Not long ago, the American Enterprise Institute (AEI) hosted an event titled, "There's a medical app for that – or not: Regulatory threats to mobile health information technologies." It was an extension of a recent Wall Street Journal article, focusing on the FDA, medical apps and the future of mobile health IT.

"All eyes are on the Supreme Court – everyone's starting at the Supreme Court, but that's not the only healthcare news in town," said J.D. Kleinke, resident fellow at AEI and healthcare business strategist. "An attempt has been made by the FDA to expand its mission to one of the more dynamic and important issues happening in healthcare and that's health IT generally, but more specifically, mobile applications."

"For the most part, health IT is a politically neutral zone," he continued. "People from the right and the left agree a computerized healthcare system makes more sense. It's a bipartisan idea, whose time has not just come but is long overdue."

Kleinke and Joel White, executive director of the Health IT Now Coalition, outline five points to consider with regard to regulatory threats to mobile health IT.

1. The FDA has taken an interest in mobile apps. In July of last year, the FDA issued its Draft Guidance on mobile medical applications. "So increasingly, we're seeing that in the market place, as more consumers become comfortable with IT and doctors use apps to treat patients, the FDA is looking at these technologies and have been for some time," said White. "IT is rapidly advancing, and they had to think about the advancements and how that'd fit into a regulatory framework." Essentially, he said, the Draft Guidance for mobile apps does a couple things. For instance, it makes it so apps fall under FDA regulatory authority as medical devices and would be classifies as Class One, Class Two, and so forth, based on what the app does in conjunction with diagnosing the patient. "It would have to go through the regulatory structure for approval," said White. "And if [the app] isn't considered a mobile device, it wouldn't have to go through this process."

[See also: Mobile health advocates say meaningful use is part of their plan.]

2. Issues arise with mobile apps and the 510(k) process. Devices are now classified under the same risk structure as the 510(k) process, which "isn't known as a rapid process," said White. "If you think about the life cycle of apps and software, generally, it is very rapid. So that change in the actual app may trigger some change in the regulatory structure if they go through the 510(k) process." He added that although the FDA does have an "appropriate role to play" in ensuring the safety and effectiveness of these apps, according to the IOM, the 510(k) process has significant issues, most notably, the length of time to get approval. "Most poignantly, the IOM said last year in a report, that the process wasn't working well for the industry or for patients," he said. "So clearly, the process has some challenges."

3. Risk factors do exist when it comes to mobile apps. An IOM report, which was released last November, did confirm three serious issues that exist with regard to mobile apps. "A panel of experts looked at issues of health IT and patient safety, and they concluded serious risk factors," said White. "Errors with how IT operates, errors with how physicians use IT, and information asymmetry issues, or information about a patient or care treatment protocol that wasn't available when using the technology in ways it was intended." What IOM concluded, he said, was there wasn't coordination across agencies, where these issues touch base in jurisdictions. "None of the agencies have resources at their disposal in terms of expertise to address some of the follow-ups in regard to patient safety."

Continued on the next page.