The rise of smart phones has resulted in an American obsession with applications, and has kept tech companies of all sizes squabbling to come up with the next big ‘app’. So it should come as no surprise that many developers have recently focused their attention on health related apps.
Currently, there are apps that can help manage sleep schedules, count calories, and calculate a healthy BMI. The list is endless. But there is also a new category of more technologically advanced health apps that, with the addition of supplemental devices, can transform a smart phone into a blood glucose meter, or give it the capability to administer an EKG.
These advances have generally been met with enthusiastic optimism. However, I see a few potential problems with the idea of moving important medical procedures out of a physician’s office and into the home,or anywhere else since smart phones can literally go anywhere.
The first major issue involves FDA regulation. It’s obvious that any app published for medical use needs to be certified and regulated. Think of the tragedies that would result if a blood glucose meter app were free to measure blood sugar according to a skewed scale. Just as there is regulation for medical devices, there needs to be regulation for medical apps.
So, is FDA regulation feasible?
It’s unclear. The tech companies developing these apps are accustomed to the exponential pace of technological innovation, while the FDA is more familiar with the drawn out process of regulation. The idea of waiting an additional year to publish apps — FDA approval can take six to 20 months — may be intolerable to many developers.
Even if developers decide to wait for an agonizingly drawn out approval, tech companies will be further hindered when they try to update their apps. It seems that any update delivered to an already approved health app would also need to pass FDA regulation. If not, what is the point of FDA regulation in the first place?
Surprisingly, current FDA regulation over medical apps is lax and has allowed a multitude of ineffective apps to become available to the public. The New England Center for Investigative Reporting determined that out of approximately 331 therapeutic health apps available since 2011, 43% rely on cell phone sound or light to "cure" conditions. Scientists are highly doubtful that these methods could actually work. The situation becomes more serious when a false cure has the potential to actually cause harm to the user.
If the FDA remains hesitant to strongly regulate health apps, the door will open for private companies to begin creating their own certification criteria. Happtique — the business arm of the Greater New York Hospital Association — has already begun developing an app certification program designed to ensure apps’ quality and the security of patient information.
Although I believe that federal regulation and certification would be the most effective way to filter ineffective apps out of the marketplace, I found the Happtique draft of App Certification Standards surprisingly comprehensive. The draft even includes a regulation standard under which apps are required to comply with all FDA regulatory mandates for medical devices.
But I’m still not convinced that this will eliminate the existence of ineffective apps, since these certification standards would only apply to apps available through Happtique. There needs to be a more universal regulation process.
Moving past regulation, I see one more potential problem with widespread health app use: the apps have the potential to act as substitutes for physicians. Although this may seem like a major benefit — especially to those who cannot afford to regularly see a physician — there can definitely be drawbacks as well.
An app may be able to administer a sophisticated exam, but can it interpret results and give advice as effectively as a human being? Can the average man or woman catch important subtleties in the EKG analysis provided by their smart phone?
Before we get overly excited and proclaim health apps to be the future of medicine, we should also consider to what degree we are willing to let these apps take over. It is my opinion that FDA approved health apps should act mostly as supplementary aids and should be monitored by physicians in real time.
There must be limitations on how far we let these apps monitor our health, or we could end up in a country full of people wrongly thinking their smart phone check ups are keeping them healthy.