Browsing: health technology assessment

Official communique from the Health Technology Assessment Review Implementation Advisory Group meeting held on 12 June 2025, available for download in PDF and Word formats.

A comprehensive analysis of accelerated approval pathways for medical devices in the United States and European Union, focusing on regulatory frameworks, funding mechanisms, and coverage policies.

The new EU-wide Health Technology Assessment (HTA) framework aims to streamline processes and accelerate access to innovative health technologies, but also presents challenges for developers.

Experts at a gene and cell therapy conference emphasize the need for flexibility in EU-level joint clinical assessments regarding evidence requirements under the Health Technology Assessment Regulation.

This study examines the role of real-world evidence (RWE) in European health technology assessment (HTA), focusing on its acceptance, use, and best practices across different HTA bodies. It analyzes the variability in RWE acceptance among HTA agencies and provides insights into the factors influencing its use in decision-making.

Publication details and download links for the HTA Review Implementation Advisory Group communiqué issued on 10 April 2025.

Meeting minutes for the Health Technology Assessment Review Implementation Advisory Group held on 10 April 2025, available for download in PDF and Word formats.

Canada’s health technology assessment agency clarifies expectations for companies using AI in evidence generation and reporting

The European Commission has adopted an implementing regulation for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) Regulation.

The European Union has initiated its first joint clinical assessments for medicinal products under the Health Technology Assessment Regulation (EU 2021/2282), focusing on treatments for paediatric cancer and advanced skin cancer therapy.