OBJECTIVES: Mobile heath (mHealth) applications are a rapidly emerging field. A 2014 European Commission report stressed the need to develop guidelines for quality assurance and appraisal of mHealth; however, there is debate over whether their cost-effectiveness should be assessed via Health Technology Assessment (HTA). An early mHealth-specific advice service, the Health Application Briefing (HAB), is under development in the UK by NICE. Here, we assess whether HTA agencies appraise mHealth applications, and provide an analysis of the first published HABs.

METHODS: mHealth evaluations from 12 HTA agencies in Canada, England, France, Germany, Italy, and Scotland, including the 3 proof-of-concept HABs, were searched for and reviewed to determine their clinical and economic evidence requirements.

RESULTS: None of the studied agencies provide formal HTA of mHealth apps. 4/12 provided guidance on appraising mHealth (England: NICE, the National Institute for Health Research [NIHR]; Scotland: the Scottish Health Technologies Group [SHTG], France: Haute Autorité de Santé [HAS]). Of these, NICE assessed 3 apps via HAB, and 1/8 published assessments from the SHTG Innovative Medical Technology Overview related to mHealth. On further assessment of the HABs, a relatively high level of clinical evidence was included, with the Sleepio app presenting 5 randomised controlled trials. No published economic evaluations were included, but all apps were expected to be cost saving.

CONCLUSIONS: The lack of mHealth assessment pathways at the national level risks the development of a disparity in market access between countries. Programmes such as the NICE HAB could provide useful minimum evidence milestones that app developers should overcome, which may protect patients from apps, such as medication monitoring, which have the potential for harm. However, without formal HTA appraisal, it remains unclear how much value mHealth technologies could provide to patients.