Research Ethics and Policy Series: Rita F. Redberg, MD, MS

The Division of Medical Ethics and Penn Health-Tech present:

Ethics and Medical Device Regulation: Balancing Safety and Innovation

Rita F. Redberg, MD, MSc
General Cardiologist and Professor of Medicine,
University of California San Francisco

In-person! Livestreaming also available.
Boxed lunches will be provided for in-person attendees.

Abstract: The standard for approving medical devices for clinical use is generally lower than the standard for drug approvals, and often does not require clinical data. There are an increasing number of programs to fast-track or accelerate devices reaching market, in the name of “innovation”. However, these expedited approvals mean there is more uncertainty about safety and effectiveness of devices for clinical use at time of approval. It also means there is more reliance on post marketing data. It is unclear how much patients (or doctors) are aware of these considerations, during the consent process or anytime in clinical care. This talk will summarize the present landscape and suggest some improvements to assure patient safety.

Rita F. Redberg, MD, MSc, is a cardiologist and Professor of Medicine at the University of California, San Francisco since 1990 and Core Faculty, Philip R Lee Institute for Health Policy Studies. After growing up in Brooklyn, she graduated from Cornell University and the University of Pennsylvania Medical School. She got a Master’s degree at the London School of Economics. Dr. Redberg is the Chief Editor of JAMA Internal Medicine since 2009 and has spearheaded the journal’s new focus on health care reform and “less is more”. Her research interests are in the area of health policy and technology assessment, and how to promote high value care, focusing on high risk medical devices as well as the need for inclusion of women in clinical trials of such devices.

Dr. Redberg served on the Medicare Payment Advisory Commission, which advises Congress on Medicare payment issues. She also served and chaired the Medicare Evidence, Development and Coverage Advisory Committee.

She has given Congressional testimony multiple times in hearings related to the issue of balancing safety and innovation in medical device approvals. Dr. Redberg worked in the office of Senator Hatch and with the Senate Judiciary Committee on FDA-related matters during her tenure as a Robert Wood Johnson Health Policy Fellow, 2003-2006. Dr. Redberg is a member of the National Academy of Medicine.

For more information, contact Mary Pham, Mary.Pham@pennmedicine.upenn.edu.