通用目的人工智能模型的法律规制——从医疗领域切入  

Legal Regulation of General Purpose Artificial Intelligence Model--Slicing from Medical Field

作　　者：李润生 LI Run-sheng(School of Humanities,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学人文学院,北京100029

出　　处：《河北法学》2025年第5期115-138,共24页Hebei Law Science

基　　金：国家社会科学基金青年项目“人机协作视野下医疗人工智能临床应用法律问题研究”(22CFX051);江苏省教育科学规划专项课题“职业教育数字化迭代转型研究:理论溯源、行动范式与未来进路”(C/2024/02/14)的成果。

摘　　要：通用模型带来了深刻的“范式变革”,“预训练+微调”成为人工智能发展的新范式,这引发了真正的通用性革命。通用模型的实践应用也带来了各种新风险,并经由模型和数据之转介放大了既有风险。然而,通用模型的法律治理仍处于早期阶段,包括我国在内的绝大多数国家或地区尚未将通用模型纳入规制体系,这是当下面临的最大现状和挑战。我国应当明确将通用模型提供者纳入规制体系,消弭法律制度与技术现实之鸿沟,并立足于通用模型的技术特性及体系定位,精准、适度赋予法律义务,实现制度安全与技术创新之平衡。结合医疗领域之特色和先例,我国应当尽快推进通用模型的立法涵摄,构建两阶段的准入审核体系。第一阶段为通用模型的准入审核,坚持内在评价,审查重点在于模型架构的科学性、数据治理的有效性、训练方法的适当性、开发组织的合规性等过程性事项;第二阶段为应用系统的准入审核,坚持外在评价,审查重点在于具体诊疗场景下预期用途和核心功能的达成性,审查方式为临床试验等结果性评价机制。医疗领域的规制方案可结合其他行业、领域的特性进行示范迁移。General purpose artificial intelligence model(GPAIM)has brought profound"paradigm change",and"pre-training+fine-tuning"has become a new paradigm for the development of AI,which has triggered a real revolution in universality.The practical application of GPATM has also brought various new risks,and has magnified existing risks through the referral of models and data.However,the legal governance of GPAIM is stll in the early stage of exploration,and most countries or regions,including China,have not yet incorporated GPAIM into their regulatory syslems.This is the biggest current situalion and challenge.China should explicily incorporate the provider of GPAIM in the regulatory system,bridge the gap between legal systems and technological realities,and base on the technical characteristics and system positioning of GPAIM to accurately and appropriately impose legal obligations,achieving a halance hetween institutional security and technological innovation.Based on the characteristics and precedents in the medical field,China should promole the legislalive coverage of GPAIM as soon as possible and build a lwo-slage access review syslem.The lirst slage is the access review of GPAIM,which adheres to internal evaluation and focuses on the scientific nature of the model architecture,the effectiveness of data governance,the appropriateness of training methods,and the compliance of development organizations;The second stage is the access review of the application system,which adheres to external evaluation and focuses on the achievement of intended uses and core functions in specific diagnosis and treatment scenarios.The review method is a result-oriented evaluation mechanism such as clinical trials.Regulatory schemes in the medical field can be adapted and transferred by combining the characteristics of other industries and fields.

关 键 词：通用模型 范式变革 立法涵摄 内在评价 医疗领域 

分 类 号：DF37[政治法律—宪法学与行政法学]