The FDA released its long-awaited final guidance on mobile health apps in September and, by all accounts, the guidance is fair and reasonable but will go through changes in the future to address gray areas.

The guidance took the FDA years to produce because the agency had to “strike the right balance between regulating what needs to be regulated and not overstepping their lines thereby inadvertently thwarting innovation in healthcare,” says Murray Aitken, executive director of the IMS Institute for Healthcare Informatics. “It’s not an easy balance to strike for any regulatory agency so they’ve taken their time.”

The guidance could help clinicians, payers and app developers “embrace the role that apps can play in the care delivery model” and accelerate development of the most valuable apps, he adds.

‘A new world’

The guidance is a good start and FDA has taken a reasonable position, agrees Jonathan Linkous, CEO of the American Telemedicine Association. “I expect with time, there will be more clarification. [The FDA] needs some experience under their belt with some of these apps. It’s a new world we’re talking about.” The agency, he says, will need to work out the process such as the standards for approval and thresholds of devices for delivering on promises.

Meanwhile, FDA approval is important to the healthcare industry because “nothing else provides that quality standard. That’s important for those apps that affect human outcomes.”

The FDA’s guidance is a “precedent-setting piece of guidance that they wanted to ensure was vetted among multiple federal agencies to garner buy-in and collaboration,” says David A. Collins, MHA, senior director of mHIMSS. “This is not a simple issue, as the apps marketplace is developing so quickly, and there is such a proliferation of apps available to the consumer.”

The mobile medical app marketplace will need to work with FDA on the regulatory process, Collins says, applying the guidance and determining what works and what might need modification. But, he notes that the agency emphasized three times in the guidance the need for app developers to follow Quality System Regulations. “I believe the marketplace will weed out those who do not follow quality guidelines. It is a very competitive field, and one that will allow the apps with the most value [functionality and integrity] to rise to the top.”

Allowing for innovation

The implicit shared agreement allows the marketplace to innovate, Collins says, but stakeholders must be wary. “If the marketplace abuses this privilege, then the FDA can enforce more stringent regulation over all mobile medical apps, rather than a specific set of apps with the highest risk to patient safety.” This dynamic marketplace will need regular assessment to ensure that policy stays aligned with advances in technology, he adds.

The FDA included multiple examples in the guidance to provide clarity as to which apps will be regulated, which will not and which the FDA reserves to apply enforcement discretion. That segmentation tells the industry what will and will not be regulated. The fact that providers are able to author their own apps and share them with their peers within a practice, Collins says, speaks to the FDA’s acknowledgement that it supports innovation.

Another pleasant surprise, according to Jeffrey K. Shapiro, attorney at the law firm of Hyman, Phelps & McNamara in Washington, D.C., is that the FDA will use enforcement discretion for apps related to medication reminders rather than requiring 510(K) clearance. The FDA exercised “good commonsense” in that decision as “it didn’t make a whole lot of sense to treat them differently than other apps that are similar.”

Shapiro points out that Congress hasn’t weighed in yet. “Congress is still looking at the FDA’s regulations of software. I would say that this guidance is the FDA’s opening bid and it’s a pretty good one. They went to some length to minimize their regulatory footprint.”

It’s not the last word, however, he says, especially because a lot of the functionality in apps also is in all kinds of software. “Eventually, it’s all going to be merged and there will be an overall approach to software—sophisticated, stand-alone software that runs on servers or on handheld platforms.” These tools often are used to help with clinical decision support but don’t determine a treatment or run a medical device.

“Congress may weigh in with a different approach. This is still unfolding and we don’t know where this is going.”

Going forward

It’s only been five years since the iPhone launched so it’s difficult to predict how the mobile health app industry might change over the next five years. Aitken hopes, however, for apps that “more directly connect with areas that we know don’t function well within the health system.” Those include medication adherence, remote monitoring and information gathering especially for people over 65 with multiple chronic conditions. That population uses a significant amount of healthcare resources but very few apps are designed for them or their caregivers.

The marketplace also needs evidence that these apps are working in the way they are advertised, Aitken says, and randomized trials that show apps are making a difference in patient care and costs.

In the meantime, “guidance is guidance,” he says. “Regulation in healthcare is not a black or white situation. Those who expect any written guidance to be definitive, permanent and bring full clarity to the situation are misguided.” There are shades of gray and there will continue to be shades of gray. “As technology advances and we learn more about the risks and benefits of mobile health, we will see the regulators continue to evolve their views, particularly in those gray areas.”