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FDA Awards a Big Grant to Health Insurance Company For Pilot Program To Monitor Safety of Drugs and Medical Devices

Posted Jan 09 2010 4:43pm

When I first read this it made me think of the phenomenal amounts of data that insurers have.   Don’t be fooled though thinking this is all healthcare oriented, it has to do with money.  Carriers, HMOs all have utilization departments that this information anyway so they can “score” and use algorithmic formulas to predict what they are going to have to spend on you for your care.  It has nothing to do with your healthcare at your present state of body.  Ask any hospitalists about what a “Utilization Department” is and how they are accountable and sometimes are ripped over the coals if they keep patients in the hospital an extra day or so.  They get all the time and have to fully justify your stay.  

Let’s jump into this a little more and ponder the types of devices that will be looked at for safety, and if you haven’t guessed it, devices that report data will be in right in here, and it also gives the health insurer a deeper look into how to potentially “score” your health information while they are at it.  Again, one more reason I believe health insurance companies need to be non profit, as this safety issue is dollar oriented from the insurer side.  It may not be the intent of the FDA, but by allowing this grant, this is what will occur. 

By continuing to have health insurance companies on the stock market the confidence of the consumer is NEVER going to be there, plain and simple.  This is why today you see organizations like Kaiser Permanente gaining traction and confidence with patients, and no they are not perfect, nobody is, but they are making a lot more headway than most.  They do not have shareholders to report to and pay dividends to.

Now the data contributed is useful and if used and evaluated properly by the FDA we could see some progress made here, so again the insurance organization should not be providing the input on recommendations, but rather data only and we need some intelligence at the FDA to evaluate such.  I have written about the Sentinel system several times on this blog and if I remember correctly, Blue Cross was one of the first health insurance companies who stated they would add data.  Again, this is what we need, data for individuals at the FDA to use, not an insurance company making their recommendations based on profitability if we are in fact imagelooking to find and create safety initiatives and programs. 

FDA's Sentinel Initiative Information Revealed – Business Intelligence

Hospitals are involved here too and using information from medical records is valuable, but again not to fall into the hands of the insurer to “score” and define profitability on one’s head and body, so input from hospitals for the sake of privacy must be separate from the insurance input if we are to have privacy issues observed here.  Insurance companies love and thrive on data, all kinds, business intelligence in particular is what they live off of and it helps them create business models that will yield dividends.  The article says it’s a shift from the FDA of being reactive, which in part is true, but again there still needs to be the open line of communication from patients and physicians to add to safety issues and concerns too.  

What amazes me and I wrote about this which is a huge safety item is HRT, and the title specifically asks the FDA and insurance companies to run some numbers, something that has been asked for a long time and we still have no action, so my own personal confidence level right now is pretty low.  We all know the health insurance industry invests heavily in technology and at this point we can’t say the same for the government as most departments have one huge project of playing catch up

FDA Approved Bio Identical HRT Versus Premarin and Cancer – Where’s the Numbers FDA and Pharma?

Also I have talked about Behavioral Health care and Pilgrim, under written by Vintage Financial Services, is right up there in that area of focus as well and safety and behavioral health are somewhat going hand in hand today, biometric monitoring and other related items. 

There was not enough detail given on how the pilot program will in fact function with the Sentinel data system of the FDA to really go much further here and I do in imagefact hope that it is the data that is used by the “experts” at the FDA and not a reliance on a health insurance company’s program to run the program entirely and have the authority to here, as we all will suffer if this occurs and shareholders may receive larger dividends.  Once again I’ll say that health insurance needs to be a non profit business and if the FDA outsources this completely, they have sold us all down the river in the hopes for better healthcare.  BD   

Harvard Pilgrim Health Care Inc. has won a major grant from the Food and Drug Administration to build a system to monitor the safety of drugs and medical devices after they have gone on the market, the federal agency disclosed yesterday.

The Wellesley-based health plan will use a five-year, $72 million grant to coordinate the efforts of 28 health care organizations around the country as they design ways to make use of information they already gather, in electronic medical records or claims data, to provide early warning of potential harm.

Mass. insurer gets FDA grant - The Boston Globe

Related Reading:

FDA May Need Major Restructuring – Catch up with Technology
Study Calling For Medical Device Information To Better Serve Patients And Doctors from the FDA
First US FDA office unveiled in Beijing
Business Intelligence for the FDA on the way
A Broken Agency – China and the FDA
Medicine is a Low Tech Business - Clinical Studies still done on paper too!
Sentinel Initiative Boosts FDA Safety Oversight
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