Global Regulation of AI – What You Need to Know (the European MDR and FDA pathways for regulating AI software)

An overview of the European MDR and FDA pathways for regulating AI software.

An overview of the European MDR and FDA pathways for regulating AI software as a medical device. Focus on the new changes to the new MDR since May 2021. Discussion of the FDAs proposed pathway for good machine learning practice.

AI4C lectures are now CME approved! MDs, DOs, NPs, and PAs can receive CME category 1 credit. Other health care professionals can get participation certificates including Information Technology professionals. Go to the following link to sign up for CME:|group-tabs-node-course-default

Dr Harvey is an experienced clinician and health technology advisor, with a focus on leveraging big data and artificial intelligence. He is a board certified consultant radiologist and academic, trained in the NHS and Europe’s leading cancer research center, the Institute of Cancer Research, where he was twice awarded ICR Science Writer of the Year. He has held lead roles at two flagship UK startups, leading to successfully gaining the world-first CE marking for an AI-supported triage service, and the first UK CE mark for a deep-learning medical device. He also acted as co-chair to the Topol health technology review for Health Education England commissioned by the Secretary of State for Health and Social Care. He now serves as managing Director at Hardian Health, consulting for many AI start-up companies across the globe and retains an academic interest as a board member of the global open source scientific journal Nature: Digital Medicine, and holds an honorary research fellowship at the Institute of Cognitive Neurosciences at UCL.



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Jun 10 2021


12:00 pm - 1:00 pm

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