Is the Quality of Mobile Health Applications for Burns Being Adequately Assessed?

ABSTRACT

High-quality mobile health applications (mHealth apps) have the potential to enhance the prevention, diagnosis, and treatment of burns. The primary aim of this study was to evaluate whether the quality of mHealth apps for burns care is being adequately assessed. The secondary aim was to determine whether these apps meet regulatory standards in the United Kingdom. We searched AMED, BNI, CINAHL, Cochrane Library, Embase, Emcare, Medline, and PsychInfo to identify studies assessing mHealth app quality for burns. The PRISMA reporting guideline was adhered to. Two independent reviewers screened abstracts to identify relevant studies. The quality of identified studies was assessed according to the framework proposed by Nouri et al, including design, information/content, usability, functionality, ethical issues, security/privacy, and user-perceived value. Of the 28 included studies, none assessed all seven domains of quality. Design was assessed in 4 of 28 studies; information/content in 26 of 28 studies; usability in 12 of 28 studies; functionality in 10 of 28 studies; ethical issues were never assessed in any studies; security/privacy was not assessed; subjective assessment was made in 9 of 28 studies. About 17 of 28 studies included apps that met the definition of "medical device" according to Medicines and Healthcare products Regulatory Agency guidance, yet only one app was appropriately certified with the UK Conformity Assessed mark. The quality of mHealth apps for burns is not being adequately assessed. The majority of apps should be considered medical devices according to UK standards, yet only one was appropriately certified. Regulatory bodies should support mHealth app developers, so as to improve quality control while simultaneously fostering innovation.