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.

A mixed methods analysis of existing assessment and evaluation tools (AETs) for mental health applications

“…Social distancing and changes in practice around COVID-19 have forced healthcare providers worldwide to provide their services through online platforms, thus acting as a catalyst to raise awareness, interest, and uptake of mobile Health Applications (mHealth Apps) ( 3 ). mHealth Apps are software applications on mobile devices that process health-related data and can be used to maintain, improve, or manage an individual’s health ( 4 ). Currently, the demand for mHealth Apps is high.…”

A systematic review of reviews on the advantages of mHealth utilization in mental health services: A viable option for large populations in low-resource settings

“…Mobile health, or mHealth, is the utilization of mobile devices like smartphones and tablets in healthcare. It includes applications for accessing medical information, monitoring health, tracking behaviors such as diet and exercise and facilitating patient-provider communication (Maaß et al, 2022 ).…”

Development and Validation of the eHealth Literacy and Use Scale (eHLUS) to Measure Medical App Literacy.

“…5 They range from pre-installed smartphone apps that track steps to web-based applications such as complex online health platforms, enabling users to actively manage their health and supporting disease treatment and prevention through personalized approaches. [5][6][7][8][9] The increasing demand for mHealth apps is attributed to the widespread acceptance of digital media by users and healthcare professionals. 3,10 mHealth solutions have evolved exponentially without control or regulation.…”

“…A narrative literature review identi ed 24 publications with different de nitions for mHealth apps and medical apps (Med-Apps). 5 A subgroup of mHealth apps are Med-Apps, which claim to be used for clinical and medical purposes and can be regulated as mobile medical devices. From a public health perspective, Med-Apps focus on secondary prevention for the early detection and treatment of acute diseases or injuries and tertiary prevention, where rehabilitation and managing chronic diseases are paramount.…”

“…From a public health perspective, Med-Apps focus on secondary prevention for the early detection and treatment of acute diseases or injuries and tertiary prevention, where rehabilitation and managing chronic diseases are paramount. 5 In Germany, in response to the growing market for mHealth apps, the 'Act to Improve Healthcare Provision through Digitalisation and Innovation' (Digital Healthcare Act -DVG) was enacted in 2019. The law stipulates that, since October 2020, physicians and psychotherapists can prescribe Med-Apps, including certi ed digital health applications (German abbreviation: DiGA), and health insurance companies will cover app usage fees.…”