In 2008 the team behind MIMvista stood on the stage at Apple’s World Wide Developer Conference to accept an Apple Design Award for its revolutionary medical Mobile MIM app, which allowed doctors to view full resolution medical images right from their iPhones. Only a few months later, the FDA would order the app be removed. It would be two more years before Mobile MIM would finally receive the FDA approval needed to list in the app store.
Apps Get The Same Treatment as an MRI Machine
Mobile innovation is evolving at such a rate that it has been difficult for government agencies to stay ahead of the technology, but the FDA is finally trying to play catchup. In July the agency released plans for widespread medical app regulation that would bring an end to the medical app free-for-all and bring clarity for medical companies like MIM Vista trying to bring legitimate health tools to market.
For doctors and consumers, this means a safer, more sophisticated app store; for medical companies and developers, it means a host of new costs and regulations to understand.
The FDA has long regulated medical software and software-based devices and has already approved a handful of mobile apps, including Mobile MIM. But outside these limited cases, apps have seemingly either slid under the radar without seeking official approval, or they become mired in the FDA review process. Under the newly proposed regulations, any app that operates like a medical device will be required to follow a set of quality guidelines, seek pre-market approval, and participate in recall, the same as any other piece of medical equipment. The government agency will essentially be able to treat medical apps with the same scrutiny as they do a new MRI machine.
Higher Standards Ultimately Help Consumers and Developers
The nearly 30 page document gives a detailed explanation of the type of apps covered and how they will be expected to comply with the regulations, but what we don’t know is how this change will affect the medical app industry. On one hand, standardization and review will elevate the perception of medical apps and demand a certain level of quality and standardization. Consumers and medical professionals will have the peace of mind that mobile apps deliver the quality they are accustomed to from any other medical equipment.
On the other hand, FDA review will add significant time and cost to medical app development. Since mobile medical apps are a nascent industry, developers and the FDA are bound to experience growing pains as they work together to shape regulations.
Medical companies and their development partners will have to work to understand both the letter and the spirit of the law, and in the end build out teams that can develop and document applications capable of withstanding FDA scrutiny.
Overall, the FDA’s requirements appear reasonable and represent a new level of legitimacy for medical apps. Since 75% of physicians in America say they use an Apple mobile device, and many more are surely using Android, BlackBerry, or Windows devices, the FDA’s move represents a significant milestone toward making those already commonplace devices as trusted and valuable as the stethoscope.