Connected Health in the United States vs. the EU

In an exclusive interview with MD+DI, Don Jones, vice president of global strategy and market development for Qualcomm Life, the wireless health arm of telecommunications giant Qualcomm, discussed a range of e-health issues, including, the genesis of ehealth, healthcare apps that work, and the perils of ehealth.

MD+DI: Is it easier to launch e-health devices in the United States or the EU?

Jones: It depends on what you’re launching. If you’re launching app-based solutions, it’s probably easier in the U.S. at this point. But if you’re launching a traditional medical device—in this case a connected medical device—in the EU it’s easier and faster to get over the regulatory hurdles, and the process is understood better. That’s because they run a formula-based process. They basically say, “If x then y,” and you know what steps to take. In the United States we follow a sit-down with the FDA examiner and depending on the examiner you’re going to get [different] requirements you have to meet. And if your examiner happens to get hit by a bus or goes on vacation, you may get a substitute, in which case the requirements may actually have just changed on you. That’s the source of the frustration between the two systems.

Once you get through that process it’s really about which market is going to adopt and buy the solution. I think there are good examples in both markets. The U.S. market shows tendencies to make self-purchases, certainly in the wellness arena. And certainly we’re seeing a lot of examples where there’s a third party willing to pay—an Aetna or Walgreens—because they get a benefit from your use of their solution. The challenge in Europe is often you have to convince an entire country that the solution is the one they should adopt because you’ve got government-paid healthcare, except where financial responsibility for one certain [medical treatment becomes regionalized]. So if managing congestive heart–failure patients gets pushed down to regional physicians and regional hospitals, now all of a sudden I don’t have to convince an entire country, I have to convince a hospital system or a physicians system. It’s local.

That allows you to get your foot in the door. But that’s relatively new in Europe, [although] it has been around for a long time in the United States. When people ask, I always think of the U.S. market as [one where] if you’re bringing something out, there’s a really good chance that you can find a customer. But you have to realize that that’s just one customer and you’ve got a lot more lined up. You’ve got to be selling over and over and over again. Whereas in Europe if you bring something out and you can convince the government payer, then you have the payment side set in place. Now you just have to get the adoption side going.

MD+DI: What’s the biggest challenge affecting the further development of connected health in Europe?

Jones: The biggest challenge is getting connected health into the workflow, which means getting the doctors to prescribe it. Just like we reach for a prescription pad because there’s a pill and that’s the solution, there’ll often be a connected-health solution, and in many cases the connected-health solution will have a medication or therapy combined with it. It’s about getting the doctors to prescribe. What we’re beginning to see in 2013—and this is a trend I would say started in 2012—is big pharmaceutical companies engaging and recognizing they have opportunities here to design apps, med-device combinations, solutions for running clinical trials, and solutions for enhancing compliance.

They have the resources—the salespeople on the street, the bank accounts—to actually drive some of these opportunities right down to the provider level and make it so that it’s normal for physicians to prescribe an app. I define an app as any singular or plural combination of software, device, and/or drug. The software might be used to help you titrate a drug like insulin, or it might be used to collect information about how you’re feeling, say, if it’s a pain-management drug. We will have to get doctors thinking about prescribing an integrated solution.

More than any other part of the industry, I think pharma will represent an opportunity to educate doctors about what’s out there and what can be prescribed for different clinical solutions. It’s important that pharma’s entering the market. It has a better footprint in terms of sales and education than medical device companies do. The other very important group will be hospitals that will begin to recognize that when people leave the hospital they need to leave with solutions for managing care as soon as they go. Hospitals will be another important force either in the form of standing orders—in other words, standing practices for what happens when you’re discharged—or in the form of getting doctors to prescribe solution apps.

MD+DI: Will connected health be widely available to all populations in Europe, or will there be inequitable access?

Jones: Europe likes to say, “We have an equitable healthcare system.” In other words, it’s the same for everybody. That’s true to the extent that there’s a base level of service that’s available and that’s the same for everyone in almost every country. Actually, if we just describe [healthcare where everyone] has access to the same system at the same level, we’re really describing Canada. We’re not describing Europe. Europe has a baseline available, and then you have the option of buying up, either through private coverage, supplemental coverage, or opting to go completely private. Basically, every country in Europe, with very little exception, has buy-up options.

Not everybody avails themselves of those. In answer to your question, it’s one of those it-depends answers. If you look at it as “will everybody have some base-level connected-health solutions,” I think the answer will be yes. But will there be more solutions because they’ll be part of the supplemental or buy-up plans? I think that’ll also be yes, especially when some of the solutions will be used to promote the business cause. You can imagine any number of services that would offer a connected-health solution for staying with that particular service. If that’s a private service, they might just offer it and say we want you on this system because we want to keep you as a customer.

John Conroy is a frequent contributor to MD+DI.