed Consent: Study on Prevention of Lawsuits for Medical Disputes at the Central Surgical Installation of PKU Muhammadiyah Sragen Hospital" is that the compliance of medical personnel in the implementation of informed consent has not been carried out in accordance with the existing SOPs, so the role of informed consent consent has not been maximally implemented by medical personnel. The concept of implementing informed consent must be made clearly in accordance with standard procedures that must be filled in completely by medical personnel working in the central surgical installation of PKU Muhammadiyah Hospital Sragen. Keywords: Medical Personnel, Informed Consent, Lawsuits, Medical Disputes. Abstrak: Manusia merupakan makhluk sosial, yaitu makhluk yang  membutuhkan interaksi dengan manusia lainnya. Interaksi antar manusia tidak hanya komunikasi saja tetapi menyangkut seluruh aspek kehidupan, tidak terkecuali aspek hukum. Berdasarkan undang undang nomor 36 tahun 2014 tentang tenaga kesehatan adalah setiap orang yang mengabdikan diri dalam bidang kesehatan serta memiliki pengetahuan dan/atau keterampilan melalui pendidikan di bidang kesehatan yang untuk jenis tertentu memerlukan kewenangan untuk melakukan upaya kesehatan. Tujuan dari penelitian ini adalah untuk mengetahui tingkat kepatuhan tenaga medis dalam pelaksanaan informed consent. Selain itu juga sebagai pemahaman tenaga medis atas peran dari informed consent dalam upaya pencegahan gugatan hukum dan sengketa medis. Metode penelitian yang digunakan adalah metode penelitian Non-Doktrinal yaitu dengan metode quesioner, wawancara langsung kepada tenaga medis, dan dokumen rekam medis, khususnya lembar informed consent. Perumusan Masalah: 1. Bagaimana Kepatuhan Tenaga Medis Terhadap Pelaksanaan Informed  Consent ? 2. Apa peran Informed Consent dalam upaya Pencegahan Sengketa Medis? 3. Bagaimana konsep tentang pelaksanaan informed consent  dalam  rangka mencegah sengketa medis? Hasil Penelitian : “Kepatuhan Tenaga Medis Terhadap Pelaksanaan Informed Consent : Studi Pencegahan Gugatan Hukum atas Sengketa Medis di Instalasi bedah sentral RSU PKU Muhammadiyah Sragen” adalah bahwa kepatuhan tenaga medis dalam pelaksanaan informed consent, belum dilaksanakan sesuai dengan SOP yang ada, sehingga peran dari informed consent belum maksimal dilaksanakan oleh tenaga medis. Konsep pelaksanaan informed consent harus dibuat secara jelas sesuai dengan standart prosedur yang harus di isi lengkap oleh tenaga medis yang bekerja di Instalasi bedah sentral RSU PKU Muhammadiyah Sragen. Kata Kunci : Tenaga Medis, Informed Consent, Gugatan Hukum, Sengketa Medis.

Lydia Tsiakiri

The medical developments and their subsequent influence on the duration of human life have brought in the limelight various moral questions. The pathological conditions do not constitute anymore the decisive causes of death, whereas an ascending number of people suffer more by being maintained in life. In this reality, the euthanasia debate seems more apropos than ever. The following article examines the aforementioned issue through the supportive argument of autonomy in contrast to a Foucauldian approach. In essence, based on the Kantian concept of autonomy, several scholars have advocated in favor of the legalization of euthanasia in order that our ability to define not only the course of our life and its duration, but also the way of our death is ensured. However, on the other side, a Foucauldian approach of the issue seems to be equally worth cited and taken into consideration. In accordance with that, the domination of Foucault's concept of biopower would deterministically imply that our choices are totally determined by a form of power that targets at the absolute control over our lives through medicine and legislation. In such a context, euthanasia could not constitute a promoter of autonomy. On the contrary, it would contribute to the absolute escalation of the governmental power that would be imposed on every inch of our lives being exclusively interested in its own prosperity!

Radboud M. Marijnissen, Kenneth Chambaere, Richard C. Oude Voshaar

Euthanasia was first legalized in the Netherlands and Belgium in 2001 and 2002, respectively. Currently they are among the few countries that also allow euthanasia on the basis of dementia, which is still considered controversial, both from a scientific and societal perspective. To date, euthanasia in dementia constitutes a small proportion of all Dutch and Belgian euthanasia cases. However, instances are rising due to a growing awareness among the general public about the possibilities of a self-chosen end-of-life and the willingness among medical professionals to perform euthanasia in individuals diagnosed with dementia. In both countries euthanasia is allowed under strict conditions in patients with dementia and decisional capacity regarding euthanasia, while in the Netherlands an advance euthanasia directive can also replace an oral request for euthanasia in those with late-stage dementia. Judging euthanasia requests from patients with dementia is complex and the assessment of the due care criteria (especially those related to decisional capacity and unbearable suffering) requires caution and great care. In this narrative review, we reflect on the legal regulation, clinical guidelines and societal debate regarding euthanasia in dementia in the Netherlands and Belgium. By discussing the 20 years of experience with the ethical dilemmas and controversial aspects surrounding this delicate topic, we hope to inform the preparation or implementation of new legislation on euthanasia in dementia in other countries.

DeWitt AL, Acker J, Larkin TA et al.

Anthony L DeWitt,1 Jaron Acker,2 Thomas A Larkin,3 Jim L Potenziano,4 Jeffrey M Schmidt5 1Penumbra Seminars, LLC, Auburn, AL, USA; 2Medical Device Marketing, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 3Device Engineering R&D, Mallinckrodt Pharmaceuticals Ireland Ltd., Dublin, Ireland; 4Scientific Affairs, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA; 5Device Development, Mallinckrodt Pharmaceuticals, Madison, WI, USACorrespondence: Anthony L DeWitt 2755 National Village Parkway, Opelika, AL, 36801, USATel +1 573 230-4220Email aldewitt@aldewitt.comAbstract: Over the past decade, international organizations have instituted strict regulations for the safe use of connected medical devices. The International Organization for Standardization and the Medical Device Single Audit Program instituted certifications to ensure that connected devices are compatible and operate within their proper clinical parameters. These efforts came about, in part, as a consequence of clinicians’ decisions to use nonstandard, modified, or improvised devices for purposes outside the original manufacturers’ approved parameters. Unapproved device modifications can be associated with increased risk of dosing errors, monitoring errors, tubing misconnections and serious or potentially fatal adverse events; furthermore, health care providers who implement unapproved device modifications may assume legal and financial liability should harm come to patients as a consequence of the modification. Using the inhaled nitric oxide delivery system as an example, the objective of this paper is to raise awareness of the potential dangers associated with unapproved modification and interfacing of therapeutic gas delivery systems and ventilators in the neonatal intensive care unit setting. The paper also highlights the rationale and necessity for rigorous validation processes that ensure that interfaced medical devices perform as intended in the clinical setting.Keywords: patient safety, equipment failure, medical device legislation

Gregorius Yoga Panji Asmara, Yovita Arie Mangesti

The advancement of civilization has led to the creation of a dual form of the doctor-advocate profession which is confronted with many conflicts of interest between two opposing interests between doctors who are also advocates. This paper uses a legal, conceptual, and eclectic approach to positive law in the dual profession of doctor-advocate with humanitarian paradigm libertarianism. The results of this study resulted in the construction of the dual law of the doctor-advocate profession, providing an understanding that each individual has the right to decide on goals to be achieved based on morality and sensitivity to fair and civilized human values, so that in constructing the dual law of the doctor-advocate profession it is done only to defend the weak, without having to leave the identity and independence of the profession as doctors and advocates.

Stephen J. Strotmeyer, Christopher Behr, Anthony Fabio et al.

Abstract Background Approximately 75% of all bicycle-related mortality is secondary to head injuries, 85% of which could have been prevented by wearing a bicycle helmet. Younger children appear to be at greater risk than adults, yet helmet use is low despite this risk and legislation and ordinances requiring helmet use among younger riders. We sought to determine whether bicycle helmets are associated with the incidence and severity of head injury among pediatric bicyclists involved in a bicycle crash involving a motor vehicle. Methods We performed a retrospective review of patients age ≤ 18 years hospitalized at a level I pediatric trauma center between January 1, 2008, and December 31, 2018. Data were abstracted from the institutional trauma registry and electronic medical record. International Classification of Diseases 9th and 10th editions and external causes of injury codes were used to identify MV related bicycle crashes and determine the abbreviated injury severity (AIS) for head injury severity. Injury narratives were reviewed to determine helmet use. We calculated the incidence of head injury from bicycle vs. MV crashes utilizing descriptive statistics. We analyzed the risk and severity of injury utilizing univariate and multivariate logistic regression. Results Overall, 226 bicyclists were treated for injuries from being struck by a MV. The median age was 11 (interquartile range (IQR): 8 to 13) years. Helmeted bicyclists (n = 26, 27%) were younger (9.4 years versus 10.8 years, p = 0.04), and were less likely (OR 0.21, 95% CI 0.09 to 0.49) to be diagnosed with a head injury compared to unhelmeted bicyclists (n = 199). Of those with a head injury, helmeted bicyclists were less likely (OR 0.57, 95% CI 0.11–2.82) to sustain severe or higher injury using AIS. When adjusting for demographics (age, sex, race) and injury severity, helmet use predicted a reduction in head injury (OR 6.02, 95% CI 2.4–15.2). Conclusions Bicycle helmet use was associated with reduced odds of head injury and severity of injury.. These results support the use of strategies to increase the uptake of bicycle helmets wearing as part of a comprehensive youth bicycling injury prevention program.

Kristy Meng-Hsi Law, Vannarath Te, Peter S. Hill

Abstract Background From 2006, the Association of South East Asian Nations (ASEAN) has been developing Mutual Recognition Arrangements (MRAs) across key professions, including medicine, dentistry and nursing, that would facilitate the development of an ASEAN Economic Community, with shared regional standards and easier mobility of the workforce. This paper examines the interface between those agreements and the registration, professional education and mobility of health personnel in Cambodia. Methods This qualitative health policy analysis combined documentary and policy review with key informant interviews with 16 representatives of agencies relevant to the development and implementation of the MRAs in health. Thematic analysis identified three themes: registration, education and mobility. Results Cambodia is an active participant in the ASEAN MRA processes for doctors, dentists and nurses reporting progress annually. Education of health professionals has been increasingly formalised in the past 25 years, with nursing moving towards a 4-year bachelor degree. The private university sector has substantially increased, with English increasingly used as a language of instruction. Recent legislation provides for enforcement through fines and/or imprisonment to ensure all practising health professionals hold initial registration as a health professional and a renewable licence to practise as a health practitioner. Continuing Professional Development is a mandatory requirement for licence renewal. This is consistent with the MRA guidelines, though the capacity for enforcement appears limited. The Medical Council of Cambodia (MCC), and more recently, the Dental and Nursing Councils, have introduced continuing professional development initiatives, using them strategically as a positive reinforcer of registration. Midwifery education and registration in Cambodia does not conform with ASEAN guidelines. In education, course durations in medicine and dentistry are longer than regional counterparts, though anxiety around maintaining clinical standards has resulted in the introduction of a National Exit Examination and reluctance to abbreviate courses. The introduction of reforms appears to reference regional standards, though parity is still some way off. Mobility at present is infrequent and more likely to result from informal mechanisms than through the MRA mechanisms. Conclusion The Royal Government of Cambodia is committed to the ASEAN MRA process. Developments in registration appear to use regional standards as benchmarks, as do reforms in the education of health professionals, though domestic factors appear to more directly impact on developments. Informal mechanisms facilitate the limited mobility currently occurring, with little formal application of the MRA provisions evident at this point.

A. Moreira, W. M. R. Günther

S. Sismondo

Duncan Shrewsbury

J. Bestrashniy, K. Winters