There is not a single day without breaking news regarding the disruptive power of artificial intelligence (AI) from generative language processing to image recognition,  financial analysis, or even cultural content creation. In medicine, AI carries the promise of better and more personalized medicine, harvesting on the growing amount of  digital health data. However, AI, like any other medical device, needs to comply to the basic principle of medical practice, “do no harm”. In Europe, this translates into the  obligation of compliance to the Medical Device Regulation and other relevant laws in the Union. This series of webinars aims to highlight some key aspects of conformity management of medical device software and AI, which are prerequisites to the application of AI medical devices in clinical practice. As the regulatory landscape evolves with new technologies, this series also aims to provide insights into the upcoming AI regulation in Europe that manufacturers or developers of AI software may want to consider early on in their development process.  

The  webinars are co-organised with the AI-Mind consortium of which DNV is a partner. AI-Mind brings together 15 partners from 8 countries to develop AI-based tools for dementia risk prediction of people with mild cognitive impairment. The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 964220. https://www.ai-mind.eu/ . To join the AI-Mind mailing list, please visit the subscription page https://www.ai-mind.eu/subscribe/

The webinars are targeted at AI-Mind members and stakeholders, the IVS network, and other relevant stakeholders researching and using AI in healthcare including  clinicians, researchers, lawyers, hospital management and IT support. 

The webinars will be delivered by medical device software expert, Dr Frédéric Courivaud from DNV’s Healthcare Research Programme.