Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
Pashkov, V. .
    Certain aspects on medical devices software law regulation [Текст] / V. Pashkov, A. Harkusha // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Tom LXIX, nr 6. - S. 765-767
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Аннотация: INTRODUCTION: some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

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2.
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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3.
Pashkov, V. M..
    Ensuring right to organic food in public health system [Текст] / V. M. Pashkov, O. M. Batyhina, L. Leiba // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 1 pt 2. - P. 226-229
   Перевод заглавия: Обеспечение права на органические продукты питания в системе общественного здравоохранения
УДК
ББК Р11

Аннотация: OBJECTIVE: Introduction: Human health directly depends on safety and quality of food. In turn, quality and safety of food directly depend on its production conditions and methods. There are two main food production methods: traditional and organic. Organic food production is considered safer and more beneficial for human health. Aim: to determine whether the organic food production method affects human health. PATIENTS AND METHODS: Materials and methods: international acts, data of international organizations and conclusions of scientists have been examined and used in the study. The article also summarizes information from scientific journals and monographs from a medical and legal point of view with scientific methods. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. The problems of effects of food production methods and conditions on human health have been analyzed within the framework of the system approach. CONCLUSION: Conclusions: Food production methods and conditions ultimately affect the state and level of human health. The organic method of production activity has a positive effect on human health.

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4.
Pashkov, V. .
    European Experience of Regulating Distance Selling of Medicines for Ukraine [Текст] / V. Pashkov, Y. Hrekov, M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, № 1. - pp. 96-100
   Перевод заглавия: Европейский опыт регулирования дистанционной продажи лекарств для Украины
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. AIM: The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. MATERIAL AND METHODS: This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. CONCLUSION: Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.

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5.
Razmetaeva, Y.
    Euthanasia in the digital age: medical and legal issues and challenges [Текст] = Эвтаназия в цифровую эпоху: медицинские и правовые проблемы и вызовы / Y. Razmetaeva, O. Sydorenko // Georgian medical news. - 2020. - Iss. 1 (298). - P. 175-180
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Аннотация: The purpose of this article is to analyze the main medical, legal, and ethical issues and challenges of euthanasia in the digital age. The methods that were used in this study are historical, logical, empirical, as well as comparative legal method for comparison of laws and practices of the EU and post-Soviet countries, including Ukraine. This choice determined by the fact that both groups of countries have common features and relations, while the features of their development affect approaches to regulating such sensitive and potentially open to abuse problems as euthanasia. There is no final legal answer as to whether to legalize, decriminalize or prohibit euthanasia in any of its forms. The features and legal terms of active and passive, voluntary and non-voluntary euthanasia and assisted suicide, especially for psychiatric and minor patients were researched, as well as conflicting arguments, which include individual autonomy, right to choose, the opportunity to get rid of suffering, as well as undermining the practice of palliative care, abuse in cases of vulnerable and dependent patients, moral burden on the doctors. The issue of control of the practice of euthanasia is complicated, given the extent to which it is possible to obtain informed consent, establish criteria for suffering and hopelessness, check the persistence, conviction and validity of requests for euthanasia, especially in the digital era. The potential legislation and judicial practice should provide for strict and effective guarantees, respect for the beliefs of each person and the right not to participate in any contentious practices, the balance of human rights and social values.

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6.
Obolentsev, V. F..
    Information technology of verification of algorithmic of medical regulations [Текст] / V. F. Obolentsev, O. M. Hutsa, O. B. Demchenko // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue:12 cz 2. - P. 2427-2433
   Перевод заглавия: Информационные технологии верификации алгоритмов медицинского регулирования
УДК
ББК Х623.211.84 + Р
РУБ DOI: 10.36740/WLek201912206

Аннотация: OBJECTIVE: Introduction: In the medical field, using of information-analytical technologies and expert systems is becoming increasingly common. Therefore, the problem of quality of normative acts (documents), which unify the standards of the newest methods of medical activity, becomes urgent. But, unfortunately, legal experts state that there is a problem of errors in regulations of different branches of rulemaking. A rulemaking error can be recognized as inconsistency of a text or a rule of law's content regarding its purpose. There are two types of legal errors: purely textual and substantive (algorithmic). The aim: The aim of the article is to demonstrate the possibilities of using information technology based on BPMN to display algorithms and identify algorithmic errors in regulations that adjust activities of health care professionals. PATIENTS AND METHODS: Materials and methods: It is used BPMN (Business Process Model And Notation) technology in the research. With its help, a logical-analytical check of algorithm scheme for treatment of abnormal uterine bleeding, provided in the normative document of the Ministry of Health of Ukraine "Unified Clinical Protocol of Primary, Secondary (specialized) and Tertiary (highly specialized) Medical Care. Abnormal Uterine Bleeding", approved by the order of the Ministry of Health of Ukraine on 13.04.2016, No. 353. Algorithmic errors in the scheme were checked using Microsoft Visio software. According to the results of the logical-analytical examination of the mentioned normative act's text, a scheme of algorithm for treatment of abnormal uterine bleeding in BPMN was constructed. RESULTS: Results: The use of the proposed BPMN-based information technology and Microsoft Visio software allows you to control the algorithmic nature of regulated medical practice processes and to detect errors, to create visual models of schematically regulated medical practice algorithms. CONCLUSION: Conclusions: The proposed information technology, based on BPMN can be used to display algorithms and detect errors in regulatory acts that adjust activity of medical professionals.

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7.
Pashkov, V. M..
    International medical law and its impact on the ukrainian health care legislation [Текст] / V. M. Pashkov, L. Udovyka, H. Dichko // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 1 pt 2. - P. 201-205
   Перевод заглавия: Международное медицинское право и его влияние на законодательство Украины в области здравоохранения
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ББК Р11

Аннотация: OBJECTIVE: Introduction: The Ukrainian state has an urgent necessity of rapid search for essentially new legal and organizational forms of the healthcare system, reform of the legal regulation of healthcare services provision. In the context of European integration, the advancement of the medical industry reform is closely related to consideration of international standards and norms of health care. The aim: To study the impact of international medical law on the Ukrainian health care legislation. PATIENTS AND METHODS: Materials and methods: International and Ukrainian regulations and documents on health care were used in the research. System and structural, functional and legal comparative methods as well as systematization, analysis and synthesis were determinative in the research process. RESULTS: Review: Systematization of international documents on health care was made. The major problems in the Ukrainian health care legislation were determined in terms of their conformity with the international legislative norms. The expediency of the Medical Code adoption was grounded and its structure was defined. CONCLUSION: Conclusions: Most health care international acts are ratified by Ukraine and their provisions are implemented in the legislation. Simultaneously, there is a row of problems, which hinder the Ukrainian health care development and place obstacles in the way of European integration. To remove these obstacles, it is expedient to create a codified act - the Medical Code, which would systematize the provisions of the current medical laws and regulations and fill in the existing gaps in the legal regulation of health care.

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8.
Pashkov, V. M..
    Legal Features of the Drug Advertising [Текст] / V. M. Pashkov, A. A. Olefir, O. Y. Bytyak // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 1 . - p. 133-138
   Перевод заглавия: Юридические особенности рекламы лекарств
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Аннотация: Abstract INTRODUCTION:In the article discribed current trends of advertising in the pharmaceutical market and foreign experience of legal regulation of these relations. As for the advertising of medicines identified it's symptoms, types, basic rules and prohibitions. Modern pharmaceutical companies can not successfully carry out economic activities without advertising. Besides we can mention some fundamental changes in society (information overload, universal access to internet, social media, freedom of movement of goods, labor and finance), also self-medication becomes more popular. At the same time, the number of deaths after improper and uncontrolled use of drugs ranks fifth in the world among the causes of death. AIM:Investigate current trends of advertising on the pharmaceutical market, find advertising signs, basic restrictions and prohibitions on advertising of medicines, as well as foreign experience of legal regulation of these relations. MATERIAL AND METHODS:Despite the fact that pharmaceutical advertising were studied by such scholars as M. Abraham, L. Bradley, C. Dunn, J. Donoh'yu, D. Castro, M. Lipski, K. Taylor and others, number of issues related features of drug advertising, remained without proper theoretical studies. RESULTS:Based on the analysis can come to the conclusion that advertising of medicinal products are the subject of special attention from the state. Drugs, unlike other products, are a group of specialized consumer products. Risks increase when patients under the influence of «aggressive» advertising resort to self-medication. If a complete ban on advertising of medicines is inappropriate, you should set stricter requirements for the content of advertising and product placement rules. That is, in the national legislation to implement regulatory requirements of Directive 2001/83 / EC. CONCLUSIONS:Legal regulation of drug advertising can be improved by such legal means: - should provide for a mechanism of public control over the observance of ethical standards in the advertising of medicinal products; - Prohibit the advertising of medicines for children, as well as drugs for the treatment of infectious, parasitic diseases and pathogens of these diseases, chronic insomnia, cardiovascular diseases, and those costs are reimbursed by government programs or trade names may lead to mix with prescription drugs; - Adopt ethical standards (codes) promotion of drugs for pharmaceutical companies; - Advertising to the public shall not contain any reference to cost or pricing features for medicines.

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9.
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
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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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10.
Pashkov, V. .
    Medical device software: defining key term [Текст] / V. Pashkov, N. Gutorova, A. Harkusha // Wiadomości Lekarskie. - 2016. - Tom LXIX, nr 6. - P. 813-817
   Перевод заглавия: Медицинское программное обеспечение устройства: определение ключевых терминов.
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ББК Р

Аннотация: INTRODUCTION: one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

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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

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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