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
