The American Enterprise Institute (AEI), a Washington-based think tank, recently hosted an event to explore regulatory threats to mobile health technologies. The session expanded upon a Wall Street Journal article that reported on the Food and Drug Administration (FDA)'s growing role in the oversight of emerging medical apps.
As J.D. Kleinke, resident fellow at AEI and healthcare business strategist, pointed out, "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."
Here are six points to consider regarding regulatory threats to mobile health IT, attributed to Kleinke and Joel White, executive director of the Health IT Now Coalition.
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 In July of last year, the FDA issued its draft guidance on mobile medical applications.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 marketplace, 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 Essentially, he said, the draft guidance for mobile apps classifies apps under FDA regulatory authority as medical devices (Class One, Class Two, and so forth) based on what the app does in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."
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 for granting pre-market approval, 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 Institute of Medicine (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 exist when it comes to mobile apps. An IOM report, released last November, confirmed three serious issues 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." IOM concluded, he said, that there was a lack of 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."
4. Science fiction is turning into science fact. One question raised by White: How should we regulate critically important technologies going forward? "What does this mean from a market standpoint?" he asked. "Think about it – the pace of IT is fast and furious, and the pace has dramatically increased since the 510(k) process was instituted." To illustrate this growth and rapid pace, he said the industry is bringing science fiction to science fact. "In 2009, there was an Italian company that inserted an electrode in [a patient's] back to leverage their neurological system and the patient can make a bionic hand move," he said. "This isn't science fiction; this is happening. The question is, where do mind-control devices fit within the 510(k) structure? We need to think about this because technology is thinking about solving issues in a different way, and regulators need to be thinking about if the structure fits anymore, or are we trying to jam a square peg into a round hole?"
5. Technology has lapped the regulatory framework. It's easy to see how health IT has outpaced the regulatory framework when thinking about the amount of IT introduced since the draft guidance was released. "Retinal scanners, for example," said White. "Another example is cloud computing. Under FDA draft guidance, I don't know if they envision the movement to the cloud in a way that's picked up by the regulation; but in the final [regulation], that's something they'll have to take into account." White went on to question if Congress has a role in rebooting policy — something he believes should happen. "If Congress set the 510(k) process, we need Congress to get involved in setting the new regulatory framework for the new technologies," he said. "What expertise is available to make informed decisions, scientific decisions? Where's the regulatory science? If it's not in the agencies, we better get up to speed quickly to promote innovation and promote safety."
6. We need a new regulatory structure. Internally, White said, he and his team believe the industry needs a new regulatory structure to deal with all the emerging technologies. "The market is exploding; it's incredibly creative and innovative, and the regulatory structure has to match that speed." An example, he said, could be similar to what the Office of the National Coordinator is using to certify EHR products. "They have experts, external to the government, [whom they] partner with, and they test it," he said. "It should be expert-based. Software folks and engineers, they're incredibly creative, and they're coming up with stuff on the fly. The innovation is incredible, and we need to rely on that expertise in developing innovation and safety outputs."