Marielle Fournier and Sylvie Le Glédic recently presented on Telemedicine and E-Health Systems at the International Workshop on Future Wellness and Medical Information and Communication Technology (ICT) Systems in Brest (France). The presentation focused on telemedicine products and the related challenges for developing and obtaining market approval. Marielle and Sylvie covered the interface between regulators, industry and users/patients, as well as the following regulatory issues: product quality, the demonstration of safety and performance-efficacy, data robustness, the identification of adequate endpoints and comparator in view of price and reimbursement negotiations.
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