8/25/21 Steering Committee Meeting
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
NIH/NCI 442 - Quantitative Biomarkers as Medical Device Development Tools for Cancer
Anticipated: 2-3 awards
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
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
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:
