12/22/21 Steering Committee Meeting

Please find the slides from the meeting here.

We had a great final steering committee meeting of the year.

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.

0:00-3:20 Introduction

3:21-10:24 National Tokenization Mechanism

10:25-19:24 CLIA Waiver Project

19:25-20:49 LDT vs. IVDR

20:50-24:23 TILs Project

24:23-35:04 Noteworthy Papers

35:05-51:00 Quarterly presentations + annual meeting discussion

51:01-end Closing remarks

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Meeting Summary

National Tokenization Mechanism

• Convergence of two prior projects, Privacy Pilot Project and Information Blocking

• Panel proposal submitted to ISPOR

• Learn more here

“CLIA Waiver” for Digital Pathology

• State survey agency contact

• Draft letter to CMS in progress

Follow-up: LDT vs. IVDR project

• More information following proposal

• Reach out to digipathalliance@gmail.com if there are topics you are interested in discussing

TILs Project

• Biomarker Terminology: Speaking the Same Language from FDA Biomarker Qualification Program (link)

• Survey for professionals and a survey for patient advocates to gain perspective on what is needed for putting forth a biomarker that is morphology based

Noteworthy Papers

• Bélisle-Pipon et al., What Makes Artificial Intelligence Exceptional in Health Technology Assessment (link)

• Sheinson et al., Trends in Use of Next-Generation Sequencing in Patients With Solid Tumors by Race and Ethnicity After Implementation of the Medicare National Coverage Determination (link)

• Sammut et al., Multi-omic machine learning predictor of breast cancer therapy response (link)

• Elemento et al., Artificial intelligence in cancer research, diagnosis and therapy (link)

• Kim et al., Hidden in Plain Sight: Clinical Informaticians are the Oncology Subspecialists You Did Not Know You Needed (link)

Quarterly Presentations

• Publication on payor strategies

• MDDT submission

• Campaign to recruit at least 2 more patient advocacy group

• Annual PIcc meeting (in-person)?

Annual Meeting

• USCAP in March (Los Angeles) = socializing event

• API in May 9th-12th 2022 (Pittsburgh) => possibility

• Proposal for a session on regulatory science (January 31st ?)

• Data gathering “Sunday before”? (FDA)

• FDA proposal for HTT project already submitted

• CAP2022 in October (New Orleans)

• Resident forum => “get the word out” to trainees

• Data gathering ?

• ASCP meeting

• Data gathering session