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

 

Premarket Submission for Device Software Functions

  • Submit comments by 2/2/2022

  • Download the document here

  • View publicly made comments (link)

 

Resources

AI reimbursement with Bruce Quinn

  • Watch the informative videos on Youtube (link)

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

      • Cancers Special Issue on Tumor Infiltrating Lymphocytes (TIL) in Solid Tumors: Training Development for the Evaluation of TILs in Breast Cancer

  • 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


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

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12/22/21 Steering Committee Meeting

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10/27/21 Steering Committee Meeting