As the federal agency charged with regulating mobile health applications, the Food and Drug Administration has come under fire from the health IT industry for not moving fast enough to finalize its mHealth regulations. Industry critics are also concerned that when the final FDA guidance is released, their mobile health apps will be subjected to the same burdensome and slow approval process that medical devices must go through.
According to the Government Accountability Office (GAO), it takes six to 20 months for the FDA to approve medical devices through its complex, time-consuming process. That's exactly what mobile health application developers are worried about.
Consequently, Congressman Mike Honda (D-Calif.) has crafted legislation that would make it easier and faster for high-tech companies in his Silicon Valley congressional district to bring mobile health apps to market. His bill is an attempt to breakdown the "barriers to entry" facing small-to-large startup entrepreneurs in Silicon Valley, and to streamline the regulatory process and make it quicker and more efficient for technology companies looking to come out with new mobile health apps.
Clearly, though, technology companies and the FDA have different agendas. Profit and speed to market drive competition, innovation and entrepreneurship in any industry—including healthcare. But for the FDA, safety is paramount and the agency must seriously and soberly assess the regulations and approval process for mobile health apps.
Just as the agency does for medical devices, the FDA should not only review manufacturers' formal applications to market mobile health apps during its premarket review process, but should also monitor these apps once the agency has approved them through its post-market efforts. It would only be prudent. After all, some mobile medical apps could potentially have serious health and privacy implications for those who use them.
We're not talking about games or other benign applications that are run on iPhones and iPads. This concerns medical apps running on mobile devices whose performance, privacy and security must not be compromised. A recent GAO report found several information security threats that can exploit vulnerabilities in medical devices that could affect their safety and effectiveness.
Similarly, mobile health apps may have some of the same vulnerabilities that make them susceptible to unintentional and intentional threats.
For these and other reasons, the FDA must be allowed to perform due diligence in finalizing its guidelines requiring mobile health application developers to apply for agency approval. While the FDA has evaluated several apps to date, ultimately, the agency's future approval of apps will serve a critical function in helping consumers to cut through the marketing hype of companies by having a "good housekeeping seal of approval" of sorts, certifying which mobile health apps actually deliver on their promises to provide accurate information.
Time is of the essence for the FDA, though, to get its ducks in a row: The flood gates are already open and about to open even wider. Today, roughly 75 million individuals are using mobile phones for health information and tools, 14 million more than last year. And it is estimated that 500 million smartphone users will have medical apps on their devices by 2015.