For months now, I’ve called for the FDA guidance to clarify medical device regulations as they apply to mHealth. While most vendors would shy away from stricter regulations and standards, I believe that FDA regulations are necessary for mobile applications and websites to ensure patient safety and privacy in this emerging space. This week my calls were answered, with the release of the FDA final guidance for mobile medical applications.
The long-awaited final guidance is a critical milestone for mHealth, and is largely aligned with what was anticipated based on earlier released drafts. But it’s what happens now that guidance is in place that will truly shape the industry. It’s critical for payers, providers and, ultimately, consumers to ensure that they are being broadly implemented.