摘要
随着人工智能技术的不断进步,目前在医疗健康领域中,人工智能(Artificial Intelligence, AI)软件作为医疗器械,比重越来越大,也越来越广泛地应用于临床诊断与治疗,辅助医生决策和智能化患者信息管理。相比传统以硬件为主、软件为辅的嵌入式医疗器械软件,人工智能产品多以独立软件形式呈现,其便捷高效的应用显示出开发周期短、更新迭代快的特征,监管与审核都有异于传统硬件设备。传统医疗器械软件监管体系主要针对嵌入式产品,审核周期长,缺乏适用于人工智能产品的审批经验和相关界定及标准,为人工智能产品上市落地带来极大影响和阻碍。针对此问题,美国FDA尝试提出面向医疗人工智能产品的医疗器械独立软件预认证项目,旨在加速与简化医疗软件上市前的审核程序,为患者尽早带去新科技的便利和福音。该项目的实施也为中国医疗器械独立软件监管的加速和完善带来借鉴和思考。
With the continuous progress of artificial intelligence technology, as a medical device, Artificial Intelligence(AI) software has a larger proportion in the field of medical health currenrtly, and is more and more widely used in clinical diagnosis and treatment to assist doctors in decision-making and intelligent patient information management. Compared with the traditional embedded medical device software which is mainly based on hardware and supplemented by software, artificial intelligence products are mostly presented in the form of independent software. Their convenient and efficient application shows the characteristics of short development cycle and fast update and iteration. Their supervision and audit are different from that of traditional hardware equipments. The traditional medical device software supervision system is mainly for embedded products. A long review cycle and lack of examination approval experience and relevant definitions and standards applicable to artificial intelligence products has greatly affected and hindered the launch of artificial intelligence products. For this problem, US FDA tried to propose a pre-certification program of independent software for medical devices for medical artificial intelligence products, so as to accelerate and simplify the pre-marketing review process of medical software, and bring convenience and benefits of new technology to patients as soon as possible. The implementation of this project also brings reference and thinking for the acceleration and improvement of independent software supervision of medical devices in China.
作者
蔡小舒
吕晖
于广军
CAI Xiao-shu;LYU Hui;YU Guang-jun(Biomedical Information Research Center,Children's Hospital of Shanghai,Shanghai 200020,P.R.C.)
出处
《中国数字医学》
2019年第11期34-37,33,共5页
China Digital Medicine
基金
上海市卫生计生委智慧医疗专项研究项目（编号：2018ZHYL0223）
上海市科学技术委员会上海儿童精准医学大数据工程技术研究中心（编号：17DZ22512000）~~
关键词
医疗人工智能
医疗器械独立软件
软件监管
预认证项目
medical artificial intelligence
independent software of medical device
software supervision
pre-certification project
作者简介
通信作者:于广军,上海市儿童医院生物医学信息研究中心,200020,上海市静安区北京西路1400弄24号2号楼。
