ISSN Print 2713-0894
ISSN Online 2713-0908
BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN
Copyright: © 2025 by the authors. Licensee: Pirogov University.
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (CC BY).
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (CC BY).
OPINION
The concept of predictable harm in development of AI-powered medical devices
About authors
Kazan Innovative University named after VG Timiryasov, Kazan, Russia
Correspondence should be addressed: Ildar R. Begishev
42 Moskovskaya St., Kazan, Russia, 420111; ur.liam@vehsigeb
About paper
Financing: the work was carried out under the grant from the Academy of Sciences of the Republic of Tatarstan, provided to young candidates of sciences (postdoctoral fellows) so that they could defend their doctoral dissertation, perform research and labor functions in scientific and educational organizations of the Republic of Tatarstan within the framework of the Scientific and Technological Development of the Republic of Tatarstan State Program.
Acknowledgements: the authors express their sincere gratitude to the Academy of Sciences of the Republic of Tatarstan for financial support of this study based on the results of a competitive selection (grant No. 153/2024-PD dated December 16, 2024) for ‘Ensuring the technological sovereignty of the healthcare system by criminal means’ research project, as well as deep gratitude to the staff of the Scientific Research Institute of Digital Technologies and Law of Kazan Innovative University named after Timiryasov VG for valuable consultations and constructive discussion of the conceptual provisions of the study.
Author contribution: Begishev IR — research conceptualization; development of predictable harm theoretical foundations; analysis of specific risks associated with using artificial intelligence in medical devices; systematization of predictable harm typology; research of legal framework for regulating AI systems in healthcare with various jurisdictions; formulation of research conclusions; preparation of the manuscript initial version; Shutova AA — development of a methodology for predicting and preventing predictable harm; creation of a matrix for assessing predictable harm at various stages of medical AI system life cycle; developing recommendations for practical implementation of predictable harm concept; analysis of literature sources; editing and critical revision of the manuscript with introduction of valuable intellectual content; visualization of research (making tables).
Compliance with ethical standards: a meeting of the ethics committee was not required, since this study is theoretical and methodological in nature and analyzes open literature sources and regulatory legal documents, without conducting experiments involving humans or animals and without using personal patient data.
Received: 2025-05-03
Accepted: 2025-05-16
Published online: 2025-06-15
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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.
Keywords: artificial intelligence, Ethics of Artificial Intelligence, medical devices, predictable harm, ethics of artificial intelligence, regulation, patient safety, risk management