The Medical Device Regulation (MDR) is critical for digital health (DH) firms.

While businesses increasingly leverage the potential of Artificial Intelligence (AI), from wearables for health monitoring and self-care apps to machine learning analysis of medical images, compliance with the MDR becomes a top priority: many DH /AI devices will need to be certified as medical devices (MD).

However, this is not the only legal challenge for operators. DH / AI tools also require GDPR compliance and may pose critical product liability concerns. At the same time, such devices have the potential of disrupting traditional NHS governance models, but existing institutional arrangements seem to prevent the exploitation of their full potential. The webinar aims to clarify these aspects for the benefit of manufacturers, public health officials, counsels, and lawyers.

15 febbraio 2021

15.00 – 15.15 Medical Devices (or not) in the Age of Human Enhancement?
Prof. Dr. Paul Quinn, VUB
15.15 – 15.30 Data Protection for DH/AI Devices: the Search for Standards and Certifications
Dr. Giulia Schneider, SSSA
15.30 – 15.45 How MD Product Liability is Poised to Develop With the Rise of DH and AI
Dr. Andrea Parziale, SSSA
15.45 – 16.00 Advancing Digital Health Governance: Ethical and Policy Aspects
Dr. Alessandro Blasimme, ETH
16.00- 16.15 Issues in Translational Biases in the Digital Health Sector
Prof. Dr. Giovanni Comandè, SSSA
16.15 – 16.30 Discussion (Q&A)

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