Background and Aim: The proliferation of novel medical technologies, such as artificial intelligence and robotic surgery, has created unprecedented legal challenges in establishing the foundations of civil liability. This research aimed to analyze these challenges and propose appropriate solutions for the Iranian legal system.

Methods: This study utilized a descriptive-analytical method, gathering data through a comprehensive review of legal texts, laws, and reputable articles. Data were examined using deductive reasoning and logical analysis.

Findings: The findings revealed that traditional concepts of fault and causation are inadequate in addressing the complexities of modern technologies. It was determined that the distribution of liability among healthcare providers, technology developers, and medical institutions requires redefinition. Furthermore, the existing legal vacuum has resulted in legal uncertainty for both patients and service providers.

Conclusion: The Iranian legal system requires the enactment of specific legislation incorporating a mixed liability regime (based on both fault and strict liability), the establishment of a compensation fund, and the formulation of transparent standards. These measures would support patient rights while providing the legal security necessary for fostering innovation in the healthcare sector.