Necessity of Regulation Development for mHealth Apps

Background: Mobile health or mHealth apps are software programs that run on Smartphone, tablet and other mobile communication devices and provide various functionalities such as track disease, access to health information, capture user data and offer diagnosis, treatment and reminders. Predictions into 2018 suggest that more than one billion individuals worldwide will use a mHealth app. Despite potential benefits by mHealth applications, they may harm the patients/users if misused or misinterpreted. Specific concerns including lack of regulation for apps, lack of protection of data security and unclear evidence of apps have been neglected so far. Objectives: The aim of this paper is the exploration of the importance of legislation for the mHealth apps. Methods: The articles published between 2006 and 2016 in Pubmed database were reviewed by using “regulation” and “standard”, in combination to “mobile/health/medical apps” and “mHealth” keywords. After removing duplicated and not available full text papers, title and abstract of articles were screened by 2 reviewers to identify related studies in this topic. Results: Several articles focused on quality of mHealth apps in a specific domain like asthma and weight management without introducing a standard framework. Many standards in the e-health field are also applicable within mHealth context such as security and interoperability guidance, while others require some modifications. However, there are only two standard development organizations that have paid particular attention to the regulation of mHealth apps:1) The National Health Service (NHS) which has provided their online health apps library aiming at reviewing apps to ensure that they are clinically safe before releasing them to the public and 2)Food and Drug Administration(FDA) which has issued its final guidance concerning the regulation of mHealth apps in 2013, But applications that provided information in a variety of formats, supported office operations and recorded health and wellness data have not been considered. Conclusion: There is a clear need for the development of quality systems for mHealth apps to application developers can evaluate apps before publication. It is important participation of every standard organization in developing standards for improvement of mHealth apps.