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.

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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

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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)

  • RWE slides (link)

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

• Initiative for real world data collection (link)

PIcc Updates

• Download Truthing & Validation group here

  • UPDATE based on questions/discussion during the meeting:

    PIcc has a glossary of introductory overview of specific terms used in the context of regulatory science and digital pathology.

    • https://www.digitalpathologyalliance.org/glossary

    • BEST (Biomarkers, EndpointS, and other Tools) Resource - NCBI Bookshelf (nih.gov)

    • Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions | International Medical Device Regulators Forum (imdrf.org)

    Brandon Gallas (FDA) created a wiki page to help image-based AI/ML developers and industry links pointing to related FDA guidance documents, links to first-of-a-kind devices, and presentations from FDA staff.

    • https://ncihub.org/groups/eedapstudies/wiki/DeviceAdviceAIMLImaging

    Brandon provided an observation that many or most of the studies on AI/ML for digital pathology images report analytical performance and that clinical performance is understudied. Brandon clarified that analytical performance is calculated by comparing the model outputs to a reference standard, often referred to as standalone performance (especially in radiology). Brandon also clarified that clinical performance is calculated by comparing the performance of pathologists with and without the AI/ML model outputs; each interpretation mode is compared to a reference standard. Such a clinical performance study is sometimes referred to as a reader study. You can refer to these (radiology) guidance documents for more information.

    Computer aided detection (CADe) guidance – Radiology

    • Webpage: Non-clinical=Stand-alone=No human in the loop:

    • Webpage: Clinical=Reader Study=Human in the loop:

• TILS survey being finalized

• website domain updating to pathologyinnovationcc.org

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)