HALL coordinator Professor Paul Quinn recently co-authored (with Richard Rak, Ph.D.) a lengthy report for the EU Commission on Enhancing “Digital Health Innovation in the EU with Effective Industrial Strategy Policies- A Focus on Wearable Medical Devices”.
The goal of the report is to analyze trends, opportunities, challenges, and barriers affecting digital health, and specifically, the innovation, deployment, and use of wearable medical devices in the EU (with comparison with the US). The report covers the technological aspects of wearable medical devices in the context of IoT-enabled telemedicine systems. It provides a cross-legislative analysis on how an emerging new EU regulatory framework (including the MDR, AI Act, GDPR, EHDS, Data Act and Cybersecurity Act) may apply to wearable medical devices. The report also addresses key factors affecting the competitiveness of the ecosystem of wearable medical devices in the EU, including problems posed by heterogenous value assessment and reimbursement frameworks, as well as the significance of technology transfers and human factors. The report concludes with recommendations to adopt necessary policy measures and corrective legislative interventions in order to help the ecosystem to thrive.
Check it out through this link for more information: https://publications.jrc.ec.europa.eu/repository/handle/JRC138798