11/24/21 Steering Committee Meeting
Please find the slides from the meeting here.
We had a great steering committee meeting with 30+ participants this month.
Please find the topics, all resources and content, along with a video recording of the meeting below.
We look forward to hearing from you.
Watch the recording of the meeting above.
0:00-3:34 Introduction and welcoming remarks
3:34-18:32 CLIA Waiver for digital pathology
18:33-24:09 ISPOR Panel
24:10-25:07 Project proposal LDT vs. IVDR
25:08-28:55 Premarket Submission for Device Software Functions
28:56-31:38 Resources
31:39-34:11 Relevant papers
34:12-45:33 Updates
45:34-48:14 Upcoming events
48:15-end Next meeting
Meeting Summary
“CLIA Waiver” for Digital Pathology
Proposal for a position letter
3 meetings to discuss:
Regulatory context. Status change during the PHE, specific changes in place today; i.e., the basis for current practice and what this means. Plan structure and format for second meeting including solicitation of practice pattern (brief survey)
Review of current practice. Participants will describe examples of current practices - review and open discussion regarding current state, benefits, and risks
Future state(s). from regulatory deviations to concrete proposals. Consider summary statement, open letter or commentary
Session 1 - Thursday, December 9 at 12:00-1:00PM ET
Session 2 - Thursday, December 16 at 12:00-1:00PM ET
Session 3 - TBD
ISPOR Panel
More information following proposal
Project proposal LDT vs. IVDR
Meeting time TBD
Laboratory Economics feature on digital pathology
Machine learning cheat sheet
Trial Snapshot
Relevant Papers
Rehm et al., GA4GH policies and standards (link)
Scheuner et al., Laboratory business models (link)
Tizhoosh et al., Can AI Remove Observer Variability in Pathology (link)
Brown et al., Clinical development times for innovative drugs (link)
Olczak et al., Presenting AI, deep learning, and machine learning studies to clinicians and healthcare stakeholders (link)
Updates
Truthing & Validation
Read about the groups progress and updates here
Published Manuscript: Dudgeon, Sarah N. et. al. “A pathologist-annotated dataset for validating artificial intelligence: a project description and pilot study.” J. Pathol. Inform. 1.45 (2021).
Manuscripts in-progress
Nature Machine Intelligence Correspondence: Research, Resources, and Collaboration: FDA Fosters Innovative Approaches
Please contact brandon.gallas@fda.hhs.gov for a pre-submission draft.
Cancers Special Issue on Tumor Infiltrating Lymphocytes (TIL) in Solid Tumors: Training Development for the Evaluation of TILs in Breast Cancer
Please contact victor.garcia@fda.hhs.gov for a pre-submission draft. We welcome feedback on this paper.
Data Collection:
Completed 8 hours of discussions about sTILs annotations with HTT panel of experts.
The eeDAP microscope system is set up at Yale. We are looking for pathologists to support the project by assessing the tumor-infiltrating lymphocytes in breast cancer slides. Click here for more information.
Other deliverables in development
Tool overview of statistical software iMRMC: Draft format for the Catalog of Regulatory Science Tools to Help Assess New Medical Devices
Please contact brandon.gallas@fda.hhs.gov for a pre-submission draft. We welcome feedback on the format of this tool overview.
Trainees
Speaker event featuring Siba el Hussein took place November 22, 2021. Watch the recording from the presentation here
MDIC
Upcoming Events
December 3 at 12:30-2:00PM ET - 2022 Medical Payment Regulations Impact on Pathology Services (link to register)
Discussion: Main membership meeting in 2022
USCAP in LA
Proposal to host “coffee chats” for PIcc members at conferences
Final Steering Committee meeting of the year will take place December 22, 2021 at 3-4PM ET