Health Technology Assessment
Health Technology Assessment (HTA) is a scientific, evidence-based process used to evaluate the clinical effectiveness, safety, and economic impact of new health technologies, such as medicines and medical devices. Inconsistencies and divergences between Member States raised the need to harmonise how health technologies assessments are carried out. To this end, the European Commission proposed the Health Technology Assessment (HTA) Regulation on 31 January 2018. The Regulation was formally adopted in December 2021 and entered into force in January 2022.
To facilitate its implementation, a three-year transition period was established. During this time, the necessary infrastructure, such as the Member State Coordination Group (HTACG) and its subgroups, was created, and detailed methodological guidance was developed.
A Stakeholder Network was also launched in 2023 to enable regular dialogue between EU institutions and health sector representatives. This preparatory phase allowed Member States to align their national HTA legislation and processes with the new framework.
The HTA Regulation became applicable on 12 January 2025, introducing a new EU framework for Joint Clinical Assessments (JCAs) of new medicines, advanced therapies and selected high-risk medical devices. By streamlining the assessment of clinical effectiveness and safety across Member States, the Regulation aims to reduce duplication, improve the efficiency and consistency of HTA processes, and support more timely, evidence-based decisions on patient access to innovative health technologies. It also establishes Joint Scientific Consultations and horizon scanning activities to help developers generate appropriate clinical evidence and enable health systems to prepare for emerging technologies.
As an active member of the BioMed Alliance and the European Cancer Organisation, and a dedicated participant in the EU Commission HTA Stakeholder Group, the European Society of Radiology actively monitors the development of the HTA framework, engages with stakeholders to represent the interests of healthcare professionals, and contributes to the implementation and enforcement of the regulation to ensure it effectively supports innovation, accessibility, and high-quality healthcare across Europe.
Medical imaging is embedded in every stage of clinical decision-making, from prevention and screening to diagnosis, treatment monitoring, and follow-up. The ESR advocates for the early integration of imaging expertise into HTA processes and presented its position on the role of medical imaging in HTA at the 7th EC HTA Stakeholder Network Meeting in Brussels in June 2026. Details on ESR activities in this area will follow.
In light of the rapidly evolving digital health landscape, including developments related to health data and artificial intelligence, the ESR also stands ready to contribute to any future follow-up actions or revisions of the HTA framework to ensure it remains fit for purpose and responsive to emerging technologies.
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