2/24/21 Steering Committee Meeting
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
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)