Challenges and Alternatives to Evaluation Methods and Regulation Approaches for Medical Apps as Mobile Medical Devices: International and Multidisciplinary Focus Group Discussion

Abstract

Background: The rapid proliferation of medical apps has transformed the health care landscape by giving patients and health care providers unprecedented access to personalized health information and services. However, concerns regarding the effectiveness and safety of medical apps have raised questions regarding the efficacy of randomized controlled trials (RCTs) in the evaluation of such apps and as a requirement for their regulation as mobile medical devices.

Objective: This study aims to address this issue by investigating alternative methods, apart from RCTs, for evaluating and regulating medical apps.

Methods: Using a qualitative approach, a focus group study with 46 international and multidisciplinary public health experts was conducted at the 17th World Congress on Public Health in May 2023 in Rome, Italy. The group was split into 3 subgroups to gather in-depth insights into alternative approaches for evaluating and regulating medical apps. We conducted a policy analysis on the current regulation of medical apps as mobile medical devices for the 4 most represented countries in the workshop: Italy, Germany, Canada, and Australia. We developed a logic model that combines the evaluation and regulation domains on the basis of these findings.

Results: The focus group discussions explored the strengths and limitations of the current evaluation and regulation methods and identified potential alternatives that could enhance the quality and safety of medical apps. Although RCTs were only explicitly mentioned in the German regulatory system as one of many options, an analysis of chosen evaluation methods for German apps on prescription pointed toward a "scientific reflex" where RCTs are always the chosen evaluation method. However, this method has substantial limitations when used to evaluate digital interventions such as medical apps. Comparable results were observed during the focus group discussions, where participants expressed similar experiences with their own evaluation approaches. In addition, the participants highlighted numerous alternatives to RCTs. These alternatives can be used at different points during the life cycle of a digital intervention to assess its efficacy and potential harm to users.

Conclusions: It is crucial to recognize that unlike analog tools, digital interventions constantly evolve, posing challenges to inflexible evaluation methods such as RCTs. Potential risks include high dropout rates, decreased adherence, and nonsignificant results. However, existing regulations do not explicitly advocate for other evaluation methodologies. Our research highlighted the necessity of overcoming the gap between regulatory demands to demonstrate safety and efficacy of medical apps and evolving scientific practices, ensuring that digital health innovation is evaluated and regulated in a way that considers the unique characteristics of mobile medical devices.

Keywords: alternative approaches; evaluation methods; focus group study; logic model; medical apps; mobile medical device regulation; mobile medical devices; mobile phone.