Smartphone apps are great when you want to tweet by breathing, figure out where the ladies and/or gentlemen are at, or replace your credit card, but when you want to monitor your health or find the answer to a medical question, apps may not alway be entirely...correct. The FDA just proposed some guidelines that would have the governmental organization overseeing certain medical/health apps to ensure they're actually helpful.
At the moment, the FDA does bestow its approval on some apps, including a radiology tool called Mobiel MIM, but that approval at the moment is both pretty scarce and totally optional--it's a nice bonus if your app is FDA-approved, but the only organization an app developer really needs approval from is Apple. The FDA strikes a tone of total support for the surge in medical apps, but states concern that there is no real approval process that vets medical apps prior to release. If you've got a weird rash or a pain somewhere in your abdomen (could it be the spleen? What is a spleen, anyway?), or want to use your phone's sensors to monitor your organs (like a spleen, which I am 99% sure is in the abdomen), you might consult an app, and the FDA wants to make sure you're getting the right information.
The FDA proposed a guideline that would have the organization overseeing certain kinds of apps. Specifically, they'd want to examine any app that is "used as an accessory to an FDA-regulated device," which seems reasonable--of course the FDA would want to make sure that any device they approve would be used with accessories of which they also approve. The other kind of app the FDA wants to regulate is any software that turns a smartphone into a "regulated medical device," like an electrocardiography machine. Again, pretty understandable--the FDA monitors EKG machines, so if you're using an iPhone as an EKG machine, that should also be monitored.
There's no mention of the FDA examining WebMD-type diagnosis apps--the proposal seems much more geared to apps that turn smartphones into legitimate medical tools, rather than just references. FDA approval might slow down the release of some of these apps, but the agency thinks added oversight will be worth the delay.
This would be a non-starter. By the time the FDA approves an application (they take 12 years for drugs) smart phones will have moved on. If consumers want an FDA stamp on their devices I'm all for it. But, the approval process should be optional and users should beware.
It will be very much required before a physician can use a smartphone as any kind of diagnostic instrument.
So if Doc Ock screws up the diagnosis of your spleen, after he used his non approved iPhone spleen checker, your lawyer will be very happy. You will get some % of the cash as well, but you may not enjoy it, due to your bad spleen.
Medical devices are regulated -- it's the law. If you want to use an app to check your own symptoms, I believe that's a different case.
It's not always such a tough deal. Most devices get to market via 510(k) -- as something equivalent to an existing device.
it's the consumer's choice to choose what information to trust and what not to trust.
The phone app market is one of the last truly free realms of commerce, and it's already being intruded upon.
From my observation as an iPhone owner for 3 years, apps live or die by way of customer review. If an app consistently shows incorrect diagnoses, then people wont trust it(and hence, wont buy/download it). If the opposite happens, people will trust it, it's that simple. It would ,however, be wise to double-check any app-based diagnoses with a doctor.
Now to wait for the wave of big-government advocates. ^_^
More fiscally irresponsible regulation from the FDA. Big surprise.
Medical apps are a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality. They also said themselves that “The safety of America’s food and medical products remains under serious threat… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques. Even then, resources will still be deployed on “data-driven risk analytics.” Hardly all-inclusive, hardly preventative. By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated.
Initially, for the first 86 years of FDA's existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.
Once again the FDA kills growth and initiative in favor of Big Pharma.