m-Health smartphone applications on chronic disease monitoring : development and regulatory considerations

Abstract

Introduction: The market for chronic disease management apps for patients is growing from year to year. However, policy and regulation of app use for medical purposes in Asia Pacific are not developed. Methods: 1) A systematic review of randomized-controlled trials of diabetes management apps for patients are assessed as to determine whether using the app (intervention group) leads to significant reductions in HbA1c levels ; 2) A comparison of paid and free apps based on number of group functions between Apple iTunes App Store and Google Play for Android. Results: 1) A reduction in HbA1c in both the intervention (m-Health) and control (usual care) group, although two studies identified the changes as statistically insignificant; 2) Apple iTunes App store included 95 free diabetes management apps for patients and 86 paid apps at an average cost of $19.91. Google Play offered 80 free apps and 31 paid apps at an average cost of $4.31. The largest HbA1c reductions could be found when clinical, social, behavioural, and affective factors are taken into account in the app’s supporting system (e.g. WellDoc™ System (WDS). Discussion: There is some evidence to suggest that mobile apps for diabetes management for patients show reductions in HbA1c similar to usual care. In Hong Kong, some progress has been made regarding the promotion of the use of m-Health for the elderly and disabled, but policies on app development, approval, and regulation are absent. Future expansion of ICT may consider m-Health for chronic disease management based on international lessons on medical device and medical apps guidelines.