Health Care Policy
Outcomes under the No Surprises Act arbitration process: A brief update
Tens of millions of medical devices are used on a daily basis in the U.S., including pacemakers, knee replacements, and glucose test strips. It is critical for providers, patients, manufacturers and others to have access to better information about the performance of these devices. Not only will this information enhance patient safety, but it will also inform the development of new and more effective products. However, in today’s current market there are limited resources and tools available to collect this information. Through a cooperative agreement with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform formed the National Medical Device Postmarket Surveillance System Planning Board; a multi-stakeholder group tasked with building this capability and designing a system to gather this information.
On February 23, the Engelberg Center hosted a discussion that highlighted the planning board’s long-term vision, identified key considerations and implications for stakeholders, and evaluated potential opportunities to support and sustain this initiative. The event included the release of the planning board’s preliminary report.
Click here to download the National Medical Device Planning Board’s February 2015 report.
Creating a Viable National Medical Device Postmarket Surveillance System
Supporting Medical Device Innovation
Congressional Leadership in Innovation and Regulation
Leveraging Current Efforts to Build a Long-Term System
Agenda
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February 23
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Opening Remarks
9:10 am - 9:25 am
JSJeffrey Shuren Director, Center for Devices and Radiological Health - U.S. Food and Drug Administration -
Creating a Viable National Medical Device Postmarket Surveillance System
9:25 am - 11:00 am
KBKathleen Blake Vice President, Performance Improvement - American Medical AssociationJMOJ. Marc Overhage Chief Medical Informatics Officer - Cerner Health ServicesOIOmar Ishrak Chairman and Chief Executive Officer - Medtronic plcBMBill Murray President and Chief Executive Officer - Medical Device Innovation ConsortiumLSLewis Sandy Executive Vice President, Clinical Advancement - UnitedHealth GroupAGAlan Guttmacher Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development - National Institutes of HealthABAlan Balch Chief Executive Officer - Patient Advocate FoundationJGDJodi G. Daniel Director, Office of Policy, Office of the National Coordinator for Health Information Technology - U.S. Department of Health and Human Services -
Supporting Medical Device Innovation
11:00 am - 11:30 am
AVKAaron V. Kaplan Professor of Medicine in Cardiology, Director, Dartmouth Device Development Symposia, and Director of Research, Cardiology Section - Geisel School of Medicine and Dartmouth-Hitchcock Medical CenterRAJRoss A. Jaffe Managing Director - Versant VenturesMMMichael Mussallem Chairman and Chief Executive Officer - Edwards Lifesciences -
Congressional Leadership in Innovation and Regulation
12:30 pm - 1:00 pm
CAClay Alspach Chief Health Counsel - U.S. House of RepresentativesWAWade Ackerman Senior FDA Counsel - U.S. SenateEFEric Flamm Detailee, FDA - U.S. House of RepresentativesGSGrace Stuntz FDA Policy Advisor - U.S. Senate -
Lunch
11:30 am - 12:30 pm
CAClay Alspach Chief Health Counsel - U.S. House of RepresentativesWAWade Ackerman Senior FDA Counsel - U.S. SenateEFEric Flamm Detailee, FDA - U.S. House of RepresentativesGSGrace Stuntz FDA Policy Advisor - U.S. Senate -
Leveraging Current Efforts to Build a Long-Term System
1:00 pm - 2:20 pm
MKMitchell Krucoff Professor of Medicine and Cardiology; Director, Cardiovascular Devices Unit and eECG Core Laboratory - Duke University Medical Center; Duke Clinical Research InstituteRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstituteCBCarmella Bocchino Executive Vice President of Clinical Affairs and Strategic Planning - America's Health Insurance PlansSOSally Okun Vice President for Advocacy, Policy and Patient Safety - PatientsLikeMe
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