Abstract：
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.
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.
摘要：
背景：应用在医疗保健和医学研究中的使用正在增加。医疗保健中的应用程序可能对患者和医疗保健专业人员有利，但是它们的使用伴随着潜在的风险。如何在临床护理中使用应用程序不是医疗培训的标准部分，导致知识的缺乏。由于医疗保健专业人员及其雇主可能会对错误使用医疗应用程序负责，这种情况是不可取的。本文从医疗保健提供者的角度讨论了有关医疗应用程序的最重要的欧洲立法。
方法：本综述概述了当前和不断变化的法规，专注于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）相关的欧洲立法及其执行，2）使用这些应用程序时，医疗专业人员的责任和责任，和3）医疗专业人员在使用或构建医疗应用程序时应该知道的最实际考虑因素的概述。
结果：在使用和开发医疗应用程序时，数据隐私必须根据GDPR指南得到保证。一些国际标准使遵守GDPR变得更容易，如ISO/IEC27001和27002。《医疗器械条例》于2021年5月26日实施，因此，医疗应用程序通常会被视为医疗设备。制造商遵守医疗器械法规的重要准则是ISO13485、ISO17021、ISO14971和ISO/TS82304-2。
结论：在医疗保健和医学研究中使用医疗应用程序可能对患者有益，医疗专业人员,和整个社会。本文为想要开始使用或构建医疗应用程序的任何人提供有关立法和全面清单的背景信息。
方法：本综述概述了当前和不断变化的法规，专注于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）相关的欧洲立法及其执行，2）使用这些应用程序时，医疗专业人员的责任和责任，和3）医疗专业人员在使用或构建医疗应用程序时应该知道的最实际考虑因素的概述。
结果：在使用和开发医疗应用程序时，数据隐私必须根据GDPR指南得到保证。一些国际标准使遵守GDPR变得更容易，如ISO/IEC27001和27002。《医疗器械条例》于2021年5月26日实施，因此，医疗应用程序通常会被视为医疗设备。制造商遵守医疗器械法规的重要准则是ISO13485、ISO17021、ISO14971和ISO/TS82304-2。
结论：在医疗保健和医学研究中使用医疗应用程序可能对患者有益，医疗专业人员,和整个社会。本文为想要开始使用或构建医疗应用程序的任何人提供有关立法和全面清单的背景信息。
