Rowland Simon P, Fitzgerald J Edward, Holme Thomas, Powell John, McGregor Alison
1Department of Surgery and Cancer, Imperial College London, London, UK.
KPMG International, London, UK.
NPJ Digit Med. 2020 Jan 13;3:4. doi: 10.1038/s41746-019-0206-x. eCollection 2020.
Despite growing interest from both patients and healthcare providers, there is little clinical guidance on how mobile apps should be utilized to add value to patient care. We categorize apps according to their functionality (e.g. preventative behavior change, digital self-management of a specific condition, diagnostic) and discuss evidence for effectiveness from published systematic reviews and meta-analyses and the relevance to patient care. We discuss the limitations of the current literature describing clinical outcomes from mHealth apps, what FDA clearance means now (510(k)/de novo FDA clearance) and in the future. We discuss data security and privacy as a major concern for patients when using mHealth apps. Patients are often not involved in the development of mobile health guidelines, and professionals' views regarding high-quality health apps may not reflect patients' views. We discuss efforts to develop guidelines for the development of safe and effective mHealth apps in the US and elsewhere and the role of independent app reviews sites in identifying mHealth apps for patient care. There are only a small number of clinical scenarios where published evidence suggests that mHealth apps may improve patient outcomes.
尽管患者和医疗服务提供者的兴趣日益浓厚，但关于如何利用移动应用程序为患者护理增添价值，几乎没有临床指导意见。我们根据应用程序的功能（如预防行为改变、特定疾病的数字自我管理、诊断）对其进行分类，并讨论已发表的系统评价和荟萃分析中的有效性证据以及与患者护理的相关性。我们讨论了当前描述移动健康应用程序临床结果的文献的局限性、美国食品药品监督管理局（FDA）现在（510(k)/FDA新分类审批）及未来的审批意味着什么。我们将数据安全和隐私作为患者使用移动健康应用程序时的一个主要担忧进行讨论。患者通常不参与移动健康指南的制定，而专业人员对高质量健康应用程序的看法可能无法反映患者的观点。我们讨论了在美国及其他地区为开发安全有效的移动健康应用程序制定指南的努力，以及独立应用程序评审网站在为患者护理识别移动健康应用程序方面的作用。只有少数临床情况有已发表的证据表明移动健康应用程序可能改善患者结局。
