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。医疗保健系统尤其依赖数据，因为它们作用于组织之间的数据流，以及社区中医疗保健专业人员和患者之间的数据流。医疗保健进一步深入社区带来了数据质量的额外不确定性。数据本身的可信度，以及设备和计算机化的基础设施对不正确或不当使用的数据的健壮性，已经变得至关重要。这些系统的设计方式需要防止或减少因旨在改善临床安全结果的数据而造成伤害的可能性。所有工业部门都已经发生了一些事故和事故，包括医疗保健，在这些领域，数据与纯软件和硬件不同，是一个主要的促成因素。随着我们的系统变得更加依赖来自不同来源的数据，更加相互关联，并使用不是由医疗保健专业人员收集的数据，这个问题将变得更加严重。这些数据可能会被输入人工智能系统甚至自主系统，产生广泛的后果，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 Digital自己的数据安全指南。我们在劳合社注册基金会的资助下开发了一个概念验证软件演示工具，它指导从业者完成数据安全评估过程，并记录从业者的分析和决策，形成可以提供给监管机构或调试组织的数据安全论点的核心。我们目前的数据安全工具是行业不可知的。该项目旨在发展该工具以消除当前的限制，在医疗保健领域对其进行验证，并了解将其部署到该领域所需的定制。我们还计划在一些研讨会上宣传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.