Director, Center for Devices and Radiological Health
Jeffrey Shuren is the Director for the Center for Devices
and Radiological Health. He oversees the Center’s operations and strategic
direction. Dr. Shuren, along with several other FDA officials, ordered the
initial computer monitoring and was a later proponent of its expansion.
Associate Director for Management and Executive Officer,
Center for Devices and Radiological Health
Ruth McKee is the Associate Director for Management and
Executive Officer for the Center for Devices and Radiological Health. McKee
reports directly to Dr. Shuren, who tasked her to lead the charge to determine
what steps the FDA needed to take after it learned of the potential leak. McKee
also ordered the monitoring and determined the initial monitoring search terms
given to the Office of Information Management.
Deputy Director for Radiological Health for In Vitro
Diagnostics, Center for Devices and Radiological Health
Mary Pastel is the Deputy Director for Radiological Health
for In Vitro Diagnostics with the Center for Devices and Radiological Health.
Ruth McKee instructed Pastel to review encrypted flash drives containing
surveillance of information on scientists’ computers.
Chief Information Officer
Lori Davis was the Chief Information Officer for the FDA.
Prior to being named the Chief Information Officer in January 2009, she served
as the Deputy Chief Information Officer. She worked with Ruth McKee to set up
computer monitoring of Dr. Robert Smith, and was asked to search through
e-mails of FDA employees to determine the source of the information leak.
Chief Information Security Officer
Joe Albaugh was the Chief Information Security Officer for
the FDA until March 2011. Lori Davis approached Albaugh to set up the computer
monitoring for Dr. Robert Smith.
Medical Officer, Center for Devices and Radiological Health
Robert Smith was a Medical Officer for the Center for
Devices and Radiological Health. He was the first employee at the FDA to
experience computer monitoring. Based on information gathered from Dr. Smith’s
computer, officials at the FDA later expanded this monitoring to include
additional FDA scientists. His contract was not renewed after his contacts with
Congress, the Office of Special Counsel, and his personal attorney were
captured through the FDA’s monitoring program.
Ombudsman, Center for Devices and Radiological Health
Les Weinstein was the Ombudsman in the Office of the Center
Director for the Center for Devices and Radiological Health. Weinstein asked
the U.S. Department of Health and Human Services Office of Inspector General to
investigate the disclosure of confidential information to the press.
Chickasaw Nation Industries Information Technology, LLC
Contract Forensic Engineer, Incident Response Team
Christopher Newsom is a Forensic Engineer with Chickasaw Nation
Industries Information Technology. Newsom conducted the computer monitoring of
FDA employees. After the FDA first set up this monitoring for Dr. Robert Smith,
Newsom prepared an interim report to summarize the status of the monitoring.
Contract Investigator, Incident Response Team
Joseph Hoofnagle is a Contract Investigator with Chickasaw
Nation Industries Information Technology. Hoofnagle installed Spector 360
software on the monitored employees’ computers. He worked with Newsom to conduct
computer monitoring of FDA employees, and assisted Newsom in writing an interim
report to summarize the status of the monitoring.
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Lana C. Keeton, Legal Consultant, Medical Device Expert, Expert Witness, Patient Advocate - When I kneel unto God, I can stand before anyone! - *Please note: Nothing on this blog is to be construed as legal and/or medical advice. Postings are personal opinion of the authors.