The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU.

Health technology assessment (HTA) is a multidisciplinary evidence-based process that allows authorities to determine the relative effectiveness of new or existing health technologies (e.g., medicines and medical devices), focusing on the added value of a health technology. The outcome of an HTA typically influences the extent to which a given health technology is adopted and/or reimbursed by a given country’s healthcare system.