If you have not seen this, here's brief description of what the FDA is doing. The FDA is a "consumer" agency and we really do have a good commissioner with Dr. Margaret Hamburg. Her background is clinical and not political so we get the real deal with her and the compassion for humanism in healthcare.
Her commencement address at Einstein a short while back is one of my favorites.
I put a short summary of my long post on this which is here if you want to see more.
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’s 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.
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.