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Healthcare in Your Hand

Tue, 03/11/2014 - 12:27pm   Michelle Taylor, Editor

Mobile solutions are revolutionizing healthcare, bringing point-of-care and personalized medicine to the forefront of the industry.  

According to industry estimates, by 2015 there will be 500 million smartphone users worldwide utilizing healthcare applications. By 2018, half of the more than 3.4 billion smartphone and tablet users will have downloaded at least one medical or health app. For most apps, the recreational use of the product does not hold long-term implications. However, there are those apps that could literally mean the difference between life and death. And that’s where the Food and Drug Administration (FDA) has decided to step in.


Late last year, the FDA issued final guidance for developers of mobile medical applications, or apps. The guidance reveals that the federal agency will focus regulation on the small subset of medical apps that present great risk to patients if they do not work correctly, rather than the larger, more inclusive subset of all healthcare apps. 


Mobile medical apps that will be regulated are those:

The FDA intends to review these mobile medical apps using the same regulatory standards as their “traditional” counterparts and other medical devices. 

Mobile apps that will not be regulated include those intended to: 

The FDA will not regulate mobile app distributors either, such as the iTunes App Store or the Google Play Store. Additionally, the new guidelines do not consider mobile platform manufacturers to be medical device manufacturers just because their platform can be used to run an FDA-regulated mobile medical app.


Of the more than 35,000 smartphone apps, only about 100 of them are FDA-approved, which equates to roughly 0.3 percent.


“An incredibly small number of digital health products are actually cleared by the FDA, and I don’t expect that number to increase. In fact, it may even decrease now,” says Chris Bergstrom, Chief Strategy & Commercial Officer at WellDoc, a technology-based healthcare company dedicated to improving disease management outcomes and reducing healthcare costs.


“FDA clearance will continue to be an arena that is only for those who truly want to be there, and have the wherewithal and resources to do so,” continues Bergstrom.


WellDoc’s BlueStar mobile platform is a first-of-its-kind product for adult patients with type II diabetes. Approved by the FDA, BlueStar allows patients to follow their healthcare provider-defined treatment plans by providing real-time coaching on all aspects—including, but not limited to, medications, physiologic data and lifestyle choices. The software provides the capture, storage and transmission of blood glucose data, analyzes and reports blood glucose test results and supports medication adherence. In addition, it provides coaching messages based on real-time blood glucose values and trends. Healthcare providers can use it to leverage decision support that combines evidence-based clinical guidelines and behavioral analytics to further personalize treatment recommendations. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Because of its ability to provide personal information and easily link patient with physician, BlueStar is only available with a valid prescription. 

Healthcare overhaul 

In its final guidance issuance, the FDA acknowledged that “mobile medical apps have the potential to transform healthcare.” 


Bergstrom agrees, and according to him, it’s a three-phase transition that begins with healthcare at the highest level. The first phase is about capturing data—which is currently taking place in digital health. This is two-fold—the first part is about digitizing the existing data, and the second is about capturing data never captured before, mostly pertaining to the quantified self. The next phase, to come in a few years Bergstrom predicts, will be about sharing the data. Finally, once all the data is obtained, it’s time to make it into something meaningful. 

“That was Google’s mission,” says Bergstrom. “To capture all the data and share it with the world. And now what they are doing is meaningfully using that data. It’s exciting to have a model of where the healthcare industry can go.”

Treatment outside traditional settings is one important aspect mobile medical apps have helped pioneer. We have all heard the stories, or perhaps you have even been a part of one—a family member is stricken with disease, but unfortunately, the best specialist practices in California, 3,000 miles away from your hometown. The family is then faced with a multitude of hard options and even harder decisions. But what if it didn’t have to be that way? With their imaging and data sharing capabilities, mobile medical apps open the possibility of virtual consults, turning thousands of miles into no problem. 

For example, a recent Univ. of Rochester Medical Center study showed that not only did telemedicine visits cost less than providing care in a traditional setting, such as a clinic or a hospital, but the virtual house calls saved patients an average of more than three hours and 100 miles of travel per visit. Adequate care was overwhelmingly given, and the amount of personalized medical recommendations was equivilant to that of in-person care. 


Currently, 44 states allow virtual physician visits, with 24 of those states allowing physicians to determine what they can and cannot do during a “visit.”

“We’re going to use technology to radically transform the healthcare system and deliver quality in a more efficient way,” says Bergstrom. “I’m optimistic. I think we’re in the most exciting time of healthcare since Medicare in the 1960’s. There’s two camps of people—those that believe healthcare is always going to be inconvenient and expensive and those that are optimistic. It’s just like every other industry where technology and infotainment are a part of the process.”