The FDA released final guidance on regulating medical mobile apps, focusing on apps that present risks to users while exercising discretion over low-risk apps for education and disease management. This provides clarity for developers and allows innovation to continue. However, some questions remain about which apps will be regulated and how accessory devices are defined. Industry leaders see this as positive overall, allowing more investment in mobile health apps, though internal regulatory processes may still inhibit some projects. Precise guidelines are needed to avoid roadblocks to bringing useful apps to market.

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Digital Health Coalition
The FDA announced this week their final guidance for developers of medical mobile apps that run on
phones, tablets, and the next generation of mobile devices. The agency revealed it will focus
regulation and scrutiny on a specific subset of apps that present a "risk" to the patient and end
users and exercise discretion within the broader category of apps facilitating education, awareness,
disease tracking and medication compliance at a high level. A key point that is good news for the
developers concerned about limiting innovation as phones offer a potential tool to impact large
populations without the need for additional hardware … the agency states that if mobile medical
apps pose a low risk to consumers they will exercise enforcement discretion over these devices. It's
not a statement to developers to create tools and platforms with no concern for regulation unless
it's a very narrow definition but it does clearly give a green light to developers seeking to build
tools that will facilitate health, wellness, and disease management. In the past decade, the FDA has
cleared approximately 100 mobile medical apps. To place that in context, there are over 100,000
apps available in the broader category of health and wellness today.
The Digital Health Coalition reached out to several thought leaders in the
industry – and members – to get their reaction with regard to what this means
for the industry, developers, start-ups and innovation overall.
Reaction By Marc Monseau, Managing Partner, Mint Collective and Member of the
DHC Board of Directors (@mdmonseau)
This week, the FDA issued its final guidance on mobile medical apps, basically finalizing the draft
issued back in 2011.
Given the uncertainty surrounding FDA regulation of digital communications, it is good news to the
industry that the agency has issued a final decision. Development of mobile medical apps that
started based on the 2011 draft guidance can continue unabated. Projects that may have been on
hold awaiting the issuance of the final guidance can now begin.
Though many may be breathing a sigh of relief that there were no surprises, the guidance does still
leave some questions unanswered. In particular, it does not include a precise definition of which
apps will be regulated, nor does it provide clarity around the exact meaning of an accessory to a
medical device. No doubt over time we will be able to glean some of these details through
interpretation, inference and FDA action, but in the meantime, there will still be some uncertainty
surrounding which mobile apps may fall into the realm of FDA oversight.
Still, the release of this final guidance is a positive development. No doubt that in the coming
weeks, months and years, we will see more money, resources and energy devoted to the
development of mobile health apps -- no doubt helped by the clarity gained by the FDA’s
decision.
REACTIONS TO THE FDA MOBILE MEDICAL APPS FINAL GUIDANCE
September 26, 2013
From The Digital Health Coalition

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Digital Health Coalition
Reaction by Erik Hawkinson, Vice President, Global Head of Strategic Marketing
Roche Diagnostics and DHC Advisory Board Member
Whenever you receive more guidance, both clearer by definition and by reflecting on the influx and
wide variety of medical apps available, it is always good news. Will healthcare companies choose to
release more applications as a result? Of course. The long term impact will be the current "guard
rails of these digital tool highway" have now been more defined, refined and sets the stage for us
as an industry to also see where the FDA may be going with their future guidance. We know it
takes months for us to move these tools through our own processes. Knowing where we can take
them today and possibly tomorrow helps us move the process along more effectively when it comes
to mobile app exploration; while never losing sight of the safety priority aspects for our patients
and customers.
Reaction by Robert Palmer, EVP, Managing Director, Juice Pharma Worldwide and
DHC Advisory Board Member
The FDA’s final guidance on mobile medical applications has elicited a collective sigh of relief
throughout the pharmaceutical industry and its agencies. The FDA has not handcuffed pharma with
unreasonable or burdensome regulation; to the contrary, it has taken a relatively enlightened
approach. But for pharmaceutical marketers and regulators there are potential unintended
consequences that could inhibit innovation or add to the time and expense of bringing new apps to
market. As is the case with the digital revolution in general, cultural shifts need to happen for
those who want to capitalize on technological advances.
While pharma loves guidelines, the interpretation of those guidelines frequently err on the side of
caution. The FDA’s intent to “exercise enforcement discretion” is coupled with a relatively broad
interpretation of what does and doesn’t make an app a medical device. That interpretation hinges
on how the app claims to diagnose, cure, prevent, or treat disease and the overall risk to the
patient if the app were to fail to operate correctly. All of this is wrapped in the FDA’s core
mission of interpreting whether a given product raises public health concerns. This leaves a loosely
defined, more complicated range of interpretation up to pharma’s internal regulators in what will
certainly be an extended pre-screening process. In this scenario it’s entirely possible that while the
FDA won’t inhibit innovation, regulatory self-policing may very well create roadblocks that ensure an
application never sees the light of day.
The response to this potential problem should be a concerted effort on the part of a
pharmaceutical company’s marketing and regulatory staff, aided by its agency partners, to create
protocols that help score and establish whether or not an app is within FDA guidelines. While little
can be done to expedite the FDA process, the internal regulatory process can be greatly enhanced.
An end-to-end protocol can be established for early approval of the general concept, careful
attention to how the app will be developed and QA’d within the platform, rigorous review of the
complex algorithms that drive clinical decisions, and early approval of appropriate disclaimer
language and how and when it is displayed.
Post-launch promotion of these devices should be thought out in the early conceptual stages. It is
often the case that apps are viewed within a vacuum, ignoring the fact that there is a large
ecosystem out there in which promotion is key. There has to be a very precise representation of

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Digital Health Coalition
what the app can do and what it wasn’t designed to do. This up-front rigor can pressure-test a
concept and avoid costly misfires.
Pharma needs to set clear internal regulatory guidelines that are specific to mobile app production.
Equating the review of a mobile application with development of a Web site will create lengthy
timelines and tortuous twists and turns in the process. When an app goes to the FDA to determine
its value as a medical device it is crucial that it is submitted bug-free and that the underlying
algorithms are validated and consistently reliable. There are currently almost 100,00 mobile health
applications in the major app stores, and there are virtually no standards regarding how well they
operate or how reliable the data is that they produce. But the risk is relatively low in most cases
because the apps don’t determine a clinical course of action. Since the FDA isn’t seeking to
regulate simple general-purpose tools that perform simple calculations, special attention must be
given to those apps that determine a course of clinical action based on complex algorithms and
solid underlying technology.
The potential upside to the pharmaceutical marketplace is enormous –
innovative, well-designed, reliable applications can save time, money, and lives. The potential
downside is that pharmaceutical marketers will consider the four to eight months of additional time
required for FDA review, on top of the perceived strain on internal regulatory resources, to be not
worth the effort. The risk/reward equation needs to be mitigated by the development of an
efficient internal regulatory process and careful preparation for delivering a compelling presentation
to the FDA.
The pharmaceutical industry and its agency partners, working together, can position themselves to
take advantage of this enlightened FDA decision. It will take some adjustments in both culture and
methodology, but it will be worth the effort.
FDA’s Mobile Medical Apps Final Guidance available here:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM26336
6.pdf
FDA’s press release on the final guidance available here:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm
For more information on the DHC, please contact Managing Director, Christine Franklin, at
cfranklin@digitalhealthcoalition.org or 410-344-7580.