Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
Pashkov, V. M..
    The theoretical and legal basis for environmental risk as a possible measurement of harm to the environment and human health [Текст] / V. M. Pashkov, M. V. Trotska, A. O. Harkusha // Wiadomosci lekarskie. - 2020. - Vol. 73, Iss.11. - P. 2523-2527
   Перевод заглавия: Теоретичні та правові основи екологічного ризику як можливого виміру шкоди для навколишнього середовища та здоров'я людини
УДК

Аннотация: OBJECTIVE: The aim: To inquire into a theoretical and legal basis that regulates relevant areas and processes; use of certain objects, associated with ecological risks, which association, in turn, indicates the likelihood of conditions that can have adverse effects on the environment, human life and well-being. PATIENTS AND METHODS: Materials and methods: In this work we study statutory regulations and scientific positions of scholars regarding the above-mentioned issue. The study analyses generalized information from scientific journals employing scientific methods from a medical and legal perspective. This article is based on dialectical, comparative, analytic, synthetic, and comprehensive research methods. CONCLUSION: Conclusions: The importance of the issue of environmental risks reflects the need in solving the problem of coexistence between human beings and nature. The analysis of theoretical and legal basis within the outlined framework will allow detecting the gaps and will help to understand in what way they are surmountable while regulating the stressors associated with ecological risks, on one hand, and, on another hand - the possible consequences, in order to prevent and eliminate them as promptly as possible and, thus, minimize their adverse effects on the environment and the health of the population.

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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..
    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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4.
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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5.
Chertov, S. O..
    The impact of agricultural production factors on children's health [Текст] / S. O. Chertov, O. M. Batyhina, A. O. Harkusha // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue:10. - P. 2017-2023
   Перевод заглавия: Влияние факторов сельскохозяйственного производства на здоровье детей
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ББК П

Аннотация: Introduction: According to the decisions of the European Court of Human Rights and the regulations of the World Health Organization, the right to health and the right to life are interconnected. However, the right to life may be a starting point in the context of the right to health. The issue of ensuring the right to life and health protection of certain sections of society, in particular, children working in agriculture, is on the agenda. The aim: To analyze the provisions of international law and scientific literature on the effects of workplace factors on the health of children working in agriculture and to examine the existing limitations of such effects. Materials and methods: International acts, data of international organizations and conclusions of scientists have been examined and used in the study. The study also summarizes information from scientific journals and monographs from a medical and legal point of view with scientific methods. The article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. Conclusions: In the context of preserving the right to health and the right to life, children are the most vulnerable categories of agricultural workers. Working conditions and workplace safety in agriculture for minors have to be properly organized. The level of traumatization, occupational morbidity and above all, the standard of health of child labourers in agriculture depend on the level of proper organization of occupational safety. In many countries, the state of the working environment and safety for child labourers in agriculture and, accordingly, the standard of their health remain unsatisfactory.

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