Navigation Links
FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System

SILVER SPRING, Md., Jan. 8 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA's Sentinel System, which will use automated health care data to evaluate medical product safety.


Reports filed by hospitals, health care professionals, and industry account for much of the information that the FDA relies on regarding medical product safety. For a variety of reasons, these reports may be incomplete or not filed in a timely manner.

The Sentinel System, once operational, will bolster the FDA's efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyze information collected during the course of routine health care, such as data from electronic health record systems, administrative and insurance claims databases and medical registries.

The one-year contract with Harvard Pilgrim, based in Wellesley, Mass., includes four renewable years for a total of $72 million. Under the terms of the contract, Harvard Pilgrim will establish a coordinating center that will operate as a scaled down version of the Sentinel System. This center, or "mini-Sentinel," will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality. To protect personal information, only summary results will be sent to the coordinating center. The data itself will remain within its database.

"The award of this contract to Harvard Pilgrim to develop a medical product safety monitoring system is an important step forward for FDA's drug and medical device safety efforts," said FDA Commissioner Margaret A. Hamburg, M.D.

The Sentinel System fulfills some requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which include provisions calling for the development of such a system.

The Harvard Pilgrim contract is one of the many activities contributing to building the Sentinel System. The FDA already has awarded 10 small contracts addressing scientific operations, data and infrastructure, privacy, and stakeholder engagement. In addition, the FDA has awarded a cooperative agreement with the Brookings Institution to convene meetings and workshops on active medical product surveillance issues. The workshop on the Sentinel Initiative is scheduled for Jan. 11, 2010, in Washington, D.C.

"The FDA has been doing the groundwork for a nationwide Sentinel System," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information."

In addition to public meetings, the FDA has opened a docket for public comment, and developed a listserv for those who want to stay apprised of Sentinel developments.

The FDA's Web Page on the Sentinel Initiative

Media Inquiries: Karen Riley, 301-796-4674,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration



SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CVS Caremarks MinuteClinic Becomes First Retail Clinic Provider to Achieve Consecutive Accreditation Awards From The Joint Commission
2. Greenway Medical Technologies PrimeSuite Wins Three Best in KLAS Awards
3. The Army Awards Follow-On Contract for Autonomous Airway Management to Energid Technologies
4. National Ergonomics Expo Sees Immediate 93% Exhibit Space Renewal for 2010; Equipois, Herman Miller, Neutral Posture, REDpoint International Win 2009 Attendees Choice New Product Awards
5. Pioneer(R) Surgical Technology, Inc. Receives Prestigious Spine Technology Awards
6. Amgen Recognized for Best Pipeline and Best New Drug at Scrip Awards
7. eCardio Named One of Houstons Fastest Growing Technology Companies at the 2009 Houston Business Journal FastTech 50 Awards Luncheon
8. U.S. Department of Defense Awards $1.2 Million to Study the Use of Vigabatrin to Reduce the Addictive Liability of Opiates While Still Effectively Managing Pain
9. National Institutes of Health Awards More Than $54 Million to Kaiser Permanente to Conduct Health Research
10. CVS/pharmacys Transportation Operations Receives Two National Safety Awards
11. Blue Shield of California Awards $29.6 Million in Pay-for-Performance Programs in 2009
Post Your Comments:
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, Inc. ... Day Software and Consulting, LLC , and named its ... Software, based in Tennessee , will ... Day expands EnvoyHealth,s service offerings for health care partners ... "In an interoperable world, ...
(Date:10/2/2017)... 2, 2017 Halo Labs announces the European launch of ... the HORIZON at MIBio 2017 in Cambridge, U.K ... particulate matter in biopharmaceutical samples with unprecedented speed and sensitivity while ... technique Backgrounded Membrane Imaging. ... HORIZON subvisible particle analysis system ...
(Date:9/28/2017)... , Sept. 28, 2017 Cohen Veterans Bioscience ... the use of wearable and home sensors for real-time ... Early Signal Foundation, a nonprofit organization focused on disruptive ... provide an affordable analytical system to record and integrate ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... a national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel ... also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in agile ... a contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise ... use of Agile methodologies in a consistent and high value manner across CMS ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
(Date:10/12/2017)... Bethesda, MD (PRWEB) , ... October 12, 2017 , ... ... Award of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s ... 4 – 8. , In honor of Morris F. Collen, a pioneer in the ...
Breaking Medicine News(10 mins):