Medical civil liability and Artificial Intelligence-Mediated Clinical Diagnosis global standards of professional conduct and lessons from the case Sampson v. Heartwise Health Systems (2023)

Abstract

The paper analyses the ethical and legal impacts of clinical diagnosis mediated by artificial intelligence (AI), demonstrating how this technology reshapes physicians’ duties of conduct and expands the role of civil liability in guiding professional conduct and risk management in clinical practice. The analysis begins with the case Sampson v. HeartWise Health Systems (United States, 2023), which illustrates the risks arising from uncritical reliance on automated decision-support systems. The study adopts a qualitative approach of a legal-dogmatic and comparative nature, combining case law analysis, a review of specialized literature, and an examination of international ethical guidelines. Based on the U.S. landmark case, the study identifies emerging patterns of professional conduct and analyses recommendations developed by medical and regulatory bodies in the United States and Europe, which converge in affirming AI as an instrument that supports, rather than replaces, human clinical judgment. In the final stage of the analysis, the article examines the recent Resolution of the Brazilian Federal Council of Medicine (CFM) No. 2,454/2026, which regulates the use of AI in medical practice in Brazil, demonstrating how this new regulation aligns with a broader regulatory trend that has been progressively consolidated at the international level. It concludes that AI does not displace the decision-making center of medical practice but raises the level of diligence required of physicians, reshaping professional duties and inaugurating a new paradigm of preventive civil liability in contemporary medicine.