Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning

Press Release

April 4, 2023 from 2pm to 4pm
Given the impact of COVID-19, the conference was held online.

Agenda / List of Handouts

  1. How to compile a report
    • Introduction
    • Analysis of related trends in Japan and overseas
    • Biases related to AI learning
    • Problems of reuse of evaluation data in post-marketing learning and the current state of research to solve the problems
    • New Approaches to Data Augmentation
    • Current status and issues of training data construction by physical model simulation
    • Perspectives on databases
  2. Others
List of Handouts
  • Document 1     Summary of Discussions at the 4th Working Group
  • Document 2     Initiatives of the AI Expert Subcommittee WG
  • Document 3     Topic Note of Discussion
  • Document 4     Agenda and Draft of Report (Repost of the 4th Subcommittee)
  • Document 5     Biases related to AI learning
  • Ref.1                Supplementary document related to ChatCAD
  • Ref.2                Materials with comments to the discussion notes