EU HTA regulation and EU harmonised assessment for digital medical devices

Digital health technologies hold great promise to transform healthcare. In particular, there is a rapid evolution in the development of technologies referred to as digital medical devices (DMDs), which can cover a multitude of solutions that enable diagnosis, monitoring, treatment and follow-up of patients.

Despite the promise of DMDs to transform healthcare, their adoption in clinical practice is very limited, their regulatory environment is still developing, and coverage decisions are lacking or incomplete. In addition, there are no standardised evaluation methods or common language at the moment to help address the uncertainty around investing in digital health technologies.

This reflection paper aims to provide an overview of existing evaluation frameworks for DMDs, with a focus on frameworks informing funding and reimbursement decisions and adoption in Europe, and to reflect on limitations and opportunities offered by these frameworks.

Read the full reflection paper below.