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

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The article reviews the concept of predictable harm as a methodological tool for a comprehensive risk assessment while developing and implementing AI-powered medical devices. The study is relevant due to exponential growth of using AI-powered technologies in healthcare and lack of unified approaches to prediction of potential negative consequences of their usage. Existing regulatory approaches to risk assessment, including Russian regulatory documents and international standards, have been analyzed. A multidimensional classification of types of predictable harm is proposed considering the entire life cycle of medical AI systems. Special attention is given to ethical aspects of using artificial intelligence in medicine, including the principles of patient autonomy, equity, non-harm and transparency of algorithms. An expanded matrix for assessing predictable harm has been developed. It integrated technological, clinical and ethical parameters for each stage of development and implementation of AI systems in medical practice. The results of the study can be used as a methodological framework for developers of medical AI systems, regulatory authorities and medical organizations in assessing safety and effectiveness of introducing intelligent technologies into clinical practice.
VIEWS 116

Popular articles

One of the important factors of medical deontology is the focus of a healthcare professional on the health of patients and colleagues in case of increased infectious morbidity within the framework of limiting transmission of an infectious agent. The aim of the study was to assess the true frequency of regulated use of PPE, including in the provision of medical care to patients with COVID-19, and compliance with the isolation regimen in case of respiratory illness among health workers. The study was conducted using the Internet (the questionnaire is posted on ancetolog.ru) from January to March 2022 (ongoing COVID-19 pandemic). Survey data of 3,570 respondents was analyzed in accordance with the quality criteria for filling out the questionnaires. The overwhelming majority of the respondents were women, 63.6% (2,269 people) and 36.4% (1,299 people) were men, the average age of the respondents was 38.9 ± 14.22 years. Non-compliance with the rules of wearing PPE was detected for every fourth respondent (24.9%), 4.1% refused to wear PPE, and 7% complied with the rules of wearing PPE in the workplace only when their non-compliance could be noticed. The data we have obtained indicates that a quarter of health workers do not follow professional ethics in the framework of preventive measures to reduce infectious diseases, threatening the health of colleagues and patients by their behavior in the workplace.
VIEWS 357
A patient-physician relationship is regulated by the principles of medical ethics and the Law on Healthcare of the Russian Federation. In pediatric practice, ethical issues are even more important. Pediatric otorhinolaryngology is one of the most popular branches of medicine that diagnoses, treats and prevents diseases of the ear, throat and nose (ENT) in children. ENT diseases are most common in childhood. Pathology of the upper respiratory tract and diseases of the ear and mastoid process account for about 20% of all cases. The prevalence of pediatric otorhinolaryngologic diseases currently accounts for 184 per 1,000 children; however, as they age, the chronic pathology of the ear, throat and nose is increasing. This field has its own unique ethical and legal aspects that require special attention of medical professionals, parents, and legislators. In Russia, ethical and legal issues of pediatric otorhinolaryngology have not been addressed for a long period of time, although it has its own peculiarities due to anatomical and physiological features of a child’s ENT organs. The article provides detailed description of ethical and legal problems in the practice of an otorhinolaryngologist and describes how to solve them. Compliance with the rules will improve quality of medical aid among children.
VIEWS 354