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Mobile Apps and the FDA: What You Need to Know

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Posted March 24, 2015 By Joe Stanganelli     Feedback

The impetus is on enterprises to know how and to what extent the FDA may regulate mobile medical apps.

With growing interest in mobile medical apps among health care providers, enterprises need to educate themselves on the possible regulatory requirements for such apps. A good place to begin is a guidance document on mobile medical applications recently issued by the Food and Drug Administration (FDA).

For the purposes of its guidance, the FDA defines a mobile medical application as a mobile software device that "is intended to be used as an accessory to a regulated medical device" – such as "stand-alone software…used to analyze medical device data" – or intended "to transform a mobile platform into a regulated medical device."

The first legal question is whether an app is a "device" at all under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the pertinent regulatory statute at issue here). 

The answer goes to purpose and intent.  In general, under Section 201(h), the term "device" refers to a tool or related item that, if not already officially recognized as such, is…

"…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."

Thus, the FDA notes, any sort of software (whether on a mobile device, a traditional computer or in the cloud) can fall under FDA device regulation if it is intended to diagnose, cure, mitigate, treat or prevent a disease; or to affect bodily structure or function. This intent can be shown by advertising, labeling and other claims by the manufacturer.

The example the FDA gives: an app that operates an LED. If the app is intended for and marketed as an illumination tool, it is not a medical device. If, however, the app is specifically marketed as a light source doctors can use to examine patients, "then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope."

Legal Nitpicking and the Apple Example

This is the kind of legal nitpicking that Apple has been wending its way around in selling iPads to doctors and hospitals. Apple conducts what has been described as a "stealth campaign" in directly targeting its marketing to medical professionals and establishments through its medical market manager – a tricky tightrope walk indeed.  As Wired observed in 2011:  "the [FDA] seems set on regulating the software that runs on the iPad, not the device itself, but if the FDA were to decide that Apple is marketing the iPad for regulated medical uses, it could unleash a regulatory nightmare on the company."

Apple has been successful thus far in avoiding regulatory entanglement with the FDA.  Last year, the FDA even went so far as to announce that it would forbear from regulating tools like Apple's HealthKit.

FDA Stance: Function vs. Platform

It is important to note that just because the FDA can apply strict regulatory standards to mobile apps does not mean that it will. The FDA affirms in its guidance report that it "intends to apply its regulatory oversight to only those mobile…medical devices… whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended."

By taking a functionality approach rather than a platform-based approach, the FDA is allowing generic tablet and smartphone sales to continue on relatively unfettered.  Therefore, for the purposes of its guidance document, the FDA is only considering a mobile app to be "medical" where patient safety might be a concern.

The forbearance news represents a load off for makers of many "wearables" and common health apps that perform such functions as keeping track of the user's pulse, calculating body mass index or otherwise allowing the user to self-monitor his or her own basic health information (so long as those apps do not offer treatment suggestions).

"Those are not normally folks who play in 'FDA Land' on a regular basis," noted Jake M. Holdreith, a partner at Robins Kaplan LLP, in a recent FDA-compliance webinar hosted by his firm.

Forbearance Is Not Forever

Still, forbearance may not last forever – so makers of medical apps that the FDA is excusing from oversight for now must nonetheless exercise caution and compliance.

"It falls on you to determine if you are regulated and comply," emphasized Holdreith, adding, "How you advertise your product makes all the difference in the world."

Indeed, these advertising concerns can have far-reaching effects – particularly when it comes to matters like patent litigation.

"It's…helpful to note if your [trial] opponent has some compliance problems or might not be able to take certain positions because they have compliance problems," explained Jamie R. Kurtz, an associate at Robins Kaplan.

"[W]hat you say and what you do in regulatory documents and how you choose your regulatory pathway can have a huge [impact] on litigation," Holdreith said.  "When we know our opponents are constrained by regulatory boundaries, that gives us a leg up."

So important are these regulatory compliance considerations to patent defense and other preventative law considerations, Holdreith pointed out, that it is not uncommon for companies to involve trial attorneys while making regulatory decisions and drafting related documents – lest they someday be caught between a rock and a hard place.

As for those apps with which the FDA does concern itself?  Their manufacturers must adhere to a plethora of FDA requirements, including but not limited to: filing annual registrations with the FDA, complying with federal labeling regulations, complying with federal quality-control frameworks for making and distributing their regulated apps or devices, and notifying the FDA whenever they have reason to believe that their regulated apps or devices have contributed to or would be likely to contribute to death or serious injury.

For now, though, it appears as if the FDA is trying to not step on the toes of innovation so long as patient safety risk is minimal and app makers are careful with their claims and advertising.

Kurtz offers what she calls a "good guidepost" for app makers in doubt: "What is the mobile app intended to be used for, and can it be used in a way that a medical device can be traditionally used in?"

Joe Stanganelli is a writer, attorney and communications consultant. He is also principal and founding attorney of Beacon Hill Law in Boston. Follow him on Twitter at @JoeStanganelli.

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