This webinar, which took place on 15 February 2021, was aimed at exploring the issue of Medical Device Regulation and Digital Heath. The webinar hosted five speakers: Professor Dr. Paul Quinn from Vrije Universiteit Brussel how presented a talk entitled ‘Medical Devices (or not) in the Age of Human Enhancement?’; Dr. Giulia Schneider, from SoBigData++ partner SSSA, who presented a talk entitled ‘Data Protection for Digital Health/ Artificial Intelligence Devices: Search for Standards and Certifications’; Dr. Andrea Parziale, from SoBigData++ partner SSSA, who presented a talk entitled ‘How Medical Devices Product Liability is Poised to Develop With the Rise of Digital Heath and Artificial Intelligence’; Dr. Alessandro Blassimme, from SoBigData++ Partner ETH Zurich, who presented a talk entitled ‘Advancing Digital Health Governance: Ethical and Policy Aspects’; and Professor Dr. Giovanni Comandé, from SoBigData++ partner SSSA, who presented a talk named ‘Issues in Translational Biases in the Digital Health Sector’.