Enhancing Digital Health Innovation in the EU with Effective Industrial Strategy Policies - A Focus on Wearable Medical Devices
The report analyses trends, opportunities, challenges and barriers affecting digital health, and specifically, the innovation, deployment and use of wearable medical devices in the EU. The use of digital health solutions along the patient pathway could drive the integration of clinical services and telemedicine to refine and enhance hybrid healthcare delivery models. In that context, wearable medical devices could play an increasingly important role in enabling remote health promotion, diagnoses, monitoring and treatments. In turn, that could help to advance patient-centred care and make health systems more efficient. Despite their potential, there are significant challenges and barriers hindering the further development and uptake of wearable medical devices in the EU. 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.
RAK Richard;
QUINN Paul;
CIUI Bianca-Emanuela;
2024-12-11
Publications Office of the European Union
JRC138798
978-92-68-19839-1 (online),
OP KJ-02-24-846-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC138798,
10.2760/88816 (online),
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