Session ID: 
14

FDA Digital Health Software Pre-Certification Program

10:30am - 11:30am Tuesday, February 12
Orlando - Orange County Convention Center
W314B

Description

With all the work underway on the Food and Drug Administration’s (FDA’s) Digital Health Software Precertification (Pre-Cert) Program and the broader agency agenda on digital health regulation, this session will focus on learning more about this program and directionally where FDA is headed.  Industry leaders will provide their perspective on the program and describe the goals and objectives behind Pre-Cert, followed by a discussion on the impact of the program on health IT regulations and broader healthcare initiatives.

Learning Objectives: 

  • Develop greater knowledge of the Digital Health Software Precertification Program and its applicability to the broader healthcare ecosystem
  • Identify the opportunities and challenges inherent in the pilot program and discuss how FDA may look to expand opportunities for participation
  • Describe areas where greater stakeholder input could be helpful in shaping the future direction of the program

Speaker(s): 

Chief Medical Officer,
Samsung Electronics America
FDA and Health Care Lawyer,
Akin Gump LLP
Senior Director, Wireless Health,
Qualcomm Incorporated
VP for Technology & Regulatory Affairs,
Advanced Medical Technology Association
Continuing Education Credits: 
ACPE
1.00
CAHIMS
1.00
CME
1.00
CNE
1.00
CPHIMS
1.00