Development of an assessment process for digital medical devices in Austria

Abstract Issue/problem Digital medical devices have experienced a rapid development in recent years and are playing an increasingly important role in healthcare. These devices offer numerous benefits and can improve patient care. However, despite their potential benefits, the use of digital medical devices also poses risks and regulation from governmental side is needed from a Public Health Perspective. This is why some countries already implemented assessment processes for Digital Medical Devices (e.g. Germany and France) leading to the question how such a process could be established in Austria too. Description of the problem While digital medical devices must fulfil requirements set by the medical device regulation to enter market, several other aspects are of interests when offering digital medical devices in routine care. These include e.g. medical effectiveness, data security and interoperability. The objective of the ongoing pilot project is to develop a process for the assessment of quality-assured digital medical devices in Austria in 2024. For this, a combination of literature research, interviews and workshops with relevant stakeholders is used in order to gain all necessary information. Process and assessment criteria will be tested and revised in a pilot phase with several digital medical devices. Results At the end of the project, an assessment framework as well as a potential evaluation process will be designed in accordance with relevant stakeholders. Moreover, legals aspects and the potential integration into the austrian health telematics infrastrucutur will be assessed. This will form a basis for implementing digital medical devices within the austrian healthcare system. Key messages • The result of this project aims to build the basis for implementing an evaluation process for digital medical devices in Austria. • The establishment of an evaluation process for digital medical devices supports the integration of quality assured digital medical devices in healthcare.