2/24/21 Steering Committee Meeting

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Meeting Summary

3:00-3:00 - WELCOME

3:05-3:35 - FEDERAL NOTICE

Joe Lennerz: Propose letter to FDA requesting statement about federal notice

  • Through our liaison, we can draft a letter asking for the FDA’s position on the federal notice

  • A comment from a relevant domain-expert within the agency about the origin and position of the FDA in relation to the Federal Notice and the relevance for regulatory science

  • Consensus: no strong opinions against this action, it presents an opportunity to establish a line of communication with the FDA and demonstrate how they might respond to future questions

Additional Fed Notice updates:

  • Esther Abels: update DPA 

    • DPA plans to support more open systems (interoperability)

    • Plan to have update in about two weeks

  • Joe Sirintrapun: update API Council 

    • Advocating for more openness than regulation: “Empower pathologists to better leverage digital and computational pathology for the benefit of our patients and professional colleagues” 

    • Plan to release comment in about two weeks

5’ additional discussion/ideas/brainstorming:

  • Professor Grace Kim (UCSF): Are institutions commenting?

    • So far, no institutional comment solicited 

  • Biden administration executive order: Regulatory freeze pending review link

    • “For rules postponed in this manner, during the 60-day period, where appropriate and consistent with applicable law, consider opening a 30-day comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by those rules, and consider pending petitions for reconsideration involving such rules.”

  • Link to PIcc statement

    • PIcc has not and will not comment on legislation and encourage a continued open dialogue. 

3:35-3:40 - WEBSITE UPDATES

Ula: Website pages: Truthing Data Sets (link), Trainees page (link); Publication updates

  • We ask all workgroup leads to send materials, papers, project proposals

  • Link to updates including relevant publications

    • Introduction to Artificial Intelligence and Machine Learning for Pathology (link)

    • The Ethics of Artificial Intelligence in Pathology and Laboratory Medicine – Principles and Practice (link)

3:40-3:50 - WORKGROUP UPDATES – REVIEW SLIDE DECK BELOW OR DOWNLOAD HERE 

Click to view slide deck with workgroup updates.

  • Truthing – Brandon & Kate

  • Pre-Analytics – Amanda & Matt

  • Trainees – Julia, Sarah & Kingsley (link to webpage)

  • Payor – Esther

  • ML Continuous Learning – Esther

PROJECT UPDATES

Standards – Esther + Kingsley (link here)

3:50-3:55 - PICC/ALLIANCE MARCH MEETING 

Joe Lennerz: Idea was originally to have speaker, however many people felt having an active workgroup session instead of a seminar to be more engaging. 

3/14 Meeting “What else are you going to do (on Pi day) during a pandemic?!” Agenda:

  • 15’ Meet & Greet

  • 60’ Workgroup Breakout Sessions – interactive breakout rooms that allow hopping from room to room 

    • Review website content

    • Review deliverables and relevance

    • Coming together in a bigger group to provide updates

  • 15’ Transition time

  • 45’ Workgroup summaries (5’ each)

  • 15’ Discussion

3:55-4:00 MDIC UPDATES

Brief overview of announcements and opportunities (link for more information here)

  • COVID-19 Patient discussion tool 

  • Playbook: Culture of Quality

  • AI/ML Workgroup

  • And events, see below

UPCOMING EVENTS OF INTEREST: VIEW ON CALENDAR HERE

  • February 25, 2021 - Tissue Microarray: Novel applications Virtual Workshop (link)

  • March 4 – MDICx: Fingerstick Blueprint - Public Comment Period- Q&A (link)

  • March 10-11 – MDMA’s FDA Forum (MDIC) (link)

  • March 12, 2021 - MIDRC Town Hall (link)

  • March 14, 2021 - PIcc/Alliance meeting 

  • March 24, 2021 - Next steering committee meeting

  • March 29, 2021 - Becker’s Healthcare Physician’s Leadership Virtual Forum (link)

  • April 12 – Design of Medical Devices Conference (MDIC) (link)

  • May 11-13 – 2021 FDA/AdvaMed Statistics Conference (MDIC) (link)

  • June 1-2 – MDIC Annual Public Forum (link)

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3/14 PIcc Alliance “Pi” Annual Members Meeting

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Federal Notice Comment Drafting Session