Anyone who thought Fitbit was just a fad has another thing coming. In a recent webinar, Digital Mobile Health Trends in 2015, MobiHealth News editor-in-chief Brian Dolan provided an overview of emerging technologies to keep an eye out for in healthcare this year, and provides some background on the policies and laws that govern them. Turns out Fitbit may soon do more than regulate how many calories you burn. The company, which is rumored to be contemplating an IPO this year, plans a future version of their wristwear that can alter the temperature in your home by connecting to your thermostat.
Reimbursements are starting to come through for digital devices
One of the biggest challenges facing developers of emerging technologies like connected devices in the medical field is normalizing them into the ‘system’. In order to get reimbursed for treatments delivered through connected devices, the devices must be assigned a Current Procedural Terminology code, or CPT code. Codes are governed by the American Medical Association. Without the right code, there can be no reimbursement, which drives down incentives for medical professionals to use these new technologies.
At long last, however, the Centers for Medicare and Medicaid Services (CMS) have announced a reimbursement code for telemedicine devices that support patients with two or more chronic conditions. Dolan cited an article from Dr. Joseph Kvedar’s cHealth blog that explores the topic more fully. Though the code, which allows physicians to bill for 20 minutes per month of non face-to-face time, is relatively small , Dolan feels that “the move will serve as an important bridge...where more providers can have telemedicine technology in place and the processes to really support that vision of accountable care that is coming.”
Important regulation updates on the horizon
Almost everyone in the tech industry is keeping an eye on developments with the Software Act, and while nothing monumental happened last year with the legislation, Dolan feels 2015 might be the year for change?? For what?. The legislation has the potential to alter the way the FDA looks at software, and medical applications in particular.
The FDA is currently authoring two “guidance” documents that provide insight into how it is thinking about connected devices. Less formal than actual rules, a guidance helps to shape future rules, and allow for a period of public comment and critique. One of the more important guidances that Dolan and his editorial staff are watching involves general wellness devices. The FDA is beginning to shape language around how wearable devices might be regulated, particularly when it comes to marketing devices that are intended for health and wellness. Fitbit and Jawbone are two examples of such devices, but there are many health-related devices that could fall under the FDA’s guidelines. The current thinking seems to be that companies may start to make claims about the health benefits of their devices if their claims are based on science that is widely established. However, it remains unclear how the validity of these claims will be checked.
Mobile medical apps are also a big topic for regulators right now. Dolan’s staff has culled through the FDA’s database to track what kind of mobile apps they have been clearing for the past 6 - 7 years, and found that clearances have historically been for apps that are serving as a second screen, or adjunct, for a primary device that is already regulated. Dolan reports that now, the FDA may be updating its approach so that apps might not have to be regulated like the parent device, and the agency may start regulating some devices as Class I devices, instead.
Dolan likes what these updates to regulations and guidelines could do for the intellectual databank in the healthcare industry. He cited the FDA’s clearance of two new algorithms developed by AliveCor, Inc. an app that can remotely detect atrial fibrillation (AFib) in patients. AliveCor’s initial algorithm detects AFib via recordings taken on a mobile phone-based monitor. The first new algorithms can detect and confirm a “normal” state and the other algorithm can determine if outside interference may have delivered a bad result and prompt the user to run the test again.
Video visits taking off – and gaining traction
Getting face time with your physician is about to get turned on its head. Prepare yourself for video visits. Video visits allow doctor and patient to meet on videoconferencing instead of in-office. Businesses are ready to embrace the idea as a way to keep employees healthy and at their desks. Dolan cited a recent study that found more than 60% of patients surveyed said they liked the idea of videoconferencing with their doctor instead of going in for an office visit. While the initial hope is to help patients get faster care for routine medical issues, some hospitals are testing the idea out for acute and emergency care, as well.
Another key metric for how well medical technology is advancing is how well it’s being funded by venture capitalists and other investment entities. Dolan cited Rock Health’s research on investment, which shows that last year, investors put more than $4 billion on the table for health companies – more than double the $1.8 billion invested the year before. While Dolan doesn’t believe that trend will continue, he notes that there will still be billions of new investment dollars in healthcare technology this year.
Dolan ended his overview with an inspiring idea he had heard from thought leader John Battelle, co-founder of Wired magazine and the Web 2.0 Summit. Battelle predicts (as does Rock Health) that a breakout healthcare startup will emerge in the consumer consciousness this year that will change the way people view their relationship with their own health data and with healthcare in general.
Who knows? Maybe this great sea of change is already on your wrist.