From Regulation to Reality: A Framework to Bridge the Gap in Digital Health Data Protection

This study addresses the urgent challenge of safeguarding sensitive health data in today’s digital age by proposing a novel, integrated data protection framework that synthesises six critical pillars—technology, policy, cybersecurity, legal frameworks, governance, and risk assessment—into a unified socio-technical model. Unlike existing piecemeal approaches, this framework is designed to bridge the gap between regulatory requirements and practical implementation through measurable, engineering-based solutions. Healthcare organisations face persistent difficulties in aligning innovation with secure and compliant practices due to fragmented governance and reactive cybersecurity measures. This paper aims to empirically validate the effectiveness of the proposed framework by quantitatively analysing causal relationships between its components (such as between governance and compliance) using advanced statistical methods, including exploratory factor analysis (EFA) and Partial Least Squares Structural Equation Modelling (PLS-SEM). A survey of healthcare professionals across multiple countries revealed significant gaps between regulatory expectations and operational realities, underscoring the need for harmonised strategies. The results demonstrate strong causal linkages between governance, cybersecurity practices, and compliance, validating the framework’s robustness. This research contributes to the fields of digital health, information systems, industrial engineering, and electronic governance by offering a scalable, empirically tested model for socio-technical data protection. The findings provide actionable strategies for policymakers, system architects, and digital infrastructure designers.