Big news in the mobile health world! The FDA approved final guidelines earlier this week on what is considered a "mobile medical app" and needs U.S. regulatory approval.
These much-anticipated mHealth guidelines come a full 27 months after the FDA issued draft guidelines and welcomed public comment, meaning the agency has spent a little over two years compiling extensive examples and finalizing the document for public release.
Being huge medical-mobile-health enthusiasts ourselves, we were excited to find out how FDA would frame its rules after so much speculation.
Significantly, the FDA has doubled down on the stance it took with its original draft guidance: they won't enforce or impose regulatory standards on mobile apps that simply log or track health data because they "pose minimal risk to consumers." They're focusing regulatory oversight on "a small subset of mobile apps that pose a risk to patients" because they interact with sensors or by some other direct action essentially turn mobile phones or tablets into medical devices, the Wall St. Journal reports. This could include future apps that actually control medical devices, like an insulin pump, via a smartphone.
We can't help wondering if there's any gray area at all between apps that just track blood and monitor diabetes data, and those that might provide more in-depth analytical tools and even suggest insulin doses to help us along...? In other words, apps that support medical decision-making...?
We reached out initially to three leaders in the diabetes tech world -- all heads of companies with FDA-approved products -- for their perspectives on the new guidelines and how they might impact us PWDs (people with diabetes):
Rick Altinger, CEO of Glooko
(a diabetes data management cable and app)
Really, this is not all that big of news for those of us who've been watching this. They came out with what they said they'd do in the drafts (two years ago), and they have a Cliffs Notes-style document for those who haven't had a chance to read all the guidelines. For us, it validates what we've been doing already and verifies what we were quite sure was the right thing to do, based on our conversations with the FDA. We had asked if we could be considered a medical data device and if we had to file as a Class II device, and that's what they have said. In fact, one of the examples that they gave on Page 15 (of the full document) was specific to us -- a mobile app that attaches to a mobile platform. That's Glooko. We don't really care for the term "blood glucose strip reader," but if they need to create their own language to get this done, so be it. I applaud them at this point, for making it more clear on what's required. For anyone who's doing real work in chronic diseases, like diabetes, and using these mobile tools, now it's crystal clear what you have to do.
One area that we would've liked to have seen the document cover in more detail was how to approach devices and apps that appear on multiple mobile platforms or operating systems. We just put out a new Glooko version of software that supports the new iOS7, but at the same time we are testing to make sure that works, we have to make sure people using older software on iOS5 are being served. There's a big matrix and a rigorous test process that we have to maintain, and the FDA could have made it more clear for those who don't have this testing in place.
There have been many Glooko advances in just 2013 so far, and the company's already submitted to the FDA an Android-version of its product that it expects will be approved in the coming weeks. In the next two months, Altinger also says Glooko will file with the FDA its Bluetooth-connected version that is still in prototype-mode now, but can be plugged into a meter and left on to wirelessly transmit data to an iPhone or Android device.
Chris Bergstrom, Chief Strategy & Commercial Officer of WellDoc
(a phone-based logging & coaching app)
Still digesting, but looks like a solid win for the industry, an accelerator if for no other reason than uncertainty has been reduced, and it doesn't affect WellDoc's strategy at all because our founders had the foresight to assume the FDA would regulate products intended for medical purposes (as they always have).
This is a classic case of what's old is new again. Today's published guidance is consistent with the draft guidance published in 2011 and with the long-standing polices of regulated medical devices even before the terms mHealth and Digital Health came to be, meaning if a mobile product diagnoses, treats, or mitigates a disease or is an accessory to a medical device, then it will be regulated. In other words -- no surprises.
Still, it's a win for the industry as it ensures patient safety and removes regulatory uncertainty, which will further stimulate investment in what is already perhaps the hottest sector of healthcare.
Further, Bergstrom tells us the guidance assures tech and device vendors and app stores (hello iTunes!) that they won't be regulated, and it can help developers decide if they want to play on the medical side of mobile health, where they will be regulated but they can help diagnose, treat, or mitigate a disease -- or if they want to be on the wellness and entertainment side of mobile, which isn't regulated. From a risk and cost standpoint the decision is not trivial, he says, as needing FDA clearance can provide a significant barrier to entry and competitive advantage. More importantly, patients and providers can know that the product has been deemed safe and effective. Although, having FDA clearance is just one element of commercializing a robust product solution.
Some still hope for better definition around "wellness vs. medical" intended uses and on what it means to be or not be a so-called MedDev accessory (software as a medical device) -- an area that Bergstrom believes will "remain gray because of the explosion of interoperable scenarios."
Since the guidance doesn't differ significantly from previous FDA feedback, Bergstrom says it won't have an impact on their soon-to-be-launched BlueStar product. "Perhaps there is an indirect effect, in that the guidance clarifies products like BlueStar do need FDA clearance, thus maintaining a barrier to entry and differentiation from potential competitors -- along with our differentiating clinical results, proprietary algorithms, and end-to-end distribution and service model," he says.
Terry Gregg, CEO of Dexcom
(continuous glucose monitoring system)
On first pass, we think it's fairly reasonable. But we want to get all the eyes on it and hear what R&D and everyone says, before forming an official position on what this means and what challenges we might specifically see from this.
Caution is perhaps in order, since these guidelines are important for Dexcom, which has been meeting with and talking to the FDA regularly about its future Dexcom Share device (which would allow CGM results to be "beamed" to multiple smartphones). The California company submitted the Share in July for regulatory review, and hopes to get approval in time for it to hit market in 2014. We're looking forward to hearing more about that, of course.
Note that about 100 medical apps have received FDA approval in the past decade, the agency's stats say, with 40% of those being approved in the past two years.
This is by no means a comprehensive view. We at the 'Mine hope to hear from many more D-tech companies and developers in the weeks and months to come. One thing's for sure: with the current boom in mHealth, official FDA guidance was certainly needed to help us all move forward!