mHealth Monthly Mashup: Release 20.0 – Regulatory update

Michael Spitz


As our ‘digital and social media’ focus month commences, Michael Spitz provides a regulatory update in the space of mobile health in his regular ‘mHealth Monthly Mashup’ article. 

Regulatory update: finding a balance between safety, innovation, and implementation

Healthcare is a continuous battle between opposing, often complementary, forces. The tripartite war between speed, cost, and quality plays itself out in countless variations, as rising expenses, shrinking budgets, aging populations, and fragmenting technologies create a whirlwind of confusion and opportunity. Nowhere are these pressure points more acute than in mobile health, an explosive amalgamation of hardware miniaturization, clinical content syndication, user experience optimization, and point of care experimentation. Despite such rapid change and uncertainty, mhealth growth has been exponential to the point where new pressures are building, these coming from regulatory bodies justifiably concerned about protecting patients from erroneous form and function. Since safety is often at odds with innovation, and since innovation is the fuel that drives the mobile health industry, a rapprochement must soon be achieved between the nimble hands of technologists, and the long arm of the law. So this month, let’s take a look at recent news from the States that may foreshadow years and perhaps decades of mobile health guidance to come.


“…let’s take a look at recent news from the States that may foreshadow years and perhaps decades of mobile health guidance to come.”


Three Days in Washington, D.C.

The mission of the United States Food and Drug Administration vis-à-vis medical devices is to protect the public health by assuring their safety, effectiveness, and security. Back in July of 2011, this column covered the newly issued draft guidance for mobile medical applications, including an interview with Bradley Merrill Thompson, a regulatory expert and Member of the Firm at Epstein Becker &amp, Green. Central to the guidance was establishing criteria for an app to be considered a “medical device,” and therefore subject to some form of regulation. The good news was that the definition narrowed down the designation to only those apps that transformed a computer, smartphone, or tablet into a tool or accessory “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body.” In other words, the 38,000+ health and wellness apps and most of the 24,000+ medical apps would fall outside the requirement for FDA clearance or approval. That said, the draft guidance nonetheless left numerous unanswered questions that continue to persist

Since then, the government has not engaged in open discussion regarding the draft guidance until the Energy and Commerce Committee of the United States House of Representatives recently held three days of hearings from March 19 to 21, 2013. As Brian Dolan of mobihealthnews has pointed out, the culmination of the testimonies revealed details about FDA regulation of mhealth to date, including:

• Approximately 100 mobile medical apps have gone through the FDA regulatory process

• Approximately 67 days are required for a mobile medical app to get through the FDA regulatory process, compared to about 143 days for all submissions

• Approximately 20 mobile medical apps get through the process each year, amounting to only 0.5 percent of the total medical devices reviewed

• No “Class III” mobile medical apps (those that would require clinical studies to prove effectiveness of diagnostics or dosing) have been identified or approved yet

• The final FDA guidance on mobile medical apps is set for release by October 2013

Particularly interesting was the news that an incredibly small volume of mobile medical apps enter the system and gain approval, final guidance is set for release this year, and how even after that release numerous challenges and uncertainties will continue to persist and define the industry for years to come.


“Particularly interesting was the news that an incredibly small volume of mobile medical apps enter the system and gain approval…”


Guidance Implications for Mobile Health

Shortly after the House of Representatives hearings in March, Mr. Thompson posted an interesting prognostication of a dozen significant post-guidance regulatory issues for mHealth. Issues of paramount importance to mobile health entrepreneurs, developers, marketers, and clinicians in the months and years ahead include:

Pharmaceutical apps: lingering ambiguity

Are they an extension of drug labeling, or a point of care treatment tool? As they evolve, likely both—but the draft guidance does little to designate distinctions, the final release potentially creating ambiguity and uncertainty for an industry already paralyzed by lack of Web and social media guidance.

FDA enforcement: who will police mHealth?

The current rate of only 20 mobile medical apps that enter the system annually pales in comparison to the hundreds if not many thousands of apps likely needing clearance and approval. Already overburdened, the FDA needs to establish an efficient, fair methodology that helps ensure patient safety without stifling creativity.

FDA expectations: data and system requirements

What kind of information will the FDA need to approve an app? Part of that efficient, fair methodology outlined above must involve the judicious transfer of relevant input data, and software development processes actually reflective of how developers code for mobile. Since systems and approaches vary widely and change frequently, this could be difficult.

US and Global involvement: increasing control

The three days of hearings for mHealth were unprecedented, and evocative of the seriousness the American government is taking mobile health. The EU and other nations have similarly expressed intense interest both on the local and regional level, with variability of focus and approach, making for a complex worldwide playing field ahead.

The “accessory rule”: where does an app stop?

The FDA defines any device that attaches to a medical device as a medical device, requiring its own clearance or approval. Since digital devices are physically and wirelessly connected to each other and entire networks, this legacy rule creates tremendous confusion and if taken literally will make the entire process ridiculous and infeasible.

Health, wellness, and disease: the line between low risk and high

The FDA takes action most frequently regarding a health claim overlapping with a disease claim, such as when a food alleges it can treat a disease. The line between health and wellness and disease management can get tricky, creating potential situations where lower risk apps get too much scrutiny, and higher risk ones less. Some standard must be set.

Multiple stakeholders: hearing many voices

The government is bringing in experts to help draft and finalize the legislation, but the voice of most constituents is not being heard. Patients, advocacy groups, healthcare professionals and organizations, including entrepreneurs, technologists, and developers creating these apps need to be heard so the guidance reflects their needs and protects the user.

Best Practices for Mobile Health

Poised on the brink of formal and finalized mobile medical app guidance from the US government, what kind of recommendations can we offer mobile health entrepreneurs, developers, and marketers?

Keep lines of communication open, and ask earlier than later

If you have any questions about whether or not your app falls into the regulated categories, reach out and ask the FDA. Similarly, if questions arise during development then running questions and challenges by regulatory as they evolve can help mitigate complexities down the road and potential backpedalling.

Stay buttoned-up, and document everything

The FDA is largely asking for reviews, use cases, and testing that you, as a capable designer and developer, should be doing anyway. Complete documentation is particularly vital for any healthcare-related app, where computational algorithms and other functionality have implications on the users health and well-being.

Remain goal-oriented, and with the end-user in mind

Mobile medical apps serve a distinct purpose for a select target audience. Getting an app cleared and approved is a laborious process, one made all the more challenging if the final product fails to meet the needs of its intended audience. Follow proven best practices, and remain focused on the ultimate end-user—the patient.

Same suggestions apply, inside or outside the States

The world is embracing mobile health, and with it the need for protecting patients, their healthcare professionals, and the organizations sponsoring these investments. Open communication, thorough documentation, and focus on the end-user are all key to success, regardless where you build, and which regulatory body holds you accountable.


About the author:

Michael Spitz is SVP, Managing Director of the Healthcare and LifeSciences division of ZEMOGA. Spitz combines his passion for technology with more than 15 years of clinical content expertise to help engineer digital healthcare solutions. 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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