SHB: Small: Toward Verifying Smart-Health Infrastructure Safety from their Impact on Human Physiology

SHB：小：验证智能健康基础设施安全性及其对人体生理学的影响

• 批准号: 1116385
• 负责人: Sandeep Gupta
• 金额: $ 48.86万
• 依托单位: Arizona State University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1116385&HistoricalAwards=false
• 关键词: SHB; Small; Toward; Verifying; Smart

This project, investigating formal modeling and analysis of medical device control operations to verify patient safety, aims to advance the state-of-the-art in guaranteeing patient safety impacted by Smart Health Infrastructure (SHI). Medical devices and their networks directly interact with human physiology and often control physiological parameters. As such, any failure in medical device control systems can cause abnormal physiological conditions resulting in health hazards and patient injury. The physiological parameters controlled by medical devices are usually governed by complex physical processes and often vary over both space and time. For example, the concentration in blood of a drug administered by an infusion pump is governed by the drug diffusion process and varies with time and distance from the site of infusion. Further, the physical processes themselves are time-variant processes, e.g. the diffusion process changes with time depending on the past history of infusion. Any formal method should characterize the time-variant processes and spatio-temporal variations to analyze the impact of the control operations in medical devices on human physiology. This renders traditional formal methods, such as hybrid automata, inapplicable for patient safety verification. The problem gets exacerbated when two or more medical devices operate simultaneously, exhibiting aggregate effects of their individual control operations. Composition of formal models for individual medical device has to characterize the aggregate effects, which themselves can vary over space and time. To address all these challenges, the PI proposes the development of Spatio-Temporal Hybrid Automata (STHA), that migrates from the conventional perspective of temporal event based state transition to a spatio-temporal perspective where state transitions are instigated over both time and space.Broader Impacts: With the increasingly aging population and a linear increase in life expectancy the need for health-care anywhere anytime is immense. Further, the cost of health-care rises exponentially when diseases are identified at a later stage. Thus, early detection of diseases can lead to better health at a lower cost. SHIs, enabling health-care anytime anywhere, and early detection of diseases require complex medical control systems to be deployed on the human body. Unsafe operation of these medical device control systems can lead to hazards within the human body. Increasing cases of such hazards leads to decreased social acceptance of these devices. Further, it also leads to stricter compliance rules on these devices from regulatory agencies such as FDA. A methodology for providing guarantees on safety of a medical device control system will make a stronger case for their reliable operation. This will help the regulatory agencies to perform a better evaluation of the device and will lead to increased social acceptance. The PI also has a history of employing underrepresented populations, particularly women and Hispanics, at both the graduate and undergraduate levels.

该项目研究医疗设备控制操作的正式建模和分析，以验证患者安全，旨在推进最先进的技术，以保证受智能健康基础设施（SHI）影响的患者安全。医疗设备及其网络直接与人体生理相互作用，并经常控制生理参数。因此，医疗器械控制系统中的任何故障都可能导致异常生理状况，从而导致健康危害和患者损伤。由医疗设备控制的生理参数通常由复杂的物理过程控制，并且通常在空间和时间上变化。例如，通过输注泵给药的药物在血液中的浓度由药物扩散过程控制，并且随着时间和距离输注部位的距离而变化。此外，物理过程本身是时变过程，例如，扩散过程根据过去的输注历史而随时间变化。任何形式化的方法都应该表征时变过程和时空变化，以分析医疗器械中的控制操作对人体生理的影响。这使得传统的形式化方法，如混合自动机，不适用于患者安全验证。当两个或更多个医疗设备同时操作时，该问题变得更加严重，表现出它们的单独控制操作的聚集效应。单个医疗器械的正式模型的组成必须表征总体效应，这些效应本身可能随空间和时间而变化。为了应对这些挑战，PI提出了时空混合自动机（STHA）的发展，它从基于时间事件的状态转换的传统视角迁移到时空视角，其中状态转换在时间和空间上都被激发。更广泛的影响：随着人口日益老龄化和预期寿命的线性增长，随时随地对医疗保健的需求是巨大的。此外，当疾病在较晚阶段被发现时，保健费用就会急剧上升。因此，早期发现疾病可以以较低的成本改善健康状况。SHI能够随时随地提供医疗保健，并能够早期发现疾病，这需要在人体上部署复杂的医疗控制系统。这些医疗器械控制系统的不安全操作可能导致人体内的危害。此类危害的案例越来越多，导致这些器械的社会接受度下降。此外，它还导致FDA等监管机构对这些设备制定更严格的合规规则。提供医疗器械控制系统安全性保证的方法将为其可靠运行提供更有力的理由。这将有助于监管机构对器械进行更好的评价，并提高社会接受度。PI也有雇用代表性不足的人口，特别是妇女和西班牙裔，在研究生和本科生水平的历史。