Agenda (tentative) (download .doc here):

• Paige Prostate: the FDA authorized the first artificial intelligence-based software that can help identify prostate cancer (link) (Paige press release)

• FDA Launches AI/ML-Enabled Medical Device List (link)

• Relevant Papers:

  • Airey et al. The In Vitro Diagnostic Regulation in Europe: Implications for Precision Medicine and Pharmaceutical Development (link)

  • Levine et al. Synthesis of diagnostic quality cancer pathology images by generative adversarial networks (link)

  • Marble et al. Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like (link)

• Workgroup Updates

  • AI/ML [Steven]

  • Truthing & Validation [Kate & Brandon]

• Information Blocking – update from ONC webinar (link)

• Projects

  • TILS WG and PIcc Joint Survey [Kim]

  •   P3 – next meeting October 20, 2021 at 3-4PM ET

  • Test Driving VALID2021 – next meeting October 21, 2021 at 2-3PM ET

  •   SEER Microscope – next meeting October 15, 2021 at 9-10AM ET

Meeting Credentials: