8/25/21 Steering Committee Meeting

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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 30+ 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.

0:00-3:29 - Opening remarks and introduction

3:29-7:28 - NIH NCI MDDT RFA Overview

7:29-15:30 - Overview of MDDTs and the above proposals from FDA perspective

15:31-25:45 - What is of interest to FDA in terms of obstacles to overcome for MDDT program?

25:47-26:10 - New projects

26:11-31:17 - Privacy Pilot Project P3

31:18-32:11 - Information Blocking

32:12-35:05 - Test Driving VALID2021

35:06-38:19 - SEER Microscope

38:20-39:48 - Payor Strategies updates

39:49-42:24 - Truthing & Validation

42:25-46:22 - Data Standardization

46:23-50:16 - MDIC Updates

50:18-57:45 - Discussion for in-person meeting

57:46-end - Closing


Meeting Summary

NIH NCI MDDT RFA

  • NIH/NCI 444 - Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies

    • Anticipated: 3-5 awards

    • Link

  • NIH/NCI 442 - Quantitative Biomarkers as Medical Device Development Tools for Cancer

    • Anticipated: 2-3 awards

    • Link

  • The white house has made a RFI about national plan for AI: link

Projects Discussion

  • We are working on four new projects. If you are interested in learning more or participating in any of the projects, information to join the meetings is included below.

    • Privacy Pilot Project P3

    • Test Driving VALID2021

    • Information Blocking

    • SEER Microscope

Privacy Pilot Project P3

  • Visit the project page here

  • Join the meeting on Wednesday, September 1, 2021 at 3:00-4:00PM ET

Test Driving VALID2021

  • Visit the project page here

  • Join the meeting on Thursday, September 2, 2021 at 3:00-4:00PM ET

Information Blocking

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  • Visit the project page here

SEER Microscope

  • Visit the project page here

  • Join the meeting on Friday, September 3, 2021 at 3:00-4:00PM ET

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Workgroup Updates

  • Payor

    • Trying to make contact with radiology groups to discuss how they established CPT codes for AI. If you have any contacts in radiology groups, please share with the Payor WG.

    • Bi-weekly meetings will resume on Tuesday, September 7, 2021 at 1:00-2:00PM ET

  • Truthing & Validation

    • 16 July 2021: Dr. Si Wen gave a presentation on “Quantiative Agreement Analysis for HTT Pilot Study Data” and the recording is now available here:

      o   Link

      o   Her manuscript, submitted to Statistics in Biopharmaceutical Research, can be read here

      o   Her github repository with an R package for the methods and simulations: link

      • 8 August 2021: Dr. Gallas presented at the American Statistical Society’s Joint Statistical Meeting

    • Link to meeting summary and recordings here

      • 8 August 2021: Public Release of the HTT Github Repository:

    • Contains primary data objects (with documentation) and supporting functions

    • Contains Pathology Informatics R markdown file with code to process data and create all figures

    • Link

      • 12 August 2021: FDA ORISE Interns JP Philips, James Setty, and Phoebe Qian participated in the FDA Summer Student Science Poster Days

    • View their posters here

      • 19 August 2021: 2021 Google Summer of Code Intern Peddi Sai Varshith recorded a video of his work with the High Truthing Project and integrating hardware with caMicroscope

    • Video and project summary here

  • Data Standardization

    • DICOM WG-26 WSI Annotation Hackathon (link)

    • The event will be held virtually over the internet from Monday, September 27, 2021 to Friday, October 15, 2021

    • A final summary session and panel discussion will take place live at the Pathology Visions 2021 conference in Las Vegas on Tuesday, October 19, 2021 9:45-10:30 AM PDT.

MDIC Updates

  • Change control plan for IVD template will be available soon

  • Medical Device Innovation Consortium's (MDIC) Science of Patient Input (SPI) Survey on Digital Health and Patient Input

In-person Meeting

  • DPA Visions is occurring in-person in Las Vegas, NV on October 17-19

  • Survey results:

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9/29/21 Steering Committee Meeting

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7/28/21 Steering Committee Meeting