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FDA has App Stores Under Surveillance

The U.S. Food and Drug Administration  is actively watching app stores for apps that it deems fill a medical purpose with an eye toward regulating them, according to Bradley Merrill Thompson, an attorney specializing in health care issues. Thompson said even smartphone apps require FDA approval, just like other medical “devices,” and the determination if an app requires federal approval is strictly the FDA’s call. Apps such as iStethoscope for the iPhone (s aapl) (featured today in the Telegraph) and Instant Heart Rate for Android (s goog) may find themselves facing a regulatory process much like other medical devices such as glucose monitors, which could stymie innovation and put the kibosh on plans to use smartphones for health monitoring.

iStethoscope uses the iPhone’s microphone to monitor the user’s heartbeat, while Instant Heart Rate uses the camera on an Android phone to serve the same function. These aren’t the first apps to appear for medical-related purposes, and they won’t be the last, So at what point will the FDA step in and put the clamps down on such apps? According to Thompson, it isn’t clear which apps might trigger FDA scrutiny.

While the iStethoscope app doesn’t make any medical diagnoses from the heartbeats detected, other apps have clearly entered the diagnostic realm. One computer program listens to coughs to determine the underlying cause, and this program can (and probably will) be ported to a smartphone app. We’ve already covered apps that listen to sensors on a patient to track vital signs, and medical researchers are actively working on smartphone apps that analyze blood or saliva samples for monitoring the condition of patients with HIV and malaria.

Some uses of these apps are more involved in the medical process than a simple stethoscope app, but where is the line drawn? In an article written last year, Thompson notes the FDA could even regulate cell phones used for medical purposes. He points out that once a program is committed to computer media, “media with the code written on it is enough of a ‘thing’ for FDA to regulate.”

I spoke with Thompson to get his take on what we can expect from the FDA. While the FDA expects developers to pursue agency approval for apps with a medical purpose, he made it clear the FDA is not relying on that to happen:

The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.

FDA involvement will complicate the app development process; developers will have to be aware that their app might warrant an FDA approval process, and if so, if it’s worth continuing with the project. As the distribution vehicle for apps, app stores will need to be aware of the implications FDA involvement brings to the process. Some apps may be rejected by the store because of potential federal scrutiny. On the positive side, smartphones have become so powerful, and apps so useful, we may be seeing some outstanding medical uses emerge. Panels at our Mobilize conference in just a few weeks will be looking at issues for app developers, perhaps this will be raised.

6 Responses to “FDA has App Stores Under Surveillance”

  1. There are similar issues in Europe with the definition of medical devices extended to cover software on its own and software and hardware combinations. The key point seems to be is whether the medical device is making a decision or not. So a medical app that records heart sounds for sending to a doctor might not be covered but a medical app that diagnoses something from the same information might.

  2. The rule of thumb on these issues is that if it acts as an autopilot, it needs FDA approval. If it acts like a textbook it doesn’t.

    Doing diagnosis doesn’t necessarily push an app into the FDA category. If it just gives an oracle-like answer, the FDA is more likely to get involved. If it just gives a bunch of likely diagnoses and data to help evaluate them, the FDA will treat it more like a textbook. Doctors prefer the latter except for things they consider to be like instruments, such as EKG reading.

  3. VincentRodriguez

    Use the “Free Speech” loophole on your medical app. Use disclaimer, “For educational purposes only” or “NOT a real medical device” or “For demonstration purposes only”. Then apply for FDA approval and watch the profits fly when you are approved in the year 2020.

  4. Boy it has been a while since commenting over here as a tablet user but still a tablet person:) On the FDA watching the Apps store, well the FDA could use some mobile technology too. Some companies are in in fact asking for FDA approval, which is a good thing, but there are tons of apps coming out all the time and actually I’m about up to my ears in apps at times:)

    The FDA would really gain a ton of expertise too if they were using mobile technology as they have no recall system. I have a campaign ongoing since October of 2009 which gives a pretty complete solution and has been covered on MSDN and on Microsoft Gov too. Use the phone as a scanner to find FDA recalls and of course device and drug companies need to buy in too but a pilot program to start would not be a bad idea. I added a new post based on your story here today.

    Also since I am on a “tech” page I’ll add that there’s a working solution for this same bar code technology to be used to authenticate a doctor for prescribing controlled substances and shoot the DEA would benefit out of that one too and be able to monitor and find counterfeit drugs a lot easier sometimes.

    One more thing too is that these can be used with PHRs, personal health records too, to import healthcare information by scanning with your phone through an encrypted Gateway. I heard recently too that someone in the UK was really looking at this part of the solution too.

    When it comes to mobile technology, having a program like this that actually shows real value to the consumer with recall information would also stand to be a driving force with involving consumers in their healthcare too, a point that everyone else seems to be missing, as conventions and web pages are not creating value, but this would if consumers could instantly find recalled items or be assured they are using a drug or device that has not be recalled as recalls will continue to grow.

    So how about those apples:) I followed you site when it first came on to the web all the time, and still do but don’t get over here as much as I used to as like everyone else I got little busier, but still check in:) If you like the idea send some folks over to vote on the poll and maybe this will get moving for the benefit of all.