Safety Analysis of Machine Learning Software to Assess the Risk of Sudden Cardiac Death

**死于心血管疾病的人数多于死于癌症的人数**。FEN EP Ltd(FEN EP)是英国医疗设备公司的一家中小型企业，致力于在英国和全球范围内拯救面临心脏性猝死(SCD)风险的患者。FEN EP正在构建和开发一种新型的颠覆性医疗设备，其嵌入式软件称为**PEFA**(步调电信号分割分析)，它将改变医疗保健路径，同时仍然无缝地适应医院的常规诊断路径。Fen EP获得专利的颠覆性PEFA解决方案包括正确诊断患者，并将患者分为需要治疗的高风险患者和不需要治疗的低风险患者。通过改进患者选择，Fen EP旨在挽救患者的生命，并显著降低国家医疗服务体系(NHS)及其他领域的医疗成本。了解导致SCD的心律失常是一个电生理学问题，可以使用Fen EP的专利技术进行分析，这是改善患者护理和提高他们的生活质量的基础。该项目的核心目标是为NHS的进一步临床试验建造10台设备，并与英国、欧洲和美国的监管要求保持一致。FEN EP的目标是尽快将其设备转化为NHS内的常规临床护理。这种由软件驱动的设备在医疗保健系统中的概念、原理和实施在多个同行评议的出版物和最近被一家国际公认的心脏病学杂志上接受的评论中阐述。医疗保健中的**人工智能**(AI)是一个总括的术语，用于描述在分析、呈现和理解复杂的医疗和保健数据时使用机器学习算法和软件来模拟人类认知。更具体地说，人工智能是指计算机算法的能力，如嵌入PEFA中的那些算法，仅基于输入数据，基于对先前获得的临床或综合派生数据的机器学习训练来近似结论的能力。这一创新项目旨在确保合规，以保护患者和治疗他们的医疗专业人员。因此，不仅保护国家医疗服务体系及其服务患者的健康，而且还能增强人们对人工智能的信心。政府的资金对这一应用的进一步发展至关重要，这也将有利于英国经济并创造新的就业机会。这一应用与英国政府将其人工智能和医疗诊断能力“外包”并建立其高价值制造能力的目标保持一致，从而增加了国际出口。

**More people die from cardiovascular diseases than from cancer**. FEN EP Ltd (FEN EP) is a UK Medical Devices SME that is dedicated to saving patients at risk of sudden cardiac death (SCD) in the UK and globally.FEN EP is building and developing a novel and disruptive medical device with embedded software called **PEFA** (Paced Electrogram Fractionation Analysis) that will transform healthcare pathways, while still fitting seamlessly into routine diagnostic pathways in hospitals. FEN EP's patented and disruptive PEFA solution involves correctly diagnosing and dividing patients into high-risk patients who need treatment and low-risk patients who do not. By improving patient selection, FEN EP aims to save patient lives and significantly reduce healthcare costs in the National Health Service (NHS) and beyond. The understanding of arrhythmias that cause SCD is an electrophysiological problem that can be analysed using FEN EP's proprietary technology and is fundamental to improving patient care and improving their quality of life. The core objectives of the project are to build ten devices for further clinical trials in the NHS and are consistent with regulatory requirements in the UK, Europe and the USA. FEN EP's objective to enable the translation of its device into routine clinical care within the NHS as rapidly as possible. The concept, rationale and implementation of this software-driven device into healthcare systems is set out in multiple peer reviewed publications and a recently accepted review in an internationally recognised cardiology journal.**Artificial intelligence** (AI) in healthcare is an overarching term used to describe the use of machine-learning algorithms and software to mimic human cognition in the analysis, presentation and comprehension of complex medical and healthcare data. More specifically, AI is the ability of computer algorithms such as those embedded within PEFA to approximate conclusions based solely on input data, based on machine learning training of previously acquired clinical or synthetically-derived data. This innovate project seeks to ensure compliance to protect both patients and the medical professionals treating them. Thereby, not only protecting the National Health Service and the health of the patients that it serves but also increasing confidence in AI.Government funding is essential to enable the further development of this application, which will also benefit the UK economy and will create new jobs. This application aligns with the UK Government's objectives of "onshoring" its AI and medical diagnostics capabilities and building its high-value manufacturing capabilities, leading to increased exports internationally.