9/29/21 Steering Committee Meeting

September Steering Comm Meeting.png
 
Please find the slides from the meeting here.

Please find the slides from the meeting here.

 

This month we had a productive steering committee meeting with 35+ participants.

The topics and all resources and content, along with a video recording of the meeting, are provided below.

We look forward to hearing from you.


Watch the recording of the meeting above.

0:00-3:12 - Opening remarks and introduction

3:14-5:41 - Paige Prostate

5:42-9:27 FDA Launches AI/ML-Enabled Medical Device List

9:28-17:54 Relevant papers

9:35-11:38 Airey et al.

11:40-14:48 Levine et al.

14:50-16:49 Marble et al.

17:55-24:55 Workgroup updates

18:24-21:33 ML/AI

21:40-24:38 Truthing & Validation

24:56-26:55 Information Blocking

26:57- Project Updates

26:59-35:29 TILS RS Project

35:30-38:46 SEER Cancer Microscope

38:47-45:55 Privacy Pilot Project

45:56-48:56 Test Driving VALID2021

48:57-51:08 MDIC Updates

51:10-end Discussion and closing remarks


Meeting Summary

Paige Prostate

FDA Launches AI/ML-Enabled Medical Device List

  • View the list here

  • FDA aims to be as transparent as possible and promote ideas within the community

Relevant papers

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

  • summary work, opinion piece and implementation plan

  • outlining some of the specific regulatory changes that are imposed here, including a proposal for a phased implementation

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)

  • regulatory paper on LDT

Workgroup Updates

o   ML/AI [Steven]

  • DPA Webinar Series - Validation of AI-based tools in Digital and Computational Pathology on 9/30/21

  • FDA Virtual Public Workshop - Transparency of AI/ML-enabled Medical Devices on 10/14/21

  • progress on framing of paper

o   Truthing & Validation [Kate & Brandon] (link)

  • 9 September: Dr. Brandon Gallas presented to the PathLake Conference at Pathology Horizons

  • 27 September: Dr. Kate Elfer was aa panelist concluding the 2021 Computational Pathology (COMPAY21) workshop as part of the 24th International Conference on Medical Image and Computer Assisted Intervention (link)

    • Panelists: Katherine Elfer (FDA); Chen Sagiv (DeePathology.ai); Roberto Salgado (TIL Working Group); Inti Ziobec (University of Bern); Faisal Mahmood (Harvard Medical School); Monika Lamba Saini (CellCarta)

  • Dr. Victor Garcia and Dr. Brandon Gallas are leading discussions to identify critical instructions for our annotation trainings that will lead to less pathologist variability (generally) and improve our future validation dataset (specifically).

    • We’d be happy to circulate summaries of the discussions and the feedback we will give to pathologists.

    • We plan to present the results at Pathology Informatics and in a publication.

Information Blocking

  • On September 14 from ONC webinar session “What Clinicians and Other Health Care Providers Need to Know”

  • link to project page

Download the slides from the presentation here.

Download the slides from the presentation here.

Project Updates


PIcc TILS RS Project

  • try to understand the best methods and tools need to have morphological entities such as H&E TILS qualified as biomarkers by regulatory agencies

  • CLARITY survey to be sent out by October 29

Test Driving VALID2021

  • Visit the project page here

  • Join the next meeting on Thursday, October 21, 2021 at 2:00-3:00PM ET

SEER Microscope

  • Visit the project page here

  • Join the next meeting on Friday, October 15, 2021 at 9:00-10:00AM ET

Privacy Pilot Project

  • Visit the project page here

  • Join the next meeting on Wednesday, October 2, 2021 at 9:00-10:00AM ET

Screen Shot 2021-09-28 at 1.13.42 PM.png

MDIC Updates

  • MDIC’s digital health initiative has added new workstreams. There may be opportunities to engage. Contact digipathalliance@gmail.com to get in touch with Jithesh for more information (link)

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10/27/21 Steering Committee Meeting

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8/25/21 Steering Committee Meeting