Development of a health technology assessment module for evaluating mobile medical applications.

OBJECTIVE: The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes. METHODS: In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs. RESULTS: Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians. CONCLUSION: An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.