Rumors and images are are rapidly crossing even the broadest of internet canyons with Apple’s highly rumored forthcoming HealthBook App. Apparently, anything from weight to oxygen saturation can be monitored. How? Many solutions may require a third party device, but others are speculating an Apple iWatch will be able to accomplish all but the most technical of health related items. With the Affordable Care Act (ACA) in full swing, questions are being asked as to whether the health and mobile high-tech convergence will be the next area of big Government regulation?
U.S. Congressional House member Robin Quain, at a recent campaign rally stated; "Health care is often a critical life or death matter, and health care solutions are something the American people expect to work, and work properly all the time. Simple startup companies working out of their garages cannot just develop and launch healthcare applications for a smartphone or smartwatch without being accurately tested and regulated as safe."
Okay — there is no Robin Quain in the U.S Congress — and that statement is completely fictitious, as I made up the person and comments out of thin air. But hopefully my fictitious congressman’s comments just made thousands of you absolutely livid, if not slightly scared.
Massively large health companies, working on both software and hardware solutions, are highly likely to lobby Congress for massive regulation over any and all newcomers in the mobile health arena. The aim is to shut out hundreds, if not thousands, of amazing solutions and ideas before they can ever get started.
Whether it is Apple, Microsoft, Google or others entering the mobile health monitoring market, tech companies are going there. Therefore it is reasonable to assume Apple, with its medical lead with the iPad, is going to be on the forefront of this mobile technology.
The FDA is largely in charge of regulatory and approval fees for the approval of medical devices that may enter the U.S. market, but the approval process often requires an army of lawyers and patent experts to traverse the complicated process. There are costly fees and time delays the federal bureaucracy creates, companies face in order for products to make it to market.
Apple, able to deploy millions of devices and services within days of their initial offerings, may be entering a new world of Government oversight they have yet to experience. With the ACA suffering from a lack of enrollment from younger Americans, experiencing a lack of financial support as a result, political maneuvering to find funding for the program is a likely next step, one where Apple may be seen as a great recourse of abundant cash through abundant regulation.
If Apple brings forth some amazing technology, all that is needed is for a few ambulance chasing lawyers to see big dollars due to an app crash or bug. Politicians will be close behind, waiting to reap political and financial rewards from those who back them.
But perhaps Apple and other third party applications will not be able to be regulated as direct-to-patient technologies, and/or the user will not be able to be classified as a patient and we can live to watch a new revolution of Apple’s distributive abilities create an entirely new market of users being amazingly health-aware, and thus healthier lives.
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