A Blockchain-Based Regulatory Framework for mHealth

Mobile health (mHealth) is playing a key role in facilitating health services for patients. Such services may include remote diagnostics and monitoring, chronic conditions management, preventive medicine, and health promotion. While mHealth has gained significant traction during the COVID-19 pandemic, they may pose safety risks to patients. This entails regulations and monitoring of shared data and management of potential safety risks of all mHealth applications continuously and systematically. In this study, we propose a blockchain-based framework for regulating mHealth apps and governing their safe use. We systematically identify the needs, stakeholders, and requirements of the current mHealth practices and regulations that may benefit from blockchain features. Further, we exemplify our framework on a diabetes mHealth app that supports safety risk assessment and incident reporting functions. Blockchain technology can offer a solution to achieve this goal by providing improved security, transparency, accountability, and traceability of data among stakeholders. Blockchain has the potential to alleviate existing mHealth problems related to data centralization, poor data quality, lack of trust, and the absence of robust governance. In the paper, we present a discussion on the security aspects of our proposed blockchain-based framework, including limitations and challenges.