Navigation Links
FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
Date:1/8/2010

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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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

http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

RELATED LINKS
http://www.fda.gov/

'/>"/>

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:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... India , December 7, 2016 According to ... (Services, Software), Delivery Mode, Product Type (Integrated, Standalone), Model (Knowledge-Based), Type (Therapeutic, ... MarketsandMarkets, The CDSS Market is expected to reach USD 1,519.2 Million by ... Continue Reading ... ...
(Date:12/7/2016)... , Dec. 7,2016  Based on ... delivery industry, Frost & Sullivan recognizes Nemaura ... & Sullivan Award for Enabling Technology Leadership. ... the loopholes in traditional drug delivery technologies, ... liquid microneedle-based drug delivery technologies, Memspatch and ...
(Date:12/7/2016)... Inc. (NASDAQ: IONS ), the leader in antisense therapeutics, ... BMO Capital Markets Prescriptions for Success Healthcare Conference on Wednesday, December ... A live webcast of the presentation will be available on the ... be available within 48 hours and will be archived for a ... , , ...
Breaking Medicine Technology:
(Date:12/7/2016)... Ill. (PRWEB) , ... December 07, 2016 , ... Levels ... early-stage brain damage, according to a study appearing online in the journal Radiology. , ... is expected to increase significantly due to the rapidly aging population. Damage to both ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... is now promoting to the US market its advanced highly customizable contact technology ... and ODU TURNTAC®. These advanced technologies are ideal for a wide range of ...
(Date:12/7/2016)... TX (PRWEB) , ... December 07, 2016 , ... ... offering insurance and financial planning services to families and business owners in the ... funds on behalf of the Dallas Fallen Officer Foundation. , Established in 2009 ...
(Date:12/7/2016)... ... , ... A. Kevin Spann Insurance, a New York-based firm offering insurance and ... a charity drive to raise funds that will benefit the Marine Corps League. , ... Navy FMF Corpsmen. Working closely with the MCL, the A. Kevin Spann team plans ...
(Date:12/7/2016)... , ... December 07, 2016 , ... ... to announce that its fully redesigned website, which launched October 17, 2016, features ... sleek responsive design and easy-to-navigate layout. Visitors and patients can discover the latest ...
Breaking Medicine News(10 mins):