Harvard Pilgrim as the article states began the FDA mini Sentinel program and the FDA is now in the process of creating a full Sentinel program to monitor drugs and devices.  This was the original plan 5 years ago when the FDA Sentinel program was announced.

Since such time we have seen other types of programs set up to monitor and research medical record information that show a profit such as at the link below.

Optum Labs Add Four Additional Data Miners To the Collaboration Looking for Data…

From the Website:

The Sentinel Initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the safety of FDA-regulated medical products.

The Initiative is the FDA’s response to the Food and Drug Administration Amendments Act (FDAAA) requirement that the FDA work with public, academic, and private entities to develop a system to obtain information from existing electronic health care data from multiple sources to assess the safety of approved medical products.

You can visit the link here to see who the collaborators are with supplying data and collaborating as a data partner.

So far there are records on 160 million patients and that’ growing pretty fast.  Some patients can be tracked for over 10 years and this is related to drugs and medical devices patients may have and it’s focus is safety and it helps with additional information needed not only in this area but provides additional background data for drugs and devices looking for approval.

This is government data mining operation where you can be assured your records are not sold for money.  BD


BOSTON -- The Harvard Pilgrim Health Care Institute has received a contract for up to $150 million from the federal government to lead a program that uses electronic health-care data to monitor the safety of regulated drugs and medical products.

Harvard Pilgrim Health Care announced the contract award from the U.S. Food and Drug Administration on Wednesday, saying the institute will partner with more than 50 health-care and academic organizations across the United States on the Sentinel System project.

The institute oversaw the development of Mini-Sentinel, a five-year, $120 million pilot project that FDA officials plan to transition into a "full-fledged program," as FDA official Janet Woodcock said in a statement released by the Boston-based health insurer.

http://www.lowellsun.com/latestnews/ci_26642756/harvard-pilgrim-wins-150m-fda-pact

0 comments :

Post a Comment

 
Top