Risk Assessment for Data related Hazards in Healthcare Equipment and Infrastructure

现代计算机系统越来越多地使用数据来做出安全关键决策。医疗保健系统特别依赖于数据，因为它们依赖于组织之间以及医疗保健专业人员和社区患者之间的数据流。医疗保健进一步进入社区，带来了数据质量的额外不确定性。因此，数据本身的可靠性，以及设备和计算机化基础设施对错误或不当使用数据的稳健性，已经变得至关重要。这些系统的设计方式需要能够预防或减少由旨在改善临床安全结果的数据所引起的伤害的可能性。在包括医疗保健在内的所有工业部门，已经发生了许多事故和事件，其中数据不同于纯粹的软件和硬件，是一个主要的促成因素。随着我们的系统越来越依赖于来自不同来源的数据，越来越相互关联，并且使用的数据不是由医疗保健专业人员收集的，这个问题将变得更糟。这些数据可能会被输入人工智能系统，甚至自动系统，产生广泛的影响，这可能不容易追溯到错误的数据。英国安全关键系统俱乐部创建了一份数据安全指导文件，该文件被广泛认为描述了当前数据安全评估的最佳实践。这导致它被纳入NHS数字自己的数据安全指南。在劳氏船氏基金会的资助下，我们开发了一个概念验证软件演示工具，指导从业者完成数据安全评估过程，并记录从业者所做的分析和决定，形成数据安全论证的核心，可以提供给监管机构或委托组织。我们目前的数据安全工具与行业无关。该项目旨在改进该工具，以删除当前的限制，在医疗保健领域验证该限制，并了解将其部署到该领域所需的自定义。我们还计划在一些研讨会上推广数据安全的问题和解决方案。

Modern computer systems increasingly use data to make safety-critical decisions. Healthcare systems are particularly dependent on data, as they act on data flows between organisations, and between healthcare professionals and patients in the community. The rollout of healthcare further into the community introduces additional uncertainty about the quality of the data. Tuus, the trustworthiness of the data itself, and the robustness of the equipment and the computerised infrastructure to incorrect or inappropriately used data, has become vital. The systems need to be designed in such as way as to prevent or reduce the likelihood of harm arising from the very data that is meant to improve clinical safety outcomes.There have already been a number of accidents and incidents across all industrial sectors, including healthcare, where data, as distinct from purely software and hardware, has been a major contributory factor. This problem will get worse as our systems become more dependent on data from diverse sources, more inter-connected, and using data not collected by healthcare professionals. This data might be fed into AI systems and even autonomous systems with wide-ranging consequences, which might not be easily traced back to the erroneous data.The UK Safety Critical Systems Club has created a Data Safety Guidance document, which is widely regarded as describing the current best practice of Data Safety Assessment. This has led to its inclusion in NHS Digital's own guidance on Data Safety.We have developed a proof-of-concept software demonstrator tool under a grant from the Lloyd's Register Foundation, that guides a practitioner through the Data Safety assessment process, and records the analysis and decisions made by the practitioner, to form the core of a Data Safety argument that could be given to a regulator or commissioning organisation.Our current Data Safety tool is industry-agnostic. This project aims to evolve the tool to remove a current restriction, to validate it in the healthcare domain, and understand the customizations that would be needed to deploy it into this domain. We also plan to promote the issues and solutions to Data Safety at some workshops.