Unit for the Study and Treatment of Pain-ALGOS, Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain.
JMIR Mhealth Uhealth. 2020 Mar 3;8(3):e13057. doi: 10.2196/13057.
In recent years, the considerable increase in the number of mobile health (mHealth) apps has made health care more accessible and affordable for all. However, the exponential growth in mHealth solutions has occurred with almost no control or regulation of any kind. Despite some recent initiatives, there is still no specific regulation procedure, accreditation system, or standards to help the development of the apps, mitigate risks, or guarantee quality.
The main aim of this study was to propose a set of criteria for mHealth-related apps on the basis of what is available from published studies, guidelines, and standards in the various areas that are related to health app development.
We used three sources of information to identify the most important criteria. First, we conducted a systematic review of all the studies published on pain-related apps. Second, we searched for health app recommendations on the websites of professional organizations. Third, we looked for standards governing the development of software for medical devices on the specialized websites of regulatory organizations. Then, we grouped and subsumed the criteria we had identified on the basis of their shared characteristics. Finally, the comprehensibility and perceived importance of the resulting criteria were evaluated for face validity with a group of 18 stakeholders.
We identified a total of 503 criteria from all sources, which, after close analysis, were grouped into eight different categories, including 36 important criteria for health apps. The resulting categories were usability, privacy, security, appropriateness and suitability, transparency and content, safety, technical support and updates, and technology. The results of the preliminary analysis showed that the criteria were mostly understood by the group of stakeholders. In addition, they perceived all of them as important.
This set of criteria can help health care providers, developers, patients, and other stakeholders to guide the development of mHealth-related apps and, potentially, to measure the quality of an mHealth app.
近年来，移动医疗（mHealth）应用程序的数量显著增加，使所有人都能更方便、更负担得起地获得医疗服务。然而，mHealth 解决方案呈指数级增长，几乎没有任何形式的控制或监管。尽管最近有一些举措，但仍没有具体的监管程序、认证系统或标准来帮助应用程序的开发、降低风险或保证质量。
本研究的主要目的是根据已发表的研究、指南和与健康应用程序开发相关的各个领域的标准，提出一套 mHealth 相关应用程序的标准。
我们使用了三种信息来源来确定最重要的标准。首先，我们对所有关于疼痛相关应用程序的研究进行了系统综述。其次，我们在专业组织的网站上搜索了健康应用程序的建议。第三，我们在监管组织的专业网站上寻找了管理医疗器械软件开发的标准。然后，我们根据其共同特征对我们确定的标准进行分组和归类。最后，我们请一组 18 名利益相关者对最终标准的可理解性和感知重要性进行初步评估，以验证其表面有效性。
我们从所有来源共确定了 503 条标准，经过仔细分析，将其分为八个不同类别，包括 36 条健康应用程序的重要标准。最终的类别包括可用性、隐私、安全、适当性和适用性、透明度和内容、安全性、技术支持和更新以及技术。初步分析结果表明，这些标准大多为利益相关者所理解。此外，他们认为所有这些标准都很重要。
这套标准可以帮助医疗保健提供者、开发者、患者和其他利益相关者指导 mHealth 相关应用程序的开发，并可能衡量 mHealth 应用程序的质量。
