In-Depth: News, novel quotes, and notable trends from the mHealth Summit 2014

By Brian Dolan
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The MobiHealthNews team spent the past week at HIMSS' mHealth Summit, which was located just outside of Washington D.C. In case you missed the event or were too busy to follow along while you were there and could use a review, we've got you covered. The in-depth report that follows is a collection of some of the more provocative comments we heard both on-stage and off. We've also rounded up much of the news announced at the event and linked out to some of our previous coverage from the past week. Let us know what we missed in the comments section below.

Most everyone's excited about CMS's $42/patient/month: On the reimbursement front, one change coming in 2015 that was brought up a number of times during conversations at the mHealth Summit was that CMS would begin reimbursing physicians $42 per patient per month for providing virtual visits and other remote care. We heard that a number of digital health companies expect big things from that new revenue channel next year -- and in the years to come.

Why one investor argues insurance companies aren't great customers right now: During a thoughtful panel session that included three venture capitalists on-stage, Dr. Stephen Block, General Partner, Canaan Partners said: "Payers are all looking at their business models now and saying, 'what we historically did for insurance -- we are very, very good at managing risk, providing insurance through employers, processing claims -- but we all know that there probably is a new business model that we are going to have to evolve to.' And they are all experimenting on the edges and trying to figure out what they are going to be doing in the future. It's different in different regions and obviously there are some national payers who are very experienced and have a lot of resources. I've seen some, like Aetna, be very active the last couple of years, and take on some small company investments, start things in-house, and try to be entrepreneurial. But they didn't actually have a lot of success, and they started retrenching pretty heavily in the last year, and pulling back. They are also trying to deal with other problems, with pricing, with the exchanges and what not. So I don't think they're necessarily great customers right now." 

Want regulatory clarity? Well, "Congress makes nothing clear": While the majority of regulatory discussions at the event focused on practical advice for navigating the FDA processes and other regulatory bodies, there was one worthwhile exchange about recent discussions in Congress to pass legislation that would impose new limits on the FDA's purview over software that acts like a medical device. In response to a question from the audience, M. Jason Brooke, CEO and General Counsel, Vasoptic Medical, an early stage medical device company developing a mobile health solution for early detection of diabetic retinopathy, offered a candid take on why he thinks some health IT companies are pushing for Congressional action:

"Was all the business of the need for clarity saying that the FDA was not doing a good job of clarifying for the innovators, the entrepreneurs, the investment community, what's going to be regulated and what's not. That's essential. I agree with that premise in the sense that we need clarity and we need to make it available... The problem was -- those [behind] this legislation, their concept was -- whoever is responsible for this -- that 'we need legislation because only Congress can make this clear'," Brooke said. "Well, anyone who is a lawyer and pays attention to what goes on, on the Hill knows that Congress makes nothing clear, and, in fact, that is by design. Our forefathers established the system that we have to allow Congress to lay the high level policy... and the people on the ground [like those at the FDA] need to figure out what that means and communicate it to people. So the legislation that has been proposed gives the high level concept but it does not give the detailed information that the FDA has been establishing about medical device regulations for 40+ years. We will get far more clarity -- and we'll get it quicker -- than we'll ever get from Congress... The only real reason any of this legislation has been put forth is truly about the medical device tax."

Why calling the FDA might be painting yourself into a corner: Later in that same session, Epstein Becker's Brad Thompson responded to a question from AliveCor co-founder Dr. Dave Albert about health startups calling the FDA directly if they had a question. Thompson: "Calling the FDA has great advantages and two limitations. Number one, I think a lot of us can tell you that the answer you get depends on who you call. It's kind of like the IRS hotline. They did a study on calling different operators there and getting different answers to the exact same question. So you have to understand the quality of the answer you are going to get depends on who you are asking. Then there is not a dilemma -- a small part of it is, sometimes they don't know collectively and so they may have to talk about it amongst themselves. Secondly, you are going to get the most conservative advice when you call the FDA. That may be just fine. If you really want to know what the FDA thinks and you are willing to do whatever they say, then go ahead and ask them. If you are worried you are going to get overly conservative advice, once you have that advice, it is really hard to ignore it."

Walgreens is offering video visits in MI and CA: Walgreens big news at the event was that it had partnered with video visits company MDLive to provide remote care to its patients in Michigan and California. If that goes well, it will roll it out in other states where such services are allowed by the local medical boards. One of the better keynotes at the event was Walgreens' Chief Medical Officer and Group VP Dr. Harry Leider offered up a number of cutting remarks about the consumer side of digital health; how startups should strategize around payers; and why he thinks consumer expectations for wearable devices are ridiculous.

Lack of short term medical costs savings from wellness initiatives are a big barrier. Here's Leider: "What I want to focus on now is the economic value propositions... It is really hard to prove that [health, wellness, fitness] in the short term saves money. Over a lifetime maybe 10, 20, 30 years -- absolutely. Exercise, eating right, all that kind of good stuff absolutely makes a difference but in the short term it doesn't save money, and I'll get to why that is so important in just a moment. It's very hard to prove that wellness does make a difference economically. With self-diagnostics, again, there are only a few applications so far in health testing where that kind of testing drive short term medical savings. But with acute care and chronic care, things like telemedicine are not only convenient, but the marketplace prices for using telemedicine are lower than going to see a doctor, going to an emergency room, or an urgent care center. Similarly, if we can manage certain types of chronic illness, like heart failure, at home and not having somebody come into the hospital, we can create economic savings."

Why is this so important? Payers want short term medical savings. Leider again: "For those of you that are out there thinking, 'how can I have my application, my mHealth solution, my device, get reimbursed?' ...Number one, ask yourself these questions. Is there a CPT code for that service or device? Because if there already is a CPT code, it is already being reimbursed by Medicare (and usually by health plans) so there's an easy path to take. That typically is not the case for new mobile health technology, but there is a CMS rule out there that is still out for debate to expand Medicare coverage for telemedicine. If that gets approved, there will be more reimbursed in the future. Number two, does the technology generate medical savings within 12 to 18 months? Fewer ER visits and fewer hospitalizations: that's how you generate medical savings in the 12 to 18 months window. Lab tests and medical visits just don't add up enough, you really have to take people who are really sick and move them from the hospital or keep them out of the hospital. Why 12 to 18 months? Because people change plans every year and there is about a 20 to 25 percent turnover rate. Health plans figured out years ago that if they are going to invest in something like a wellness program that's going to maybe prevent a heart attack 10 years down the road, economically it just isn't worth it. Finally, if it is a Medicare health plan... there are these things called Star Ratings. Plans that earn an additional 3 to 5 percent bonus if their quality ratings go up. Many of these quality ratings are things like adherence to medications or getting immunizations. If makers of mobile health technologies can improve those Star Ratings, it can prove to be some very strong economic incentive to these Medicare plans to get those ratings up. The reality is, if you don't have a 'yes' to one of these three questions -- CPT codes? short term savings? quality ratings? -- it is extraordinarily hard to get health plans to adopt new technologies or services. Very, very hard."

Wearables aren't going to put pharmaceutical companies out of business: Leider: "We all know there's been an explosion of wearables, apps, devices, and sensors. That's one of the reasons many of us are here. You all know about the functionalities. What I do want to suggest to you is that there is very limited data that supports the effectiveness of wearable and fitness technologies [to show] they actually improve health and wellness. There are not good controlled studies. There is some encouraging evidence here and there, but we are not at a point where we can clearly state that people are improving their health and longevity by using these devices. But despite the lack of evidence US consumers are incredibly optimistic. Many of you may have seen that PricewaterhouseCoopers surveyed consumers about wearables. Here's what it showed. About half of the people surveyed believe that these devices are going to help them live 10 years longer, lose significant amounts of weight, and dramatically increase their athletic ability. Can you believe that? Ten years longer, lose lots of weight, and dramatically improve your athletic ability. We've got the pharmaceutical companies shaking in their boots! It's incredible. It looks like a bad internet ad."

Pharma interventions need usability, not just good clinical outcomes: At the mHealth Summit's Pharma Roundtable, the discussion was a little more wide-ranging than session's title suggested, but a number of panelists shared insights about what needs to happen for pharma to move forward in the digital health space. Matt Quinn, formerly of the FCC and now east coast managing director for healthcare and life sciences at Intel, stressed the need to develop tools from the perspective of the end user: "There’s a statistic I like to throw out because it’s so telling: 87 percent of African American mothers, recently surveyed, said they’d like to use digital health tools for the health of their families," he said. "How many do you think actually do? Thirteen percent. So the question is ‘why is the gap?’ Most of it is that the tools don’t serve their needs."

Joel White, president of Prescriptions for a Healthy America, cited research his group had conducted that showed, regardless of the reason for medication nonadherence, 89 percent of people wanted their doctor to have tools to track their medication-taking behavior and 86 percent wanted a tool like that for themselves. His group is focused on changing the antikickback laws that make it difficult for pharma to partner with providers on adherence.

Finally, Eddie Chan, AVP & Global Head, Customer Solutions & Innovation at sanofi-aventis, the only actual pharma representative speaking at the roundtable, implied that for pharma to succeed in a digital world, it might need to look for new business models: "One of the interesting hypotheses of finally delivering care is that improved clinical outcomes, just to be a bit provocative, may not necessarily entail increased product utilization," he said. "And this is the one thing that we as an industry don’t often acknowledge."

Two takes on the new house call: Two interesting telemedicine approaches were presented at a panel moderated by MobiHealthNews' own Jonah Comstock. Pager, a new startup in New York City, is actually bringing doctors to patients' homes via a mobile app, and a project out of the University of Rochester, supported by Verizon, has seen tremendous interest in a series of pilots for patients with Parkinson's disease.

Content is key for texting interventions for problem drinking: A couple of different small pilots showed promise in using text messaging to curb problem drinking in college students and adults, but not just any text messages. In both interventions, from Brown University and North Shore Health System respectively, careful design of the message content was key.

Samsung seeks developers, especially for enterprise: In a keynote presentation, and in an aside with MobiHealthNews, Samsung's Chief Medical Officer David Rhew made a plea for more developer partners for Samsung's open access development platform, including more partners on the enterprise medical side: "We know that, while we can do a significant amount in this area, we can’t do it alone," he said. "That’s really why we’re here at [the] mHealth [Summit]. We’re counting on developers, mHealth companies, other key stakeholders, to help us create an open ecosystem so we can develop, test, validate these solutions and ultimately improve health outcomes through patient engagement."

Details emerge on HealthKit in the hospital: Dr. Ricky Bloomfield of Duke University and Dr. Richard Milani of Oschner Health System shared some more details about working with Epic and Apple HealthKit in a hospital setting. Some takeaways included a promising future for reimbursement, an assurance of privacy (at least on Apple's side), and high hopes for chronic diseases and medical research. Read our full report here. And also check out Bloomfield's post about CPT codes useful to providers leveraging HealthKit.

KP's focus: physician-patient engagement: Kaiser Permanente SVP Christine Paige told the crowd that KP has no plans or desires to get into the fitness app business. The company's digital strategy is all about the patient-doctor relationship, and she stressed the importance of improving that relationship while maintaining patient trust.

iTriage shares short-term, long-term plans: On the sidelines of the conference, iTriage President Jim Greiner gave MobiHealthNews some insights into the platform's future. In the short term: a shift in focus from scaling to demonstrating ROI. In the long term: an expansion into price transparency and even video visits.

Verizon: Patients are demanding new kinds of care, but security is still a concern: Janet Schijns, vice president of global enterprise, government and channels marketing at Verizon Enterprise Solutions, spoke enthusiastically in her keynote about the way patients are beginning to take charge of their own care, and the need for technology to keep up: "We’re faced with something we’ve never seen before," she said. "We’re seeing patients, people, consumers -- whatever you want to brand them -- creating their own content, filling the gaps in traditional channels with their own community, their own answers, and they won’t be stopped."

But she warned that, in Verizon's experience, firms are underestimating the security threat inherent in the work they do: "As I travel the world and talk to global technologists, CIOs chief medical officers, chief marketing officers and everyone in between who’s driving these trends there is one thing I see, and that’s that each and every one of them underestimates the risk inherent in these technologies," she said. "As we conduct mock intrusion exercises for our enterprise customers, we notice that firm’s ability to understand the breach, respond to the breach, and fix the breach is at an all-time low."

Pfizer's two approaches to external innovation: Pfizer's Vice President of Worldwide Innovation Wendy Mayer said in her keynote at the event that Pfizer's approach to innovation is largely external, but that takes different forms. One thing the company has done is launch open innovation challenges, not just in medical areas, but also around marketing: "Pharma has been a little bit slow in terms of social media," she said. "But we’ve used our traditional ad agencies to develop social media campaigns. What very often happens is you get this common think approach where they know our business so well, that you get a lot of the same approaches you’ve seen in the past or they’re thinking along the same lines as the team. So we utilized open innovation with an ad agency that has an open source approach, and they essentially put out different challenges to a broad audience of ad executives that can come out with new campaigns. We were able to develop fresh, new campaigns in the realm of social media and reduced the cost from our traditional approaches by 20 percent."

The other kind of external innovation the company is using is working with the startup scene in Israel to explore innovative approaches to things like drug delivery and data collection. Mayer said the partnerships they are building bring new technologies to light and allow them to work with a smaller, more nimble subset of the business to get those innovations out of the proof of concept stage.

Digital health service providers need to take into account health literacy: A popular topic of conversation this year at the mHealth Summit was health literacy. Vanessa Mason, the senior manager for eHealth at consulting group ZeroDivide, explained in a session that it's important for people developing health content for apps to take lower literacy levels into consideration. She explained that "the health literacy issue is not simply one just restricted to Latino populations." Instead, it's important to recognize that health literacy is also an issue for native English speakers as well. The problem "extends to everything from people not quite understanding what it means when you say ‘take twice daily’, to understanding how to set self management goals". Mason also offered some suggestions: "In general our healthcare delivery system does not cater to the working literacy level of most patients. Plain language and using more audio and video aids are something that will be more conducive to more positive health outcomes for everybody, regardless of whether or not they’re what we consider underserved consumers.”

Linda Fleisher, a senior researcher at The Children’s Hospital of Philadelphia’s Center for Injury Research and Prevention, shared a similar view of the importance of health literacy: "The majority of Americans read at about an 8th grade reading level. So if you think about the content that you’re developing, that’s probably the target you should aim for, which is actually very challenging when you start talking about health-related content."

A reminder about the power of peer networks and forums: Activity Exchange CEO Mikki Nasch discussed some takeaways from her experiences while developing her company. Nasch: "One of the key things that had such awesome data and really good signaling was the forums. If you think about when you talk about COPD, and you talk about all these forums where people are trying to quit smoking -- the amazing thing is somebody who has COPD will not tell their spouse that they started smoking again and they probably won’t tell a physician. But they’ll go tell a stranger on their smoking forum that they fell off the wagon. You can actually really start getting much more quantitative data about all of these things, and understand the behaviors within that."

Gecko expands inhaler sensor business to adults: GeckoCap, a Cambridge, MA-based company focused on gamified inhaler caps for children with asthma has been quiet for the past year. That's because the company, now called Gecko Health Innovations, has widened its scope to include inhaler adherence for adults with a new product called CareTRx. The sensor and app are being marketed to hospitals, and the company also provides population health management features that work with the sensors.

Validic adds a customer and a partner: Durham, North Carolina-based Validic announced a new customer -- consumer health giant Everyday Health -- and a new ecosystem partner, Adidas, which will connect its sports and fitness apps and devices to Validic's health data platform. Release

Wireless, smartphone-connected ultrasound handheld: Seoul, Korea-based Healcerion took the stage at the Venture+ Forum session and showed off their wireless, smartphone-connected, mobile ultrasound device for both providers and patients. According to the company's bare bones website, it raised $1.8 million last year. Site

Women-only wearable: Boulder, Colorado-based Prima-Temp pitched its device -- OvuRing, a wireless, continuously sensing temperature sensor for fertility tracking and a number of other medical issues. Site

Visualizations and vanity for behavior change: AprilAge pitched its visualization software, which shows patients how smoking, obesity, and sun exposure may affect the way their face and body looks as they get older. (Long time Mobi-readers may remember our take on this a few years ago because of the memorable headshot photo.) Site

Preventice and Mayo: Partnerships are key for startups. Preventice, newly merged with eCardiosent president Jon Otterstatter to present on a panel with the Mayo Clinic's Dr. Charles Bruce. They spoke about how Mayo Clinic is using Preventice's BodyGuardian system to detect and treat cases of atrial fibrillation that go undetected with traditional technologies. Bruce described how the irregularity of atrial fibrillation allows it to go undetected in as many as 60 percent of cases. Otterstatter attributed Preventice's success to their prioritizing of good, reputable partners like the Mayo Clinic and Merck Global Health Innovation Fund, one of their largest backers: "It’s built to leverage the strengths of the participants," he said. "If you think about the core of Mayo Clinic and the strength and patience of a Merck that’s been in healthcare for many, many years, and the accepted relationships eCardio diagnostics has: that’s the platform we’ve created in the last five years."

Clinical is Raiing's new business focus: On the show floor, MobiHealthNews spoke to connected thermometer maker Raiing who recently launched a pilot with Partners HealthCare. A Raiing exec said that, at least in the short term, Raiing expects the clinical business to be more significant than their direct-to-consumer business, iThermometer for parents monitoring their children's health and Smart Fertility Tracker for couples trying to get pregnant.

Sharecare goes Android: One year after launching for iOS, the company WebMD founder Jeff Arnold co-founded with Dr. Mehmet Oz, Sharecare, launched its AskMD app for Android devices at the mHealth Summit this year. The Android app will bring the app to 95 percent of smartphones in the US, according to the company.

HIMSS survey on provider mobile tools: More than two-thirds of clinicians at US hospitals use smartphones or tablet computers at their facilities, according to a small HIMSS survey of 139 clinicians.

Partners' cHealth Compass app: The Center for Connected Health, which is a division of Partners HealthCare in Boston, announced a research tool, called cHealth Compass, that aims to help device manufacturers, startups, and investors understand what consumers want from and how they want to use digital health technologies. Kamal Jethwani, the Center’s corporate manager for research and innovation, explained that this offering solves two barriers that startups have to deal with when testing products -- getting an IRB and finding the right focus group. Jethwani explains: "We have thousands of patients that have been pre-vetted and pre-enrolled into a group and we’re opening that up as a sandbox for companies and for product manufacturers to come in and find the right target audience easily. And then run product assessments, product evaluations, and other things with these real patients who are now willing to take part in research. ... You come in, you tell us what you want. You know — 'I want 10 patients with asthma who are African American'. We’ll pick that group for you and hand it over to you."

AliveCor partners with Omron: Japan-based medical device company Omron Healthcare has partnered with AliveCor to help bring AliveCor’s FDA-cleared smartphone-connected electrocardiogram (ECG) to more online and brick and mortar retailers. AliveCor CEO Euan Thomson told MobiHealthNews in an interview that Omron already sells its own products at various retailers, and through this partnership, Omron will bring AliveCor’s smartphone ECG device to market through some of its existing channels. Retail locations that carry Omron devices today include Rite Aid, Target, Walgreens and Walmart.

CAIL Mobile partners with B2 Group: Mobile app developer CAIL Mobile partnered with consulting firm B2 Group to build the Activity Kit Health Solution, which will be a platform that aggregates app and wearables data for corporate wellness programs.

Qualcomm partners with vitaphone e-health solutions: Qualcomm subsidiary Qualcomm Life announced a collaboration with telehealth company vitaphone e-health solutions.  Vitaphone will integrate its chronic disease management offerings into Qualcomm Life's HealthyCircles and 2net platforms so that patients can send biometric data from connected medical devices to the platform.

 NetComm Wireless launches health device connectivity platform n-Hub: NetComm Wireless launched n-Hub, a device that connects digital health apps and devices over a 3G network.

Bluetooth group tries to standardize CGM data collection: The Bluetooth Special Interest Group (SIG) recently announced new standards for Continuous Glucose Monitoring (CGM) data collection, measurement, and delivery.

Text2Floss launches oral hygeine app: File this one under novel texting interventions: Text2Floss, an initiative out of AT Still University supported by Johnson and Johnson, was on hand at the Summit's exhibit floor. The program launched it's texting initiative, which reminds users about oral health tips, last year, but followed it up in August with an iOS app that reminds users to brush twice a day, and floss and rinse every day. The app also includes a dental hygiene timer, medical history recorder, and dental clinic locator.