Controversies in the Application of AI in Radiology-Is There Medico-Legal Support? Aspects from Romanian Practice.

Abstract

Background/Objectives: Artificial intelligence (AI) is gaining an increasing amount of influence in various fields, including medicine. In radiology, where diagnoses are based on collaboration between diagnostic devices and the professional experience of radiologists, AI intervention seems much easier than in other fields, but this is often not the case. Many times, the patients orient themselves according to the doctor, which is not applicable in the case of AI. Another limitation rests in the controversies regarding medico-legal liability. In the field of radio-imaging in Romania, the implementation of AI systems in diagnosis is at its beginning. An important aspect of this is raising awareness among the population about these assistive AI systems and, also, awareness of the technological evolution of AI among medical staff. This narrative review manuscript analyzes the existing literature data regarding the medico-legal aspects of AI application in radiology, highlighting the controversial aspects and the lack of statutory legislative regulations in Romania. Methods: A detailed search was conducted across three electronic databases including MEDLINE/PubMed, Scopus, and Web of Science, with 53 papers serving as the literature corpus of our review. Results: General requirements for artificial intelligence systems used in radiology have been established. In the radiological diagnostic process, there are five levels of AI system implication. Until now, completely autonomous AI systems have not been used. Regarding liability in the case of malpractice, at the currently accepted legislative level, most of the time, the radiologist is liable for their own fault or non-compliant use of diagnostic AI systems. Controversies arise in the case of radio-imaging diagnosis in which AI systems act autonomously. Conclusions: In order for AI diagnostic radio-imaging systems to be implemented, they must meet certain quality standards and be approved. The radiologist must know these systems, accept them, know their limits, and validate them in accordance with their degree of involvement in radiological diagnosis. Considering the evolution of technology in the Romanian medical system, including radiology, in the future, an alignment with the legal standards established/proposed at the European level is desired.