Despite the promise of digital health technologies to transform healthcare, (whereby continued work is ongoing to
exactly define these technologies and develop a taxonomy), their adoption in clinical practice is very limited, their
regulatory environment is still developing and coverage decisions are lacking or incomplete
The focus of this reflection paper is on a subset of digital health technologies, referred to as digital medical devices (DMD), for which CE-marking according to requirements of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) is a mandatory step to gain marketing authorisation in the EU3,4.
To increase the adoption of DMDs in various care settings, their full value and impact must be understood. However, at the moment there are no standardised evaluation methods or common language to help address the uncertainty around investing in digital health technologies. While a few frameworks exist to evaluate DMDs and inform reimbursement, the scope of such frameworks remains too restrictive to provide a solution for all DMDs. For example, there is a lack of AI focus and DMDs intended for use by healthcare professionals are generally not in scope.