Governing Digital Health Transformation in South Africa: Are Policies, Standards, and Legislation Fit for Purpose?

Abstract This study examines the legislative and regulatory governance mechanisms influencing digital health transformation within Provincial Departments of Health in South Africa. It aimed to evaluate the effectiveness of existing legislative, regulatory, and policy frameworks in supporting digital health implementation and to develop a Provincial Digital Health Governance and Implementation Model to strengthen governance across provincial health departments. A qualitative multiple case study design, underpinned by the interpretivist paradigm, was employed. Data were collected through semi-structured interviews with Chief Information Officers and ICT Managers from six Provincial Departments of Health and complemented by content analysis of key legislative, regulatory, and policy documents. Data were analysed thematically. The findings indicate that South Africa has established comprehensive legislative, regulatory, and policy frameworks to support digital health transformation; however, implementation remains inconsistent across provinces. Although these frameworks provide a foundation for digital health governance, their effectiveness is constrained by weak implementation mechanisms, limited institutional capacity, inconsistent ICT governance, inadequate infrastructure, insufficient digital skills, fragmented interoperability, and uneven compliance with information governance and information security standards. The study demonstrates that the principal challenge is not the absence of legislative and policy frameworks, but the governance capacity required for effective implementation. In response, the study proposes a Provincial Digital Health Governance and Implementation Model that integrates legislative and regulatory frameworks, health standards, institutional policies, governance structures, and implementation mechanisms to strengthen coordination, accountability, interoperability, regulatory compliance, and institutional readiness. The study contributes to digital health governance literature by providing a contextually relevant governance framework to support sustainable digital health transformation within South Africa's provincial healthcare system.