Readers Weigh In: The FDA Should Regulate Mobile Medical AppsSeptember 23, 2013 by Melissa McCormack
In early July, I published a report called “Medical Apps: To Regulate, or Not To Regulate?” It highlighted two groups battling over final guidance from the Food and Drug Administration (FDA) on regulation of mobile medical apps. It also discussed the motivations of each group.
In the report, I asked readers to vote on whether the FDA should regulate apps. The response? Yes! 68 percent of readers polled think the FDA should regulate mobile medical apps.
Should the FDA regulate mobile medical apps?
And low and behold, the day we were set to publish our poll results, the FDA finally released its final guidance on mobile medical apps. Well, I believe final guidance will actually propel the app industry forward, not stifle it as opponents fear, by clarifying the obligations of app developers and even lightening the loads of some.
Background on Medical App Regulation
First of all, it’s important to know that the discussion about regulating apps doesn’t apply to all health and wellness apps. The FDA is only concerned with apps that “transform a mobile device into a medical device already regulated by the FDA” or that can be used “as an accessory to a medical device already regulated by the FDA.” They’ve termed this group of apps “mobile medical apps.”
This could include, for example, an app like AliveCor that lets doctors perform electrocardiograms (ECGs) with their smartphones. The key is that if a patient could be seriously harmed if an app is not working properly, the FDA wants to review that app.
Now, let’s back up and look at the timeline of events related to app regulation, starting with the first mobile medical app to receive FDA approval in 2011.
June saw the issue heat up when two opposing coalitions, within days of each other, lobbied the Obama administration with opposite aims. The first group, an unnamed coalition, urged the administration not to rush into any regulatory guidance. The other group, the mHealth Regulatory coalition, called for the FDA to publish its final guidance as soon as possible.
One thing to keep in mind is that “final guidance” is not synonymous with regulation. Final guidance is intended to explain the FDA’s existing regulatory stance. Regulation can still happen without final guidance, and according to our handy timeline, it did.
As I discussed in my July report, the coalition that wanted to delay guidance was probably gunning for one of two things: (1) to stall regulatory guidance indefinitely and eventually get rid of regulation for medical apps altogether; or (2) to convince the government to create a new, non-FDA body to regulate medical apps. Now that final guidance has been released, it's this latter concern that remains most relevant.
So the key questions surrounding the issue of regulation seem to be:
- Should mobile medical apps be regulated at all?
- If so, who should regulate them?
(Some) Mobile Medical Apps Should Be Regulated
Mobile medical app regulation is already happening–and it should continue.
The FDA has been regulating traditional, non-app medical devices since 1976. And when medical apps came on the scene, the FDA turned its eye toward apps that might act as medical devices. Since 2011, they’ve reviewed some 100 medical apps.
Section 201(h) of The Food, Drug and Cosmetic Act defines a medical device as something intended for use in diagnosis, cure, treatment, or prevention of a condition, and which isn’t consumed like a drug. Nothing in Section 201(h) excludes apps from the definition of medical devices, so it stands to reason that apps meeting the definition of a device could legally be treated as devices.
But not all health and wellness apps meet the definition. For example, the popular FitBit app that does things like count your steps wouldn’t be a medical device, mainly because its makers don’t intend it to diagnose or treat a condition. On the other hand, an app like iExaminer which is intended to help diagnose eye conditions like glaucoma would be considered a device.
So, should apps that do meet the definition be regulated? I’ve broken down the main arguments on each side of the debate. Take a look:
|The case against regulation:||The case for regulation:|
A possible alternative to regulation would be some kind of certification program, which would be less formal and wouldn’t carry criminal penalties for noncompliance.
Some of the stakeholders opposed to regulation are electronic health record (EHR) companies, whose own software products are exempt from regulation and receive certification instead. They’re pushing for apps to be treated the same way. But EHRs are record-keeping systems, not medical devices–a key difference.
Safety issues with tools like EHRs tend to result from user error, such as a doctor entering the wrong drug dosage into the computer. In this case, it’s up to the user to operate the software safely. But the biggest safety issues with apps could result from problems in the function or design of the app itself: for example, a diabetes app that doesn’t capture blood-glucose information as advertised could compromise patient safety. Here, it’s up to the app maker to design the system safely and keep it working properly.
That’s why it makes sense for “device”-type apps to be regulated the way medical devices are. True, regulation can create complicated hurdles for developers–but the stakes are high enough for patients to warrant that level of oversight.
So apps should be regulated. But that still leaves our second overarching question facing the industry: Is the FDA the right group to regulate apps?
The FDA Should Be Responsible for Regulating Mobile Medical Apps
As I’ve mentioned, some of the stakeholders trying to stall FDA final guidance are hoping for the creation of a new body to regulate medical apps–preferably a branch of the Office of the National Coordinator for Health IT (ONC).
Today, government programs reward doctors for "meaningfully using" ONC-certified EHR software. Some companies behind that software want medical apps included in these meaningful use programs–for their own benefit. It's no wonder they support having ONC regulate these apps, instead of the FDA.
Other stakeholders opposed to FDA regulation seem to believe the FDA is downright incompetent, and that apps need a new regulatory body. But groups in the this camp probably won’t be big fans of any regulatory agency; it’s the bureaucratic nature of regulation itself they oppose, not the agency in charge of it.
Creating a new agency to do essentially the same thing as an existing one smacks of inefficiency. The medium of delivery for the apps in question is less important than their function. It makes more sense that everything functioning as a medical device – app or otherwise – should be overseen by the same agency.
Still, “health IT” is a relatively new category, and even some in favor of FDA regulation for apps think the agency could benefit from greater expertise in the health IT arena.
On September 4, the Health IT Policy Committee (HITPC) convened in Washington, D.C. and adopted final recommendations for a regulatory framework for health IT. Those recommendations called for the FDA to release final guidance for mobile medical apps, suggesting the Committee is on board with the FDA’s oversight of app regulation. However, they also recommended more funding for the FDA, along with new staff dedicated specifically to health IT.
HITPC also pointed out an informational problem related to app regulation, one they think final guidance could solve. Final guidance, they believe, will correct “inconsistent regulatory treatment and information dissemination” and will help “eliminate ambiguity and misinformation” (source).
In other words, the FDA should be responsible for regulating apps, but they should clarify their position and streamline their approach. And they may need additional resources to do that effectively.
How Will Final Guidance Impact the Industry?
Opponents worry that FDA final guidance will put a damper on the abundant development of medical apps the last few years have seen, stifling the industry.
But remember, regulation has already been happening. In a recent MobiHealthNews article, Bradley Merrill Thompson, an attorney specializing in FDA regulatory issues, clarifies this point: FDA final guidance will not change whether or not medical apps are subject to regulation – they already are. Final guidance will simply clarify and streamline the FDA’s regulatory guidelines and processes.
Under these streamlined processes, it’s possible some apps that previously escaped the FDA’s regulatory eye could find themselves subject to it now. But it isn’t as if final guidance means all medical apps suddenly come under fire.
In fact–and maybe most importantly–the FDA has indicated that they don’t want to regulate all medical apps that meet the definition of a device. Final guidance will clearly outline which apps will not be subject to approval requirements. That’s why stakeholders such as the companies of the mHealth Regulatory Coalition are calling final guidance “deregulatory.”
So while the FDA doesn’t want to regulate all medical apps, before final guidance it was unclear which apps would be exempt–and that’s cast a shadow of uncertainty over the app development industry. Developers couldn’t be sure whether they were in the clear.
For developers whose apps are subject to regulatory requirements, final guidance shouldn’t change much, except to clarify their obligations up front (versus a surprise inquiry like developer uChek found itself subject to). Knowing their responsibilities from the start will help developers be more efficient and make apps safer for patients.
Meanwhile, final guidance will allow developers whose apps will not be subject to regulatory requirements to move full speed ahead. That will get more apps into the hands of patients faster. And patients can breathe a little easier knowing that the groups creating apps and the group reviewing app safety are on the same page. In either scenario, patients win.
Should the FDA regulate mobile medical apps? The answer, from readers around the Web to the government itself, seems to be “YES”. And now that final guidance has been released, changing the regulatory body for apps doesn't seem likely. Will final guidance propel the app industry forward? We'll see what happens.
Thumbnail image created by Jason Howie.