FDA Issues New Guidance On Digital Health Products, But Provides Very Little Additional Clarity

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Last week, the FDA released new guidance on the regulatory stance it will take over digital health products, namely mobile health apps. The FDA issued long-overdue guidelines for the mobile health industry in September 2013, following years of urgent demands from industry advocates and Congress to clarify its role in regulating the budding industry. Within that guidance, the FDA established different regulatory requirements for high-risk and low-risk digital health applications.

The guidance was warmly received by entrepreneurs and investors because it defined most applications as low-risk and took a largely hands-off approach to regulation in those cases, but Congress found the guidance too restrictive and too vague. In November 2013, Jeffrey Shuren, MD, and FDA director over the Center for Devices and Radiological Health, was called to testify over the FDA’s new guidance. During the hearings, a bi-partisan committee of congressman lambasted the administration’s new guidelines.

By March 2014, a bipartisan group of senators launched an effort to push the FDA to further clarify its stance over low-risk apps. In a letter signed by Michael Bennet (D-CO), Orrin Hatch (R-UT), Tom Harkin (D-IO), Lamar Alexander (R-TN), Mark Warner (D-VA), and Richard Burr (R-NC), the congressman warns the FDA that the new guidelines may be unnecessarily ambiguous in their definition of low-risk applications. The congressman called on the FDA to clarify its definition of “low-risk” applications to help ensure that “innovation is not stifled through uncertainty or over-regulation,” and to help avoid “stakeholder confusion over how a wider range of medical software might be appropriately regulated.” Since receiving the request, the FDA has failed to provide any additional clarification. Congress has since moved on, and is now considering several new bills restricting FDA oversight on digital health applications.

Now, the FDA has responded to congressional demands, publishing new guidelines which attempt to clarify exactly what it considers a “low-risk” application, and how it will regulate this “low-risk” market. The guideline first defines what a “general wellness” application is, and then goes on to define what criteria must be met for a general wellness application to be viewed as “low-risk.” The new guidance starts out by assuring the public, and Congress, that the FDA will not engage in fishing expeditions looking for applications that may be out of regulation, explaining that the FDA:

“does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act”

Next, the new guidance provides clarity over what exactly constitutes a general wellness application. The guidance defines general wellness applications as ones that have:

(1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

Essentially, the FDA has defined the general wellness market broadly enough to include activity trackers, apps that addresses fitness, diet, and even apps that include disease-specific support features. The guidance breaks the “general wellness” market into two groups, saying that if the app does not make any disease-specific claims then it falls outside of regulatory oversight completely. Further, if the app does make disease-specific claims, but those claims are based on undisputed recommendations where “healthy lifestyle choices” can help treat or prevent a specific illness, then they also will be considered general wellness applications and thus exempt from oversight. Advising a user that their chronic condition could be managed better if they got more exercise, followed a different diet, or got more sleep would all be okay. 

Beyond defining what does and does not constitute a “general wellness” application, the guidance provides a decision-tree to help the public determine whether the general wellness application qualifies as a “low-risk” product – a key to avoiding oversight. The draft does not make any changes to the regulatory oversight it established for “high-risk” applications in its September 2013 publication. According to the new guidelines, a product qualifies as a “low-risk” general wellness application if it complies with the above definition, and does not, or is not:

1) invasive;
2) an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants;
3) raise novel questions of usability; or
4) raise questions of biocompatibility.

Therefore, according to the new regulations, the only digital health products that would require FDA review are ones that present users with disease-specific recommendations that go beyond simple healthy lifestyle recommendations. A digital health product could also be subject to oversight if it does not meet all of the criteria outlined in the definition of a “low-risk” application.

This new guidance will likely still leave the industry, and investors, with questions. At what point does an application introduce “novel questions of usability” and therefore lose its “low-risk” status? Where do patient portals or telehealth apps fit into the guidelines on what constitutes a “general wellness” application? They facilitate communication between patient and provider, and always include disease-specific recommendations that go far beyond advocating “healthy lifestyle choices.” Similarly, where do medication adherence applications fall in this guidance? Is reminding a patient with anxiety that they should take their medication a “well understood healthy lifestyle choice?”

These kinds of questions were vaguely addressed in the September 2013 guidance, which explicitly listed various types of digital health applications (including medication adherence, telehealth, and patient portals) that the FDA said technically did fall under regulatory oversight, but that would not be regulated. More specifically, the FDA said that it would “exercise enforcement discretion” over these applications, meaning they would not regulate them unless compelled to do so. It was this ambiguity that prompted Congress to seek more clarity from the FDA, after the September 2013 guidance was released.

Unfortunately, the new regulatory guidance issued by the FDA only clarifies that fitness and wellness-based applications will not be regulated, which leaves a large portion of the digital health community in regulatory limbo as it does not address whether these “grey-area” applications will be regulated, not regulated, or perpetually subject to the whims of the FDA’s “enforcement discretion.”


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