Health Policy Town Hall Session
Wednesday, May 4 | Room 132 | 1:00–4:00 p.m.

The Heart Rhythm 2011 Health Policy Town Hall is divided into two distinct sessions. In the first session, the U.S. Food and Drug Administration (FDA) will discuss its perspectives on several topics related to EPs such as AF Ablation and pre-market approval process. The second session will feature leading physicians engaging in a lively discussion regarding the value of registries as a quality improvement tool.

Session Chair:

Richard I. Fogel, MD, FHRS CCDS, Heart Rhythm Society Health Policy Chair
The Care Group LLC, Indianapolis, IN

Session One: Regulation of Devices throughout the Total Product Life Cycle
This Town Hall session focuses on the FDA's perspectives on several salient topics, including pre-market approval, AF ablation; and the MRI and implantable pulse generators.

• FDA Update 2011
  Mitchell J. Shein, MS, CCDS, FDA, Silver Spring, MD
• EMC Issues including Radio Frequency Identification
  Soma S. Kalb, Ph.D., FDA, Silver Spring, MD
• Expanding and Limiting Indications for CRT
  Kimberly A. Selzman, MD, FHRS, FDA, Silver Spring, MD
• Diagnostics in Implantable Devices, Data Requirements, Tool Claims
  Brian M. Lewis, MD, FDA, Silver Spring, MD

Q&A Session

Session Two: Why Collect Longitudinal Data?
The second Town Hall session addresses the value of registries as a quality improvement tool. Experts will address registry use in Europe and discuss the benefits and obstacles to registries in the United States.

• Quality Improvement, Payment: Pay for Performance, Public Accountability, Research
  Kathleen Blake, MD, New Mexico Heart Institute, Albuquerque, NM
• Advantages of Registries
  Stephen C. Hammill, MD, FHRS, Mayo Clinic, Rochester, MN 
• Disadvantages of Registries
  Eric N. Prystowsky, MD, FHRS, The Care Group, LLC, Indianapolis, IN
• The Danish Pacemaker and ICD Registry
  Jens B. Johansen, MD, Ph.D., Aarhus University Hospital, Cardiology, Aarhus, Denmark

Q&A Session