scholarly journals Ensuring the confidentiality of patient information obtained during a clinical trial of a medicinal product

2021 ◽  
pp. 143-150
Author(s):  
Olena Ponomarova
Keyword(s):  
Clinical Trial ◽  
Medicinal Product ◽  
Criminal Liability ◽  
Personal Data ◽  
Research Process ◽  
Human Right ◽  
Confidential Information ◽  
Legal Norms ◽  
Object Of Study ◽  
The Right

Keywords: clinical trial, confidential information, personal data, patient Clinical trials are conductedin accordance with legal norms, subject to human rights and in accordance with internationalethical principles. Each clinical trial for the patient (subject) begins on a voluntarybasis and with acquaintance of the patient (subject) about the features of the study, itspurpose and purpose, explanation of possible risks, in addition, the patient is informedabout innovative drugs and access to free treatment during research. The patient participatesin the study of the drug of his own volition, signing a voluntary informed consent.It is important to ensure that the rights of the patient (subject) in the clinical trial of themedicinal product to privacy and the protection of personal data, which is confidential informationabout the person who is the subject of the study, are respected. During clinicaltrials, researchers and all persons involved in the research process should treat responsiblythe person participating in the study of the medicinal product as the object of study,namely with respect for the human right to privacy and its secrecy. Individuals and legalentities should be able to protect information legally under their control from disclosure,acquisition or use by others without their consent in a manner contrary to fair commercialpractice, if such information is confidential in the sense that it is as a whole or in theexact configuration and combination of its components, commonly known or available topersons in the circles normally involved with the information in question. It is importantto note that any information that becomes known about the patient (subject) during theclinical trial of the drug should be carefully protected by the party conducting the study.Therefore, it is important to note that the right of a patient not to disclose confidentialinformation about him is guaranteed by the Constitution of Ukraine. The right to medicalsecrecy is enshrined in the Law of Ukraine "Fundamentals of Health Legislation". Incases where the rights of the patient (subject) have been violated, the legislator providesfor criminal liability for intentional disclosure of medical secrets to a person who becameknown in connection with the performance of professional or official duties, if such an actcaused serious consequences and for illegal collection, storage, use, destruction, disseminationof confidential information about a person or illegal change of such informationcomes criminal liability.

Respecting care home residents’ right to privacy: what is the evidence of good practice?

2018 ◽  
Vol 22 (4) ◽  
pp. 198-210 ◽  
Author(s):  
Caroline Emmer De Albuquerque Green ◽  
Anthea Tinker ◽  
Jill Manthorpe
Keyword(s):  
Literature Review ◽  
Care Home ◽  
Good Practice ◽  
Physical Space ◽  
Personal Data ◽  
Care Homes ◽  
Right To Privacy ◽  
Human Right ◽  
Content Type ◽  
The Right

Purpose The purpose of this paper is to review and discuss evidence of good practice in respecting care home residents’ right to privacy. The right to privacy is a fundamental human right as enshrined in international and domestic law and standards. In the context of increasing interest in using a human rights approach to social care in care homes for older people, this literature review summarises research evidence on what respecting the human right to privacy of care home residents entails in practice. Design/methodology/approach This literature review followed a rigorous systematic approach to the scoping review, inspired by the Joanna Biggs Institute’s guidelines for conducting systematic reviews. A total of 12 articles were included in the review. Findings The research took a multidimensional understanding of privacy in their studies. The dimensions can be categorised as physical, inter-relational or related to personal data. The review highlights three good practice points. First, it is good privacy practice in care homes to make available single-occupancy bedrooms to residents since this offers the opportunity to personalising this physical space with furniture and web belongings, adding a sense of ownership over the space. Second, residents appreciate being able to choose when and how they spend their time in their own bedrooms. Third, it is good practice to respect residents’ private physical space and private choices, for example by knocking on doors before entering or agreeing with the resident when it is permissible to enter. The review also found that in some studies privacy considerations were relevant to communal living areas within care homes, including the use of surveillance cameras and the sharing of personal data. Originality/value This literature review adds to the body of academic literature on human rights and social care in practice. It also highlights areas for future research relating to the right to privacy in care homes.

scholarly journals COVID - 19 AS A “SIGNIFICANT CIRCUMSTANCE” FOR RISK ASSESSMENT IN LIFE INSURANCE (IN AND AFTER THE PANDEMIC)

2021 ◽  
Author(s):  
Željka Primorac
Keyword(s):  
Risk Assessment ◽  
Health Status ◽  
Life Insurance ◽  
Personal Data ◽  
Severe Form ◽  
Insurance Contract ◽  
Hospital Treatment ◽  
Legal Norms ◽  
Legal Standards ◽  
The Right

The data on the health status of a policyholder represent a significant circumstance for risk assessment and concluding a life insurance contract, and are also legally relevant circumstances for exercising the rights from that contract. The author starts from a theoretical analysis of the perception of data on the health status of policyholders as personal data, comparing the right to confidentiality of such data with the duty to report them (before concluding a life insurance contract) in terms of reporting all circumstances relevant to the insurance risk assessment. In order to properly fulfil the obligation of pre-contractual nature, the paper analyses the legal norms governing this issue and also provides a comparative overview of the Croatian and German insurance legislation with special emphasis on the scope of health data that the insurer is authorised to require, the clarity of legal standards and legal insurance norms contained in the insurance questionnaires and the life insurance offer. Presenting the importance of COVID-19 infection and possible chronic consequences for human health, the author indicates the extent to which COVID-19 infection (mild or severe form of disease, possible need for hospital treatment) will have an impact on the design of new insurance questionnaires and the relevance of genetic testing results in the context of concluding future life insurance contracts.

scholarly journals РОССИЯ И КИТАЙ: СОВЕРШЕНСТВОВАНИЕ ЗАКОНОДАТЕЛЬСТВА В ОБЛАСТИ БОРЬБЫ С ДОПИНГОМ

2020 ◽  
Vol 56 (3) ◽  
pp. 157-166
Author(s):  
В. В. Литовченко
Keyword(s):  
High Performance ◽  
Criminal Liability ◽  
National Level ◽  
Criminal Policy ◽  
Legal Protection ◽  
Political Influence ◽  
Legal Regulation ◽  
Special Role ◽  
Legal Norms ◽  
The Right

Спорт высших достижений является отражением экономического и политического влияния на международном уровне. Россия со времен СССР, являясь одним из мировых лидеров, занимала ведущие позиции в мировом спорте. Вместе с тем последние события в сфере крупных международных соревнований, серьёзные допинг-скандалы, отстранение ведущих спортсменов от соревнований показывают, что успех в современном спорте высших достижений неизменно связан с правильной трактовкой и реализацией на национальном уровне международно-правовых норм, связанных с допингом. Особую роль занимает уголовно-правовая охрана «чистоты» спорта от преступных посягательств в сфере использования и оборота допинговых средств. Автором проанализированы основы законодательства Российской Федерации и Китайской Народной Республики в области противодействия применению запрещённых препаратов в спорте. Осуществлена оценка на-ционального законодательства двух стран в контексте их соответствия междуна-родно-правовым договорам и соглашениям. Проведён сравнительный анализ действующих административных и уголовно-правовых норм. Систематизированы ос-новные положения и подходы в правовом регулировании данной сферы в России и Китае. Отдельно рассмотрены нормы, регламентирующие уголовную ответствен-ность за преступные деяния, в которых допинг является предметом преступления. Также в работе уделяется внимание уголовной политике в сфере борьбы с использованием допинга национальными спортсменами. Автор приходит к выводу, что две страны – на правильном пути, модифицируя нормы, касающиеся допинга, в соответствии с текущими реалиями спорта высших достижений. Несмотря на необ-ходимость внесения некоторых изменений, в дальнейшем принятые меры в России и Китае должны дать положительный результат. Ключевые слова: спорт высших достижений, законодательство, существующее в России и в КНР, субъекты международной спортивной деятельности, правоотношения, ответственность, борьба с допингом, незаконное употребление, наказание. The sport of records reflects the economic and political influence at the international level. Since the times of the USSR, Russia has been one of the world leaders, hold-ing leading positions in world sports. At the same time, the latest events in the sphere of large international competitions, serious doping scandals, banishment of the leading athletes from the competitions demonstrate that a success in modern sports of the highest achievements is inevitably connected with the correct interpretation and implementation of international legal norms related to doping at the national level. A special role is played by criminal legal protection of sport "cleanliness" from criminal encroachments in the sphere of use and circulation of doping means. The author analyzed the basics of legislation of the Russian Federation and the People's Republic of China in the sphere of counteraction to the use of prohibited drugs in sport. National legislation of the two countries was assessed in the context of their compliance with international legal treaties and agreements. A comparative analysis of existing administrative and criminal legal norms was made. The main provisions and approaches to legal regulation in this area in Russia and China were systematized. The norms regulating criminal liability for criminal acts in which doping is a subject of crime are considered separately. Also, attention is paid to criminal policy in the sphere of struggle against doping by national sportsmen. The author comes to the conclusion that the two countries are on the right track by modifying the norms concerning doping according to the current realities of the high-performance sport. Despite the necessity to make some changes in the future, the measures taken in Russia and China should give positive results. Keywords: sport of records, legislation existing in Russia and the PRC, subjects of international sports activities, legal relations, liability, the fight against doping, illegal use, punishment.

scholarly journals Confidential Information and the Right to Freedom of Speech

2021 ◽  
Vol 10 ◽  
pp. 648-651
Author(s):  
Svitlana Bevz ◽  
Keyword(s):  
Human Rights ◽  
Mass Media ◽  
Public Interest ◽  
Criminal Liability ◽  
Freedom Of Speech ◽  
Confidential Information ◽  
Public Authorities ◽  
The Public ◽  
The Mass Media ◽  
The Right

The article is devoted to the problem of ensuring balance in the realization of two fundamental human rights and freedoms in a democratic society – the right to freedom of speech and privacy. It has been concluded that the rights to freedom of speech and privacy are recognized as fundamental human rights that do not conflict with each other but are intangible, inherent in every person. The right to freedom of journalism is a continuation of the right to freedom of speech and information and consists in the collection, storage, and dissemination of socially important information through the mass media. The usage of the rights in question, including in the mass media actions, may not be grounds for restricting or violating the right of everyone to privacy, the confidentiality of correspondence, correspondence, telephone conversations, and entails criminal liability in cases provided by law. In the public interest, the law provides grounds for exempting a journalist from criminal liability for disclosing confidential information, in particular in the case of disclosure of information of public interest or has already been published in other media, or concerns officials of public authorities.

THE ENFORCEMENT OF EMPLOYEE RIGHT TO PRIVACY IN THE RUSSIAN FEDERATION

2019 ◽  
pp. 116
Author(s):  
Anna V. Andreyanova
Keyword(s):  
Russian Federation ◽  
Labor Law ◽  
Personal Data ◽  
Right To Privacy ◽  
Human Right ◽  
The Right To Privacy ◽  
Judicial Practice ◽  
International Labor ◽  
The Russian Federation ◽  
The Right

The right to privacy is a constitutionally safeguarded human right. The employee right to privacy exists due to consolidation of the mentioned liberty in the Constitution of the Russian Federation. The Labour Code of the Russian Federation does not secure employee right to privacy directly, it regulates the issue of the employee personal data. But the employee right to privacy is characterized by particular qualities that are extrinsic to general human privacy. The aim of the present research is to analyze different spheres in which the employee right to privacy realizes. In response to this aim, firstly, the concepts of the privacy will be evaluated, the national and international labor law will be examined, and the judicial practice will be reviewed. Eventually, some unresolved points of the process of employee right to privacy enjoyment will be identified.

scholarly journals IMPLEMENTATION OF THE ECOSYSTEM APPROACH AS A NECESSARY CONDITION FOR ENSURING THE CONSTITUTIONAL HUMAN RIGHT TO A SAFE ENVIRONMENT FOR LIFE AND HEALTH

2020 ◽  
Vol 73 (9) ◽  
pp. 2062-2067
Author(s):  
Yevhenii P. Suietnov
Keyword(s):  
Historical Analysis ◽  
Scientific Research ◽  
Ecosystem Approach ◽  
Legal Framework ◽  
Necessary Condition ◽  
Human Right ◽  
Legal Norms ◽  
Analysis And Synthesis ◽  
Promising Area ◽  
The Right

The aim: Is to study some aspects of the formation of the ecosystem approach, develop on its basis the latest and promising area of scientific research – EcoHealth and determine the legal framework for the implementation of this approach in Ukraine. Materials and methods: The research is based on international legal documents, statistical reports and information of the WHO, practice of the ECHR, constitutional acts of foreign countries, legislation of Ukraine, works of scientists on ecology, medicine, environmental and medical law. For achievement of reliable and objective results general philosophical (dialectical), general scientific (historical, analysis and synthesis, analogy) and special (comparatively-legal, interpretation of legal norms) methods of scientific knowledge were used. Conclusions: A necessary condition for ensuring the constitutional human right to a safe (favorable, benevolent, healthy, etc.) environment for life and health and, consequently, the right to life and health, is the implementation of an ecosystem approach into national strategies and legislation of different countries, including Ukraine. The development of this approach at the international level has led to the emergence of a new area of scientific research – EcoHealth, which studies how changes in the Earth’s ecosystems affect human health. In Ukraine, the issue of implementing an ecosystem approach to health is not widespread in the scientific literature yet, but this trend is clearly visible in environmental legislation.

scholarly journals THE HUMAN RIGHT TO THE PROTECTION OF PERSONAL DATA ON THE INTERNET: THEORETICAL AND LEGAL ASPECTS

2021 ◽  
pp. 51-54
Author(s):  
T.P. Popovych
Keyword(s):  
Service Providers ◽  
Personal Information ◽  
Personal Data ◽  
Legal Aspects ◽  
The State ◽  
The Internet ◽  
Specific Information ◽  
Human Right ◽  
Internet Service ◽  
The Right

The article is devoted to the analysis of theoretical and legal aspects of the human right to the protection of personal data on the Internet. The author believes that at the present stage the field of personal data protection on the Internet is becoming especially important, linking it with the universal importance of communication that occurs within the Internet, as well as the threat of unauthorized dissemination of information through it. The right to the protection of personal data is considered as one of the forms of realization of the human right to the respect for his private, family life, in the context of his inviolability on the Internet. Scientific intelligence begins with a review of information protection models that have emerged in the world. Yes, we are talking about the American, European and mixed models. However, the article provides an overview of the acts adopted by the relevant European institutions in this area. In addition, the article examines the experience of some foreign countries in ensuring the human right to the protection of personal data on the Internet, in particular Brazil, France and the Republic of Belarus. The author notes that the protection of personal data involves a number of positive and negative obligations of the state and individuals. Negative obligations are aimed at prohibiting the processing of personal data without the consent of the person to whom the specific information relates. The positive obligations of public organizations and individuals (organizations) are to comply with the established legal regime of personal data processing, including the use of appropriate technical means. That is, the author emphasizes that the legal obligations in the context of ensuring the right to protection of personal data on the Internet are imposed not only on the state, but also on Internet service providers, owners of online services and websites, etc., given the possibility that they have access to personal information.

scholarly journals Protection of Human Rights in the Context of Fight against Gene Doping

2020 ◽  
pp. 67-77
Author(s):  
A. I. Redkina ◽  
O. A. Shevchenko ◽  
D. I. Vorontsov
Keyword(s):  
Human Rights ◽  
Criminal Liability ◽  
Legal Regulation ◽  
High Tech ◽  
Human Right ◽  
Gene Doping ◽  
Right To Health Care ◽  
Testing Procedures ◽  
Protection Of Human Rights ◽  
The Right

This article examines issues related to the protection of human rights in the context of the fight against the use of gene doping. The fact of using gene therapy in relation to a person already includes a significant range of potential ethical problems, including probable health risks, the degree of awareness of the patient’s consent to perform certain manipulations, as well as the long-term consequences for a person’s life, and, which is equally important, for future generations. At the same time, the problems of the use of gene doping in relation to athletes significantly aggravates and complicates the process of building regulatory approaches. The article notes the particular susceptibility of the athlete's right to health care in the context of the problem of gene doping. The paper studies the features of the implementation and protection of the human right to protect health and the right to privacy, including legislation aspect of biomedicine and bioethics, as well as taking into account the difficulties associated with the identification of the use of gene doping. Conclusions regarding possible areas for improving legal regulation in this area, among which, strengthening or detailing the legal regulation of the provision of high-tech medical care, properly informing athletes, coaches and other sports professionals about the possible risks of applying genetic engineering methods to humans, proper regulation of testing procedures, toughening criminal liability and expansion of the subject matter of such crimes are formulated.

The Dark Side of the Knowledge Graph - How Can We Make Knowledge Graphs Trustworthy?

2020 ◽  
Author(s):  
Robert Huber ◽  
Jens Klump
Keyword(s):  
Personal Information ◽  
Open Data ◽  
Personal Data ◽  
Research Process ◽  
Fundamental Principle ◽  
Critical Discussion ◽  
Dark Side ◽  
General Data Protection Regulation ◽  
Knowledge Graphs ◽  
The Right

<p>“<em>We kill people based on metadata.</em>” (Gen. Michael V. Hayden, 2014) [1]</p><p>Over the past fifteen years, a number of persistent identifier (PID) systems have been built to help identify the stakeholders and their outputs in the research process and scholarly communication. Transparency is a fundamental principle of science, but this principle of transparency can be in conflict with the principles of the right to privacy. The development of Knowledge Graphs (KG), however, introduces completely new, and possibly unintended uses of publication metadata that require critical discussion. In particular, when personal data, as is linked with ORCID identifiers, are used and linked with research artefacts and personal information, KGs allow identifying personal as well as collaborative networks of individuals. This ability to analyse KGs may be used in a harmful way. It is a sad fact that in some countries, personal relationships or research in certain subject areas can lead to discrimination, persecution or prison. We must, therefore, become aware of the risks and responsibilities that come with networked data in KGs. </p><p>The trustworthiness of PID systems and KGs has so far been discussed in technical and organisational terms. The inclusion of personal data requires a new definition of ‘trust’ in the context of PID systems and Knowledge Graphs which should also include ethical aspects and consider the principles of the General Data Protection Regulation.</p><p>New, trustworthy technological approaches are required to ensure proper maintenance of privacy. As a prerequisite, the level of interoperability between PID needs to be enhanced. Further, new methods and protocols need to be defined which enable secure and prompt cascading update or delete actions of personal data between PID systems as well as knowledge graphs. </p><p>Finally, new trustworthiness criteria must be defined which allow the identification of trusted clients for the exchange of personal data instead of the currently practised open data policy which can be in conflict with legislation protecting privacy and personal data.</p><p>[1] https://www.nybooks.com/daily/2014/05/10/we-kill-people-based-metadata/</p>

scholarly journals Medical secrecy: the rights and responsibilities of participants of the medical process

2020 ◽  
pp. 172-174
Author(s):  
N.O. Lisnevska
Keyword(s):  
Medical Information ◽  
Viral Infections ◽  
Personal Information ◽  
Criminal Liability ◽  
Legal Framework ◽  
Medical Professional ◽  
Third Parties ◽  
Criminal Proceedings ◽  
Confidential Information ◽  
The Right

Background. Medical secrecy (MS) is a set of information about the disease, its treatment, the results of examinations, which became known to certain healthcare workers (HCW) during their professional activities. The attending physician and the nurse who performs the drug administration are most aware of the patient’s condition. The information included in the MS is divided into two types: medical and personal information of the patient, which became known during the performance of medical professional duties. Objective. To describe selected aspects of the MS problem. Materials and methods. Analysis of the legal framework. Results and discussion. Medical information belongs to professional confidential information and should not be disclosed. Even the information about the very fact of seeking medical care belongs to professional confidential information. Unlawful intentional disclosure of MS by a person to whom it became known in the course of its professional duties entails criminal liability. This applies not only to HCW, but also to other staff of medical institutions. It is possible to provide information about the treatment and even the patient’s stay in the hospital to third parties, including relatives of any degree of kinship, only with the patient’s own consent. Exceptions include cases of extreme urgency, such as when a patient is taken to hospital unconscious and relatives can provide information on existing allergies and comorbidities. Of course, in such cases, the necessary disclosure limits should be followed. If a relative or other person wishes to visit a patient in the hospital, he or she should be contacted in person and visited only with personal consent. With regard to law enforcement officers, the answer to the question of whether a particular patient is treated in this institution should be given only in the presence of criminal proceedings and after resolving this issue with the chief physician. It should be noted that medical information concerning the deceased is also confidential and cannot be disclosed. It should not be assumed that the deceased can no longer be harmed, so any liability will be absent. Disclosure of such information is also a crime, on the basis of which criminal proceedings may be started. Recently, the medical legislation in Ukraine was changed, and as of today, the fine for disclosing MT is over UAH 50,000. When treating patients with disabilities, all necessary information should be provided to their parents or carers. When treating children aged 14-18, it is impossible not to provide information about treatment to parents, although this may be contrary to the wishes of the child. An important issue is the provision of information to children who are incapacitated by age, but legally capable. If a 5-year-old child asks questions about his or her health, a doctor or other HCW must answer them in a form that is accessible. A similar situation occurs with mentally ill patients: they are deprived of legal capacity, but they have the right to know about their health. You should also be very careful in keeping medical records. For example, information on viral infections (hepatitis, HIV/AIDS) should not be placed on the cover of the medical history, but inside. Conclusions. 1. MS information is divided into two types: medical and personal information of the patient. 2. Medical information belongs to professional confidential information and should not be disclosed. 3. It is possible to provide information about the treatment and even the patient’s stay in the hospital to third parties, including relatives, only with the patient’s own consent. 4. In the treatment of patients with disabilities, all necessary information should be provided to the parents or carers.

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