ISSN Print 2713-0894    ISSN Online 2713-0908
Medical Ethics
BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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Review Analysis of requirements for confidentiality and exchange of digital health data
Alzubaidi AK
The article provides answers to immediate questions associated with the state regulation of confidentiality of information and exchange of data in the era of digital healthcare. The institute of medical confidentiality which originated in the ancient world is still evolving throughout the development of medical law. In the current era of global digitalization, however, the issues related to data confidentiality have become more relevant than ever. With all the modern technologies and digital health care platforms on the rise, new challenges associated with protection of these patients are emerging. To ensure the reliable protection of patient’s personal and medical information, doctors and medical institutions have to meet data security standards. It becomes vital to develop effective strategies and mechanisms to prevent unauthorized access and data leakage due to a larger volume of electronic medical records and digital data exchange. Strict rules and standards regulating collection, storage and transfer of medical data belong to a key aspect in this area. The Russian Federation is making great efforts to create the legislation which could protect the rights of patients and made medical establishments to follow the high standards of confidentiality, and to develop technical aids that provide data encryption and protection against hacker attacks.
Received: 2023-10-14
Published online: 2023-12-06
DOI: 10.24075/medet.2023.030
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VIEWS 14
Review Medicinal product early access programs: experience of the BRICS group, European Union, and United States of America
Оmelyanovskiy VV, Rukavitsyna NP, Mukhortova PA, Kingshott AA, Zinadinov SI, Kharitonova AG, Minakova EI, Krekhtunova LO, Barysheva VO
Timely accessibility of effective and safe medicinal products is one of the main tasks of healthcare. The goal of the present review is to assess various approaches that provide an early access to medicinal products within the BRICS group (list of participants as of 01.10.2023), European Union and United States of America. The stage of the life cycle of medicinal products is closely associated with their further movement in the market, patient access rate, and partially with the issues of their financing and reimbursement, which directly influence their affordability for population. The article contains data about the specifics of expanded access to unregistered medicinal products used on a compassionate basis and presenting therapy under early access programs financed by pharmaceutical companies; it also describes approaches to accelerated registration and registration of medicinal products in case of limited clinical data. Experience of the reviewed countries in early access programs is described.
Received: 2023-10-31
Published online: 2023-11-27
DOI: 10.24075/medet.2023.029
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VIEWS 67
Review Medical students in clinical training: ethical aspects
Deeva VA, Guseva EV, Demуanov VS, Isaeva PA, Polushkina MA, Ruck DM, Tihonova AS, Kim TG
The article is devoted to ethical aspects of bedside training. Education of future specialists in the clinical setting is important to acquire knowledge, skills, professional competencies and to form clinical thinking. Transfer of professional medical experience occurs simultaneous to the development of communication skills which are required to deal with patients, their relatives, colleagues and mentors. It is about comprehension of how the normal standards of medical deontology are implemented in real practice and how important the effective therapeutic alliance is while interacting with the patient. Though bedside training is a long-standing tradition of medical education, the origins of which are associated with the Ancient Greek Healing Practices, it is not always understood and supported by patients and their relatives, and requires students to get more familiar with ethical standards regulating similar education and their behavior within a medical group and institution.
Received: 2023-10-31
Published online: 2023-11-23
DOI: 10.24075/medet.2023.028
Comments 0
VIEWS 82
Review On justifiability of animal research (based on the article by Cameron Shelley entitled ‘Why test animals to treat humans? on the validity of animal models’)
Lugowska HG
The article sums up the pros and cons regarding the animal models selected and critically explored by Cameron Shelley in the article entitled ‘Why test animals to treat humans? On the validity of animal models’. Special attention is given to the adaptation of the topic-related English version of this discourse for a Russian-speaking reader. Arguments of supporters and opponents of animal models provided by C. Shelley are reviewed. The issue of the effective use of animals in biomedical research considering the validity criterion is being discussed. The connection between the validity and morality of an animal model suggested by C. Shelley is further elaborated. According to C. Shelley, out of three critical arguments for animal modeling, the pseudoscience argument and the disanalogy argument do not work, as the pressing issues they raise are interpreted by supporters in the wrong way. The predictive validity argument is not sufficient, as the doubts raised about the predictive power of animal models are either not supported or lack clear formulation. C. Shelley states that assessing the validity of an animal model is a complex task, which includes various approaches to determining the extent of model validity as appropriate, and defines the problem as an issue of determining the type of validity and its effect on the assessed morality of an animal model. According to the author, ethical issues come down to pragmatics of validity as a criterion capable of disorientating critics of animal modeling or at least reconciling them with the necessity and inevitability of animal experiments.
Received: 2023-08-21
Published online: 2023-11-20
DOI: 10.24075/medet.2023.026
Comments 0
VIEWS 72
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Popular articles

Original research The ‘sovereign decision’ in the discourse of medical ethics
Lukovich M, Meistorovich K, Knezhevich D
Recently, there has been tension is our society because of health-associated problems resulting from at least two factors. First, we are facing collision of neoliberal economics with the traditional ethics of our society. Simplistic understandings of social tendencies typical of our society and processes within the global community provoke a reaction in the form of various conspiracy theories supported by a dualistic ethical approach within our society. In one case, it is based on neoliberal trends and is increasingly manifested through the views of non-governmental organizations. In the other case, it is extremely conservative and tied to the traditional morality. The politics that tends to act within the bounds of the possible goes through both options, creating even more confusion. Another factor, which is no less important, includes blurred connotation and denotation of such notions as ‘freedom’, ‘sovereign’, ‘sovereign decision’, ‘human life sacredness’, resulting in various misinterpretations. The purpose of this article is to review the occurring dilemmas by disclosing the terms in the historical context. The possible conclusion is that the common global tendency of law harmonization under the influence of neoliberal economics is far from the dream about the Perpetual Peace as seen by Kant two hundred years ago. Regular standards that form the basis of the social ethics occupy less space in the legislation just like the ethics itself, even if used as a corrective measure, with economic logics taking up a larger place. There will be a ‘market price’ for everything (Kant). In the light of the above, we tried to review vaccination and euthanasia as two very specific and pressing issues.
Received: 2023-08-16
Published online: 2023-09-12
DOI: 10.24075/medet.2023.018
Comments 0
VIEWS 200
Review Ethical issues in pediatric clinical trials
Kolbin AS, Emelianova LI
Historically, instead of conducting well-designed research studies in the pediatric population, drug monographs indicate that safety and efficacy in children have not been evaluated. Among the main challenges in clinical trials for children, ethical issues occupy a special place, as they arise at almost all stages — from clinical trials to extrapolation. In the article, the authors present the history of clinical research in pediatrics and neonatology, how the view of involving children in clinical trials has changed, the specific ethical problems of children’s participation in clinical trials, legislative initiatives and other agreed measures taken and what they have led to. The ethical issues of microdosing in pediatrics, methods for the first-in-pediatric dose selection, issues of acceptability and drug development for the treatment of rare diseases are discussed separately. Conducting trials in the most vulnerable pediatric groups — newborns and premature newborns — is presented in detail. The potential reasons for trial failures in children are presented with specific examples.
Received: 2023-05-29
Published online: 2023-06-28
DOI: 10.24075/medet.2023.016
Comments 0
VIEWS 199