This post was written by Deniz Temelli, Business Analyst at TechAlliance
In a previous blog post, I looked into the differences between the life science and digital media industries, including development timelines, level of investment capital needed and infrastructure requirements. One area that brings these two together and removes many of the differences is medical smartphone apps.
In my last blog post I looked into the various health and wellness apps that are gaining momentum in the consumer app space. In this case, I mean medical apps which actually aid in the diagnosis and treatment of specified disease states. These apps go beyond simple fitness and diet apps which are targeted towards wellness, not illness.
Traditional medical devices require regulatory approval which includes providing safety and efficacy data. As with many industries, regulations and policies lag behind technology advancement, and this is no different. With the proliferation of smart phones and the connectivity and accessibility they provide, it’s no surprise that companies are trying to apply that value to the health care industry. But as lawmakers are still trying to understand the space in order to figure out how best to regulate it, we are in a situation where medical apps can be freely used by anyone, which may be do more bad than good.
A recent study published in the JAMA Dermatology compared the accuracy of four skin cancer consumer apps in which users take a picture of a mole and the app determines whether it is melanoma or not. Although the apps varied in terms of their diagnosis accuracy, one of the apps was only 6% accurate. The potential impact of this result is scary, especially considering this is only one app within one medical specialty. It is clear that some sort of regulatory framework must be applied to medical apps.
In July 2011, the FDA released draft guidance for mobile medical app regulations. Although it only covers a small portion of apps and is still very general, it does show the direction that the regulations are headed. Essentially, similar to traditional medical devices, an app that helps treat or diagnose a disease by analyzing or manipulating data or images, or that allows a smart phone to control a medical device will likely be at least a class 2, which requires safety and efficacy information. In July 2012, President Obama signed new legislation allowing the FDA to proceed with their draft, signalling the increased momentum for these regulations.
In an industry when the best new apps have a shelf life of 6-12 months, an unknown regulatory path which could potentially take 12-18 months could hinder innovation and leave developers in limbo. So in the meantime, before these regulations are official, what does this all mean for companies who are developing new medical apps? One approach would be to stay ahead of the curve and get approval right now, before the regulations are solidified. But it seems like every few weeks a new high profile app gets FDA approval, so this may soon be the norm, even before legislation is passed.
A second option would be to scale down functionality of the app in order to release a non-classified app then begin to roll out features as the regulations become clear. There are countless other ways to approach this situation, all with various pro’s and con’s. But one thing is certain, regardless of whether FDA regulations are in place or not, a medical app should be fully tested to ensure patient safety is not compromised, otherwise the whole purpose of mobile medical apps is diminished.