EU HTA Regulation: Taskforce To Develop Evaluation Framework For Digital Medtech

Several national health technology assessment bodies in Europe have joined forces with EU-level organizations to develop recommendations on harmonized evaluation guidelines for digital medical devices under the upcoming EU Regulation on HTA.

Medical Software — • Source: Shutterstock

A taskforce co-chaired by France’s Ministerial Delegation for Digital Health and the European Network for Health Technology Assessment (EUnetHTA) has been launched with the aim of establishing “real-world-ready” recommendations on how best to evaluate the cost and clinical-effectiveness of digital medical devices (DMDs).

In a statement published on 26 October, the French National Authority for Health (HAS) outlined how key representatives from...