Health Technology Assessment Framework for Certification of mHealth Apps

Numerous mobile health (mHealth) apps offer novel approaches to diagnosis and treatment, but their reliability and usability require thorough assessment. The purpose of this study is to create a customized Health Technology Assessment (HTA) framework that is intended exclusively for mHealth apps’ certification. It also provides links to pertinent data sources. The proposed HTA framework was devised based on the EUnetHTA Core Model. The developed framework consists of nine domains, encapsulating 52 topics and more than 100 assessment related issues, which were appropriately adapted to mHealth apps evaluation. An indicative AI-skin diagnosis app is subjected to high-level evaluation of the proposed HTA framework to test case the framework. In addition, it is benchmarked against similar apps to illustrate app strengths, weaknesses, and market positioning, leading to a prescriptive approach for improvements. The proposed tailored framework establishes a holistic and rigorous evaluation process to ensure that mHealth apps are technologically robust, ethically sound, safe, effective, usable, and user friendly. It can also provide a general understanding of the app's standing in the market. This adapted framework leads to the creation of a comprehensive HTA report. The HTA report can aid app developers, technology, engineering, and product managers to meet the necessary HTA requirements for apps’ assessment. It can also be used by healthcare decision-makers, payers, and policymakers as a decision-support tool to inform decisions regarding the adoption, reimbursement, and utilization of mHealth apps.