The MobiHealthNews Podcast: Q1 in Review

By: Brian Dolan | May 2, 2013        

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Podcast imageIn this past month’s MobiHealthNews podcast, Jonah Comstock and I reviewed some of the most important mobile and digital health stories and trends that emerged during the first quarter of the year. This short (7-minute) podcast riffs off our recently released Mobile Health Q1 2013 State of the Industry Report, which we just published yesterday morning.

We’ll be back later in May with our podcast dedicated to fitness apps and devices, which should be particularly interesting considering the recent acquisition of longtime wearable health sensor company BodyMedia by cash-flush Jawbone.

Our April podcast is available for download or streaming over at Hipcast now (check it out here!) and over at iTunes (here’s the link).

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Intuitive, now Vivify Health, raised $3.4M from Ascension, Heritage Group

By: Jonah Comstock | May 1, 2013        

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vivifyPlano, Texas-based remote monitoring startup Intuitive Health has finally emerged from stealth mode with a new name, Vivify Health. At the end of January, MobiHealthNews reported that the company, which offers a cloud-based device-agnostic remote monitoring software, had raised $3.4 million from undisclosed sources. Our January report also noted that the company was participating in a pilot with AT&T and Texas Health Resources.

This week, the company announced that the funding came from healthcare investment firms Ascension Health Ventures and Heritage Group. The company is using the money “to accelerate the delivery of Vivify’s cloud-based remote care management platform that enables hospitals, home health agencies, payers and other stakeholders to accomplish population health objectives, including reducing readmissions, managing chronic diseases, improving care transitions, and engaging patients in their own wellbeing,” according to their press release.

Vivify has been quietly working on its software-as-a-service offering since CEO Eric Rock founded the company in 2009. The company claims to market its software directly to consumers, but its website seems to court providers, health plans, and even pharmaceutical companies. Vivify’s software suite includes a wide range of home monitoring features: coaching, customized care plans, video conferencing with physicians, and educational video content. The system integrates with remote monitoring technology like health and vital sign sensors, as well as with EHRs, PHRs, and HIEs, according to the company. Consumers can access the software through mobile devices, computers, and Internet-connected television.

Vivify has been deployed in large health systems since 2011, according to the company. In addition to the partnership with AT&T, the company has worked with Ericsson, Polycom, and Samsung.

“We recognized early on that delivering a scalable consumer-connected platform, including mobile high-definition video conferencing, requires core competencies of these leading consumer technology providers,” said Rock in a statement.

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Tips for integrating health apps and EHRs

By: Jonah Comstock | May 1, 2013        

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WellDoc DiabetesManagerBaltimore-based WellDoc has announced the publication of a case study on the integration of it’s mobile diabetes management offering with the electronic health record system Allscripts, implemented at George Washington University School of Medicine. Back in 2010, MobiHealthNews reported on the partnership, which was funded by the US Air Force.

WellDoc’s diabetes management offering is FDA-cleared as a Class II medical device, and the study refers to it as a “mobile-integrated therapy” (MIT). It uses patient-entered data, data from sensors built into a smartphone, and data from connected sensors (like a continuous glucose monitor), to provide personalized coaching to the user. In integrating the MIT with the Allscripts EHR, patient data was shared bi-directionally, according to the paper.

For the study, which was published in the Journal of Diabetes Science and Technology, WellDoc conducted interviews with mobile development and testing teams, the EHR software consultants, the hospital IT team, patients, project managers, and business analysts. They collated that information into eight lessons learned from the integration.

1. The integration must take into account each user’s day-to-day life and workflow, including patients, providers, IT staff, and additional caregivers. Some users will need access to a greater depth of information, while for others design and usability will be paramount.

2. The design should be interoperable and support the integration of multiple MITs into a single EHR. In particular, developers should make sure to eliminate redundancies between the systems, where app users and EHR users might enter the same data into different fields.

3. Multiple environments have to be secure, but their security can’t keep them from interacting with each other. Stakeholders WellDoc interviewed reported problems with competing firewalls in implementing the integration.

4. Both halves of the integration, but especially the patient-facing app, should work natively on as many mobile devices as possible. Patients are most likely to use a system that allows them to continue using their device.

5. The mobile health offering is subject to a limitation already standard for EHR apps: it must be able to run even when network connectivity is sparse or intermittent, as is sometimes the case in large hospital complexes.

6. It’s crucial to have a support team in place familiar with the technology  to help acquaint users with it.

7. Make sure the two systems adhere to common standards. Not only data interchange standards like HL7, but also making sure that measurements in both systems use the same units. If lab-collected blood glucose data in the EHR and patient-collected blood glucose data have the same unit, but one is potentially more accurate, the integrated system should easily identify and distinguish the two.

8. The team working on an integration should be ready for a more complex process than anticipated. A clear vision, good communication, and a steering committee are important for anyone attempting to integrate a mobile heath offering and an EHR.

The paper also indicates that a paper with results from a clinical trial with more quantitative data about the George Washington University School of Medicine trial is still to come.

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Managing your business risk in mobile health: Part 2

By: admin | May 1, 2013        

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Bradley Merrill ThompsonBy Bradley Merrill Thompson

As I said in the prior post, this series is for two types of companies: (1) those that are merely dipping their toes into mHealth because they’re afraid of the water, and (2) those that are diving right in head first with no idea how deep the water is. Both types of companies might be making mistakes, either by letting good opportunities go by or by incurring undue regulatory risk. I’d like to convince both types to be more measured and informed in their approach to mHealth.

In the first post, I laid out all the nasty stuff that can happen if you enter mHealth and your app or your hardware ends up FDA regulated, but you don’t comply. That post was ugly, but it had to be done, because it laid the groundwork for this post. Now I’d like to share the good news that there is plenty you can do to mitigate your risk of FDA enforcement. As usual, I think in lists. The following is my checklist.

1. Check your attitude. I’ve been doing this for almost 30 years now, and I can generally tell which companies will succeed and which will fail when it comes to FDA compliance. There is one very clear hallmark of the companies that succeed—in their attitude they are able to embrace the FDA and put patient safety first. If you can do that, you’ve won easily half the battle. It sounds almost silly, but it goes to the very DNA of the organization. If the organization views FDA as a stakeholder that needs to be kept happy, they will organize their business partly around pleasing that stakeholder, in addition to customers, shareholders, employees and others. These companies make it part of their mission to learn the rules and play by them. If you can’t do that, my advice is simple. Stay out of this space.

2. It’s all about intended use. In prior posts, I’ve tried to explain the concept of intended use. As you might recall, intended use is the manufacturer’s objective intent with regard to how its customers will use its product. This concept is the linchpin of FDA regulation. It determines everything, including (1) whether or not FDA regulates your product, and (2) if it’s regulated, to what level. Intended use is therefore by far the single biggest determinant of regulatory risk, and companies that figure that out put in place robust systems for managing the intended use of their products. That means they carefully manage how they promote the products and what design features they add. They tightly control all of the things which ultimately determine the company’s intended use for their product, so that it stays exactly where they wanted it to stay.

3. Aim as low as you can. To reduce regulatory risk, focus on the lowest risk conditions and the least claims you can make. The risk associated with the health conditions you target partly determines the regulatory category (it’s an element of the intended use), and the claims you make about your product need to be proven to FDA’s satisfaction. So I say, aim as low as you can. I can almost hear the marketing people screaming. Okay, I get it — you need to be bold in business to make money. So what I’m really saying is pick a happy medium between the “our product will save the world” claims the marketing people want to make, and selling an inert paperweight. Carefully pick whatever the least is that can accomplish your sales goals. Less can definitely be more. Further, many companies not traditionally in the healthcare space confuse “common” with “low” risk. Diabetes is quite common these days, but not low risk. Similarly, claims of real time monitoring of patients with serious conditions are not low risk. Learn the difference.

4. Pursue a generic intended use. You don’t always have to tell people exactly how to use something. I can make and sell test tubes without regulatory oversight so long as I’m just making a glass tube and the claims I make relate, for example, to the quality of the glass and its cleanliness. I can make a network router that is just a router. Where I tend to get put in the regulatory soup is when I start to make specific medical claims that, for example, my router is especially good because of its design for some specific medical application. For the generic intended use strategy to be legitimate, there have to be legitimate nonmedical uses, which for test tubes and routers is not a problem. Please remember, though, how broad the concept of intended use is, in that it encompasses, for example, (1) the words I use to describe the product, (2) any special design features I might add that have only medical uses, as well as (3) uniquely medical channels of distribution I choose to pursue.

5. Take a more nuanced approach. It’s not all in or all out. There are many different roles the company can play in the industry. Companies can avoid many of the regulatory obligations by limiting their role to serving as a contract manufacturer. Or a design firm can collaborate with the manufacturer without taking on all of the regulatory obligations. Or you can just be a distributor of someone else’s willing to be the manufacturer. There are lots of roles to play, they aren’t all equally risky. I explained that in excruciating detail in a prior post.

6. Manage your supply chain well. The most successful folks I know in the medical device industry would put this at the top of their list, as a matter of general business practice. It makes my list with regard to ensuring regulatory compliance for several specific reasons. Companies should get accustomed to using supplier contracting to share the burdens of regulatory compliance—asking their suppliers to shoulder some of the obligations. At a minimum, contracts should specify the regulatory obligations rather than leave the issues unaddressed. Warranties are important, and there is even a so-called “pure food and drug warranty” in the FDA regulations which if you use that wording you can shift regulatory risk upstream. There also are whole tasks that can be outsourced, notably the clinical research function to a Clinical Research Organization. This is a little bit controversial in the device area; there’s an express provision on the drug side of FDA that allows this but not so on the device side. Even so, using a CRO typically can help reduce the risk. Keep reading>>

Proteus Digital Health raises $45 million, inks clinical trials deal with Oracle

By: Brian Dolan | May 1, 2013        

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Proteus Biomedical's Raisin system

Proteus Biomedical's Raisin system

Redwood City, California-based Proteus Digital Health announced that it had raised $62.5 million in its latest round of funding led by Oracle with participation from existing investors Otsuka, Novartis, Sino Portfolio and others. MobiHealthNews reported on the first $17.5 million that Proteus raised for this round a year ago, so the $62.5 million includes an additional $45 million raised over the course of the past year. In total, Proteus, which was founded in 2001, has raised north of $170 million from a long list of investors that includes Medtronic, Itochu, St. Jude Medical, and Kaiser Permanente Ventures.

Proteus Digital Health, which changed its name from Proteus Biomedical last July, is developing an intelligent medicine offering called Raisin, and the basic system includes sensor-enabled pills, a peel-and-stick biometric sensor patch worn on the body, and companion smartphone apps. The patch records when a pill is ingested and also tracks other things like sleep patterns and physical activity levels. The ingestible sensor component of the Raisin offering gained FDA clearance last July, while the company’s sensor-laden patch secured clearance in 2010.

Oracle and Proteus will work together to help investigators in clinical trials to better understand and measure medication ingestion, dose timing, and associated physiologic responses from patients. Proteus’ ingestible sensor technology will be integrated into Oracle’s clinical trial products, including InForm, Data Hub, and its Siebel clinical trial management system.

Last summer Proteus announced a partnership with Japan-based Otsuka Pharmaceutical, which is known for its Abilify drug for schizophrenia and bipolar disorder, that will bring technology based on Proteus Digital Health’s Raisin platform to that country.

In January 2012, UK-based retail pharmacy chain Lloydspharmacy inked an exclusive deal with Proteus to launch Proteus’ first commercial product, Helius, an offering that includes sensor-enabled pills, a peel-and-stick sensor patch worn on the body, and a mobile app. The offering is similar to Proteus’ Raisin technology but instead of integrating the sensor in the pharmaceutical itself, patients have to swallow a separate pill with their medication.

Proteus also licenses its peel-and-stick sensor patch technology to other companies in digital health, including BodyMedia, which had planned to launch a disposable sensor patch through a deal with Avery Dennison. Given its recently announced acquisition by Jawbone, it’s unclear whether that BodyMedia device will ever ship.

For more in depth coverage, visit our research store.

Hospital CTO helms pager replacement business

By: Jonah Comstock | May 1, 2013        

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SorensenMichael Sorensen, in his old job as chief technology officer of the University of Chicago Medical Center, had a problem: pagers.

Healthcare is one of the few areas where the pager still tenaciously hangs on in the age of the smartphone. A combination of factors contributes to this: many hospital CTOs find pagers more reliable than cellphones in a large hospital complex, and a switch to smartphones has to be done carefully to maintain privacy and security of patient information. But Sorensen didn’t find the case for the legacy devices compelling.

“Pagers are not as reliable as everyone thinks they are. If you drill down, there’s so many single points of failure that we were suffering outages all the time. We measured it in the most recent year. Within a calendar year, we missed about 2,000 pages,” he said. “And then finally the other thing that was frustrated was the expense associated with it. I was spending over half a million dollars a year on paging services. That was one of my top expenses.”

In addition, unlike pagers, smartphones can, in Sorensen’s words, “close the loop” — users can be notified when a recipient receives their message and when they open it. This ensures that, for instance, if a nurse sends an urgent message to a doctor who for any reason doesn’t receive it, the nurse can try another doctor right away.

So Sorensen founded a company, called Stage 8 Systems, which he ran in a largely advisory capacity while continuing to work as CTO at University of Chicago Medical Center. Stage 8 Systems was developing a secure messaging system on BlackBerry before the iPhone was even introduced, according to Sorensen. When the company was acquired by software company Mutare at the end of last year, Sorensen left the University of Chicago Medical Center to become president of Mutare’s newly established healthcare division.

“I either needed to go the route of VCs or find a company like Mutare. … I was able to find a company that had some of this mass notification technology already in their portfolio, and then assume a key role that allowed me to drive the innovation and the market strategy,” he said.

Plenty of startups are tackling the pager problem by including secure hospital messaging systems for smartphones as part of their offerings: AmcomVoalte, TigerText, and Docbook MD are just a few of the players MobiHealthNews has written about, many of which have been in the space for a number of years.

Sorensen feels many of his competitors (he didn’t name names) are offering too basic a product at too high a cost.

“I don’t want to trade my $500,000 paging bill for a $300,000 smartphone app,” he said, referring to the 4,000-pager system he had at the University of Chicago Medical Center. “I want to drive that down as low as I can get it.”

Sorensen said Mutare could get that number as low as $150,000, and their pricing scales with the number of users, allowing smaller practices to use the system for as little as $10,000. And on top of secure, HIPAA-compliant two-way messaging, the platform includes built-in disaster recovery (a back-up site kicks in in the event of a power failure at Mutare’s facility or in the hospital), mass notification for non-patient information that needs to get out to all hospital personnel, and basic patient engagement messaging, like sending out surveys to help reduce re-admissions.

Mutare’s messaging system, called Vital Link, works via a web application, as well as through native apps for iPhones, iPads, and Android and BlackBerry devices. Sorensen said the company is continuing to add features, and is also willing to customize the platform for hospitals’ individual needs.

“What really drives me is I’ve got some customers that really get this, that get the platform concept. We have a major customer in South Carolina who says ‘Couldn’t I send notifications out ot family members in our surgery waiting area?’ We get back here, we start literally adding on to the platform,” he said. “We are building that custom and near-cost for that hospital. … We come with these core capabilities, but if you want it to flash blue when you send a code blue message, we can do that. If they can tell me it will improve workflow and outcomes, I’m all set to make that happen.”

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