Medical malpractice liability in large language model artificial intelligence: legal review and policy recommendations.

The emergence of generative large language model (LLM) artificial intelligence (AI) represents one of the most profound developments in healthcare in decades, with the potential to create revolutionary and seismic changes in the practice of medicine as we know it. However, significant concerns have arisen over questions of liability for bad outcomes associated with LLM AI-influenced medical decision making. Although the authors were not able to identify a case in the United States that has been adjudicated on medical malpractice in the context of LLM AI at this time, sufficient precedent exists to interpret how analogous situations might be applied to these cases when they inevitably come to trial in the future. This commentary will discuss areas of potential legal vulnerability for clinicians utilizing LLM AI through review of past case law pertaining to third-party medical guidance and review the patchwork of current regulations relating to medical malpractice liability in AI. Finally, we will propose proactive policy recommendations including creating an enforcement duty at the US Food and Drug Administration (FDA) to require algorithmic transparency, recommend reliance on peer-reviewed data and rigorous validation testing when LLMs are utilized in clinical settings, and encourage tort reform to share liability between physicians and LLM developers.

Discordance of the Urinary and Pleural Fluid Antigen Test and False Positive for Streptococcus pneumoniae in Empyema Secondary to Necrotizing Bacterial Pneumonia.

Empyema is a severe complication of pneumonia with high morbidity and mortality rates. Rapid diagnosis and tailoring of antibiotic therapy are crucial to treatment success for these severe bacterial lung infections. A Streptococcus pneumoniae (S. pneumonia) antigen test drawn from the pleural fluid rather than a urine sample has been found to have equivalent diagnostic utility to the urinary antigen test. Discordance between these tests is rare. We report a case of a 69-year-old female with CT imaging findings consistent with empyema and a bronchopulmonary fistula. A rapid S. pneumonia antigen test was negative from the urinary sample but positive when drawn from a patient's pleural fluid sample. Final pleural fluid cultures resulted in Streptococcus constellatus (S. constellatus). This case demonstrates discordance between the results of urinary and pleural fluid S. pneumoniae antigen tests, representing a potential pitfall in using rapid antigen testing on pleural fluid samples. False positives for the S. pneumoniae antigen in patients with viridans streptococci infections have been documented due to the cross-reactivity of cell wall proteins in different streptococcal species. Physicians encountering bacterial pneumonia of unknown etiology complicated by empyema should understand the potential for discordance and false positives using this diagnostic method.