Details: Bill that calls for mobile health office at FDA

By: Brian Dolan | Dec 4, 2012        

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Brian Dolan, Editor, MobiHealthNewsAs expected, Silicon Valley’s Congressman Mike Honda (D-CA) introduced a bill this week that — among other things — seeks to create an Office of Wireless Health at the Food and Drug Administration (FDA). While the bill has been talked about in the past few weeks, its specific details have only now been made public. The bill also calls for a HIPAA-focused developer support program at HHS, an X Prize-like prize program in addition to small “innovator challenge” to “stimulate new approaches”, a low interest loan program for small physician practices and clinics that want to purchase “non-EHR” health care technology, and two year grants that assist medical care providers in retraining employees on how to use health IT.

Rep. Honda proposed the bill, called Healthcare Innovation and Marketplace Technologies Act (HIMTA), Monday in the House of Representatives, so it is currently far from becoming law. In some ways the bill appears to be a mini-stimulus for digital health technologies.

“As we continue to improve our health care system, technology can and should play a prominent role in achieving better care for Americans,” Rep. Honda said in a statement. “Investments, development, and adoption of technologies remain stagnant. Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space. Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” he continued. “There is also a lack of an established marketplace for new technologies and a lack of trained workers to handle the implementation and use of these technologies. This bill begins to bridge these gaps.”

The headline-grabbing portion of the bill is that it seeks to establish an office at the FDA that specifically focuses on “wireless health” that will work with other government agencies and private companies to help the FDA Commissioner develop and maintain a “consistent, reasonable, and predictable regulatory framework” for wireless and digital health technologies. Rep. Honda’s office makes clear the bill does not aim to expand the role of the FDA, just to help it clarify and simplify existing regulations.

The secondary initiative that the bill tackles on the regulatory front is the formation of a developer support program for mobile health at the Department of Health and Human Services (HHS). The specific aim here is to help developers navigate the somewhat complicated nuances of privacy regulations like HIPAA. The support program would include a national hotline, educational website, and an annual report that translates privacy guidelines into “common English”.

While the bill aims to offer small loans to physician practices that want to adopt certain digital health technologies, it also calls for a tax deduction for practices of up to $250,000 annually but equal to the amount that practice spends on qualified health technology during the year. “Qualified health technology” is defined as: “the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making. Such term does not include certified EHR technology,” according to the bill.

The last part of that definition is important: Not EHRs. The small loan program has similar but different exclusions:

The small loan program is aimed at helping small practices adopt various types of information technology that focuses on patient engagement or improved workflow (and more), but does not include “information technology whose sole use is financial management, maintenance of inventory of basic supplies, or appointment scheduling.”

The program calls for upwards of $250,000 in loans to single physician practices and upwards of $500,000 in loans to group practices.

For more on the contents of the HIMTA bill, read the summary over at Rep. Honda’s site.

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Almost half of clinicians collect data at bedside via mobiles

By: Brian Dolan | Dec 4, 2012        

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physician ipadResults from two surveys focused on healthcare provider adoption of mobile technologies published this week from HIMSS Analytics and Spyglass Consulting Group. While both point to substantial growth in adoption, Spyglass’ survey points to IT support issues arising from the well-documented Bring Your Own Device (BYOD) trend.

Over the course of four months starting in May 2011, Spyglass Consulting conducted in-depth interviews with more than 100 nurses working in acute care environments in the US to determine smartphone adoption and usage among the group. About 69 percent of the hospitals interviewed for the survey had nursing staff using smartphones on the job that the facility’s IT department were not willing to support on the hospital’s network. Spyglass said the communications device provided to nurses by IT were often found to be difficult to use and of limited functionality.

“Hospital IT is concerned that personal devices on the hospital’s network pose a significant security threat to patient health information stored on the device or the network,” Gregg Malkary, Managing Director of Spyglass Consulting Group, said in a statement. “Supporting nursing ‘Bring Your Own Device’ initiatives would require hospital IT to define comprehensive mobile governance strategies and to deploy enterprise-class tools to centrally monitor, manage and protect mobile devices, apps and data.”

It was almost unanimously agreed among those nurses surveyed that first generation Tablet PCs were not the right device to support bedside nursing, and, according to the group, Apple’s iPad won’t succeed either despite its current popularity. Nurses cite durability, infection control, limited data entry, and lack of native applications as the reasons for iPads not making it longterm. Tablets aside: About 25 percent of the nurses were dissatisfied with the quality and reliability of their hospital’s wireless network.

The second annual HIMSS Mobile Technology Survey, sponsored by Qualcomm Life paints a rosier picture. The survey of about 180 IT professionals working at healthcare facilities found that half of them believe the use of mobile technology would substantially impact patient deliver. An additional 16 percent said it would dramatically change the future of healthcare delivery. Most believed pharmacy management, i.e. medication reminders, and remote monitoring would see the biggest benefits from mobile.

The survey found that clinicians are using their mobiles in care settings more and more. About 45 percent of respondents said clinicians collected data at the bedside on their mobiles, up from 30 percent last year. Bar code readers on mobile jumped from 23 percent last year to 38 percent. Monitoring data from medical devices notched up to 34 percent from 27 percent year-over-year. Using the camera on the phone to capture patient data more than doubled from 13 percent last year to some 27 percent today. About 25 percent said all data captured on mobiles is integrated with an EHR.

Few of those surveyed said their facilities had developed apps intended for use by patients — only 13 percent. About half of survey respondents said clinician adoption of apps is high and is likely to increase over the next year. About 5 percent of those surveyed offer some kind of app marketplace and about 11 percent are considering it.

Finally, the survey found that the biggest challenges facing an IT department’s mobile strategy today are funding and security of patient data.

Real games for health and the trouble with gamification

By: Jonah Comstock | Dec 4, 2012        

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Ben Sawyer

Ben Sawyer

Motivating behavior change has long been one of the biggest challenges and opportunities in mobile health. One avenue for addressing that challenge is to take lessons from a field that doesn’t suffer from any engagement problems: gaming.

For the first year, the mHealth Summit 2012 featured a Games for Health pavilion, focused on companies using games and the lessons learned from gaming to innovate mobile health. Games at the conference seem to fit into two broad categories: simulations that increase readiness and preparedness for medical events and gamified tracking and motivating apps.

A lot of the energy in gamification is focused on using game mechanics to motivate people to healthy behaviors, such as staying active. Ben Sawyer, co-founder of Games for Health, said this is a natural space for mobile gaming.

“There are some really uniquely mobile ideas,” he said. “The [kind] of exercise that hits the largest part of the population is walking, so we see a lot of games built around that. This is something that really speaks to the ‘health games for everyone’ notion.”

Mindbloom is an example of such a company. Their “life game” pairs up each user with a virtual tree that represents the different spheres of life like health, career, and spirituality. To make the tree grow you have to water it by taking small actions toward those goals.

The company recently partnered with Elbrys to create Juice, an energy tracking app that uses the visual metaphor of a juice bottle. Users can input data from activity trackers or enter the information manually, and then compare the sleep, food, and exercise their getting to their energy levels throughout the day. The app also offers a reward system that allows users to unlock content and tips.

Another game in that space is HotSeat, which uses social motivation — users sharing and challenging other users — to get office workers to engage in mini-activity during 2-minute work breaks. Workers choose from a dropdown menu with everything from “walking” to “Gangham Style” and the app will alert them to break and do their chosen activity or activities throughout the day.

Activity motivating apps aren’t just targeting the worried well or the workplace, they have found their way to healthcare facilities, too.

Doug Elwood of the NYU Langone Medical Center presented findings on a motivating game deployed at the hospital to get amputees moving with scheduled mini-dance parties. Although the app was extremely simple, Elwood said it really worked.

“Games don’t need to be complex,” he said. “We tapped into dance as a form of engagement.”

While some companies are using games to motivate action in adults, others are applying a similar model to kids. Zamzee has developed an activity tracker, “safe” social media platform, and rewards system for kids to get them moving. The company just completed a clinical trial in September, which showed that the platform made kids move 58 percent more. Kids collect points by moving and completing challenges, and they can exchange those points for virtual rewards, like swag for their on-site avatars, or physical rewards, like pink duct tape sent through the mail.

But Dan Botwinick, Device and Operations Director for Zamzee, said the game is designed so the fun of the experience will keep kids playing even if they lose interest in the rewards: “Extrinsic motivation starts the behavior, but is less effective over time,” Botwinick said. “A positive mindset sustains those behaviors.”

Micheal Fergussen, CEO of Canadian health games company Ayogo, echoed that sentiment a bit more brashly.

“Bribery is not a game,” he said. “It’s not enough just to give people rewards for doing the right thing. Points and badges are to games what page heading and chapter numbers are to books. I can put page numbers and chapter headings on my VCR manual, but that doesn’t make it ‘War and Peace’.”

Ayogo builds motivating games targeted at adults and kids, including an app game for children with diabetes called “Monster Manor.” The game rewards kids for checking their blood glucose regularly with short minigames that add up to unlock features and characters. It automatically sends the results to the parents’ smartphone, and has a back-end built in where parents can give kids rewards directly through the game.

IMG_1735 (640x480)But Sawyer said games have great potential for pro-active care.

“We think there’s a world where we can get to you earlier about health and healthcare,” he said. “These are actually assets that you need ahead of time, so that at the point of hitting a health problem, you just plow right through it. You’re prepared.”

Several of the games at the summit fell into that category instead. BreakAway and Kognito produce computer games that act as simulators to train doctors, patients, or caregivers in situations it can otherwise be hard to train for. BreakAway has a training tool where players interview a virtual patient and have to decide which questions to ask and make a diagnosis. They’re also working on a large-scale hospital simulator that can be configured to help train emergency personnel for a catastrophic event. It looks like a hospital version of the classic video game The Sims. Kognito makes training tools for difficult conversations, like convincing a veteran to seek help for PTSD.

One of the most interesting companies working on that side is TiltFactor, a game company/research lab out of Dartmouth whose board game and free app ZombiePox was designed as an education tool, to teach the importance of vaccinations. When people see that the only way to win the game is to focus on vaccinations rather than trying to cure a rapidly spreading disease, the developers believe they internalize the lesson, and hopefully will be motivated to get their shots.

Sukie Punjasthitkul, of TiltFactor, said that in tests, the lesson was better internalized by the group that played the tabletop version of the game than by the group that played the mobile-enabled one. He’s not sure why that is, but the answer might provide some insight into what it really takes to change behavior through gaming.

So is mobile gaming the “Holy Grail” of behavior change? Most of the experts at the mHealth Summit this week agreed that driving behavior change required real games, not just gaming elements like attractive interfaces and point systems.

“What’s really important to me is that the intrinsic reward of a game comes from the actual process of play,” Sawyer said. “That is hard to do if you’re gamifying something that has a low frequency of engagement.”

Aetna to launch CarePass for mobile in 2013

By: Jonah Comstock | Dec 3, 2012        

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IMG_1727 (640x480)Aetna CEO Mark Bertolini kicked off the mHealth Summit this morning by announcing a launch date for the mobile implementation of their health data syncing platform CarePass, which will combine Aetna’s recent mobile acquisitions and partners into a single offering.

CarePass has been available as a web platform, but Bertolini said it would go mobile in March 2013. The platform connects iTriage, the patient app Aetna acquired in December 2011, with a variety of fitness apps like Fitbit and MapMyFitness and food management apps like BetterLife and SparkPeople. It will also connect to Medicity’s iNexx health information exchange platform, which Aetna acquired in December 2010.

Like iNexx, CarePass has an open API and is available to third-party developers. Bertolini said the company has been hosting hackathons and codeathons to bring more apps onto the CarePass platform.

“This is not an Aetna propriety platform,” said Bertolini. “This is for everyone. Noble cause. Why not? It’ll make our economy healthier.”

New developer partners for Aetna include Earndit, FoodEssentials, and Personal.com.

Bertolini gave an example of how the platform might be used by a consumer. A person can look up a symptom on iTriage and discover what kind of specialist they need to see. They can then get a list of doctors who take their insurance in that specialty, and which of those doctors are good matches. (“Think of it as eHarmony for doctors,” Bertolini said.) From the app, a user can make an appointment with that doctor.

If the doctor needs to run lab tests, they can inform the patient of the results via a native messaging system, and can even send a prescription to both the patient and their pharmacist online.

Bertolini stressed that connecting data-gathering fitness apps is an important aspect, because of the “obesity pandemic” in the country. That data should help physicians treating patients dealing with weight issues. He listed Fitbit, fitsync, Goodchime, GYMPACT, MapMyFitness, Active, Runkeeper, and Strava on the fitness side, and food management apps Thryve, FatSecret, BetterLife, and SparkPeople. Bertolini listed medication adherence apps mHealthCoach and Pilljogger partners, too.

He also previewed a new fitness app, Passage, that takes users on virtual trips around the world while they work out. It was developed by Aetna in conjunction with Microsoft and is available in the Windows Store.

Bertolini said that CarePass is a part of Aetna’s strategy to reduce healthcare costs. He said that since the 70s, health insurers have been trying different strategies to reducing costs: managed care, purchasing providers, and making reimbursement burdensome for patients. None has been effective.

“The only way to make it work is to facilitate the relationship between patients and doctors, to get out of the way and let the system really work,” he said.

FDA clears AliveCor heart monitor, doctors can pre-order

By: Brian Dolan | Dec 3, 2012        

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AliveCor Heart Monitor

The FDA has granted a 510(K) Class II clearance to San Francisco-based AliveCor’s iPhone-enabled heart monitor, which has been commonly known as the “iPhoneECG” since it first made an appearance at CES two years ago. The company announced the clearance as the mHealth Summit kicks off this week in the Washington DC area. AliveCor will begin pre-selling the $199 clinical-quality, ECG monitor, which has the form factor of an iPhone case that fits iPhone 4 and 4S devices, directly from its website starting today, December 3rd.

AliveCor CEO Judy Wade told MobiHealthNews that within a few months the heart monitor will be made available in three different ways. Starting this week physicians can buy them from AliveCor’s website for $199, and the site will require them to provide the medical identification numbers to prove that they are indeed a physician. Wade said that pricepoint is less expensive than most electronic stethoscopes. Starting early next year the company plans to encourage physicians to make the device available to their heart patients via prescription. While the specific details, including pricepoint for prescribed devices, has not yet been fully worked out, Wade told MobiHealthNews the price of the device could hover somewhere around $99 for patients whose doctor prescribes one. Finally, assuming the company secures its next 510(k) clearance, Wade expects the over-the-counter version of the heart monitor to become available sometime during the second quarter of 2013.

Wade said there are a couple of initial use cases for the device: Patients who feel like they have a heart arrhythmia problem, but are asymptomatic and it doesn’t show up when they visit their doctor’s office. This device can be at the ready if the patient has it with them, and it can be used to record the heart rhthym strip the next time the patient feels something. Another use case is for someone who has already been diagnosed with atrial fibrillation and has been treat with ablation and/or medications. Wade said a physician could prescribe the device for at-home use so that they could monitor the patient remotely and determine whether the therapy was effective or is working. The device is also a preventive medicine tool since it detects arrhythmias, which can be a problem in and of themselves sometimes but can also be associated with something else — like an imminent heart attack.

Wade said that longterm the company sees a lot of power in recording and analyzing peoples’ EKGs. AliveCor refers to this as the “deep data” opportunity, as opposed to the more commonly used “big data”.

“Our vision is for everyone to have their health at their fingertips. Hopefully, before long, we will have millions of [ECG] recordings that we will be able to contextualize around simple things like your age and height. In the future the platform won’t only be interpretive it could be predictive as well. That’s why we have been very active in participating in clinical research and trials with the device because hopefully a lot of interesting research will come out of it.”

This week’s FDA clearance enables AliveCor’s Heart Monitor to be sold and marketed to “licensed medical professionals to record, display, store, transfer, and evaluate single-channel electrocardiogram (ECG) rhythms,” according to the company. “The rhythm strips can be of any duration, and are stored on the iPhone and securely in the cloud for later analysis, sharing and printing through AliveCor’s secure website. The ECG data is sent wirelessly from the Heart Monitor via AliveCor’s low-power, proprietary communication protocol, and requires no pairing between the iPhone and the device.”

Here’s how the device works: “The device incorporates electrodes into a case that snaps onto the back of an iPhone 4 or 4S. The Heart Monitor is used by launching the corresponding AliveECG app on the iPhone, holding the device in a relaxed state, and pressing fingers from each hand to each of the two appropriate electrodes on the device. The device can also be used to obtain an ECG by placing it on the chest.”

AliveCor expects to launch its Heart Monitor in the form of a “universal module” (that is similar but different to the credit card-sized prototype the company has demo’d in the past) that will work with iOS and Android devices by Q3 next year. Following that the company plans to launch a “pad” version of the heart monitor that is big enough to place your entire hand on. This form factor could be placed in health kiosks or doctor’s offices. Each of the form factors would likely require additional clearances from the FDA.

The company also secured its CE Mark and a European launch for the initial form factor is expected early next year.

Scanadu unveils smartphone-enabled home diagnostics

By: Jonah Comstock | Nov 29, 2012        

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scanadu SCOUTScanadu, the 2-year-old San Francisco startup aiming to develop a handheld medical scanner for home use, similar to the Star Trek tricorder, has unveiled its first three products, set for release by the end of 2013.

The Scanadu SCOUT is the central scanner component. The NASA Ames Research Center-based company says that customers simply hold the small, lightweight device to the patient’s temple and it will return five vital sign results with 99 percent accuracy in less than 10 seconds.

“Consumers’ attention deficit is increasing,” CEO Walter de Brouwer told MobiHealthNews in an interview last month. “And if they have a device that can do diagnostics, they are not willing to spend more than 10 seconds waiting. They’d like to have real time, they’ll settle for 10 seconds, but a minute would be too long.”

The data from the scan will be uploaded to a Scanadu app via Bluetooth and will track pulse transit time, heart rate, electrical heart activity, body temperature, heart rate variability, and blood oxygenation. The company plans to sell the device for less than $150, and the firmware will be remotely upgradable, allowing Scanadu to add new scanning metrics in the future.

“We found in user testing that the consumer doesn’t want to go through the ritual of the doctor checkup,” de Brouwer told MobiHealthNews. “The consumer wants one position on the body. And he wants to do the diagnostics all in that one position. And the consumer is price-specific. For the consumer, the price sensitivity will be very high.”

In addition to the SCOUT, the company announced two “low-cost and disposable early detection tools,” which will be integrated with the Scanadu app.

Project ScanaFlo will be used to conduct urinalysis. Customers can buy an over-the-counter disposable cartridge, and the software will test urine for preeclampsia, gestational diabetes, kidney failure and urinary tract infections. Pregnant women will also be able to scan for pregnancy complications or to monitor their health throughout the pregnancy.

Project ScanaFlu, meanwhile, will analyze saliva in cases of cold-like symptoms. It will test for Strep A, Influenza A and B, adenovirus, and RSV.

Scanadu plans to submit the products to the FDA for review as soon as next week. De Brouwer said that as a medical device with a consumer-focused use case, it’s not clear whether the FDA will consider the device unique. The SCOUT goes into manufacturing next month, freeing up the company’s team to work on the software side, particularly the user interface.

Scanadu also stressed in the announcement that Scanadu can be used by healthy customers, too, to monitor personal average vitals, so that when a person does get sick doctors have more information about what’s normal for that individual.

Dr. Alan Greene, Chief Medical Officer at Scanadu, said in a statement, “Health decisions shouldn’t be based on averages, they should be based on a real, accurate and personalized healthfeed of data — which we now have the power to give to the consumer in the palm of their hand.”

Scanadu is one of the more visible companies competing in the Qualcomm Tricorder X Prize, a competition to develop a device much like this one. The announced vitals the SCOUT can read line up fairly closely with the draft guidelines for the prize, with the exception of respiratory rate. De Brouwer said the device can read respiratory rate, but not within Scanadu’s self-imposed 10-second window. He said a marketable consumer product is a higher priority than the prize, which is still a year out from its first judging round.

De Brouwer believes Scanadu will be just one step in a personal health revolution.

“This is the beginning of a nascent industry of personal healthcare and consumer health. The first time in my life I’ve seen this excitement was with the personal computer, the second time was with the Internet and now it’s about health,” de Brouwer said.

He said he wants this product to change the relationship consumers of health care have with providers, making consumers the keepers of their own health information.

“Now we treat doctors as accountants who have to keep records for us,” he said. “They were not trained to do this. What they were trained to be was an analyst of data, to give us their point of view, their therapy.”