健康和与健康相关的相关对象:监管交叉点,灰色区域和盲点
Ana Nordberg1, Déborah Eskenazy2, Petra Holmberg1
1Faculty of Law, Lund University, Lilla Gråbrödersgatan 4 83198 222 22 Lund Sweden.
European journal of health law
|June 20, 2025
概括
欧盟对联网医疗器械的新法规带来了复杂的法律挑战. 目前对健康数据隐私和设备使用的保护措施不足,需要为以患者为中心的数据保护提供更清晰的框架.
科学领域:
- 卫生法 法律 卫生法
- 数据隐私法 数据隐私法
- 监管合规性 监管合规性
背景情况:
- 连接的物体会产生大量的健康数据.
- 欧盟对健康数据的法律框架是分散的.
- 最近的立法,如欧洲健康数据空间 (EHDS) 法案,增加了复杂性.
研究的目的:
- 分析欧盟关于连接健康对象和数据的法律框架.
- 识别现行法规中的法律不确定性和漏洞.
- 从以患者为中心的角度评估现有保障措施的充分性.
主要方法:
- 对欧盟法规 (EHDS法,GDPR,MDR,数据法,AI法) 的法律分析.
- 检查各种法律文书之间的交叉点.
- 专注于数据质量,设备可接受性,数据访问和隐私.
主要成果:
- 欧盟的法律框架以复杂的交叉点和灰色区域为特征.
- 现有的法规和认证机制提供了不足的保护.
- 目前的框架对卫生部门用户来说过于复杂,繁且不透明.
结论:
- 目前对连接健康对象和数据的监管保障是不充分的.
- 法律框架未能充分解决卫生部门用户的需求.
- 需要一种简化,更透明,以用户为中心的监管方法.
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