The EU Commission’s Proposal for the Regulation of Artificial Intelligence and “human-centric” Regulation for AI as Medical Device
*Daria Onitiu from https://ec.europa.eu/futurium/en/ai-alliance-consultation/guidelines.1.html The EU Commission’s proposal for the Regulation of Artificial Intelligence (the ‘AI Act’) will bring significant changes to standard-setting for high-risk systems, including medical AI. The proposal’s risk-based approach intends to balance the socio-economic benefits of medical AI and the need for harmonised standards for safety-critical applications in healthcare. From medical…