BACKGROUND: The mass gathering event (MGE) industry is growing globally, including in countries such as Canada. MGEs have been associated with a greater prevalence of injury and illness when compared with daily life events, despite most participants having few comorbidities. As such, adequate health, safety, and emergency medical planning is required. However, there is no single entity regulating these concerns for MGEs, resulting in the responsibility for health planning lying with event organizers. This study aims to compare the legislative requirements for MGE medical response systems in the 13 provinces and territories of Canada.
METHODS: This study is a cross-sectional descriptive analysis of Canadian legislation. Lists of publicly available legislative requirements were obtained by means of the emergency medical services directors and Health Ministries. Descriptive statistics were performed to compare legislation.
RESULTS: Of the 13 provinces and territories, 10 responded. For the missing 3, a law library review confirmed the absence of specific legislation. Most (n = 6; 60%) provinces and territories referred to provisions in their Public Health laws. Four confirmed that MGE medical response was a municipal or local concern to be addressed by the event organizers.
CONCLUSIONS: No provinces could list specific legislation guiding safety, health, and medical response for an MGE.

Incidence rates of melanoma and keratinocyte skin cancers have been on the rise globally in recent decades. While there has been a select focus on personal sun protection awareness, to our knowledge, there is a paucity of legislation in place to help support citizens\' efforts to protect themselves from the harmful effects of ultraviolet radiation (UVR). Given this, we conducted a comprehensive review of legislation and guidelines pertaining to a variety of sun protection-related topics in countries of the Group of Seven (G7), Australia and New Zealand. Australia was the only country to have banned tanning beds for individuals of all ages, while other select countries have instituted bans for minors. In workplace policy, there is very little recognition of the danger of occupational UVR exposure in outdoor workers, and thus very few protective measures are in place. With regard to sports and recreation, certain dermatological/professional associations have put forward recommendations, but no legislation was brought forward by government bodies outside of Australia and New Zealand. With regard to youth, while there are various guidelines and frameworks in place across several countries, adherence remains difficult in the absence of concrete legislation and standardization of procedures. Finally, only Australia and a few select jurisdictions in the United States have implemented sales tax exemptions for sunscreen products. In light of our findings, we have made several recommendations, which we anticipate will help reduce the rates of melanoma and keratinocyte cancers in years to come. However, minimizing UVR exposure is not without risk, and we, therefore, suggest the promotion of vitamin D supplementation in conjunction with sun protective practices to limit potential harm.

The new 2023 Canadian Brain-Based Definition of Death Clinical Practice Guideline provides a new definition of death as well as clear procedures for the determination of death (i.e., when that definition is met). Since physicians must practice in accordance with existing laws, this legal analysis describes the existing legal definitions of death in Canada and considers whether the new Guideline is consistent with those definitions. It also considers how religious freedom and equality in the Canadian Charter of Rights and Freedoms might apply to the diagnosis of brain death.
We performed a legal analysis in accordance with standard procedures of legal research and analysis-including reviews of statutory law, case law, and secondary legal literature. The draft paper was discussed by the Legal-Ethical Working Subgroup and presented to the larger Guideline project team for comment.
There are some differences between the wording of the new Guideline and existing legal definitions. To reduce confusion, these should be addressed through revising the legal definitions. In addition, future challenges to brain death based on the Charter of Rights and Freedoms can be anticipated. Facilities should consider and adopt policies that identify what types of accommodation of religious objection and what limits to accommodation are reasonable and well-justified.
RéSUMé: OBJECTIF: Les nouvelles Lignes directrices canadiennes de pratique clinique pour la détermination du décès cérébral de 2023 fournissent une nouvelle définition du décès ainsi que des procédures claires pour la détermination du décès (c.-à-d. lorsque cette définition est respectée). Étant donné que les médecins doivent exercer conformément aux lois en vigueur, la présente analyse juridique décrit les définitions juridiques existantes du décès au Canada et vise à déterminer si les nouvelles Lignes directrices sont conformes à ces définitions. Cette analyse examine également comment la liberté de religion et l’égalité dans la Charte canadienne des droits et libertés pourraient s’appliquer au diagnostic de mort cérébrale. MéTHODE: Nous avons effectué une analyse juridique conformément aux procédures habituelles de recherche et d’analyse juridiques, y compris l’examen du droit écrit, de la jurisprudence et de la littérature juridique secondaire. L’ébauche du document a été examinée par le sous-groupe de travail juridico-éthique et présentée à l’équipe élargie du projet des Lignes directrices pour commentaires. RéSULTATS ET CONCLUSIONS: Il existe certaines différences entre le libellé des nouvelles Lignes directrices et les définitions juridiques existantes. Pour réduire la confusion, il convient de remédier à ces problèmes en révisant les définitions juridiques. De plus, les défis futurs à la mort cérébrale fondés sur la Charte des droits et libertés peuvent être anticipés. Les établissements devraient envisager et adopter des politiques qui précisent quels types d’accommodement d’objection religieuse et quelles limites d’accommodement sont raisonnables et bien justifiés.

OBJECTIVE: Concussions are a major public health concern, and, thus, specific policies have been developed for implementation targeting vulnerable populations such as school-aged children and youth in the school setting, in whom the majority of concussions are sports related. Currently, concussion policies exist in various jurisdictions, including Canada\'s first concussion policy for schools, Ontario\'s PPM158, initiated in 2014. However, these policies are often variable in terms of content and comprehensiveness. Our objective was to develop a consensus for the content of concussion policy for schools.
METHODS: Following a pilot study in one Ontario school board in 2015, which identified missing elements in existing concussion policy, we employed a modified Delphi method to develop consensus for the content of concussion public policy for schools. We used an integrated knowledge translation approach with participation from a multidisciplinary stakeholder group of 20 experts including principals, school board directors, physicians, policymakers, public health representatives and parents.
RESULTS: Based on the experts, we created a list of 30 policy recommendations for concussion policy in the school setting. This comprehensive list reflects the diverse perspectives of the experts and addresses the role of parents, teachers, coaches, school administrators, referees, trainers, physicians/nurse practitioners, public health and students.
CONCLUSIONS: This is the first expert consensus for content of concussion public policy for schools and can be used for policy development or enhancement in schools in other jurisdictions. We provide a comprehensive list of 30 recommendations to guide best practices for policy development and implementation to enhance school-based concussion prevention and management.

Artificial intelligence (AI) has made impressive progress over the past few years, including many applications in medical imaging. Numerous commercial solutions based on AI techniques are now available for sale, forcing radiology practices to learn how to properly assess these tools. While several guidelines describing good practices for conducting and reporting AI-based research in medicine and radiology have been published, fewer efforts have focused on recommendations addressing the key questions to consider when critically assessing AI solutions before purchase. Commercial AI solutions are typically complicated software products, for the evaluation of which many factors are to be considered. In this work, authors from academia and industry have joined efforts to propose a practical framework that will help stakeholders evaluate commercial AI solutions in radiology (the ECLAIR guidelines) and reach an informed decision. Topics to consider in the evaluation include the relevance of the solution from the point of view of each stakeholder, issues regarding performance and validation, usability and integration, regulatory and legal aspects, and financial and support services. KEY POINTS: • Numerous commercial solutions based on artificial intelligence techniques are now available for sale, and radiology practices have to learn how to properly assess these tools. • We propose a framework focusing on practical points to consider when assessing an AI solution in medical imaging, allowing all stakeholders to conduct relevant discussions with manufacturers and reach an informed decision as to whether to purchase an AI commercial solution for imaging applications. • Topics to consider in the evaluation include the relevance of the solution from the point of view of each stakeholder, issues regarding performance and validation, usability and integration, regulatory and legal aspects, and financial and support services.

Faecal microbiota transplantation is an emerging therapeutic option, particularly for the treatment of recurrent Clostridioides difficile infection. Stool banks that organise recruitment and screening of faeces donors are being embedded within the regulatory frameworks described in the European Union Tissue and Cells Directive and the technical guide to the quality and safety of tissue and cells for human application, published by the European Council.
Several European and international consensus statements concerning faecal microbiota transplantation have been issued. While these documents provide overall guidance, we aim to provide a detailed description of all processes that relate to the collection, handling and clinical application of human donor stool in this document.
Collaborative subgroups of experts on stool banking drafted concepts for all domains pertaining to stool banking. During a working group meeting in the United European Gastroenterology Week 2019 in Barcelona, these concepts were discussed and finalised to be included in our overall guidance document about faecal microbiota transplantation.
A guidance document for all domains pertaining to stool banking was created. This document includes standard operating manuals for several processes involved with stool banking, such as handling of donor material, storage and donor screening.
The implementation of faecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor faeces preparations for patients.

The opioid epidemic has been declared a public health crisis, with thousands of Americans dying from overdoses each year. In 2017, Ohio passed the Opioid Prescribing Guidelines (OPG) limiting narcotic prescriptions for acute pain. The present study sought to evaluate the effects of OPG on the prescribing behavior of orthopedists following total knee arthroplasty (TKA) and total hip arthroplasty (THA).
An institutional database was queried to compare morphine equivalent dose (MED) prescribed at discharge, acute follow-up (<90 days), and chronic follow-up (>90 days) pre-OPG and post-OPG. Cases were identified over a 2-year period starting 1 year before OPG implementation.
Nine orthopedic surgeons performed 1160 TKAs (692 pre-OPG, 468 post-OPG) and 834 THAs (530 pre-OPG, 304 post-OPG). Total MED for TKA and THA dropped post-OPG (1602.6 ± 54.3 vs 1145.8 ± 66.1, P < .01; 1302.3 ± 47.0 vs 878.3 ± 62.2, P < .01). Much of the total MED decrease was accounted for by the decrease in discharge MED, which was the largest in magnitude (904.8 ± 16.4 vs 606.2 ± 20.0, P < .01; 948.4 ± 19.6 vs 630.6 ± 25.9, P < .01). Seven of the 9 surgeons statistically reduced mean MED prescribed at discharge following OPG. The percentage of patients receiving new narcotic scripts at acute follow-up increased post-OPG for both TKA (41.5% vs 47.2%, P = .05) and THA (18.3% vs 25.7%, P = .01).
Orthopedists reduced total MED prescribed after TKA and THA following the onset of OPG. The majority of this decrease is explained by decreased MED at discharge. Conversely, the post-OPG period saw slightly more new narcotic scripts written during acute follow-up.

This review examines different nutritional guidelines, some case studies, and provides insights and discrepancies, in the regulatory framework of Food Safety Management of some of the world\'s economies. There are thousands of fermented foods and beverages, although the intention was not to review them but check their traditional and cultural value, and if they are still lacking to be classed as a category on different national food guides. For understanding the inconsistencies in claims of concerning fermented foods among various regulatory systems, each legal system should be considered unique. Fermented foods and beverages have long been a part of the human diet, and with further supplementation of probiotic microbes, in some cases, they offer nutritional and health attributes worthy of recommendation of regular consumption. Despite the impact of fermented foods and beverages on gastro-intestinal wellbeing and diseases, their many health benefits or recommended consumption has not been widely translated to global inclusion in world food guidelines. In general, the approach of the legal systems is broadly consistent and their structures may be presented under different formats. African traditional fermented products are briefly mentioned enhancing some recorded adverse effects. Knowing the general benefits of traditional and supplemented fermented foods, they should be a daily item on most national food guides.

Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies.
1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned.
We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers).
With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the study.

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