Do you have an idea to use AI within the health sector? This session will help you to have a toolbox in regulatory affairs to optimize the planification of your project.
Management and hosting of health data will be presented within the scope of the General Data Protection Regulation (GDPR) and the legal framework of health data hosting (“hébergement de données de santé” or HDS). Added to that artificial intelligence can be qualified as a medical device (MD) in certain cases according to the new European regulation: the Medical Device Regulation (MDR). We will discuss the issues at stake in the MDR and compare it with the regulations applicable in France.
This session will be held by Ms. Claire Behar, Director of the Data Science department at Excelya & Ms. Céline Frisch, Head of Regulatory Affairs France at Excelya.