A recent article in the Washington Post raises concerns about the legitimacy of mobile health apps.
As chairman of the committee that developed Draft Standards for the Happtique App Certification Program, I applaud the author for taking a critical look at the "Wild West" of health and medical apps. We developed rigorous standards around safety, privacy, operability and content of the apps. The draft standards were open for comment and the final standards will be made public soon and the Certification Program will begin in the next few months.
We see these standards as a compliment to FDA oversight. This article is a sobering contrast to another that described FDA oversight of medical apps as an assault on the industry. While there are common issues around both consumer and medical apps, there are significant differences. Consumer health and wellness apps not classified as medical devices (see FDA oversight) will not fall under FDA auspices because of their low risk of harm. The FDA estimates that a minority of apps (those defined as mobile medical apps) will require FDA consideration. Those will include apps that function as a traditional medical device or are part of or extension of a traditional medical device. These apps have the potential for harm, which is the prime concern of the FDA.
Other apps defined as mobile medical apps will fall under a discretionary category. Those would include patient self-management apps and simple tracking or trending apps (not intended for treating/adjusting medication).
There are unanswered questions at this time. What is the FDA's role in regulating software? There is a suggestion that there will be separate draft guidance with regards to this. What is specifically meant by "enforcement discretion?"
As a former cardiac electrophysiologist, I consider medical mobile apps to be a bit similar to catheter ablation for arrhythmias from the standpoint of timing of FDA guidance and the maturation of the industry. Initially, the catheter technology for radiofrequency ablation to treat heart rhythm disorders was developed and widely adopted before FDA guidance for human use was developed. It was used for some rhythm disorders (atrial fibrillation) before large clinical trials were mandated by the FDA in order to evaluate its efficacy compared to medications. (It has since been shown to be effective.)
The release of final FDA guidance will, I am convinced, lead to studies of efficacy of mobile medical apps. As with the introduction of any new technology, there is quite a difference between adoption that might bring financial success and positive efficacy studies that would signal clinical success (though the latter usually results in the former).
The cat is out of the bag. Medical mobile apps are here and I believe here to stay. Efforts on the part of the FDA, Happtique, NIH/PCORI initiatives, Johns Hopkins and Duke University will help, as a group, to identify safe, reliable and effective apps. Healthcare practitioners, app developer/owners and mHealth adopters should come together and embrace developments like app certification and efficacy studies.
There are plenty of willing partners to join these efforts that should be seen as the cost of doing business because nobody wants their product to be labeled "flimsy medicine" or "snake oil." Let this "flimsy medicine" article be a call to arms signaling the true maturation of mHealth technology developers and we won't read stories like "As Boom Lures App Creators, Tough Part is Making a Living." If medical app companies want to really make a difference, they should do more than chant the mantra of "better outcomes and less cost."
David Lee Scher is a former cardiac electrophysiologist and is an independent consultant and owner/director at DLS Healthcare Consulting, LLC, concentrating in advising digital health companies and their partnering institutions, providers and businesses. A pioneer adopter of remote cardiac monitoring, he lectures worldwide promoting the benefits of digital health technologies. Twitter: @dlschermd, He also blogs at http://davidleescher.com. He was cited as one of the 10 cardiologists to follow on Twitter and one of the top ten blogs on healthcare technology.