Department of Health and Human Services Secretary Michael Leavitt announced a new plan Wednesday to improve patient safety and quality of care by sharing Medicare patient data on drug and medical device use in real-time across a number of federal agencies and some private companies.
The plan involves exchanging data between the Food and Drug Administration, Centers for Medicare & Medicaid Services, Veteran's Administration, Department of Defense and other private healthcare organizations.
The FDA initiative to share the data, called the Sentinel System, will give the federal government "an unprecedented ability to detect problems as they first begin to surface," according to FDA Commissioner Andrew C. von Eschenbach, MD.
The newly announced FDA Sentinel System will analyze "significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems," said von Eschenbach.
"With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people," he said. "The era of 'wait and see' is going to become the era of 'tell me right now.'"
The FDA has released a white paper describing the Sentinel Initiative, in conjunction with CMS' final rule to allow the data-sharing.
"The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality healthcare," Leavitt said.
CMS Acting Administrator Kerry Weems said the system will particularly help monitor Medicare patients who are typically on more prescribed medication than the average American and more likely to have adverse reactions.
How do you view the new Sentinel System? Will it help or hinder? Send comments to Senior Editor Diana Manos at diana.manos@medtechpublishing.com.