Regulatory Landscape Survey


A project to capture key issues that can be addressed using regulatory science


Background

Regulatory complexity around digital pathology and AI has been a long-term topic of the PIcc Alliance. Here, a subgroup from the PIcc steering committee designed a regulatory landscape survey.


Survey

The survey takes ~5 minutes and contains 10 questions.

This survey aims to capture broad insights from stakeholders across academia, industry, healthcare providers, patients, and advocacy groups to identify and prioritize key regulatory hurdles in these emerging fields. 

When providing input, please consider that we are looking for statements and questions that can be addressed using regulatory science. 

For example, we are not looking for generic statements about the field (“AI should be implemented faster”). The survey aims to collect elements that can be addressed using regulatory science methods (“There is a lack of standardized protocols and guidelines for integrating AI decision support tools in digital pathology”). Collecting your input will help shape collaborative efforts to address these challenges through regulatory science methods, ultimately advancing the safety, effectiveness, and timely delivery of innovative pathology solutions to patients.

Participation is voluntary, open to all stakeholders, and the results of this survey will be published on this PIcc project page.

Please feel free to share the survey with your colleagues.


Timeline

February 2024 – Conceptualization and initial design

March 8-12th 2024 – Feedback and revisions

March 12th-18th 2024 – Revision of the survey

March 21st 2024 – Survey go-live via an ‘all member email’ to PIcc

March 23rd 2024 – Shared at ADASP annual meeting – Dr. Joe Lennerz

March 25th 2024 – Shared at USCAP (DPA session) – Dr. Brandon Gallas

March 27th 2024 – Announcement at the PIcc’s March Steering committee meeting


Regulatory Landscape Survey Team

Joe Sirintrapun, MD, MassGeneralBrigham

Helen Hou, MGH Pathology

Amanda Lowe, Visiopharm

Laura Lasiter, AstraZeneca

Brittany McKelvey, Friends of Cancer Research

Noor Falah, MDIC

Kevin Schap, College of American Pathologists

Erin O’Reilly, BostonGene

Joe Lennerz, MD PhD, BostonGene

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