10:15

Regulatory Challenges for In Vitro Diagnostics

Joseph Hackett, Special Projects Officer, Office of In Vitro Diagnostics, FDA

10:55

Challenges in Assessing the Safety and Efficacy of Cancer Detection Devices

David Feigal, Director, Center for Devices and Radiological Health, FDA

11:35

DISCUSSION

12:30

LUNCH

1:15

CMS Perspective on Adoption of New Breast Cancer Detection Technologies

Sean Tunis, Acting Chief Medical Officer, CMS

1:55

Private Health Payers’ Perspective on Adoption of New Breast Cancer Detection Technologies

Alan Rosenberg, Vice President of Medical and Credentialing Policy, WellPoint Health Networks

2:35

DISCUSSION

2:50

BREAK

3:10

Better Information and Decision Tools: The Needs of the Consumer

Mary Ropka, University of Virginia Medical School

3:50

Decision Support in Breast Cancer Detection Options: Health Systems Perspective

Nananda Col, Brigham & Women’s Hospital

4:30

DISCUSSION

4:45

ADJOURN



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