1/26/22 Steering Committee Meeting

 

Please find the slides from the meeting here.

 

We had a great first steering committee meeting of the year with about 35 members joining and participating.

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.

0:00-3:46 Introduction

3:47-12:33 CLIA Waiver Project

12:34-14:55 FDA Transition Plan

14:56-24:15 Noteworthy Papers

24:16-30:05 Truthing & Validation Update

30:06-40:18 PANDA challenge discussion

40:19-46:50 Patient Advocacy Update

46:51-47:22 ISPOR

47:29-49:32 ONC Technical Specifications

49:33-52:23 FDA Updates

52:24-53:20 MDIC

53:21-55:14 Upcoming Events

55:15-end Discussion and concluding remarks


Meeting Summary

“CLIA Waiver” for Digital Pathology

  • Learn more on the project page here

  • Need input and/or supplementation from Steering Committee on next steps

    • what do folks think about attaining additional regulatory input from CLIA State Survey Agency Contacts?

      • send out a survey monkey to get a larger sample of responses

      • hear whether they would provide input themselves on how they would provide participate

FDA Transition Plan

  • FDA Website link to comment here

  • Posted in Federal Register as notice, currently provided for commenting

  • 2 elements of transition plan:

    • medical devices with issued EUA towards a more permanent solution

    • and/or medical devices that fall within enforcement policies

  • Marble et al. paper describes changes during pandemic implemented early 2020 are still in effect

Download here

Download here

 
 

Noteworthy Papers

  • Bauer et al. Making a science out of preanalytics: an analytical method to determine optimal tissue fixation in real-time (link)

 
  • Morjaria et al. Strategic thinking in test selection for mass SARS-CoV-2 testing (link)

 
  • Lee et al. Disruptive and sustaining innovation in telemedicine: a strategic roadmap (link)

 
  • Bulten et al. Artificial intelligence for diagnosis and Gleason grading of prostate cancer; the PANDA challenge (link)

  • Discussion:

    • Field is currently lacking studies of algorithm in the hands of pathologists (not algorithm vs truth but the algorithm in the hand of the end user)

    • Augmented AI paper example (link)

    • Language needed to clarify (technical vs clinical validation, read studies, autonomous vs aid, etc.)

      • Link to PIcc glossary. Feedback, comments and additions are welcome


Patient Advocacy Update

  • Sepsis Alliance

    • Sepsis = multi-billion dollar impact on healthcare industry

    • cross collaborative community effort, with introduction by Michelle Tarver, FDA

    • first meeting happened on 1/19/22

    • discussing how to become a collaborative community

  • APPIA

    • focusing on a pre-analytics project: TOPS program administered through partnership with NSH (link)

    • presenting scope and materials of PIcc at their upcoming board meeting

  • Additional meetings pending with other patient advocacy groups

  • If you have a contact, please share





HIT (ONC) Technical specifications

  • Complexity of standards

  • Project US@ (link)

FDA Updates

  • Clinical Investigator Training Course Update (link)

  • 2022 Summer OSEL Regulatory Research Experience (SORRE) (link)

  • Initiative for real world data collection (link)

PIcc Updates

MDIC Updates

  • Job positions available (link)

  • Emerging Healthtech Series (link)

  • MDICx: AI/ML Framework Public Comment Q&A (link)

Upcoming Events

  • 2/22/22 10AM-1PM ET PMLS Virtual Series 2022 – Precision Pathology (link)

  • 2/22/22 12-1PM ET FOCR Virtual Meeting: Supporting Development of Diagnostic Tests for Unmet Needs (link)

Discussion

  • Keith W: History of Telepathology to 2000 (link)

  • Joe. S: NIST Seeks Comments on Concept Paper for AI Risk Management Framework (link)

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2/23/22 Steering Committee Meeting

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12/22/21 Steering Committee Meeting