What exactly qualifies an app as a medical device? The healthcare industry has been waiting for a little more clarity on this issue ever since the FDA said it would regulate medical apps that can be used as an accessory to a medical device or transforms a mobile platform into a medical device. Well, the FDA has finally released its final guidance on medical mobile apps to offer a clearer definition of a medical device app and what they plan to do with those apps that fall into that gray space between just an app and a medical device.

The final draft guidance does not offer too many surprises from the original draft released in July 2011, but the addition of several appendices offer manufacturers examples of the types of apps that will and will not be regulated. Perhaps the section most relevant to marketers in this industry is: Appendix B: Examples of mobile apps for which FDA intends to exercise enforcement discretion. These are the apps that may qualify as medical devices, but pose a lower risk to the public so the FDA will not regulate them at this time. Some examples of these apps include:

  • Mobile apps that keep track of medications and provide user-configured reminders for improved medication adherence.
  • Mobile apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women.
  • Mobile apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location.
  • Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home.
  • Mobile apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported.
  • Mobile apps that provide patients a portal into their own health information, such as access to information captured during a previous clinical visit or historical trending and comparison of vital signs (e.g., body temperature, heart rate, blood pressure, or respiratory rate).

The Agency provides a few more examples in this category as well as apps that are not remotely considered a medical device (such as medical dictionaries or textbooks) and the apps that will be regulated along with some examples of current regulations. Now that the industry has a better idea of how the FDA plans to approach apps, the question becomes whether this will change the industry’s approach to apps and how this guidance will ultimately help and/or limit the industry.

“That sound you’re hearing from our industry is a big exhale,” exclaims Frank Saia, General Manager at Group DCA. “This is because the new FDA guidelines regarding mobile medical apps will lift a great burden off both healthcare agencies and pharmaceutical companies alike. We believe this new environment could potentially speed up the process of bringing apps to market as long as they are developed with the new guidelines in mind.”

How The Guidance Will Help The Industry

John Avellanet, a Managing Director & Principal at Cerulean Associates LLC and an expert on FDA compliance issues, says that these guidelines will help current app developers in three ways:

1. The FDA’s “rules of the road” are now much clearer, so this should help developers understand where and how to draw the boundaries of what their apps can and cannot do if they want to avoid detailed scrutiny (and lengthy review processes).

2. This will also help developers and marketers promote usage of their medical apps by patients, physicians and other healthcare providers. The guidance and FDA’s webpage on medical apps can give users confidence that their medical app followed the rules—this is something that savvy marketers and developers can point out.

3. This can help speed up the development and adoption of mobile medical apps. If I know the rules of the road, and I know what I want to achieve with my app, I can now clearly figure out a way to get there without running afoul of the FDA or inadvertently causing my app to come under greater scrutiny and review.

“It is a good step in the right direction,” says Ben Putman, VP, Director of Emerging Technology and Media at Juice Pharma Worldwide. “The guidance lets us move forward with providing useful apps to patients and healthcare providers, while still giving the FDA the ability to regulate in the future. Pharma companies will have their own processes to manage risk, which could extend the time-to-market initially, but ultimately I think the regulation will allow for a more efficient process than currently exists.”

Where Companies Still Need to be Cautious

In the FDA’s own tweet chat on this topic on September 26th, the official Twitter handle for FDA Medical Device news, @FDADeviceInfo, proclaimed this a “a big de-regulatory action.” But that doesn’t mean app developers should just read these guidelines and feel comfortable if they are not listed under the “will regulate” category, especially if they fall into the “enforcement discretion” category.

“Enforcement discretion does not mean the absence of regulatory considerations,” says Marian J. Lee, a Partner at the FDA & Life Sciences Practice Group at King & Spalding. “FDA ‘strongly recommends’ that manufacturers of all mobile apps—even those within enforcement discretion—comply with the Quality System requirements in design and development and the initiation of timely corrections to the apps in order to protect the public health.”

Neil F. O’Flaherty, Principal at OFW Law where he concentrates in the area of FDA regulation of medical devices, adds that while a lucky few will have their app addressed specifically in one of the guidance’s appendices, many will be left wondering whether their app is a close enough analogy to one of the examples provided or where their app falls if it doesn’t come close to any of the examples listed. In those cases, the companies developing apps may need to seek out advice from a specialized attorney or consultant or even reach out directly to the FDA.

“It is important for these firms to develop a defendable position as to where their apps land in the scheme of things under the final guidance,” explains O’Flaherty. “Having such a position can be very important if the FDA questions or scrutinizes your app’s regulatory compliance status in the future.”

The other main area of concern may be in the app store. Bradley Merrill Thompson, a Member of the Firm at Epstein Becker & Green, P.C where he leads the Medical Device Regulatory Practice, says that lately the Federal Trade Commission (FTC) has also been making noise about focusing on health apps and they have jurisdiction over all apps—whether related to health or not. The FTC requires truth in labeling, which among other things means that any claims that app developers make have to be substantiated with appropriate evidence. Thompson adds that the FDA also cares passionately about labeling and instructions for use and the summary at the point of purchase is a very key element for creating the intended use of the product. This means that both the FDA and FTC will be paying close attention to what developers say about their app.

Avellanet explains how companies can take precautions: “First, make sure to be clear in your app—within the code itself (such as in a commented section)—the purpose of the app: Is the app informational and educational; is it designed to supplement and help patients and physicians manage a condition; or is it designed to actually diagnose and/or treat patients (e.g., act as a medical device). Second, make sure this purpose is clear in the marketing write-up (app store summary) of your app. The app is either information/educational or the app helps managing a condition or the app is a medical device. You can’t be a little bit pregnant, and an app can’t be a little bit of a medical device.”

Which Questions Still Need to be Answered

Thompson believes that this guidance is actually the least helpful to pharma companies since it fails to address clinical decision support (CDS) software, which the FDA is supposed to include in its full report on Health IT, which is due to Congress by January 2014.

Thompson says that the “high-value” pharma apps are those that can help guide treatment, and most of those would use CDS software. For example, apps that could allow the clinician to enter all the relevant information about a patient’s weight, sex, age and anything else that impacts the proper dosage in order to produce a specific dosage recommendation. Or, when instructions for how to use a certain medication are really complicated, pharma companies would like to develop apps that really lead the doctor through the prescribing decision-making process to ensure that a patient truly is a good candidate for the drug. Meanwhile, Thompson says that the FDA itself is open to using apps and perhaps software that would be deployed at a pharmacy as a basis for assessing whether a patient should take a given drug. But, all of these types of apps are not addressed in the current regulation, so developers will have to wait for the report due in early 2014.

In fact, Dan Haley, Vice President of Government and Regulatory Affairs at athenahealth believes we will not have true “clarity” from the FDA regarding apps until that report is released.

“Bear in mind that every single page of the [recently released] guidance bears the header ‘Contains Nonbinding Recommendations,’ ” explains Haley. “The guidance, in other words, is nothing more than a statement of present regulatory intent. That is well and good, but it certainly does not provide anything approaching regulatory clarity.”

Thompson, however, says that the FDA is legally required to include that statement about the recommendations being nonbinding on every single guidance document. Consequently, for all practical purposes, the industry can rely on the guidance.

“That said, the FDA can change its mind, and they specifically left open the possibility, but doing that would mean first revising the guidance document by going through the rather elaborate notice and comment process,” says Thompson. “They would not do it by surprise nor would they do it retrospectively. Everyone would get considerable advance warning.”

Haley does feel, however, that assuming that the FDA sticks to its statement of present intent, the pace of growth and innovation in the mHealth industry will not be negatively impacted. And other mHealth developers agree.

A mHealth Developer’s Take

WellDoc, a healthcare company that leverages technology to improve clinical outcomes and reduce healthcare costs, was one of the first companies to receive FDA approval for their diabetes mobile medical device back in 2011. Chris Bergstrom, Chief Strategy & Commercial Officer of WellDoc, says that there were really no surprises in the guidance and that it has not affected WellDoc’s strategy when it comes to developing mHealth products.

“The guidance is a win for the industry as it ensures patient safety and removes regulatory uncertainty, which will further stimulate investment in what is already perhaps the hottest sector of healthcare,” explains Bergstrom.

He adds that there are currently two camps in healthcare:

1. Those who believe healthcare will always be inefficient, inconvenient and stuck in the dark ages.

2. Those who are optimistic that just like every other industry from financial services to media/entertainment, we can leverage technology to radically transform the quality and efficiency of healthcare delivery. Digital health is the embodiment of this camp and the recent guidance simply allows for a clearer path for those that pursue innovations designed to radically and positively impact healthcare.

“We are entering the great wave of ‘data capture,’ which will be quickly followed by ‘data sharing’ and culminating in the true value creation of ‘data analysis,’ ” says Bergstrom. “These waves are codified in the Meaningful Use criteria, and mobile health will be the lead surfer as each wave rolls across healthcare.”

The Future of mHealth

According to Haley, Health IT—including mobile health IT—has tremendous, still largely untapped potential.

“I believe Health IT will continue to grow and improve, realizing in small but steady steps the great potential to revolutionize healthcare,” says Haley. “[That is] if the FDA and the rest of the government can manage to avoid the kind of regulatory overreach that stifles innovation in other industries.”

For instance, Brad Einarsen, Director of Digital Insight at Klick Health thinks that the biggest news to come out of the guidance was that “behavior modification’” apps, such as those that promote compliance and adherence, will not be regulated by the FDA.

“Companies that succeed in mobile will be the ones that integrate these behavior modifying apps with traditional therapeutic products,” says Einarsen. “If apps are seen as part of the product development process, rather than just as a marketing effort, they can be developed with the rigor and testing required to show measurable patient benefit.”

And in today’s environment, pharma must go beyond traditional product promotion to look at how the industry can best promote improved patient outcomes, says Dale Cooke, Vice President/Group Director, Regulatory Review at Digitas Health. In fact, Cooke says that at Digitas they call it the “Helping, Not Selling” mindset.

Putman, from Juice Pharma Worldwide, agrees. He also believes that the ability of apps to help increase adherence, to connect patient communities and to streamline healthcare is enormous. Furthermore, he thinks this is a great opportunity for pharma companies to demonstrate their commitment to improving overall health outcomes by delivering value through such apps.

“A well-executed, thoughtful app that provides value to patients or doctors increases confidence in the company’s commitment to treating the condition and supporting the patient,” says Putman. “It can provide the daily positive reinforcement that the brand is truly there to improve patient outcomes.”

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