Amsterdam UMC location University of Amsterdam, Surgery, Meibergdreef 9, Amsterdam, the Netherlands; Amsterdam Gastroenterology and Metabolism, Amsterdam, the Netherlands; Amsterdam Public Health, Digital Health, Amsterdam, the Netherlands.
Amsterdam UMC location University of Amsterdam, Surgery, Meibergdreef 9, Amsterdam, the Netherlands; Amsterdam Gastroenterology and Metabolism, Amsterdam, the Netherlands; Amsterdam Public Health, Digital Health, Amsterdam, the Netherlands.
Int J Med Inform. 2023 Sep;177:105141. doi: 10.1016/j.ijmedinf.2023.105141. Epub 2023 Jul 3.
The use of apps in healthcare and medical research is increasing. Apps in healthcare may be beneficial to patients and healthcare professionals, but their use comes with potential risks. How to use apps in clinical care is not standard part of medical training, resulting in a lack of knowledge. As healthcare professionals and their employers can be held accountable for the wrongful use of medical apps, this situation is undesirable. This article addresses the most important European legislation regarding medical apps from the perspective of healthcare providers.
This review provides an overview of current and changing regulations, focusing on apps used in healthcare and medical research. Three topics are discussed: 1) the relevant European legislation and its enforcement, 2) the responsibilities and liability of the medical professional when using these apps, and 3) an overview of the most practical considerations medical professionals should know when using or building a medical app.
When using and developing medical apps, data privacy must be guaranteed according to the GDPR guidelines. Several international standards make it easier to comply with the GDPR, such as ISO/IEC 27001 and 27002. Medical Devices Regulation was implemented on May 26, 2021, and as a result, medical apps will more often qualify as medical devices. The important guidelines for manufacturers to comply with Medical Devices Regulation are ISO 13485, ISO 17021, ISO 14971 and ISO/TS 82304-2.
The use of medical apps in healthcare and medical research can be beneficial to patients, medical professionals, and society as a whole. This article provides background information on legislation and a comprehensive checklist for anyone wanting to start using or building medical apps.
医疗保健和医学研究领域中应用程序的使用正在增加。医疗保健应用程序可能对患者和医疗保健专业人员有益，但它们的使用也存在潜在风险。如何在临床护理中使用应用程序并不是医学培训的标准部分，因此导致知识的缺乏。由于医疗保健专业人员及其雇主可能需要为不当使用医疗应用程序承担责任，因此这种情况是不理想的。本文从医疗保健提供者的角度出发，探讨了最重要的欧洲关于医疗应用程序的法规。
本综述提供了当前和不断变化的法规概述，重点讨论了在医疗保健和医学研究中使用的应用程序。讨论了三个主题：1）相关的欧洲法规及其执行情况，2）医疗专业人员在使用这些应用程序时的责任和责任，3）医疗专业人员在使用或构建医疗应用程序时应了解的最实际的考虑因素概述。
在使用和开发医疗应用程序时，必须根据 GDPR 指南保证数据隐私。一些国际标准使遵守 GDPR 变得更加容易，例如 ISO/IEC 27001 和 27002。《医疗器械法规》于 2021 年 5 月 26 日实施，因此，医疗应用程序更有可能被认定为医疗器械。制造商为遵守《医疗器械法规》而必须遵守的重要指南包括 ISO 13485、ISO 17021、ISO 14971 和 ISO/TS 82304-2。
在医疗保健和医学研究中使用医疗应用程序可能对患者、医疗保健专业人员和整个社会都有益。本文提供了法规方面的背景信息，并为任何想要开始使用或构建医疗应用程序的人提供了全面的清单。
