Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
Pashkov, V. M..
    3-D Bioprinting Law Regulation Perspectives [Текст] / V. M. Pashkov, A. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 3 pt 1. - p. 480-482
   Перевод заглавия: 3-D перспективы регулирования биопринтинга
УДК
ББК Х833

Аннотация: INTRODUCTION: Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: General debate of last few years comes down to an attempt to resolve hesitation between legal attempts for regulation of 3-D biobrinting and concept of complete prohibition of such activities. An adequate response to the mentioned challenge is a reasonable position between some aspects of prohibition and self-regulation, resulting in a moderate number of regulations and standards for developing and marketing. Such regulations may concern an intellectual property (IP) rights, regulation of distribution, premarket restrictions, control mechanism etc. CONCLUSION: Scientific approach and regulatory settlement of 3-D bioprinting sphere must unite to achieve a fair balance between the interests of humanity and of individuals - on the one hand, and development of science and business benefits for stakeholders - on the other. The main instruments for this must be balanced regulation of intellectual property (IP) rights, regulation of access and distribution, premarket restrictions, control mechanism etc.

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2.
Pashkov, V. M..
    Artificial intelligence in medical practice: regulative issues and perspectives [Текст] / V. M. Pashkov, A. O. Harkusha, Y. O. Harkusha // Wiadomosci lekarskie. - 2020. - Vol. 73, Iss. 12, cz. 2. - P. 2722-2727
   Перевод заглавия: Штучний інтелект у медичній практиці: регулятивні питання та перспективи
УДК
РУБ PubMed ID33611272 + DOI: 10.36740/WLek202012204

Аннотация: OBJECTIVE: The aim of the research is to identify specific of AI in healthcare, its nature, and specifics and to establish complexities of AI implementation in healthcare and to propose ways to eliminate them. PATIENTS AND METHODS: Materials and methods: This study was conducted during June-October of 2020. Through a broad literature review, analysis of EU, USA regulation acts, scientific researches and opinions of progressive-minded people in this sphere this paper provide a guide to understanding the essence of AI in healthcare and specifics of its regulation. It is based on dialectical, comparative, analytic, synthetic and comprehensive methods. RESULTS: Results: One of the first broad definitions of AI sounded like "Artificial Intelligence is the study of ideas which enable computers to do the things that make people seem intelligent ... The central goals of Artificial Intelligence are to make computers more useful and to understand the principles which make intelligence possible." There are two approaches to name this technology - "Artificial intelligence" and "Augmented Intelligence." We prefer to use a more common category of "Artificial intelligence" rather than "Augmented Intelligence" because the last one, from our point of view, leaves much space for "human supervision" meaning, and that will limit the sense of AI while it will undoubtedly develop in future. AI in current practice is interpreted in three forms, they are: AI as a simple electronic tool without any level of autonomy (like electronic assistant, "calculator"), AI as an entity with some level of autonomy, but under human control, and AI as an entity with broad autonomy, substituting human's activity wholly or partly, and we have to admit that the first one cannot be considered as AI at all in current conditions of science development. Description of AI often tends to operate with big technological products like DeepMind (by Google), Watson Health (by IBM), Healthcare's Edison (by General Electric), but in fact, a lot of smaller technologies also use AI in the healthcare field - smartphone applications, wearable health devices and other examples of the Internet of Things. At the current stage of development AI in medical practice is existing in three technical forms: software, hardware, and mixed forms using three main scientific-statistical approaches - flowchart method, database method, and decision-making method. All of them are useable, but they are differently suiting for AI implementation. The main issues of AI implementation in healthcare are connected with the nature of technology in itself, complexities of legal support in terms of safety and efficiency, privacy, ethical and liability concerns. CONCLUSION: Conclusion: The conducted analysis makes it possible to admit a number of pros and cons in the field of AI using in healthcare. Undoubtedly this is a promising area with a lot of gaps and grey zones to fill in. Furthermore, the main challenge is not on technology itself, which is rapidly growing, evolving, and uncovering new areas of its use, but rather on the legal framework that is clearly lacking appropriate regulations and some political, ethical, and financial transformations. Thus, the core questions regarding is this technology by its nature is suitable for healthcare at all? Is the current legislative framework looking appropriate to regulate AI in terms of safety, efficiency, premarket, and postmarked monitoring? How the model of liability with connection to AI technology using in healthcare should be constructed? How to ensure privacy without the restriction of AI technology use? Should intellectual privacy rights prevail over public health concerns? Many questions to address in order to move in line with technology development and to get the benefits of its practical implementation.

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3.
Pashkov, V. M..
    Challenges of classification of stand-alone software as a medical device [Текст] / V. M. Pashkov, O. S. Soloviov, Ye. O. Harkusha // Wiadomosci lekarskie. - 2021. - Vol. 74, Iss. 2. - P. 327-333
   Перевод заглавия: Проблемы классификации автономного программного обеспечения как медицинское устройство
УДК

Аннотация: Through a broad literature review, analysis of EU, USA, Ukraine regulation acts, scientific research, and opinions of progressive-minded people in this sphere, this paper provides a guide to understanding the essence of classification of stand-alone software with medical purpose and specifics of its regulation. This research is based on dialectical, comparative, analytic, synthetic, and comprehensive methods.

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4.
Pashkov, V. M..
    Concept of Waste and its Impact on Human Health [Текст] / V. M. Pashkov, O. M. Batyhina, M. V. Trotska // Wiadomosci lekarskie. - 2017. - Vol. 70, No. 5. - P. 964-969
   Перевод заглавия: Концепция отходов и их влияние на здоровье человека
УДК
ББК Х625.80

Аннотация: INTRODUCTION: Impact of the environment on human health is increasingly being paid attention both at the international level and at the level of individual countries. Among the factors that anyhow can affect it negatively, various objects are distinguished and waste is not of the last consequence. It has different nature of origin, ways of further utilization and a degree of impact on human health and the environment. Its generation, utilization and neutralization are determined by the relevant processes; their research allows continuous improvement and reduction of their negative impact on human health and the environment. THE AIM: To analyze provisions of the international legislation concerning the concept of waste and its classification, as well as its potential impacts on human health and the environment. MATERIALS AND METHODS: The study analyzes and uses international legal documents, data of international organizations and scientists' deductions. Furthermore, the study integrates information from scientific journals with scientific methods from the medical and legal point of view. Within the framework of the system approach, as well as analysis and synthesis, the concept of waste, its classification and impact on human health and the environment have been researched. RESULTS: In consequence of the conducted study, it has been found that at the European level, considerable attention is paid to waste in the context of its possible negative impact on human health and the environment. Solution of this problem is carried out with the integrated approach, which is expressed both in enacting statutory acts and amending existing ones, as well as elucidating various aspects at the scientific, methodological, statistical and other levels. CONCLUSIONS: Waste in itself has different nature of origin, negative impact, ways of its further utilization. Some kinds of it can be used further in order to achieve other goals and needs that are not related to their generation, others can no longer be used for human benefits taking into account existing achievements.

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5.
Pashkov, V. M..
    Enforceability of non-compete agreements in medical practice: between law and ethics [Текст] / V. M. Pashkov, A. O. Harkusha // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue: 12 cz 2. - P. 2421-2426
   Перевод заглавия: Возможность применения неконкурентных соглашений в медицинской практике: между законом и этикой.
УДК
ББК Х623.211.84
РУБ DOI: 10.36740/WLek201912205

Аннотация: OBJECTIVE: Introduction: The core of physician's non-compete agreements problematics lies in complex system of controversial interests, rights and goals of subjects involved. On the one hand non-compete restrictions and their enforceability is an obvious part of employer's legitimate business interest based on the freedom of contract, on the other - free unrestricted market, preventing of monopolization, availability of medical assistance and healthcare, right to choose a doctor are social standards and thus - a part of public interest, in addition to this - non-compete restrictions impact physician's right to work. Balance between these components is pretty sensitive and hard to achieve. We can find enforceability of physician's non-compete provisions in different types of relations: employment contracts, partnership agreements, sale of medical practice. But complexity of mixing law, ethical, social issues along with different approaches of legal regulations rises the relevance of research. PATIENTS AND METHODS: Material and methods: This study is based on German, British, Spain, Swiss, USA regulation acts, scientific researches and opinions of progressive-minded people in this sphere. The article is based on dialectical, comparative, analytic, synthetic and comprehensive methods. RESULTS: Results: Non-compete agreements may have social benefits in some situations: serve as an instrument to protect trade secrets thus stimulate innovation; reducing of worker's exit probability could increase quality of medical services due to training of employees etc. But also, there are some serious risks to employee, to employer and to society as a whole. Analyzing the sense of non-compete clause in general we can assume that it includes seven main points: the subject; the form; the time; the territory; the scope and type of restrictions; "buy out" of the clause and the compensation. These characteristics are the core of non-compete clause, and, taking into account the principle of freedom in terms of agreement conclusion, it is up to law enforcement practice to determine minimal and maximal limits of such restrictions. US legal concept is clearly based on implementing of legally prescribed restrictions for non-compete with physicians (along with other categories). European practice being pretty similar in view on what non-compete agreement is and what principles it is based on however is obviously different in approach chosen because of absence of special legal provisions for physicians' non-compete regulation. CONCLUSION: Conclusion: Lack of legal regulation and law enforcement practice in this sphere worldwide is obvious, so the starting point in resolving of physician's non-compete enforceability issue will be choosing of suitable concept. Analyzing of proposed concepts, we came to the conclusion that the most perspective will be an approach of specification and clarification of "reasonability" meaning in terms of evaluation physicians' non-compete agreement validity and their impact on public interest.

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6.
Gutorova, N. .
    Ensuring the citizens' rights and freedoms in case of COVID-19 vaccinatio in the public health system [Текст] / N. Gutorova, V. M. Pashkov, T. Kaganovska // Wiadomosci lekarskie. - 2021. - Vol. 74, Iss. 11, cz. 2. - P. 2863-2869
   Перевод заглавия: Забезпечення прав і свобод громадян при вакцинації проти COVID-19 в системі охорони здоров’я
УДК
РУБ PMID: 35029547 + DOI: 10.36740/WLek202111201

Аннотация: ABSTRACT The aim: To study the legal and regulatory framework for ensuring the right to health of patients depending on the legal status of coronavirus vaccines in different countries as an essential element influencing the right to public health and other rights of citizens. Materials and methods: In this paper, we study the legal norms and scientific positions on the above issue using generalized information from scientific journals that use scientific methods from a medical and legal point of view. This article is based on dialectical, comparative, analytical, synthetic, and complex research methods. Using the above methods, we studied the attitudes of different categories of citizens to vaccination against coronavirus disease through questionnaires on the following issues: attitudes to vaccination in general; motivation for vaccination, in case of consent to vaccination; reasons for refusal of vaccination. The case-law of the European Court of Human Rights on vaccination and ensuring the rights of citizens to health care was also analyzed. Results: Proper legal regulation of the right to health depending on the legal status of the vaccines is important in order to implement restrictive measures to combat COVID-19 and, accordingly, to prevent the possible spread of a pandemic in the public health system. Conclusions: Ensuring the right to health and applying restrictive measures to prevent the spread of a pandemic is an essential element of the public health system. However, the question of the legal status of vaccines is crucial to prevent the spread of the disease. That is, it is essential to go through all the stages of clinical trials for the vaccines used. Their safety and effectiveness and proving the fact that the harm of vaccination is much less than the harm of the spread of coronavirus disease. In the process of ensuring the right to health, including by making compulsory vaccination against COVID-19, legal framework and practice are critical components that aim to minimize the potential hazards that threaten the health and lives of the population.

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7.
Gutorova, N. O..
    Illegal internet pharmacies as a threat to public health in Europe [Text] / N. O. Gutorova, V. M. Pashkov, O. S. Soloviov // Wiadomosci lekarskie. - 2021. - Vol. 74, Iss. 9 cz 1. - P. 2169-2174
   Перевод заглавия: Нелегальні інтернет-аптеки як загроза громадському здоров’ю в Європі
УДК
РУБ DOI: 10.36740/WLek202109125

Аннотация: OBJECTIVE: The aim: This article aims to raise awareness and stimulate serious discussion about the dangers of illegal Internet pharmacies for patient safety and public health, the necessity to improve legal instruments, and unite the efforts of governments, professional organizations, and civil society for combating this activity. PATIENTS AND METHODS: Materials and methods: This study is based on the Medicrime Convention, empirical and analytical data of the WHO, Interpol, Europol, NABF, Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011, the regulatory acts and juridical practice of Ukraine, experts interview of pharmacy practicians, analysis of websites. Totally 18 laws and papers, 34 court judgments, 50 websites were analyzed, six experts were interviewed. Dialectical, comparative, analytic, synthetic, system analyses and sociological research methods were used. RESULTS: Results: Illegal Internet pharmacies are widespread in Europe, especially during the COVID-19 pandemic. This black market poses a severe threat to patient safety and public health as falsifying, substandard, and smuggled medicines are sold through these channels. Without any exception, all illegal pharmacies sell prescription drugs without any prescriptions. Regulatory and protective legal instruments at the national and international levels are insufficient to counter the Internet trade in medicines. CONCLUSION: Conclusions: The widespread proliferation of illegal Internet pharmacies in Europe requires European states to work together to protect patient safety and public health. A legal mechanism needs to be established to exchange information and combat illegal pharmaceutical activities on the Internet at the international level. At the national level, it is necessary to strengthen control over the wholesale of prescription medications to prevent them from entering the black market.

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8.
Horodovenko, V. V..
    International legal instruments in the field of bioethics and their impact on protection of human rights [Text] / V. V. Horodovenko, V. M. Pashkov, L. G. Udovyka // Wiadomosci Lekarskie. - 2020. - Vol. 73, Iss. 7. - P. 1554-1560
   Перевод заглавия: Международно-правовые инструменты в области биоэтики и их влияние на защиту прав человека
ББК Х623.211.84
РУБ PubMed: 32759454

Аннотация: OBJECTIVE: Introduction: A rapid development of biomedicine, genetics, pharmacology, transplantation and biotechnology has posed a number of problems to humanity, in particular, with regard to human rights protection in healthcare. These problems solution requires considering the achievements and propositions of biology, medicine, ethics and law. International legal standards in the field of bioethics are of significance in development of national states regulations on bioethics and biotic legislation. Aim: To investigate the impact of international legal instruments in the field of bioethics on protection of human rights. PATIENTS AND METHODS: Materials and methods: In the research the international legal instruments and documents in the field of healthcare and bioethics were used. Civilizational, axiological, dialectical, systemic and comparative legal methods as well as systematization, analysis and synthesis were decisive in the research process. CONCLUSION: Conclusions: Legal instruments in the field of biomedical technologies (directives and regulations) are mainly advisory by nature. In many cases, the problems arising in biotechnology are resolved through establishment and involvement of national supervision bodies: councils (commissions, committees) in bioethics as well as courts. An important role in protection of human rights in the field of biotechnology is played by the ECHR the decisions of which are dynamic, based on the Convention and consideration of national legislations. At the same time, a number of problems remain unresolved because of constant development of biomedical technologies, necessity to take into account the latest achievements and discoveries as well as all types and methods of applying of genetic engineering to humans. In general, insufficient attention is paid to the problems of medical biotechnologies application both at the international and national levels.

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9.
Pashkov, V. M..
    Legal Aspects of Counteracting the Trafficking of Falsified Medicines in the European Union [Текст] / V. M. Pashkov, A. Soloviov, A. A. Olefir // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:4. - P. 843-849
   Перевод заглавия: Правовые аспекты противодействия торговле фальсифицированными лекарствами в Европейском союзе
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: The paper identifies key risks associated with the illegal production and sale of medicines. Also there were generalized features of criminal responsibility for acts related to the trafficking of drugs in some Member States of the EU and analyzed legal means of combating the falsified drugs today. The problem concerning falsification of medicines is particularly acute not only in developing countries but also in developed ones. Fake is one in ten - twenty drug. The largest share of falsified drugs comes from the so-called «Asian tigers», already from which they come to the EU market. THE AIM: In this publication authors have set following objectives: - to determine the risks associated with illegal production and sale of medicines; - organize legal means of combating the falsified medicines in the EU member states; - clarify features of criminal responsibility for acts related to the trafficking of drugs in the EU countries. MATERIALS AND METHODS: The article bases on the works of scholars and experts, statistical information and other sources. Particular attention is paid to the analysis of regulations of the EU institutions and national criminal laws. So, provisions of the criminal codes of 10 EU member states were taken into account. RESULTS: There is a system of legal measures which counter the circulation of falsified medicines in the EU and consists of general and specific regulatory requirements, mainly of economic and legal nature. The most important role among the last play package labeling requirements for drugs and license conditions. DISCUSSION: In the article were discussed factors that stimulate the production and sale of falsified drugs and the risks associated with these. Demarcated the concept of «falsified medicinal product», «counterfeit drug», «substandard drug». CONCLUSIONS: Although there are guidelines for patients to identify falsified drugs, still a major role in this process should play public authorities and enterprises. In all the countries illegal circulation of falsified drugs is prohibited under threat of criminal or administrative responsibility.

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10.
Pashkov, V. M..
    Legal Regulation of the Production and Trade of Medical Devices and Medical Equipment in the EU and US: Experience for Ukraine [Текст] / V. M. Pashkov, А. Kotvitska, A. O. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 614-618
   Перевод заглавия: Правовое регулирование производства и торговли медицинскими приборами и медицинским оборудованием в ЕС и США: опыт для Украины
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: The need for effective legal regulation of production and sale of medical products in Ukraine due to its social effect is obvious and requires a high level of clarity. The experience of more advanced countries in this area, given the way chosen by Ukraine to harmonize our laws with EU legislation, is certainly could be a useful source of information. The urgency of issues need further intensification of national legal reforms. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Legislation of Ukraine, European Union, United States of America, Guidelines, developed by European Commission & Food and Drug Administration's (FDA), recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: This study provide a possibility to state that main difference of regulatory systems in EU and US is that the legal framework of the EU is more flexible. This flexibility is grounded on main principle that only basic quality requirements for medical devices is defined by legislative acts however more detailed requirements are defined in standards, technical regulations, specifications, which are discretionary in nature. Contractors are free to choose any technical solution that provides compliance with the essential requirements, they can choose among different conformity assessment procedures and between accredited conformity assessment bodies to which they want to apply. The contractors themselves is interested to pass the conformity assessment procedure and have the right to put a conformity mark on their medical device because it will give them a real competitive advantage. In contrast, US State regulatory system provides strict control over business entities and law act establishes the quality requirements of medical products. The only body that can authorize the introduction of medical products and perform post-market monitoring is Food and Drug Administration (FDA), which has almost unlimited competence in this sphere. CONCLUSION: Taking into account further deepening of the European integration process of Ukraine, establishing of the regulatory system as much similar to that of the EU as possible is a main goal of legal reforms in abovementioned sphere. On the one hand, such system allows to implement effective control of contractors in the sphere of production and sale of medical products and provide safety of medical devices that are introduced, on the other hand, it does not afflict contractors with excessive and total control, allowing them to choose behavior that is most acceptable, understandable and user-specific. However, US's experience also has some positive characteristics, which could be taken into account. Therefore, such complex symbiosis of approaches from our point of view will balance controversial interest of manufacturers, sellers and consumers of medical devices.

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Умовні позначення місця знаходження

3_пов.(ЗПІ) – зала правової інформації, НБК

4_пов.(НАб) – абонемент наукової літератури, НБК

4_пов.(ДБФ) – довідково-бібліографічний фонд, НБК

5_пов.(З/П) – зала періодичних видань, НБК

6_пов.(АХЛ) – абонемент художньої літератури, НБК

6_пов.(ЗІЛ) – зала літератури іноземними мовами, НБК

7_пов.(Хр) – книгосховище, НБК

8_пов.(РК) – книгосховище рідкісних видань та дисертацій, НБК

НБВ – інформаційно-бібліографічний відділ, НБК, 7 поверх

Ст.Аб. – студентський абонемент, НБК, 5 поверх

Філ №1 – філія № 1 (вул. Динамівська, 4)

Філ №2 – філія № 2 (вул. Пушкінська, 106)

Полт. фак. – Полтавський юридичний інститут, м. Полтава