1-Hour Program

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Overview

AI and machine learning are leading to the updating of healthcare regulations and introducing new complexities into regulatory compliance for clinicians and researchers.  Of particular importance are the evolving regulatory schemes of the Food and Drug Administration, which treats AI/ML-based software as regulated medical devices, and the Federal Trade Commission, which has issued new regulations and is focusing on AI, fairness and transparency in the use of personally identifiable information under its rules prohibiting unfair and deceptive trade practices.  Thus identifying and addressing bias in algorithms may make AI in healthcare “Augmented Intelligence” rather than “Artificial Intelligence.”   

Please join William A. Tanenbaum and Jason E. Johnson, partners at Moses & Singer LLP as they address:

  • FTC regulations and their application to requirements of fairness and transparency in the use of AI - 15 minutes
  • Identifying bias in algorithms and how doctors are addressing it - 15 minutes 
  • FDA regulations and this agency’s rules for treating “Software as a Medical Device” - 15 minutes
  • Supply chain issues in maintaining regulatory compliance devices incorporating software - 15 minutes
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