Medical Apps: To Regulate, or Not To Regulate?July 8, 2013 by Melissa McCormack
On June 18, a coalition of more than 100 high-profile health IT stakeholders sent a letter to the Obama administration urging the government not to rush into regulatory guidance for the mobile medical app industry. Three days later, a separate coalition of high-profile stakeholders sent another letter urging exactly the opposite: that the government provide final guidance on regulation as soon as possible. I thought I should take a look at who’s on each side, and why.
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What’s at issue?
First, let’s contextualize. The Food and Drug Administration (FDA) of the United States is a regulatory body responsible for protecting and promoting public health. Among other things, it regulates drugs, vaccines – and, central to this discussion, medical devices.
Mobile medical apps refer to applications that can be downloaded on mobile devices (smartphones or tablets) and used in some health-related capacity, by patients or physicians. Have type 2 diabetes? There’s an app for that!
The FDA has made clear that while it won’t be regulating all medical apps, it does mean to regulate those whose failure to work as intended could result in serious harm to the user. Specifically, if an app “transforms a mobile device into a medical device already regulated by the FDA” or can be used “as an accessory to a medical device already regulated by the FDA,” the FDA says that app will be subject to regulation.
A Brief History of Mobile Medical Apps and Regulation
The history of medical apps – and all mobile apps, really – is itself quite brief, but usage has grown exponentially over the last few years. In 2010, MobiHealthNews reported that there were 5,820 medical apps available for smartphones. By June 2012, Kaiser Health News was reporting 40,000 medical apps. The number of apps continues to grow – as does their use.
Patients and doctors alike use medical apps. Physicians can access symptom checkers, drug information, medical calculators and more via smartphone and tablet apps. Patients can use apps to find doctors, track calories, measure their heart rates and even monitor chronic diseases like diabetes – only the latter of which would concern regulators.
Some apps are free; others cost as much as $40. For patients, apps provide a new avenue to get involved with managing their health. And new levels of patient engagement have many physicians excited about apps as well.
Regulation for medical apps is in its infancy, and is today somewhat ambiguous. Notable developments include:
- February 2011: The FDA gave approval to the first medical app, an imaging app that allows physicians to view radiology scans on a mobile device.
- July 2011: The FDA released Draft Guidance discussing its intention to regulate some medical apps, and soliciting public comment on what will and won’t be regulated. A Final Guidance document from the FDA making its regulatory intentions clear was expected to follow, but is as yet forthcoming.
- July 2012: The Obama administration created a Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup, charged with publishing a report by January 2014 to identify a regulatory framework for “health IT,” which includes mobile medical apps. The Workgroup is under oversight of the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC).
- March 2013: During hearings before a House of Representatives committee, Christy Foreman, Director of the Office of Device Evaluation, indicated that the FDA had approved some 100 medical apps already. Foreman suggested that the FDA’s final guidance for mobile medical apps would be published by October 2013.
- May 2013: The FDA made clear it means business by launching its first inquiry into a urinalysis app that the agency said needed but did not have FDA approval.
Should Mobile Apps be Regulated?
Many decry regulation in general as an innovation stifler. The steps required to comply with regulatory guidelines or receive regulatory approval require time and money, adding new layers of complexity to development. The American Thinker raised alarms early on about FDA involvement, pointing out that regulation would raise the cost of entry for app developers and compromise their ability to get apps to market quickly.
However, it seems clear that some medical apps could pose serious risks to users if they don’t work as advertised.
Most stakeholders seem to have accepted that regulation of some sort is inevitable; indeed, it’s already occurring, despite the lack of final guidance from those dishing it out. And all parties, including the FDA, seem to prefer a “less is more” approach. In other words, only apps determined to pose serious risk upon malfunction should fall under the regulatory umbrella.
So why can’t we all just get along? While regulation may be inevitable, the exact form of that regulation isn’t yet clear. This seems to be what’s at issue with our two opposing coalitions.
The Yeas – Who Wants Final Guidance Right Now?
The group urging for final guidance to be published as soon as possible styles itself the mHealth Regulatory Coalition. It consists largely of medical device companies and app developers along with telecom and carrier giants like AT&T and Verizon.
Their stance is fairly easy to interpret. Since regulation is inevitable, they want regulatory standards to be made clear so that app development can continue without uncertainty looming. Their stake isn’t so much in the form of regulation – they care more about knowing what rules they’ll need to follow. For this group, lack of final guidance creates a planning problem.
App developers and medical device companies making apps don’t want to invest in trying to comply with FDA guidelines if it turns out their app won’t require FDA approval after all. They argue that the lack of guidance is hampering innovation, preventing developers who would otherwise create apps from doing so until standards are clearer. It’s also likely that FDA-approved apps will command a premium price, potentially boosting profit margins for the device and app companies who create them.
Mobile companies want to encourage app development. New apps mean more time and money being spent in the mobile category, both on the part of developers and end users. This means more business for carriers like AT&T and Verizon.
Most obviously, and what these stakeholders have been most candid about: final guidance will ease the minds of investors, who will be more likely to invest in apps with the degree of certainty afforded by a defined regulatory environment. The underlying motivation for this group would seem to be the bottom line. Final guidance means clarity around guidelines, which ensures confident development (and thereby usage) of apps and buttresses investment in the industry.
The Nays – Who is Urging Caution and Slower Action?
The group of stakeholders urging caution is slightly more diverse, and its motives slightly harder to pin down. The coalition consists on the one hand of hospital, physician, and patient organizations like the American College of Emergency Physicians and the Lukemia and Lymphoma Society; and on the other of IT companies like McKesson, Microsoft, Dell, Intel and Siemens and payer organizations like UnitedHealth.
Provider-oriented groups represent physician and health system interests. It’s not surprising that this category might be in of favor slow, deliberate consideration. As a rule, provider groups tend to favor abundant research before supporting change.
This group doesn’t seem to be opposed to regulation on principle (though exceptions do exist), but rather would prefer regulation to occur later after thoughtful research and deliberation. In the long run, the interests of this group may align better with the “yays,” so we may see shifts in alliance as time passes.
Unlike our “yeas” group, the IT giants and payer organizations do seem to have preferences about the form regulation takes. As such, they seem to want to postpone final guidance in order to maximize their time to coalesce and lobby for their interests.
To put things into perspective, some of the largest signatories of the letter urging slower action include Microsoft, McKesson, Siemens, Dell, and Intel. These companies spent a combined total in excess of $20 million dollars on lobbying efforts in 2012. These folks have a financial dog in the fight and aren’t shy about spending money to protect interests. (This is not to suggest that our “yeas” don’t also spend their fair share on lobbying; the interests of the “yeas” group in this instance simply seem to align with regulation rather than against it.)
Companies like McKesson, Greenway, and other electronic health record (EHR) makers may worry that the regulatory eye will turn to them next. Currently, EHRs don’t require regulatory approval, relying instead on “certification” by independent organizations which are in turn approved by Office of the National Coordinator for Health IT (ONC). EHRs are currently exempt from FDA regulation, and EHR vendors want to keep it that way.
These stakeholders seem to prefer the FDA not be responsible for regulating medical apps at all. The coalition’s letter suggests that the administration may wish to reconsider Section 201(h) of The Food, Drug and Cosmetic Act – the section identifying the FDA as the appropriate regulator for medical devices, and on which the FDA is relying to extend its purview to apps.
This isn’t a new suggestion. McKesson and some of its allies sent a letter to ONC earlier in the year proposing that medical apps and all of “health IT” should be considered separately from medical devices, and that ONC should create its own regulatory body to govern that category.
This earlier letter even calls on ONC to “synchronize [its] patient safety Plan with related meaningful use and other health IT requirements.” The government’s meaningful use requirements for EHR systems have helped bankroll the EHR industry by offering incentives to physicians to purchase EHRs and eventually leveling penalties against those who do not.
Though this earlier letter doesn’t directly suggest that medical apps be lumped in with meaningful use requirements, the idea that meaningful use should be include non-EHR requirements has to appeal to EHR makers, who face a potential contracting market as meaningful use incentives and penalties pass.
Finally, we have our payors. Payor organizations can’t be enthusiastic about the reimbursement implications associated with FDA-approved medical apps. Presumably insurers would sooner avoid having to cover the cost of medical device apps for patients or reimburse physicians who prescribe them. This group would likely be content to kick the regulatory can down the road.
Underlying motivations on the nay side also largely boil down to the bottom line. Whereas the yeas are looking at increased profits once regulatory guidance is clear, the nays face potential increased costs. On this side of the fence, stakeholders are trying to put off regulation, or perhaps buy time to effect a change in which regulatory body governs medical apps.
What’s Best for Patients?
Despite some ulterior motives, stakeholders on both sides of the fence have legitimate financial concerns and legitimate concern for patient safety. However, I tend to side with the yeas on this one.
Regulation is inevitable, is already happening to some (albeit ambiguous) degree, and is appropriate, given the intended functions of the apps in question. Since patient safety is at issue, the lack of clear guidance from the existing regulatory body for patient safety issues is frankly alarming.
The sooner the FDA can make clear what they will and won’t regulate, and to what degree, the more efficiently development and use can unfold. Final FDA guidance will give developers much-needed direction. More importantly, it will give patients and providers the assurance of knowing that apps which impact their safety are, in fact, safe.
Thumbnail image created by Intel Free Press.