电子健康中基于数字孪生的软件设计——健康/医疗软件产品的新开发方法

Rainer Lutze
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引用次数: 12

摘要

已经提出的用于健康和医疗软件产品信息管理的数字孪生概念进一步阐述了法规要求、FDA和欧盟唯一设备标识(UDI)系统以及软件产品生命周期管理。该概念建立在(1)个人数字双胞胎作为患者的双子,(2)对软件指定用户组建模的群体数字双胞胎,以及(3)软件产品本身的系统数字双胞胎。除了阐述数字孪生概念外,我们还介绍了基于数字孪生的健康和医疗软件设计和开发方法的优势和局限性。在这个应用领域,与基于v模型的经典软件开发相比,这种方法有意地需要对敏捷开发技术的更好支持。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Digital Twin Based Software Design in eHealth - A New Development Approach for Health / Medical Software Products
The already presented digital twin concept for information management of health and medical software products is further elaborated with respect to regulatory requirements, the FDA and EU unique device identification (UDI) system, and software product lifecycle management. The concept builds on (1) a personal digital twin as a Gemini of the patient, (2) a group digital twin modelling the designated user group of the software, and (3) a system digital twin for the software product itself. Beside the elaboration of the digital twin concept, we present the strengths and limitations of a digital twin based software design and development approach for health and medical software. The approach deliberately entails a better support of agile development techniques in comparison to the V-model based classic software development in this field of application.
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