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欧盟数字卫生技术早期可行性研究的利益相关者观点:定性访谈研究

Marlen Peseke¹, Ilja Michaelis¹, Ornella Tangila Kayembe²

¹Institute for Digital Medicine, University Hospital Giessen-Marburg, Philipps University Marburg, Baldingerstrasse, Marburg, 35042, Germany, 49 642158625.

Journal of medical Internet research

|October 1, 2025

概括

由于监管障碍,数字卫生技术 (DHT) 的早期可行性研究 (EFS) 在欧盟未得到充分利用. 需要协调,DHT特定的EFS指导,以促进创新和确保患者安全.

科学领域:

数字卫生技术数字卫生技术
医疗器械规则医疗器械规则
医疗保健中的人工智能

背景情况:

早期可行性研究 (EFS) 对于评估医疗器械的安全性和性能至关重要,特别是在新技术方面.
尽管有潜力,但EFS对数字健康技术 (DHT) 的应用,包括支持AI的设备,是有限的.
不断变化的欧洲监管格局 (欧盟MDR,欧盟AI法) 为DHT开发人员增加了复杂性.

研究的目的:

探索欧洲利益相关者的观点,以了解EFS对DHT的使用,障碍和机遇.
为针对DHTs量身定制的欧盟范围协调的EFS框架提出建议.

主要方法:

使用半结构面试进行的定性描述性研究.
12家DHT公司和3家CRO公司参加了会议,代表了不同规模的公司和设备风险类别.
通过演和归纳编码,对转录的采访进行主题分析.

主要成果:

对于人为因素反和设计代来说,EFS是有价值的,但目前尚未得到充分利用.
主要障碍包括不清楚的,以硬件为中心的法规,分散的解释,资源限制和有限的监管对话.
预计欧盟人工智能法案将增加复杂性,一些公司由于更明确的指导,更倾向于美国FDA的途径.

结论:

在欧盟的DHT行业中,EFS的不足使用源于监管的复杂性和缺乏具体指导.
一个协调的,DHT特定的EFS框架,有明确的定义和标准化的流程,可以加速创新.
协调的监管方法对于平衡创新,安全和患者利益至关重要,因为MDR和AI法案正在融合.

关键词:

支持人工智能的医疗设备.在MDR中使用MDR.数字健康技术数字健康技术早期的可行性研究.医疗器械监管法规医疗器械监管法规定性研究是指质量研究.监管框架监管框架监管框架

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