9/29/21 Steering Committee Meeting
Please find the slides from the meeting here.
This month we had a productive steering committee meeting with 35+ participants.
The topics and all resources and content, along with a video recording of the meeting, are provided below.
We look forward to hearing from you.
Watch the recording of the meeting above.
0:00-3:12 - Opening remarks and introduction
3:14-5:41 - Paige Prostate
5:42-9:27 FDA Launches AI/ML-Enabled Medical Device List
9:28-17:54 Relevant papers
9:35-11:38 Airey et al.
11:40-14:48 Levine et al.
14:50-16:49 Marble et al.
17:55-24:55 Workgroup updates
18:24-21:33 ML/AI
21:40-24:38 Truthing & Validation
24:56-26:55 Information Blocking
26:57- Project Updates
26:59-35:29 TILS RS Project
35:30-38:46 SEER Cancer Microscope
38:47-45:55 Privacy Pilot Project
45:56-48:56 Test Driving VALID2021
48:57-51:08 MDIC Updates
51:10-end Discussion and closing remarks
Meeting Summary
Paige Prostate
the FDA authorized the first artificial intelligence-based software that can help identify prostate cancer
FDA Launches AI/ML-Enabled Medical Device List
View the list here
FDA aims to be as transparent as possible and promote ideas within the community
Relevant papers
Airey et al. The In Vitro Diagnostic Regulation in Europe: Implications for Precision Medicine and Pharmaceutical Development (link)
summary work, opinion piece and implementation plan
outlining some of the specific regulatory changes that are imposed here, including a proposal for a phased implementation
Levine et al. Synthesis of diagnostic quality cancer pathology images by generative adversarial networks (link)
Marble et al. Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like (link)
regulatory paper on LDT
Workgroup Updates
o ML/AI [Steven]
DPA Webinar Series - Validation of AI-based tools in Digital and Computational Pathology on 9/30/21
FDA Virtual Public Workshop - Transparency of AI/ML-enabled Medical Devices on 10/14/21
progress on framing of paper
o Truthing & Validation [Kate & Brandon] (link)
9 September: Dr. Brandon Gallas presented to the PathLake Conference at Pathology Horizons
Title: Regulatory Mechanisms and Tools for Software as a Medical Device
Includes short discussion about algorithm change control plans
Slides: NCI Hub - Group: eeDAP studies ~ Wiki: Presentation 2021: PathLake Conference
10 Sept-1 Oct: Joint TILs Annotation and Discussion Sessions with Pathologists
27 September: Dr. Kate Elfer was aa panelist concluding the 2021 Computational Pathology (COMPAY21) workshop as part of the 24th International Conference on Medical Image and Computer Assisted Intervention (link)
Panelists: Katherine Elfer (FDA); Chen Sagiv (DeePathology.ai); Roberto Salgado (TIL Working Group); Inti Ziobec (University of Bern); Faisal Mahmood (Harvard Medical School); Monika Lamba Saini (CellCarta)
Dr. Victor Garcia and Dr. Brandon Gallas are leading discussions to identify critical instructions for our annotation trainings that will lead to less pathologist variability (generally) and improve our future validation dataset (specifically).
We’d be happy to circulate summaries of the discussions and the feedback we will give to pathologists.
We plan to present the results at Pathology Informatics and in a publication.
Information Blocking
On September 14 from ONC webinar session “What Clinicians and Other Health Care Providers Need to Know”
link to project page
Download the slides from the presentation here.
Project Updates
PIcc TILS RS Project
try to understand the best methods and tools need to have morphological entities such as H&E TILS qualified as biomarkers by regulatory agencies
CLARITY survey to be sent out by October 29
Test Driving VALID2021
Visit the project page here
Join the next meeting on Thursday, October 21, 2021 at 2:00-3:00PM ET
SEER Microscope
Visit the project page here
Join the next meeting on Friday, October 15, 2021 at 9:00-10:00AM ET
MDIC Updates
MDIC’s digital health initiative has added new workstreams. There may be opportunities to engage. Contact digipathalliance@gmail.com to get in touch with Jithesh for more information (link)