6/29/22 Steering Committee Meeting

Please find the slides from the meeting here.

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.

0:00-3:22 Intro

3:23-9:27 FDA Guidance

9:28-13:00 European Artificial Intelligence Act

13:01-16:14 HHS withdrawing the SUNSET final rule

16:15-25:31 AMA CPT Coding

25:32-27:08 CURE ID

27:09-29:04 Books of Interest

29:05-42:03 Featured work

42:04-52:25 Featured papers

52:26-53:05 What’s coming next month

53:05-end Discussion & closing

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Meeting Summary

FDA Guidance:

• ctDNA OOTD Guidance Review Session on July 21 at 11AM ET (link)

  • FOCR ctMoniTR project event July 20 at 11:30AM ET (link)

• Cybersecurity in Medical Devices (link)

  • Bill - Healthcare Cybersecurity Act of 2022 (link)

  • Article - FDA Document Details Cyber Expectations for Device Makers (link)

  • Bill - Strengthening Cybersecurity for Medical Devices Act (link)

  • Article - Bill Calls for Frequent FDA Device Cyber Guidance Updates (link)

• Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions  (link)

  • FDA Issues Final Guidance For Radiological Devices Using Quantitative Imaging

  • This document is an update to FDA 2019 guidance

European Artificial Intelligence Act (AIA)

• April 2021

• First law on AI by major regulator

HHS withdrawing the SUNSET final rule

• Article - HHS finishes off Trump-era rule that would've erased basic FDA regs without frequent reviews (link)

• Economic Impact Analyses of FDA Regulations (link)

AMA CPT Announces New Digital Pathology Codes

Books of interest

Uta Schmidt-Strasßburger

Improving Oncology Worldwide

Kroese et al.

Data Science and Machine Learning Mathematical and Statistical Methods

Ronald Christensen

Analysis of Variance, Design, and Regression: Applied Statistical Methods

• Continuing Medical Education Program "Master Online Advanced Oncology" (part-time) (link)

Featured work:

• Brian Ford – History of AI (link)

• QUAREP-LiMi (link)

• Margaretta Colangelo (link)

• PathML (link)

• MedTech Color Collaborative Community Annual Report

• American Board of Pathology Annual Report

• The Commonwealth Fund Meeting America’s Public Health Challenge

• Other project updates pushed to July

Featured papers:

• Diamantopoulou et al. The metastatic spread of breast cancer accelerates during sleep (download)

  • Ball & Nagrath. Cancer cells spread aggressively during sleep (download)

• Drews et al. A pan-cancer compendium of chromosomal instability (download)

• Gounder et al. Clinical genomic profiling in the management of patients with soft tissue and bone sarcoma (download)

• Jorgenson. Missing Companion Diagnostic for US Food and Drug Administration–Approved (download)

• Lips et al. Genomic analysis defines clonal relationships of ductal carcinoma in situ and recurrent invasive breast cancer (download)

• Maier-Hein et al. BIAS: Transparent reporting of biomedical image analysis challenges (download)

• Mund et al. Unbiased spatial proteomics with single-cell resolution in tissues (download)

• Nacev et al. Clinical sequencing of soft tissue and bone sarcomas delineates diverse genomic landscapes and potential therapeutic targets (link)

• Park et al. Artificial Intelligence–Powered Spatial Analysis of Tumor-Infiltrating Lymphocytes as Complementary Biomarker for Immune Checkpoint Inhibition in Non–Small-Cell Lung Cancer (download)

• Reinke et al. Common Limitations of Image Processing Metrics: A Picture Story (link)

• Sherman et al. Genome-wide mapping of somatic mutation rates uncovers drivers of cancer (download)

General Updates:

• Next month’s steering committee on July 27, 2022 at 3:00-4:00 PM Eastern Time. Things to expect by then:

  1)Update MDUFA/VALID act

  2)Updates from projects and workgroups

  3)Please send links/papers/other