A couple weeks ago I had a couple posts referencing the partner ship with Anthem Blue Cross with utilizing their data bases for such a project as well...The new FDA white paper, titled "The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety," ... totally amazing now that the FDA is coming of age with technology when not but a few months ago some of the top researchers in the agency didn't even own a computer! Welcome to the 20th century....a little bit of technology will go a long way with accessing and analyzing the information needed...this is the big grand daddy data base with more information than all the insurers put together.
Next plan of action, get some security vendors lined up since there will be a enormous amount of exposure of what has been locked up as Pandora's box for years....and that should be an under statement. This does not eliminate clinical trials by any means though, but should serve to compliment data already being gathered...and what is the next roller coaster... personalized medicine... that will present another new frontier in the data analytical game... HL7 for genomics...will be a whole new data base to add in to the process soon as testing will continue to grow...BD
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.
Medicare drug claims will be linked to other Medicare information on patient care, such as hospitalizations and physician visits, and made available to other federal agencies, state Medicaid programs, researchers, and beneficiaries for their personal health records.
"With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation."
"This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market," Secretary Leavitt said. "We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services."
In a white paper released by the FDA today, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.