Scripps' Steven Steinhubl: Success in mHealth requires 'hard evidence'

While the growing use of mobile technology in clinical settings represents a promising future for the healthcare industry, according to Steven Steinhubl, M.D.--director of digital medicine for the La Jolla, Calif.-based Scripps Translational Science Institute--its integration, he says, is a process that cannot be rushed.

"The whole medical field is full of examples of therapeutic interventions that everyone just assumes make so much sense that they have to be good for you, but a lot [of] times, those interventions turn out to be dangerous," Steinhubl (pictured) says." We [at Scripps] feel it's really important to have the highest potential level data available to show how different technologies fit in."

In an exclusive interview with FierceMobileHealthcare, Steinhubl talks about how he and his colleagues are rigorously studying emerging technologies to find "hard evidence" that such tools can have a real impact on patient care. He also discusses how his long and winding career path prepared him for his role at STSI, a National Institutes of Health supported consortium led by San Diego-based Scripps Health.

FMHC: Talk about the recently launched Wired for Health trial; what do you expect to come of that?

Steinhubl: The project is geared specifically toward employees of Scripps Health. It's looking at individuals who are at higher risk or high need of healthcare utilization for either chronic illnesses or intermittent, acute problems, and their use of specific mobile tools. There are three specific focuses: diabetes, hypertension and people with palpitations or dysrhythmias.

For diabetes population, use of the iBGStar wireless glucose monitor is being studied. For hypertension, the Withings wireless blood pressure cuff is being studied, and for people with palpitations or dysrhythmias, we're examining the AliveCor EKG monitor.

What we want to do is empower patients as much as they'd like to be empowered with their own information so that they can act on that; that's our long-term goal. These studies are just the first look at that.

It goes without saying, however, that for all of this to eventually really work, what I call the perverse financial incentives that exist right now in the healthcare system have to change.

FMHC: What do you see as realistic expectations for patients becoming more engaged in their own health with mobile devices?

Steinhubl: It's hard to answer and it's challenging, but it's easy to imagine that 100 percent of consumers could, in the not too distant future, use mobile health in one way or another. There are two broad categories of how mobile health technology can help patients: diagnoses of acute illnesses and management of chronic diseases.

If you look at the most expensive acute illnesses in the U.S., upper-respiratory tract infections are right up there. But for a primary care doctor, there's no throat cultures or X-rays involved with those visits; there's nothing that needs to be done in the physician's office, but it's still one of the most common reasons patients go to see doctors.

Primary care doctors, right now, their practices are not even close to being feasibly designed where they can do everything that's expected of them. Mobile technology could help to trim back some of the acute visits that aren't necessary, as well as the chronic disease visits that aren't necessary.

FMHC: How importance is the role of the FDA in the success of mHealth?

Steinhubl: I think that this is a real challenge on both sides. There has to be regulation, but I also recognize that regulation can stymie innovation. We have to figure out way to balance that.

Why do we need regulation? When you look at 100 years ago, the pharmaceutical industry wasn't regulated. Not only was there this plethora of cure-all elixirs, but there were also really respectable companies that marketed drugs that never had to be studied and proved to be dangerous. My favorite example is Bayer Pharmaceuticals. Bayer, as everybody knows, developed aspirin--a wonderful, life-saving drug--but the same chemist who developed aspirin also developed another medication that Bayer advertised together and touted as a non-addictive cough suppressant. That second medication turned out to be heroin.

If you don't have regulation in mHealth, you can see some well-intended, very good devices or apps out there that may end up being dangerous. A lot of things that seem like they would make sense in medicine don't prove out. There's still too much we don't understand about the human body and disease states to just take a logical leap.

Hopefully, though, the FDA has learned from some of the downsides of the pharmaceutical companies, and will recognize that when they make those companies pay several million dollars to get an FDA review, that those are coming from billion-dollar corporations that are able to recoup that. The entrepreneurial space of mobile devices can't follow that same pathway.

FMHC: How does that apply to what you're doing at Scripps?

Steinhubl: There are two ways to look at that. For instance, let's look at the Scanadu Scout. One of the things that it can do is measure blood pressure in a very unique way, so one thing from a regulatory standpoint that Scanadu needs to do is prove that when they say 'we can measure blood pressure' that the Scout measures BP accurately. That's important, but we think it's a bare minimum.

What we want to do is go to the next step and say "OK, how does having such a tool … fit into clinical care where you can increase patient convenience, keep them healthier, and decrease healthcare costs?" That's the kind of stuff that really excites us; showing that we can provide better care at less cost in the long run.

FMHC: You have quite a smattering of experience, from your Air Force experience to clinical research to your work at Geisinger as director of cardiovascular wellness; you even briefly worked in the pharma industry. How do you think all of that has prepared you for the innovative work you'll be doing at Scripps?

Steinhubl: I had a chance to be exposed to many different healthcare systems, many different ways of practice, many different practitioners and many different patients, in addition to exposure to the industry side of things. I think in coming [to Scripps], my real focus has been to take these devices being developed primarily by technical entrepreneurs who have no clinical background, and work with them to say, "What is important? How does this fit into clinical practice? And how do we design a clinical trial around that to prove that?" I've been very fortunate to have experience in all aspects of that to help make it as successful a project as possible.

Editor's note: This interview has been edited for length and clarity.