Ensuring market access : a framework for introducing digital therapeutics in Malta

Abstract

Digital therapeutics (DTx) are evidence-based digital interventions designed to prevent, manage, or treat medical conditions, representing a new and rapidly expanding frontier in healthcare. This dissertation explores how such technologies can be integrated within Malta’s health system, focusing on issues of access, regulation, and implementation. A mixed-methods approach was adopted, combining a literature review with a local survey among healthcare professionals from multiple clinical disciplines and semi structured interviews with key stakeholders across both public and private sectors. The survey results provided measurable indicators of awareness and readiness, whereas the interviews captured broader policy and implementation perspectives. The findings were then analysed thematically and consolidated through a SWOT framework to identify the key strengths, weaknesses, opportunities, and threats shaping Malta’s readiness for DTx adoption. The study found strong appreciation of the clinical and patient-centred potential of DTx, yet awareness and practical understanding among clinicians remain limited. The gaps persist in regulatory clarity, reimbursement mechanisms, and digital infrastructure. Nonetheless, stakeholders expressed readiness to adopt DTx provided that coherent policy direction and a supportive regulatory environment are established. Building on these insights, the dissertation proposes Malta’s first dedicated framework for digital therapeutics, based on four strategic pillars: Governance and Regulation, Clinical Integration, Education and Awareness, and Digital Infrastructure. The framework is designed not as a stand-alone initiative but as an extension of Malta’s National Health Strategy [1] and Digital Roadmap [2], reinforcing the country’s broader vision of a digitally enabled healthcare system. This dissertation provides both a practical roadmap for policymakers and regulators, and an academic contribution by consolidating national perspectives on DTx. It underscores the importance of cross-sectoral collaboration and supportive regulation to ensure the safe, effective and equitable integration of DTx in Malta.