The U.S. Food and Drug Administration made the biggest mHealth news of the year when it published its regulatory strategy for mobile medical apps.
At the 2013 mHealth Summit Dec. 8-11 in National Harbor, Md., Food and Drug Administration (FDA) Commissioner Margaret Hamburg will deliver a rare keynote address to developers and healthcare providers to offer insight on the agency's plan for overseeing the safety of mHealth information systems moving forward.
"With the FDA guidance being released, and all the issues that are very topical right now, it's really the best time for the FDA commissioner to come to the event," said Rich Scarfo, mHealth Summit director. He added that since its founding four years ago, the conference has worked closely with the FDA, the National Institutes of Health and the U.S. Department of Health and Human Services. Those relationships paved the way for the commissioner's appearance. "It's the right platform and time for her to address the audience."
Despite the FDA's guidance, there's still a struggle on Capitol Hill to find the balance between promoting patient safety and inadvertently stifling innovation through regulation, said Robert Jarrin, mHIMSS advisory council chair, who testified before Congress in November on mHealth regulation. Rep. Marsha Blackburn (R-Tenn.), who introduced a bill to limit regulations on mHealth as well as clinical decision support systems, EHRs and other health IT software, offered her perspective at the hearings, along with representatives from industry, healthcare providers and the FDA, among others.
"The final guidance itself covers a very small subset of apps; it doesn't cover every single health and wellness app that's out there," said David Collins, mHIMSS senior director..
But despite the different perspectives on FDA mHealth regulation between Rep. Blackburn and the agency, she and Jeffrey E. Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, agreed that no one wants to slow down innovation in healthcare, Collins added. "FDA did that on purpose so it doesn't impact absolutely everything that's being developed."
The Food and Drug Administration Safety Innovation Act Workgroup plans to release a report to Congress in January offering additional clarity on the mHealth regulations, which could ease developer worries about future apps. That report, Collins said, would likely precipitate more congressional hearings about mHealth regulations in the spring.
Mobile-enabled meaningful use, ACOs
Other hot topics at the 2013 mHealth Summit will include patient data security on mobile devices, how payers are using mHealth to promote wellness, and also how U.S. healthcare can tap into the big data sets collected through mHealth apps to get better insight on treatment and motivations for patients to lead healthier lifestyles. There will be more sessions and keynotes focused on healthcare provider IT leaders attending this year's conference, including areas of interest tied to the HITECH Act's EHR incentives, such as mobile-enabled efficiencies promoting patient engagement, as well as chronic disease care, a linchpin of the Affordable Care Act's accountable care organizations (ACOs).
A whole track, "mHealth in the Hospital," is devoted to "the value equation of keeping costs down and increasing care quality -- and mobile is one of the kingpins here in making that happen," Collins said. One of the sessions, "Big Data Trends: Accessing Information at the Right Place and Time," will explore how providers can harness the data streams coming through mobile devices and social media to find useful information about their patients.
Don't forget clinical data security
As mHealth apps and device users proliferate over the next three years -- Gartner Inc. estimated nearly a half-billion tablets alone will be sold annually by 2017 -- and as new HIPAA requirements make protecting patient data a priority, data thieves will have exponentially more opportunities to rip off patients. Because of this, software developers and their healthcare provider customers are putting more emphasis on mobile device security.
Leaders at the mHealth Summit hope to drive home the point of how vulnerable these devices can be with a live hacking demo. Not to give attendees ideas of how to steal data, Collins said, but to show them how real these risks are, and what's at stake if security isn't baked into mHealth data systems.
"As mobile becomes more prominent, and more used, people want to make sure it's secure," Collins said.
Scarfo added that previous mHealth Summits might have emphasized the potential for mobile technology, but now it's also time to increase scrutiny on security because of the skyrocketing number of patient encounters using the apps.
"Instead of what's coming down the road, now it's: 'It's here, how do we deal with it, and what are the things we need to pay attention to?'" Scarfo said.
Editor’s note: This story has been updated to reflect that Robert Jarrin, mHIMSS advisory council chair, testified in Congressional hearings on mobile health regulation policies, not David Collins, mHIMSS senior director.