mHealth Monthly Mashup: release 2.0 – peering into the future of mHealth through the eyes of last week’s FDA draft guidance

Michael Spitz

Ignite Health

Although the issuance of draft guidance for mobile medical applications by the FDA on July 19th came as a surprise to many, experts close to the field have sensed that this summer would prove to be an important and pivotal period for the mHealth regulatory scheme. In fact, the independent mHealth Regulatory Coalition has been working steadily and in parallel with the FDA to issue their own draft guidance recommendations, while Bradley Thompson, a medical device attorney and regulatory expert with Epstein Becker Green has been publicly sharing his analysis and predictions regarding mHealth regulation for quite some time.

Now that the FDA draft guidance has been released, what does it mean for the future of mHealth and its potential for pharma? Will the Wild Wild West of mHealth medical apps finally be corralled for the safety of patients and the protection of physicians? What will the new regulatory environment cost mHealth in terms of slowed innovation, increased barriers of entry, and the active involvement of an already over-extended governmental agency? And how will this draft guidance, presumably soon to be finalized and made binding, ultimately impact the mHealth industry?

“What will the new regulatory environment cost mHealth?”

Initial excitement, continued confusion

The big news is that the FDA expressed its intention to apply regulatory requirements to only that subset of mobile apps which impact patient treatment, leaving out entire categories of apps such as electronic medical textbooks, health and wellness apps, and electronic health records, among others. Given that approach the immediate media reaction had a curiously celebratory tone. Some saw the guidance as “exempting most pharma apps from scrutiny” while others emphasized that the focus on high-risk mobile medical apps “excuses a whole raft of lower-level health apps from the strictest Class II and III regulations.” But is such a narrowing of regulatory scope to high-risk necessarily a good thing for pharma?

Not necessarily. Although pharma routinely relies on unbranded educational content to market condition physicians, patients, and caregivers with disease state information and resources, branded communications are where impactful calls-to-action and actual Rx conversions take place. In the field of mobile medical apps this is even more significant due to the plethora of available content—what would motivate a diabetic patient to download a pharma-sponsored unbranded diet and exercise app, for instance, when hundreds of comparable and even superior apps are already available through the App Store or Android Market? And conversely, branded apps that feature diagnostic tools, dosing calculators and the like prove most relevant for pharma target audiences yet de facto may fall into the “high risk” device category that the FDA has suggested it intends to regulate.

Another media reaction has been the assertion that the draft guidance clearly and unambiguously delineates the boundary between apps that should and shouldn’t be regulated—but is that entirely true? Mr. Thompson doesn’t think so. “The problem is that this guidance doesn’t explain how to determine whether an app meets the medical device definition in areas where questions remain about intended use. We need more clarity as to what types of claims a company can make about health and wellness that also implicate a disease before we can determine whether the app needs to be regulated or not.” So if a diet and exercise app is meant for diabetics, where will the line be drawn between data management and manipulation, between information processing and patient treatment recommendations?

“The problem is that this guidance doesn’t explain how to determine whether an app meets the medical device definition in areas where questions remain about intended use.”

Mr. Thompson also warns that an app that doesn’t run any hardware other that the mobile platform itself might still be regulated. In other words you don’t need to add any additional tools or sensors on a mobile platform to make it a medical device, as even simple computer running software used to analyze clinical data that advises a healthcare professional can, in certain circumstances, ultimately be considered a medical device falling under the auspices of FDA regulatory control. Similar problems may apply to electronic medical textbooks de facto considered outside the FDA’s sphere, even though some of them may contain the very types of calculators and diagnostic tools otherwise demarcated for regulation.

Regulation without exception

An0ther robust topic of discussion is whether or not the FDA will enforce the entire mHealth landscape comprehensively and rigorously. As Mr. Thompson states the point is likely moot, since regulatory requirements are by definition not optional. “The FDA can’t treat mHealth regulation like a Good Housekeeping Seal of Approval where certain apps get an extra marketing bonus if they go and get approval. The mandate must apply to everyone or no one when it comes to technology that performs the same way, and do so uniformly, regulating all categories of products within the prescribed high risk category equally, albeit with a lighter touch than for, say, pharmaceuticals.”

The question then becomes how the FDA could possibly muster the additional resourcing necessary to handle this increased volume of regulation, especially considering that nearly twenty thousand mHealth apps in one form or another already exist for download. Those familiar with the relatively sluggish, expensive, and time consuming approval process endemic of the pharmaceuticals and medical device industries shudder. But Mr. Thompson seems less concerned: “We should keep in mind that regulation is supposed to be a self-sustaining system. Congress has set up user fees, so each new applicant pays in, enabling the FDA to presumably hire additional bandwidth to tackle the increasing burden. The only potential problem is if the applications come in faster than the agency can ramp up and allocate the necessary resources. But the system is designed to be scalable and accommodate even exponential increases in demand.”

Additional resources might be available to the FDA for monitoring and even enforcing compliance. Eileen O’Brien of Siren Interactive has discussed the possibility of a “Bad App Program” analogous to pharma’s “Bad Ad Program,” while Brian Dolan of mobihealthnews has discussed the intriguing yet potentially troubling prospect of Apple, Blackberry, and Android partnering with the FDA to help regulate their own app stores. Off the hook for regulation so long as they “exclusively distribute” apps, these distributors might not only cooperate with the regulated app developers in the event of correction or recall, but conceivably help monitor and police the playing field. Even smartphone manufacturers that demonstrate no intended uses for device could conceivably play a role in monitoring and maintaining the integrity of high-risk mobile health apps.

“There’s absolutely no doubt that regulation slows innovation. After all, that’s what regulation should do, in order to successfully protect people from possible harm.”

Even smartphone manufacturers that demonstrate no intended uses for devices could conceivably play a role in monitoring and maintaining the integrity of high risk mobile health apps.

More questions, potential benefits, and milestones along the road ahead

Initial impressions and questions aside, so far the guidance is in draft form, and the FDA is welcoming and encouraging feedback for the next 90 days. That same spirit of transparency and openness was shared last week during their #FDAApps tweetchat moderated by @FDADeviceInfo, where the agency welcomed real time questions and comments. As Michelle Petersen, healthcare communications specialist and moderator of the #healthinnovations Twitter stream points out, “top of many minds is the need for additional details regarding 51o(k) submission for approval and clearance. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time, or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. So if you are the first person to manufacture a mobile cataract diagnosis app, say, will you be able to demonstrate there are other medical devices that work in a similar way to avoid a clinical trial? And will this draft guidance be considered retrospective in the sense of identifying originators of unique function, to preclude the reintroduction of already-approved devices?”

Regardless where they net out on these and other issues, however, the intent, general flavor, and boundaries set by the current documentation all invite speculation, and help create a vision for what the mHealth landscape may be like in the very near future. Considering the pharmaceutical and medical device industries as analogs where innovation cohabitating with regulation is nothing new, similar challenges and opportunities can be extrapolated into mHealth. “Every indication is that the FDA very much appreciates the need for mHealth, and the need particularly for innovation, and allowing that innovation to blossom,” continues Mr. Thompson. “But there’s absolutely no doubt that regulation slows innovation. After all, that’s what regulation should do, in order to successfully protect people from possible harm. Not only is regulation clearly needed in the space, but it will in the long run benefit more than just the end-user.”

The good news is that by creating this barrier to entry, mHealth businesses will have to be more serious, focused, and funded, their reward eventually being higher profits and room for growth within a more restrictive though better regulated playing field. So the companies that do tackle these technologies and do so in a manner that is more responsible and compliant stand to gain the most. A vast majority of the more than twenty thousand registered mHealth companies with the United States qualify as small businesses under Department of Commerce criteria. Historically the emphasis has been on venture capital backing, because in contrast to consumer electronics, where the margins are razor thin, the potential profits in mHealth are much greater. Eventually this fragmented, unregulated playing field will likely shrink into a smaller number of larger, better-funded and more committed companies compelled to operate in a fully regulated environment. On the flipside mHealth app costs will rise, perhaps exponentially, as will time to market—but innovation and regulation have been bedfellows for decades in other industries, and mHealth will similarly adapt.

Patients and their physicians will also gain considerably through mHealth regulation. Fewer, better-funded companies creating higher quality, safety proven apps will help ensure end users are kept as far from risk as possible, improving outcomes and reducing physician exposure to liability. And as Michael Smallwood, VP of Ignite Health’s Mobile Division foresees, “while the current marketplace is flooded with an app tsunami of greatly varied quality, functionality, and purpose, the future mHealth landscape will feature more powerful, sophisticated, and clinically proven tools that can be used with the confidence and trust displayed by surgeons with their instruments and prescribing physicians with their drugs, medical devices, and diagnostic tools.”

“the future mHealth landscape will feature more powerful, sophisticated, and clinically proven tools.”

What next?

Is this the end of regulation, or the beginning? Mr. Dolan speculates that the FDA, historically slow to the plate will likely tweak the existing draft and run with it, creating a lasting precedent for years to come. Others take a less conservative approach, speculating that this draft guidance is just the beginning of an evolving, soon to be updated and improved regulatory scheme for mHealth. And some even hope that this regulation will open the door to long-awaited guidance for healthcare social media.

Meanwhile, on July 27th a large group of individuals involved in the mobile health space will be congregating at the Continua/ATA Summit to discuss regulation of mHealth products. “Bakul Patel, the mobile health policy guru at FDA, will be there to discuss the details of this guidance,” says Mr. Thompson, “as will the mHealth Regulatory Coalition, which is set to release its own version of proposed mHealth guidance in the coming weeks. The discussion will surely be lively and informative. Your voice can be heard, and there’s still time to register. ”

Part 3 of this series will be published in August

About the author:

Michael Spitz is VP of Digital Strategy at Ignite Health, with offices located in New York City, New York, and Irvine, California. Spitz combines his passion for technology with more than 15 years of clinical content expertise to help engineer healthcare communications solutions across numerous treatment areas for many of the pharmaceutical industry’s major companies. Follow @SpitzStrategy on Twitter for his daily – often hourly – updates on all things digital for the ultimate benefit of patients worldwide.

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