数据集在人工智能医疗器械质控中的角色与要求

The Role and Requirement of Datasets in the Quality Control of Artificial Intelligence Medical Device

人工智能(artificial intelligence,AI)医疗器械是医疗器械新发展方向。其研发与质控需要高质量的临床数据集。由于人工智能医疗器械在国内外尚无标准规范,如何科学合理地构建数据集,如何发挥数据集的价值、降低临床试验成本,是产业发展的关键问题。该文参考国外行业和监管领域的现状和指导原则,分析了数据集在人工智能医疗器械质控中的角色与要求,对于监管部门制订人工智能医疗器械的监管决策提供支持,为全社会开发利用医疗数据提供参考。

Artificial intelligence is a blooming branch of medical device. Its development and quality control all rely on high quality clinical data. Since there is no established standard or guidance yet, it is important to study how to build and utilize a dataset appropriately and scientifically, especially for the decrease of clinical trial expense. With reference to the current status of premarket review and related guidance in developed countries, this paper analyzes the role and requirement of datasets in the quality control of AI medical device, providing useful information for regulation agencies and the development of public datasets for AI.