Documents reviewed.

In emerging economies, the widespread penetration and mainstreaming of Clinical Information Systems (CIS) and Knowledge Management (KM) practices are challenging and often hindered by fragmented regulatory environments, professional resistance, and cultural misalignment. Drawing on Scott’s institutional theory and its three pillars—regulative, normative, and cultural-cognitive—as an analytical framework, the study aims to inform both policy and practice, contributing to ongoing efforts to strengthen digital health implementation, governance, and institutional capacity in low and middle-income countries (LMIC). The study employed qualitative methods, including analysis of policy documents, key informant interviews, and institutional case study analysis. The findings revealed policy-practice misalignment in the institutionalization of CIS and KM. There is limited engagement of senior management at the facility level in the institutionalization process. Key actors—including government agencies, healthcare providers, regulatory bodies, development partners, and healthcare workers—were identified, along with their roles and responsibilities in shaping institutional outcomes. Application of digital health policies and strategies in Malawi is hindered by limited resources, unclear guidelines, and weak enforcement mechanisms. Consequently, stakeholder engagement is essential for the successful and effective use of technology. These findings suggest that policy–practice gaps are shaped not only by policy design, but also by institutional arrangements and power dynamics within the digital health ecosystem. Thus, successful integration of CIS and KM requires alignment between policy and practice, ongoing training, active participation in system design, and a willingness to integrate digital tools into clinical workflows.