Mobile health (mHealth) applications (app) are being integrated into healthcare by patients and practitioners in Australia. However, there are currently no policies or frameworks available that can be used to conduct a health technology assessment (HTA) on mHealth apps for reimbursement purposes. The aim of the study was to determine what policy changes and assessment criteria are needed to facilitate the development of a system that evaluates mobile medical apps for regulatory and reimbursement purposes in Australia.

To obtain the information to determine what policy changes are needed and create an evidence-based framework that can evaluate mHealth apps for reimbursement decision-making, four studies were conducted. This research included (i) a policy analysis on international mHealth app regulation; (ii) a case study on American and Australian app regulation; (iii) a methodological systematic review on the suitability of current mHealth evaluation frameworks for reimbursement purposes; and (iv) the identification of HTA pathways and impediments to app reimbursement through stakeholder interviews. An evaluation framework for apps was created by combining and synthesizing the results.

Software changes, connectivity, and cybersecurity need to be considered when evaluating mHealth apps for reimbursement purposes. Additionally, the potential dangers of apps providing misinformation, and poor software reliability in current regulation must be considered. Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement in Australia. They expressed caution around the lack of clarity regarding who is responsible for app quality as well as concerns about the digital literacy of medical practitioners and their patients.

Since stakeholder trust in the current HTA process for medical devices in Australia is high, the process was adapted to create an evaluation framework for mHealth apps. The adaptations included making provisions for cybersecurity, software updates, and compatibility issues. Provisions to address concerns around practitioner responsibility and misinformation were incorporated into the framework.