I knew this would happen. I warned that this would happen. Just didn’t think it would happen this fast. The Food and Drug Administration has now begun cracking down on medical applications that offer “medical diagnosis”.
Biosense Technologies’ product uChek is now in the cross hairs of Big Brother with a formal inquiry underway by the FDA.
As with many forays into governance of new technology, the language surrounding this decision is tricky. If I were queried by my representative to Washington, of course I would love it if I were protected from technology that could possibly misdiagnose any illness. However, this app is not meant for “diagnosis”.
This is about controlling information for the medical community and ensuring we don’t cut out the middle man with our dollars: medical practices.
Granted, I would not be here if it weren’t for a litany of excellent doctors and nurses that have helped me regulate my diabetes with extreme care. I needed some guidance with regards to my test results and how I can tighten my control.
What I want to know is how this app is different than other “at home” tests we can run on our own?
If I am able to run a Hemoglobin A1C screen (the lifeblood of diabetes care data) on my own, I don’t think that should change when I want to record the results with my iPhone.
I hope this is a big misunderstanding on my part. The FDA could just be doing some quality assurance on new data gathering applications trying to make sure I don’t fall prey to poorly designed medical products. That’s what they are there for, or what they want you to think. Rather, I’m a little concerned that this will stymie innovation in the medical community and keep us in the 20th century.
Reach out to your representative and ensure that old mindsets don’t hold back true technological innovation from allowing users to gather data to improve health. The FDA has too much power as it is in this country, keep them out of your mobile devices.