人员管理对人工智能医疗器械用数据集质量的影响分析  

Analysis of Personnel Management on the Quality of Datasets for Artificial Intelligence Medical Device

作　　者：王权[1] 王浩[1] 孟祥峰[1] 刘艳珍[1] 任海萍[1] WANG Quan;WANG Hao;MENG Xiangfeng;LIU Yanzhen;REN Haiping(Division of Active Medical Device and Medical Optics, National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院光机电室,北京100050

出　　处：《中国医疗设备》2018年第12期6-9,共4页China Medical Devices

基　　金：国家重点研发计划项目(2016YFC0107100);体育总局重点课题联合中国红十字基金会燎原基金项目(2015B101)

摘　　要：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数据集。人员是数据集的质量管理中的重要组成部分,对产品质量有直接的影响。本文结合人工智能医疗器械用数据集的建设过程和经验,分析了人员在各个环节对医疗影像AI数据集质量的影响,阐述了数据集建设与质控的过程中对人员管理(尤其是标注人员)的要求,例如选拔、评价和考核方面应当注意的因素,加强人员数据集的质控提出了建议。Novel medical device driven by artificial intelligence(AI)is developing fast.The research,development and quality control activities need clinical datasets with high quality.Human factor is an important element in the quality management of datasets,which has significant impact on the quality of AI medical device.With reference to practical experience during construction of datasets for AI,we discussed the impact of personnel on the quality of medical AI datasets and described the requirement on personnel management,such as issues with qualification,evaluation and examination,further providing advice for quality control of datasets from the perspective of human factor.

关 键 词：医疗器械 质量控制 人员管理 人工智能 数据集 

分 类 号：TP181[自动化与计算机技术—控制理论与控制工程] TH772[自动化与计算机技术—控制科学与工程]