The lengths to which this administration goes to stifle private innovation never ceases to amaze me. Enter, stage left, the FDA.
New technology is beginning to arrive that will allow you to communicate with your doctor without visiting your doctor. Apps are being developed even as we speak that will allow you send, for example, your blood sugar levels, or your blood pressure levels directly to your doctor via your cell phone, or your tablet.
This is good. It both saves you money in unneeded visits to your doctor, and, saves your doctor time for patients who truly need to “see” their doctor. This model of efficiency may soon change.
The FDA wants to regulate software used to support the decisions made by patients and health-care providers the same way it regulates the software embedded in hardware such as X-ray machines and infusion pumps [that is, by calling them, "medical devices"]…The result could be the worst regulatory mismatch possible. An FDA process that takes years cannot possibly be applied to technologies that run on our phones or IPads and get updated on a regular basis.
Well, how do we know these apps are safe, you ask?
The process already exists for safeguarding the public for computers in health care. It’s not the FDA premarket review but the health information technology certification program, established by President George W. Bush and is still working fine…
But, there is an extra added government benefit from calling these apps “medical devices”. When Obamacare is implemented, all medical device manufacturers will pay a 2.3% tax on their gross sales, not their profits.
So, if you are a bright computer whiz kid what will you do? Develop an app that allows a patient to communicate with their doctor, but may take years to receive FDA approval, and chew up your profits with the Obamacare “medical device” tax, or, develop an app that, let’s say, enables people to find out what is on sale at their local grocery store?