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This paper analyzes the current state of Health Technology Assessment (HTA) in Slovenia and the challenges and opportunities presented by the upcoming European Union HTA Regulation. The study uses a mixed-methods approach, including a narrative overview and findings from multi-stakeholder workshops, to assess Slovenia's HTA framework. Key findings emphasize the need for strengthened methodological capacity, stakeholder engagement, transparency, and integration of real-world evidence, particularly for medical devices and digital health technologies.
This study highlights the critical need for Slovenia to establish a central HTA body and enhance its HTA processes to align with EU standards, particularly regarding the evaluation of medical devices and digital health technologies.
Abstract Introduction Slovenia has engaged with Health Technology Assessment (HTA) for over two decades, but its system remains fragmented and underdeveloped. Until recently, responsibilities for evaluating health technologies were dispersed across multiple institutions without a central coordinating body or standardized methodology. Medicinal products have been subject to structured evaluation through the Health Insurance Institute of Slovenia, while other health technologies, including medical devices, diagnostics, and preventive interventions, have followed less consistent pathways under the Ministry of Health. The adoption of the European Union Health Technology Assessment Regulation), entering into force in January 2025, has provided new impetus for reform, requiring Slovenia to designate a national HTA body to participate in joint clinical assessments and align national processes with EU standards. Methods A mixed-methods analysis combining a narrative overview of HTA in Slovenia with findings from two multi-stakeholder workshops held in 2025. These workshops, which convened Slovenian and international experts, policymakers, clinicians, and patient representatives, explored opportunities and challenges for developing a robust HTA framework. Results Key findings highlight the need to strengthen methodological capacity, introduce systematic stakeholder engagement, ensure transparency, and integrate real-world evidence into decision-making. Particular emphasis was placed on expanding HTA to medical devices, diagnostics, and digital health technologies, and on anticipating future innovations such as artificial intelligence. Conclusions Slovenia now stands at a pivotal juncture. Establishing a central HTA body with a clear legal mandate, building national expertise, and leveraging regional and European collaboration is essential to creating a transparent, evidence-based, and patient-centred HTA system.
