A Pragmatic Approach towards Safe and Secure Medical Device Integration
A Pragmatic Approach towards Safe and Secure Medical Device Integration
复制标题
实现安全可靠的医疗设备集成的务实方法
DOI：
--
复制
发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Christoph Woskowski
中科院分区：
文献类型：
--
作者：
Christoph Woskowski
与其他安全相关领域相比，在医疗设备领域，在实时和远程控制方面协调电子设备集成和交互的努力没有那么雄心勃勃。这一进展受限的原因有几个。传统上，医疗设备要么是小尺寸的，要么是自给自足的，要么是由一个供应商提供的完整设置中高度集成的部分。特别是在装备重症监护病房等重症监护设施时，生产商和品牌的多样性较低，而竞争压力很大。其结果是在连接设备以进行交互时获得专有的通信和控制解决方案。另一方面，任何现代医院都严重依赖高度可用的关键医疗设备提供和共享数据，但也依赖于至关重要的信息的机密性和完整性。
本文讨论了一种实用的基于风险的方法来处理上述当前情况下的集成问题，同时关注未来的发展挑战。本文的背景是定义一个安全可靠的集成接口，该接口向集成伙伴开放，使其能够对关键医疗设备进行监控和远程控制。
Compared to other safety-related domains, harmonizing efforts regarding electronic device integration and interaction in terms of real-time and remote control are conducted less ambitious in the medical device sector. There are a couple of reasons for this restrained progress. Traditionally, medical devices are either both small-sized and self-sufficient or they are highly integrated parts of a complete setup provided by one vendor. Especially when equipping critical care facilities such as intensive care units, producer and brand diversity is low, whereas the pressure of competition is high. The results are proprietary communication and control solutions when connecting devices in order to interact. On the other hand, any modern hospital heavily relies on highly available critical medical devices providing and sharing data but also on confidentiality and integrity of vitally important information.
This paper discusses a pragmatic risk-based approach to handle integration problems facing the current situation described above, while focusing on future development challenges. The background of this paper is a project for defining a safe and secure integration interface that open to integration partners enables to monitor and remote-control a critical medical device.