[Chinese expert consensus on the standardized application of generative artificial intelligence large models in ophthalmology (2026)].

Abstract

With the rapid development of generative artificial intelligence (AI) technologies and large AI models, these technologies are expected to play an important role in multiple aspects of medical workflows in ophthalmology. However, their rapid and widespread adoption has also introduced multiple challenges regarding application specifications, ethical constraints, and legal compliance. To ensure the safe, effective, and compliant application of generative AI large models in ophthalmology, the Intelligent Ophthalmology Subcommittee (China) of Technical Committee on Smart Medical Digitalization of IEEE Technology and Engineering Management Society convened domestic experts in the field. Drawing upon relevant Chinese laws and regulations governing medical practice, data security, and privacy protection, and incorporating the latest research advances, the expert panel held multiple online and offline seminars nationwide. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, Good Practice Statements, and the Delphi method, the panel developed a consensus framework addressing the ethical, technical, and legal issues associated with the application of generative AI large models in ophthalmology. Designed to be continuously updated as technology advances, this framework aims to provide evidence-based support for clinical practice. 随着人工智能（AI）生成技术和AI大模型快速发展，其在眼科领域医疗流程的诸多方面有望发挥重要作用。然而，技术快速普及也带来应用规范、伦理约束及法律合规等多重挑战。为确保生成式AI大模型在眼科领域安全、有效及合规应用，国际电气电子工程师学会技术与工程管理分会智能医疗数字化技术委员会智能眼科分部（中国）组织国内相关专家，参考中国医疗行为规范、数据安全及隐私保护法律等多项法规，结合最新研究进展，在全国范围内经过多次线上及线下研讨会议，并基于推荐分级的评估、制订与评价系统以及良好实践主张、德尔菲法，针对生成式AI大模型在眼科应用中的伦理、技术和法律问题，达成可随技术进步持续更新的共识性意见，为临床开展工作提供依据和支持。.