Ethical and Regulatory Perspectives on Generative Artificial Intelligence in Pathology.

CONTEXT.—: Technology companies and research groups are increasingly exploring applications of generative artificial intelligence (GenAI) in pathology and laboratory medicine. Although GenAI holds considerable promise, it also introduces novel risks for patients, communities, professionals, and the scientific process.

OBJECTIVE.—: To summarize the current frameworks for the ethical development and management of GenAI within health care settings.

DATA SOURCES.—: The analysis draws from scientific journals, organizational websites, and recent guidelines on artificial intelligence ethics and regulation.

CONCLUSIONS.—: The literature on the ethical management of artificial intelligence in medicine is extensive but is still in its nascent stages because of the evolving nature of the technology. Effective and ethical integration of GenAI requires robust processes and shared accountability among technology vendors, health care organizations, regulatory bodies, medical professionals, and professional societies. As the technology continues to develop, a multifaceted ecosystem of safety mechanisms and ethical oversight is crucial to maximize benefits and mitigate risks.