This is a great idea as it has been a cumbersome process in reporting such to the FDA.  The application can be downloaded to an Android or IPhone unit and is called MedWatcher.  It was developed at Boston Children’images Hospital and Harvard Medical with coordinating efforts with the FDA, all working together.  Epidemico, a company that was spun out from Boston Children’s Hospital run the system.  The information submitted is de-identified and sent to the appropriate government agency.  This is the first privacy notice that is really understandable too, straight out unlike the ones we read that kind of tell you they don’t sell your data but they do. The software does not take responsibility for errors as this is a community effort and they have the right to remove an item as such.

“We will credit your contribution by publishing it with your name or an acceptable pseudonym of your choosing, or you may remain anonymous. We collect personal information such as, but not limited to, your email address and Internet Protocol (IP) address. We reserve the right to use this information internally, including for correspondence with the contributor, but will not sell, share, rent, or otherwise reveal this information to any third party except as required by law, or to address issues of noncompliance.”

It appears that this data will more than likely contribute to the FDA Sentinel program which began a few years ago to where information is gathered again to help the FDA inform and investigate potential harmful issues and you can easily access the data base to look up information on file too, a winner.


“Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. But, currently, the Agency’s efforts are limited to its largely passive safety monitoring systems, which depend on healthcare professionals, patients, consumers and pharmaceutical companies to report any adverse effects of FDA-regulated products. The Sentinel System enables the FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.

In addition the FDA is wanting to involve the consumer with helping educate  with medical devices and it is called the FDA Patient Network.  You can read Dr. Hamburg’s announcement here and view the video introduction below on how it works.  Nice work from the FDA!  You can also keep updated here with clinical trial information and recalls. 

And now a word about FDA/NIH funding…above I mentioned their privacy statement and if you read the news of late there’s been all types of articles about keeping them funded.  Here’s a link that would solve that problem with licensing and taxing data sellers (so we know who they are and what they sell and the money would go to both agencies so keep them from serious funding cuts.

Corporate US profits from selling and mining data are in the billions with profits, ie. Walgreens making short of $800 million in 2010 alone, and of course being in healthcare they would benefit from the FDA’s work so a tax I would think they and all other banks and companies should not resist and consumers would win with a federal site listing all data seller licenses and what kind of data they sell and to who.  It’s an epidemic that needs to be regulated anyway as it is truly impacting inequality in the US as some data gets used out of context and the more that is sold without some form of regulation right now is leading to more flaws and more exposure to security breaches as data is stored on multiple locations and we don’t know if all of those are secure or not, they should be but the news tells us otherwise sometimes.  Here’s a general explanation of my campaign on this topic. 

One More Good Reason to Tax the Data Sellers– Create Additional Funding for the NIH and FDA From Sources That Otherwise Are Too Greedy to Share & Contribute

You may have seen the United Labs and other United Healthcare subsidiary news articles and it’s complex to read the entire structure but pretty much the exact same type of data is being collected and it looks to be data and analytics for sale that just flat out competes with what the FDA is doing here with device and drug information, so license them too and apply the excise tax to what they are doing for profit.  BD 

More Data For Sale Soon With Shared Clarity With United Healthcare Labs and Dignity Health–Crunching Numbers on Medical Devices With Shared Clarity

The Food and Drug Administration is creating a largely automated surveillance system to monitor safety of high-risk medical devices and has authorized a smartphone app for doctors to simplify reporting deaths and injuries to the agency.

The federal agency's efforts are designed to spot early on possibly dangerous flaws in high-risk medical devices like defibrillators, pacemakers, heart valves and joint implants. In recent years, when some of these medical devices have malfunctioned, it has taken months or even years before authorities were certain whether those flaws were a major public-health hazard—or simply a smattering of isolated bad events.

The early-warning system will rely on electronic medical information including patients' medical records and bills, insurance databases and companies' registries of experience with individual devices.

When a device malfunctions, or needs to be surgically replaced far more often than other devices, the FDA will be able to track these events. In time, when hospitals include UDI information in their own records, injuries or deaths related to devices will get automatically reported to the FDA, he said.


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