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Medicine is an important component of the stability of any state, so the study of teaching the legal problems and state regulation of this sphere is useful from both theoretical and practical points of view. Currently, the health protection of the country is one of the priorities of the state policy in the social sphere, which is vividly demonstrated in the "May" decrees of the President of the Russian Federation from 2012 and 2018. Thus teaching the health care financing is the most important instrument of state regulation of this sphere of public life. The article analyzes the main tasks and directions of development of state support for the health care system in recent years. That also allowed to identify the most acute problems. This work may be useful for developing proposals for improving the relevant legislation in this area. In addition, this article will be useful for representatives of both medical and legal science. In the future, it is necessary to improve scientific cooperation between representatives of legal and medical Sciences.

Background: Consumer Medicine Information (CMI) forms an important basis for the dissemination of medicines information worldwide. Methods: This article presents an overview of the design and development of Australian CMI, and discusses "user-testing" as an iterative, formative process for CMI design. Findings: In Australia, legislation and templates guide the creation of CMI by pharmaceutical manufacturers using principles of written health information design, giving consideration to both content and structure. Following these principles to the letter, however, does not always assure the creation of a useable document. A suggested method to gauge the usability of CMI is "user-testing". The process, based on observing individuals using the CMI to answer specific questions, aims to identify areas of weakness in the document allowing targeted improvement. Each question identifies whether (a) the individual can find the relevant information and (b) they can understand it. It is an iterative process designed to be performed repeatedly until it results in a highly-useable CMI. Crucially, the revisions of this information between rounds of testing need to be based on principles of good writing and information design. Other methods of analysing CMI do not actively engage the target audience while simultaneously testing the usability of both content and structure. Although developed in Australia, user testing is not routinely performed on Australian CMI. This is despite the fact that user testing is a legal requirement for leaflets for all new medicines across the European Union (EU). Conclusions: Given CMI's role in empowering patients with information, it follows that every attempt should be made to ensure that they are consumer friendly and usable. There is a strong argument that user testing should be employed in writing medicine information.

Broadly defined, evidence-based practice (EBP) is fundamentally about professional practice being informed and guided by best available evidence of what works. The EBP movement had its origins in the early 1990s in the United Kingdom in medicine and health care services. Sackett et al. defined evidence-based medicine as the "conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. This practice means integrating individual clinical experience with the best available external clinical evidence from systematic research." This definition has pervaded the now wide-ranging EBP literature across many fields of practice, drawing on the idea of meshing research-based evidence with professional knowing and experience to make professional decisions and implement professional action. Interest in EBP has grown, and its application has extended from medicine to allied disciplines, such as nursing, pathology, and cardiology, and to the social sciences and business professions. Both the education and librarianship fields are developing strong approaches to EBP, and these provide directions, and pose challenges and tensions for EBP for school librarianship. Two characteristics stand out in the EBP frameworks being developed in education and librarianship: (1) using the best available evidence, which gives preeminence to evidence derived through randomized controlled trials; and (2) combining this evidence with professional acumen to deliver high-quality services. It is a question of evidence. The professional practice of school librarianship sits at the confluence of education and librarianship. Like evidence-based education, evidenced-based librarianship places emphasis on evidence-based decision making over opinion-based decision making, and on the conscientious interpretation and integration of research-derived evidence to shape and direct professional practice. What the EBP approach in school librarianship appears to make more explicit is not just the use of research-based evidence to make judgments and decisions about how to deliver the instructional and service roles of the school library to meet the goals of the school. The EBP approach to school librarianship also gives explicit attention to "user-reported evidence," that is, evidence of outcomes and impacts of professional practice based on student-generated evidence. (Contains 1 table.)

3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes. [ABSTRACT FROM AUTHOR]

Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation on medical devices (Regulation (EU) 2017/745, MDR) and the EU regulation on in vitro diast medical devices (Regulation (EU) 2017/746, IVDR) resulted in a need for regulatory adjustments to German medical device law. This has created a new legal framework in which institutes for pathology operate, depending on their function as users, operators or in-house manufacturers of in vitro diagnostic medical devices. This overview of the current legal situation represents a snapshot and provides an up-to-date overview of the landscape of European and German medical device law.

Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally, have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable. These therapies, which include cells and gene therapy (GT) labeled as Advanced Therapeutic Medicinal Products globally, have complex mechanisms of action. Owing to their highly personalized and intricate nature of these therapies, developing the latter often presents unique challenges above and beyond those encountered for small molecule drugs. We recently looked through some cell and GT clinical trials and realized the lacunae in the informed consent form (ICF) provided by the investigators. Especially in a country like India, where the general understanding and perception of patients is limited regarding clinical trials, it is felt that any lapses in the consent process may jeopardize the informed decision-making and safety of the participants and tarnish the reputation of India globally. The present article highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies and aims to address all the elements of ICF in light of the challenges associated with these innovative therapies.

ABSTRACT Objective: To evaluate the correlation between blood alcohol levels and the severity of injuries assessed by the Injury Severity Score (ISS) in patients who were victims of traffic accidents admitted to the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (HCFMUSP). Methods: Cross-sectional study carried out between July 2018 and June 2019, at the Central Emergency Room of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (PSC-HCFMUSP). A total of 172 hospitalized patients victims of traffic accidents were included in this study. Blood samples were analyzed by the FMUSP Toxicology Laboratory. Results: 36 patients (20.9%) had positive BAC (≥ 0.2 g/L) with a mean of 1.21 g/L. Overall, patients had a mean age of 37.2 years old, and 136 (79.1%) were men. The ISS of the total casuistry was 15.6; regarding the external cause, the motorcycle was ranked first with 100 cases (58.1%), and drivers were the majority with 57.4% of the sample. Conclusion: There was no correlation between the severity of the injuries and the blood alcohol levels of traffic accident victims admitted to a reference hospital. Level of Evidence II, Cross-Sectional Study.

This paper summarized the school nutrition lunch legislations and nutrition status in China and abroad. School lunch system is relatively well-established and mature in Japan， the United States and Sweden and the lunch system has been gradually as an important part of basic education， which is worth learning by other countries and regions. China started its pilot school nutrition lunch program in 1987， and has improved the nutritional status of students， especially the students in rural areas， significantly. However， there still exists certain gaps compared with developed countries. We should actively learn from those countries， so as to provide reference for the formulation and improvement of China’s nutritional lunch policies.