ABSTRACT
The application of Artificial Intelligence (AI) facilitates medical activities by automating routine tasks for healthcare professionals. AI augments but does not replace human decision-making, thus complicating the process of addressing legal responsibility. This study investigates the legal challenges associated with the medical use of AI in radiology, analyzing relevant case law and literature, with a specific focus on professional liability attribution. In the case of an error, the primary responsibility remains with the physician, with possible shared liability with developers according to the framework of medical device liability. If there is disagreement with the AI's findings, the physician must not only pursue but also justify their choices according to prevailing professional standards. Regulations must balance the autonomy of AI systems with the need for responsible clinical practice. Effective use of AI-generated evaluations requires knowledge of data dynamics and metrics like sensitivity and specificity, even without a clear understanding of the underlying algorithms: the opacity (referred to as the "black box phenomenon") of certain systems raises concerns about the interpretation and actual usability of results for both physicians and patients. AI is redefining healthcare, underscoring the imperative for robust liability frameworks, meticulous updates of systems, and transparent patient communication regarding AI involvement.
ABSTRACT
Universal Health Coverage (UHC) is a set of principles adopted by the World Health Organization (WHO) aimed to guarantee access to primary care for the entire world population through a range of essential health services without neglecting the diagnostic aspect. Italy is one of the signatory states, which means that diagnostic services should be appropriated and exigible throughout the national territory equally. Our research analyzed and identified the main criticalities in terms of age, territorial distribution, and technological and health appropriateness of installed Computed Tomography (CT) needed to meet the principles of UHC. Data analyzed in our study were published by Assobiomedica at the end of 2016 and by COCIR, which included and investigated the installed fleet of diagnostic equipment in the Italian sanitary system and in various European countries. The 6th point of the Alma Ata Declaration defines the concept of "primary health care", which includes the importance of the diagnostic phase in the Italian health care system to provide Essential Levels of Assistance (LEA). It is clear from our studies that the technology at the national level is not adequate to satisfy the UHC principles or the European criteria, with negative effects on the diagnostic standards and on advanced screenings. This study conducted on the installed CTs in Italy at the end of 2016 confirms the persistence of progressive aging that has been recorded for several years in the health facilities of the country and suggests incentive policies for the replacement of obsolete equipment, which represent a form of investment rather than a cost, due to the nature of the expenditure itself, one-off and amortizable over time.