At no other point in time have mobile health applications, devices, and platforms been as popular as they are now.
A recent survey
from the Healthcare Information and Management Systems Society (HIMSS) reveals that 90 percent of healthcare provider organizations are utilizing mobile health (mHealth). From a consumer side, companies like Apple, Samsung and smaller niche companies like Fitbit are driving up adoption. With the introduction of Apple’s HealthKit and ResearchKit platforms, as well as other integration platforms, clinical and consumer mHealth is now coming together.
To get some clarity on a congested market, Healthcare Informatics Senior Editor Gabriel Perna spoke with The Advisory Board’s managing director Kenneth Kleinberg at the annual HIMSS conference, this year held at McCormick Place in Chicago. Below are excerpts from that interview.
The mobile health landscape is very crowded. Do you think we'll start to see that change anytime soon?
It depends on your boundaries of the mobile health space. Certainly, developing and deploying to a smartphone or tablet is certainly easier now than what it took in the past. It’s allowed people with great ideas—or sometimes not so great ideas—to bring products into the marketplace more rapidly than ever before. The small guys can almost always create stuff faster. They’re more nimble. That’s a classic disruption type of model. But the bigger, more established players look to see what's working, they look to see what their clients want and they add that to their roadmaps. Sometimes they do it by acquiring the companies that are leading the charge. There is always new disruption coming and there is always consolidation between existing players. That’s why we don't see more or less vendors
coming to HIMSS, we see the same number but just a lot of new ones. Most of the big names have some staying power.
What kind of impact could FDA regulation have on mobile health and remote patient monitoring?
You'd think that because there are more systems developing and coming up and more interaction with consumers, the FDA would get more directly involved with this than not. But there’s also a balance with overregulation, market dynamics, and progress. The FDA was in a position to go after regulation for not just mobile, but all of health IT. They backed off from that to leave that, in a lot of cases, to the [Office of the National Coordinator for Health IT], the Agency for Healthcare Research and Quality (AHRQ), and whomever else that could be more appropriate. There has been a genera withdrawal from the FDA for software system (regulation) and they recently backed off the enforcement of regulation for mobile medical apps and medicalized data systems. There’s actually a concern that they haven't retracted regulations, but they’ve just been forward that they’re not going to enforce. They always have a discretion capability if they feel patient safety is at risk. It doesn't give companies a fuzzy feeling that they could potentially still the subject of a regulatory enforcement. People have complained about it. I understand both sides. Congress, as a whole, has tried to limit the extent of FDA regulation.
When it comes to remote patient monitoring, are we seeing a real progress of integration of clinical and patient-generated data at major provider organizations?
There are two waves. There is.top down wave and a bottom up wave of remote patient monitoring. The top down wave is driven by hospitals, established vendors
, regulated by FDA, and often focus on chronic disease. An organization that is leading the charge in this area might only be looking at a couple of hundred of patients in that fashion. The bottom up wave are consumers by the hundreds of thousands, if not millions, that are potentially going to use these devices and track their steps, motion, sleep, eating habits, how they’re taking their meds, etc. and bring it to physicians for their analysis and use.
The established vendors
never had a place for all of that data being collected by consumers. They’re just working to find a place for the data collected from the top down. Apple basically created their own data model. They hired data experts and work with the leading institutions, but that data model is theirs. It’s not a standard and it’s not a model that any leading provider created on their own. It’s not the data model that any EHR vendor created. We’re at a point where the industry has to think about consolidating a data model. We’re at the stages where we have to figure out how we’re going to make this data interoperable because there isn’t a place for it to go yet. What has generally been done is the use of a separate repository for medical device data, separate from the EHR, and analytics, BI, preferences, filtering are applied against that data to decide what makes it into the EHR and the attention to the physician.
What will it take for this proliferation of remote monitoring devices to have an impact where it matters most?
The fact is as patients get in tune with their own fitness and what they're eating, etc. That alone, even if the physicians weren’t involved, would have some value. As physicians gain confidence in the quality of that data, they’re more likely to accept it from the patient.