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

New articles

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 76

Popular articles

This article highlights the ethical aspects that arise when the attending psychiatrist communicates with patients and their family members on the issues of planning a pregnancy. While counseling people with mental disorders about their reproductive plans, it is difficult from an ethical point of view to discuss some issues such as the risks of pathology in an unborn child and a possibility of reducing the risks, in particular the probability of genetic inheritance of a mental disorder; the expediency of discontinuing psychotropic drugs used by the expectant mother and/or father to treat or prevent a mental disorder exacerbations, given that drugs can affect the quality of reproductive biological material, whereas cancellation of therapy is associated with risks to the mental health of expectant parents; the need to inform the patient’s family members about his/her mental disorder, the treatment used and all available personal risks to offspring. Different literature sources, including domestic and foreign ones, were reviewed. The keywords used in literature were “genetics”, “psychiatry”, “ethical aspects of genetic counseling”, “psychopharmacotherapy during pregnancy”, “the effect of psychotropic drugs on spermatogenesis” with filtering by language (Russian and English) and document type. Two own clinical observations are presented. The purpose of the article is a comprehensive analysis of ethical aspects of counseling people with mental disorders on pregnancy planning by a psychiatrist.
VIEWS 428