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一同看亿同看GTV:那些真实的夜晚,笑声与挑战交织的奇妙时光
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来源:@华夏时报微博

华夏时报记者杨燕北京报道

随着人工智能技术在医疗领域的广泛应用,医疗行业正迎来前所未有的变革浪潮。

从智能诊断系统到手术机器人,从疾病预测模型到个性化治疗方案,AI的应用场景不断拓展,为医疗效率和质量的提升带来了巨大潜力。然而,技术的快速发展也对监管政策提出了新的挑战。

一位数字医疗行业资深从业者对《华夏时报》记者表示,AI时代的监管框架不仅包括对AI医疗器械的安全性和有效性进行严格评估,还涉及数据隐私保护、算法透明度、责任界定等多方面的问题。

近日,第二届GHWP创新医疗器械报告会在CMEF期间成功举办,众多全球医疗器械领域的监管专家、行业领袖与创新力量汇聚一堂,围绕“全球创新政策协同”与“人工智能技术突破”两大主题展开深入探讨。

人工智能与数字医疗的创新应用

药监局医疗器械技术审评中心审评员张晨光表示,早在2017年,药监局审评中心就开始了与AI相关的研究工作,2019年第一次发布了辅助决策医疗器械软件的审评要点,为了应对业界出现的AI+医疗器械大量出现的现象,审评中心也提前做了相应的技术储备和研究。

张晨光进一步深入介绍了中国在人工智能医疗器械评价研究框架的构建、测评数据库的评估方法、产品分类界定等方面的工作进展,以及手术机器人在政策监管、产业发展等方面的情况。

据其所言,目前监管部门对于AI应用软件产品的分类界定指导原则中,核心内容明确了产品的用途必须为医疗用途而不是健康用途,核心功能在于数据加工而不是电子化和信息化,处理对象是医疗器械数据而不是医疗信息。不过目前这些规定还在研究阶段没有作为法规实施阶段。

在张晨光看来,一些能帮助医生给出具体病种的分类或者诊断结果的产品,应当被看作用户的助手,而另一些非辅助决策类的产品则应当看作用户的工具,例如原本医生用超声检查一个部位,需要6—7个操作,AI算法优化后可以缩减到2—3个,这种应当被看作用户的工作,这是从监管认知角度对不同AI器械的分类。

截至2024年4月份,审评中心已经批准了85个AI独立软件,适应症大多集中在CT、CTA、眼底等医疗器械上,部分则集中在心脏、冠脉等部位。从地域角度来说,当前GE医疗中国首席数字官黄峰介绍了GE医疗在中国的AI本土生态建设,重点介绍了GE医疗推出的三个数字平台——影像“源启”、超声“超智汇”、云平台“E影”,以及这些平台在推动医疗创新、提高诊断效率和质量方面的应用。

关于AI在实际工作当中的应用和迭代,黄峰着重强调了三点,第一是更多的算力和提速,第二则是自动化,第三则是如何赋能临床。

迈瑞医疗体外诊断临床部总监祁欢则在分享中探讨了AI驱动的体外诊断产品研发。祁欢指出,体外诊断领域在医疗器械中体量较大,但业务分支众多,以人工智能的视觉来重新审视体外诊断不同的检测技术,会带来意想不到的突破。

对一个普通三甲医院的检验科而言,每天要分析5000—10000个样本,产生10万以上量级的数据,经手的患者数量相比很多国际医院是它们5倍甚至10倍,不仅如此,国内对于检验时效性的要求同样非常高,往往希望在一个小时之内完成报告,这么庞大体系的运行中,任何一个微小的问题都会带来系统效率的问题或者比较大的风险,而人工智能对于解决质量和效率问题都能提供很大的帮助。

祁欢还介绍了迈瑞医疗在检验前、中、后阶段的AI应用探索,包括机器视觉与深度学习的全景检测技术、基于显微成像和深度学习的细胞识别系统、基于患者数据的实时质量控制研究等。

微创集团血管介入机器人及上游市场总监林蕾介绍了冠状动脉介入手术系统的AI技术应用。她指出,冠脉介入手术的发展背景是隔离射线,降低医生的辐射剂量。她还介绍了血管介入机器人在全球的临床应用情况,以及中国在该领域的快速发展。她强调了AI技术在冠脉介入手术中的应用,包括医学图像处理、病变腔内测量、手术规划和导航等方面,以及如何通过AI算法实现更精准的操作。她还分享了微创集团在该领域的研发成果和临床应用案例。

数坤科技首席技术官郑超分享了医学遇上大模型的研发攻坚与多元应用。他介绍了数坤科技在多模态大模型上的工作,以及如何将大模型应用于医疗场景和流程。他还分析了通用大模型在医疗领域的局限性,并提出了构建医学专业模型的必要性。他分享了数坤科技在训练多模态模型方面的经验,以及如何通过数据知识化、模型运维体系等手段提高模型的性能和应用效果。他还介绍了数坤科技在医疗影像、病历报告、体检报告、超声科、影像科质控、科研等方面的应用案例。

深睿医疗高级副总裁刘建探讨了医疗全流程的超级大脑——多模态大模型驱动的全场景AI数智化全流程。他指出,影像科在医疗中面临诸多痛点,如工作时长过长、数据流通不畅等。他介绍了AI技术在医疗影像科中的发展,从单一的分割到检出,再到大智能诊断。他还分享了深睿医疗在打造多模态大模型驱动的全场景AI数智化方面的努力,包括发布“METAIX”产品,实现从扫描、预约到诊断出报告、科研的全流程AI植入。他强调了多模态数据模型、大模型与AI中台的深度融合,以及如何通过智能化的预约、质控、报告生成、纠错等功能提高医疗效率和质量。

中国医疗器械监管政策与创新实践

药监局器械监管司副司长张琪在分享中提到,科技创新和产业创新是发展新质生产力的基本路径,药监局将不断深化医疗器械审评审批制度改革,优化审批流程,提高审批效率,为创新医疗器械的研发和上市提供有力保障。

据张琪介绍,截至2024年年底,国家药监局已批准创新医疗器械65件,较2023年同期增长8.5%,截至目前,国家局已累积批准创新医疗器械达到了334件。当前监管部门已经建成了四级医疗器械法规体系,包括1部医疗器械监管条例,14部部门规章,140余项配套的规范性文件,以及2000余个标准和600多个技术审评指南。

其中尤为值得注意的是在2023年首次被列入立法计划的《医疗器械管理法》,已经在2024年研究起草了草案征求意见稿,并向公众公开征求意见,年底已由药监局提交市场监管总局,有望在不久的将来推动中国医疗器械发展迈向新的台阶。

药监局器械审评中心综合业务部副部长邓俊分享了当前创新医疗器械技术审评工作的相关情况。邓俊表示,在高强度的审评数量下,当前平均审评时长基本是100个工作日左右,比法定的150个工作日缩短了不少。

邓俊提到,过去一年批准的65个创新产品中包括了质子治疗系统、肾动脉、人工血管等等,近年来创新器械审评产品中已经出现了不少标志性的成果,例如有4款基因测序产品获准注册,5款质子治疗产品进入了创新审查通道,脑机接口类产品进入审评程序的产品同样不少见。

邓俊同样强调,审评中心搭建了三大创新合作平台,包括人工智能医疗器械创新合作平台、生物材料创新合作平台以及高端医疗装备创新合作平台,目前已经有105个涉及人工智能辅助诊断软件的产品通过这三大平台获批上市。

责任编辑:姜雨晴主编:陈岩鹏

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