TY - JOUR AU - maß, Laura AU - Freye, Merle AU - Pan, Chen-Chia AU - Dassow, Hans-Henrik AU - Niess, Jasmin AU - Jahnel, Tina PY - 2022 DA - 2022/10/31 TI -从公共卫生和法律的角度对健康应用程序和医疗应用程序的定义:定性分析的一个跨学科的文学概述乔- Uhealth Mhealth JMIR SP - e37980六世- 10 - 10 KW -移动健康KW -健康应用KW -医学应用KW -数字医疗KW -监管KW -移动医疗设备KW -数字医疗应用KW - DiGA KW -数字保健应用KW - DiPA KW -雪球搜索KW -手机AB -背景:健康应用和医疗应用条款往往交替使用但并不一定意味着同样的事情。为了更好地理解这些术语并更好地规范这些技术,我们需要对健康和医疗应用程序进行明确的定义。目的:本研究旨在从跨学科的角度对健康和医疗应用程序的定义进行概述。我们总结了已确定定义的核心要素,以便在数字公共卫生背景下对其进行整体理解。方法:美国、欧盟和德国医疗器械监管的法律框架构成了本研究的基础。然后,我们在6个数据库中搜索了从跨学科角度定义健康或医疗应用程序的文章。叙事文献综述是通过向前和向后滚雪球式搜索来支持健康和医疗应用程序的更多原创定义。对每个定义的相关方面和核心要素进行定性分析。基于这些发现,我们制定了健康和医疗应用程序的整体定义,并创建了一个决策流程图,以突出这两种类型之间的差异。 Results: The legal framework showed that medical apps could be regulated as mobile medical devices, whereas there is no legal term for health apps. Our narrative literature review identified 204 peer-reviewed publications that offered a definition of health and medical apps. After screening for original definitions and applying the snowball method, 11.8% (24/204) of the publications were included in the qualitative analysis. Of these 24 publications, 22 (88%) provided an original definition of health apps and 11 (44%) described medical apps. The literature suggests that medical apps are a part of health apps. To describe health or medical apps, most definitions used the user group, a description of health, the device, the legal regulation, collected data, or technological functions. However, the regulation should not be a distinction criterion as it requires legal knowledge, which is neither suitable nor practical. An app’s intended medical or health use enables a clear differentiation between health and medical apps. Ultimately, the health aim of an app and its main target group are the only distinction criteria. Conclusions: Health apps are software programs on mobile devices that process health-related data on or for their users. They can be used by every health-conscious person to maintain, improve, or manage the health of an individual or the community. As an umbrella term, health apps include medical apps. Medical apps share the same technological functions and devices. Health professionals, patients, and family caregivers are the main user groups. Medical apps are intended for clinical and medical purposes and can be legally regulated as mobile medical devices. SN - 2291-5222 UR - https://mhealth.www.mybigtv.com/2022/10/e37980 UR - https://doi.org/10.2196/37980 UR - http://www.ncbi.nlm.nih.gov/pubmed/36315221 DO - 10.2196/37980 ID - info:doi/10.2196/37980 ER -
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