AI CoE Webinar: Challenges in the Regulation of AI Software as a Medical Device


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Event Type

Date: July 28, 2021

Time: 4 pm BST / 11 am EDT / 8 am PDT

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Webinar Summary

Software as a medical device (SaMD) that leverages artificial intelligence (AI) has the opportunity to reshape healthcare. It also raises unique challenges for developers and regulators. As healthcare advances and digital solutions leveraging AI becomes more prevalent, it is important that medical device regulatory frameworks also advance to match the speed of innovation. The panel will review key terms related to AI SaMD and describe unique regulatory challenges associated with devices that leverage AI. Additionally, the panel will explore novel regulatory approaches to the regulation of AI SaMD currently under consideration by international regulatory authorities.



  • Nathan A. Carrington, Ph.D. Head of Digital Health and Innovation, Roche
  • Pat Baird Sr. Regulatory Specialist – Head of Global Software Standards, Philips
  • Loganathan Kumarasamy, Head of Scientific Informatics, Validation and Compliance services, North America, Zifo R&D