Quality and Risk, the Netherlands.
Flinders Medical Centre, Adelaide, South Australia.
Stud Health Technol Inform. 2022 Jun 6;290:508-511. doi: 10.3233/SHTI220128.
This paper investigates consistency of ISO/IEC-standards on quality and safety of telehealth services and mobile medical apps. Since mobile medical apps are 'software as a medical device', requirements for these apps are in software standards, in particular health software standards, as well as in medical device standards. These requirements were analyzed within an analysis model that has three domains: quality and safety management, core healthcare processes and resources. Telehealth services are healthcare processes and mobile medical apps are resources. There is good alignment of the standards that pertain to quality and safety management, the healthcare processes and medical devices. However, there is a lack of alignment, consistency and transparency of the ISO/IEC-standards on quality and safety of telehealth services and mobile medical apps. An international effort to address these issues is recommended.
本文研究了 ISO/IEC 标准在远程医疗服务和移动医疗应用程序的质量和安全方面的一致性。由于移动医疗应用程序是“医疗器械软件”，因此这些应用程序的要求既在软件标准中，特别是在健康软件标准中，也在医疗器械标准中。这些要求在一个分析模型中进行了分析，该模型有三个域：质量和安全管理、核心医疗保健流程和资源。远程医疗服务是医疗保健流程，移动医疗应用程序是资源。在质量和安全管理、医疗保健流程和医疗器械方面，标准的一致性较好。然而，在远程医疗服务和移动医疗应用程序的质量和安全的 ISO/IEC 标准方面，存在缺乏一致性、一致性和透明度的问题。建议进行国际努力来解决这些问题。
