The Third SoBigData++ Awareness Panel Medical Device Regulation and Digital Health:  Problems and Perspectives will take place on-line on 15th of February 2021 at 3 p.m.

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.


15.00 – 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)

Join us on Webex:

For info:

ph. +39 050883533