AI as Medical Device - Interaction between the AI Act and the Medical Device Regulation | скачать в хорошем качестве

AI as Medical Device - Interaction between the AI Act and the Medical Device Regulation |

Heinz-Uwe Dettling | Partner | Head of Life Sciences, Ernst & Young Law Medical devices which leverage artificial intelligence systems – usually via a combination of software and hardware (i.e., robotics) - are poised to transform healthcare on a global scale that will undoubtedly improve and save countless lives. At the same time, however, regulators must grapple with the political, economic, and ethical challenges in regulating rapidly-evolving AI technologies in an already heavily-regulated industry. AI developed with so called „machine learning“ techniques is designed to continuously learn and improve and, over time, change itself. Notably, an AI system using machine learning techniques is often considered „blackbox AI“ since such AI systems have the ability to create their own parameters and rules. Intriguing questions therefore arise in the context of AI as a medical device on the one hand and regulatory requirements such as repeatability, reliability, verification, validation and prior approval of changes on the other hand. In that respect, the proposed Regulation on Artificial Intelligence (Artificial Intelligence Act), which was presented as a legislative proposal by the European Commission on 21 April 2021 (the Proposal), could provide much needed clarification. The Artificial Intelligence Act as proposed will introduce a harmonized regulatory framework for the development, placement on the market and use of AI systems in the EU in accordance with a risk-based approach to classification. This balanced approach to implementing a harmonized AI regulatory framework Union-wide as it relates to the existing EU Regulation on Medical Devices is the subject of this presentation. More about Big-Data.AI Summit: https://www.big-data.ai/