Dig ita l Health Coal i t ion

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 Dig ita l Hea lth Coal i t ion reached out to severa l thought leaders in the industry – and members – to get the i r react ion with regard to what th is means for the industry, developers, start-ups and innovat ion overa l l .

React ion By Marc Monseau, Managing Partner , Mint Col lect ive 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 Development of mobile medical apps that started based on the 2011 draft guidance can continue unabated.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 F INAL GUIDANCE

September 26, 2013 From The D ig i ta l Hea l th Coa l it ion

 

Dig ita l Health Coal i t ion

React ion by Er ik Hawkinson, Vice Pres ident, G loba l Head of Strategic Market ing Roche Diagnost ics 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.

React ion by Robert Pa lmer , EVP, Managing Director , Ju ice Pharma Wor ldwide 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

 

Dig ita l Health Coal i t ion

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/UCM263366.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.