探索健康中的监管互动万物互联网:数字健康技术,数据保护和网络安全
1Department of Law, University of Turin Via Giuseppe Verdi 8, 10124 Turin Italy.
European journal of health law
|August 15, 2023
概括
欧盟医疗器械条例 (MDR) 制定了连接到万物互联网 (IoE) 的医疗器械的基本安全和隐私标准. 它应对包括人工智能在内的数字健康技术的复杂监管挑战.
科学领域:
- 医疗器械规则 医疗器械规则
- 网络安全法 网络安全法
- 数据保护法 数据保护法
背景情况:
- 万物互联网 (IoE) 连接了众多设备,人员和流程,为医疗设备带来了重大隐私和安全挑战.
- 现有的法规必须适应互联医疗技术的不断变化的环境.
研究的目的:
- 在IoE的背景下分析欧盟医疗器械条例 (MDR),重点关注医疗器械的数据保护和网络安全.
- 评估MDR在解决 IoE 中连接医疗设备所带来的挑战方面的有效性.
- 探索数字卫生技术的监管相互作用,并考虑拟议的欧盟人工智能法规.
主要方法:
- 对MDR的法律分析 (欧盟 (EU) 2017/745条例).
- 检查与医疗器械相关的数据保护和网络安全要求.
- 讨论监管互动和拟议的欧盟人工智能法规的影响.
主要成果:
- 该MDR为医疗器械的安全和保护设定了一个基本标准.
- 存在复杂的监管相互作用,需要对数字健康技术采取协调方法.
- 拟议的欧盟人工智能法规对数字健康技术提出了进一步的考虑.
结论:
- 虽然MDR为IoE的医疗器械安全提供了最低标准,但仍然存在挑战.
- 导航数字健康技术的监管环境需要一个协调的战略.
- 不断变化的监管框架,包括人工智能法规,需要对医疗设备隐私和安全进行持续评估.
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