Safety concerns with consumer-facing mobile health applications and their consequences: a scoping review

Abstract Objective To summarize the research literature about safety concerns with consumer-facing health apps and their consequences. Materials and Methods We searched bibliographic databases including PubMed, Web of Science, Scopus, and Cochrane libraries from January 2013 to May 2019 for articles about health apps. Descriptive information about safety concerns and consequences were extracted and classified into natural categories. The review was conducted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) statement. Results Of the 74 studies identified, the majority were reviews of a single or a group of similar apps (n = 66, 89%), nearly half related to disease management (n = 34, 46%). A total of 80 safety concerns were identified, 67 related to the quality of information presented including incorrect or incomplete information, variation in content, and incorrect or inappropriate response to consumer needs. The remaining 13 related to app functionality including gaps in features, lack of validation for user input, delayed processing, failure to respond to health dangers, and faulty alarms. Of the 52 reports of actual or potential consequences, 5 had potential for patient harm. We also identified 66 reports about gaps in app development, including the lack of expert involvement, poor evidence base, and poor validation. Conclusions Safety of apps is an emerging public health issue. The available evidence shows that apps pose clinical risks to consumers. Involvement of consumers, regulators, and healthcare professionals in development and testing can improve quality. Additionally, mandatory reporting of safety concerns is needed to improve outcomes.