When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Neil Ebenezer; and Brad Thompson of the Epstein, Becker & Green law firm, covered a range of territory related to the quickly developing realms of social media for healthcare purposes and mobile medical applications.
Pitts opened the session focusing mainly on social media, and emphasizing its place as a communications medium that is important not only to young populations but to everyone. He chided those life sciences companies which would ignore it altogether out of fear, citing the example of an unnamed large pharmaceutical company that refuses to monitor social media because it does not wish to uncover adverse events for which its responsibility and expected response are unclear. "We have to get over this," said Pitts. He argued that social media presents "the opportunity to do a better job" understanding how healthcare products are actually working for real patients in the real world, outside of clinical trials.
While the US Food and Drug Administration (FDA) may not have issued official platform-specific social media guidelines, Pitts told the audience that Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, has said FDA encourages the use of social media because it's where the people are, and that the agency understands the inherent issues of speed and timing, but doesn't quite know how to address them.
Intent is key, said Pitts. Putting social media to use as a tool for improving public health is the right thing to do and the right way to use the medium. It cannot simply be viewed as "the new DTC." "We need to go beyond marketing," said Pitts, who advocated for using social media as a tool for teaching and education and for interacting with patients, not as a one-way communications channel, and for marketing only in a tertiary way.
He asked regulatory professionals in attendance to think of social media in terms of risk vs. benefit, as they might about a drug or medical device. Like these products, social media comes with risk, but also can offer benefits to patients and companies.
The next two speakers, MHRA's Ebenezer and Epstein Becker & Green's Thompson, examined the regulation of software and mobile health applications in the EU and US, respectively.
Like social media, the usage of mobile apps for health-related purposes has grown rapidly over the past few years and continues to do so. Thompson, filling in for FDA Center for Devices and Radiological Health Policy Advisor Bakul Patel, who couldn't attend, cited Patel's slide showing the number of "health and fitness" apps growing from 9,428 in May 2011 to 17,828 as of October 2012, and the number of "medical" apps growing from 6,848 to 14,558 over the same period.
This presents regulators-in the US, EU and elsewhere-with the challenge of determining which of these apps are defined as medical devices, subjecting them to regulatory oversight. Again, Intent is important. As Ebenezer pointed out, software, including apps, can be considered medical devices under EU directives, but simply being used for a medical purpose is not enough to make software-mobile app or desktop-based-a device. If that were the case, an Excel spreadsheet could be regulated as a medical device. Thus, any software designed to keep medical records or with other administrative purposes would not meet the criteria, but apps that have a therapeutic or diagnostic purpose would, said Ebenezer.
In the fast-moving mobile app world, postmarketing surveillance is critical, and Ebenezer told attendees social media can play a role here, too, helping companies engage with patients. Echoing Pitts, he emphasized that mobile devices, telehealth technology and software solutions offer unprecedented opportunities to make improvements to diagnosis, monitoring and treatment.
In talking about the range of medical and health apps, Thompson divided them into three categories, according to FDA: the relatively few that clearly meet the criteria as regulated devices; the large number of health apps that are not under FDA's purview, such as calorie trackers and the like; and those in the middle that meet the textbook definition of a regulated device but represent such low risk that they are not worth pouring agency time and resources into regulating. This appraoch is "not unprecedented," he said, but "it is unusual for FDA to be so clear that they think they have regulatory authority but they're not going to exercise it." He said Patel would have told the audience that FDA plans to watch that "gray area" to see if it may regulate those apps in the future.
It is unclear where exactly FDA draws the distinction between a regulated app and one that is in this regulatory gray area, said Thompson. He is among those asking the agency for clarification on this point.
The challenge of regulating quickly developing technology and regulated industry's desire for more clarification from regulators were frequently repeated themes, both from speakers and audience members who asked questions of the experts. While there remain more questions than answers, it seems, and more gray areas than clear distinctions, there appeared to be general agreement on the need to move forward and not ignore emerging technologies out of fear or uncertainty.