A Process Reference Model for Blockchain dApp Development for the Health Domain

Abstract

Abstract Blockchain technology has gained significant attention across various fields in recent years, including its applications in the health domain. Examples of such applications are medicine supply chain management, health record management, clinical trial management, and remote patient monitoring. Although the health domain is highly regulated, there is currently a lack of comprehensive studies presenting the essential blockchain processes, practices, and guides for development teams for ensuring health regulations. To address this gap, this study proposes the Blockchain Health dApp Process Reference Model (BDRM) specifically for developing blockchain dApps in the health domain. The BDRM was developed through a systematic review of formal and gray literature, considering expert opinions to specify the processes and practices, and integrating IEC 82304, IEC 62304, ISO 14971, and ISO/IEC 12207 standards’ requirements to make the reference model regulatory compliant. The model consists of 15 processes and 68 practices associated with these processes. The study also describes the application of design science research during the model's development. The proposed BDRM can benefit developers, researchers, and decision-makers by providing a useful resource for the development of blockchain applications in the health domain.