The Definitions of Health Apps and Medical Apps From the Perspective of Public Health and Law: Qualitative Analysis of an Interdisciplinary Literature Overview

Abstract

Background: The terms health app and medical app are often used interchangeably but do not necessarily mean the same thing. To better understand these terms and better regulate such technologies, we need distinct definitions of health and medical apps.

Objective: This study aimed to provide an overview of the definitions of health and medical apps from an interdisciplinary perspective. We summarized the core elements of the identified definitions for their holistic understanding in the context of digital public health.

Methods: The legal frameworks for medical device regulation in the United States, the European Union, and Germany formed the basis of this study. We then searched 6 databases for articles defining health or medical apps from an interdisciplinary perspective. The narrative literature review was supported by a forward and backward snowball search for more original definitions of health and medical apps. A qualitative analysis was conducted on the identified relevant aspects and core elements of each definition. On the basis of these findings, we developed a holistic definition of health and medical apps and created a decision flowchart to highlight the differences between the 2 types.

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.

Keywords: DiGA; DiPA; digital care applications; digital health; digital health applications; health app; medical app; mobile health; mobile medical device; mobile phone; regulation; snowball search.

Figure 1

Flowchart of the search strategy.

Figure 2

The connection between health apps, medical apps, digital health applications (DiGA), and digital care applications (DiPA). °Can be affected by medical device regulation because of the intended use for medical purposes. ~Regulated by section 33a of volume 5 of the German Social Insurance Code and DiGAV as low-risk mobile medical devices in Germany only. *Regulated by section 40a of volume 11 of the German Social Insurance Code in Germany only.