Medical device tax could hurt medical app developers

By: Brian Dolan | Oct 2, 2012        

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iBGStar Diabetes Manager App iPhoneIn an editorial published in The Wall Street Journal last week, former Senator Evan Bayh, a Democrat from Indiana, argued that at least one provision in the Affordable Care Act “threatens thousands of American jobs and our global competitiveness”. Bayh was pointing to the 2.3 percent tax that the law requires medical device companies to tack on to each sale starting in January.

For the first half of his editorial Bayh extols the medical device industry before making his most provocative point:

“All of this is now threatened by the only law that is guaranteed to pass in Washington: the law of unintended consequences. A 2.3 percent tax on medical-device sales, not profits, was imposed under the theory that sales to medical device companies would surge after patients newly insured by the Affordable Care Act poured into the system. What the industry lost in margins, it was supposed to make up in greater volume. That calculation ignored the fact that the vast majority of medical-device consumers already are covered by Medicare, Medicaid or private insurance,” Bayh writes.

Bayh also glancingly referenced FDA regulated medical apps, which, of course, are also medical devices:

“Especially hard hit could be the hundreds of small companies developing medical software applications. These apps promise to revolutionize the practice of medicine—for instance, by delivering blood-sugar test results for diabetics. The IRS is deciding now whether to treat apps as medical devices subject to the tax,” he writes.

Bayh, who now works at a law firm that represents a number of medical device companies, points out that the House has already voted to repeal the medical device tax, but the Senate appears less likely to do so.

Quick Plug: The medical device discussion here on MobiHealthNews is largely centered on remote patient monitoring — using converged medical devices and sometimes companion medical apps on mobile devices to provide care any place and any time. MobiHealthNews is excited to discuss this trend with the Mayo Clinic and their partner Preventice during a free webinar this Thursday at 2PM ET. Don’t miss it! Register here for The Inevitable, Imminent Rise of Remote Patient Monitoring to join the discussion.

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Coast Guard taps Lockheed to build mobile EHR interface for $2.3M

By: Brian Dolan | Oct 2, 2012        

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Epic's iPad app Canto

According to an announcement on the Federal Business Opportunities site, the US Coast Guard has awarded a $2.3 million contract to Lockheed Martin to develop mobile access to the Coast Guard’s electronic health records system. Lockheed will develop a secure mobile interface that can access data from the Coast Guard’s 43 clinics and one support facility, which are located all over the US and as far away as Hawaii and Alaska. The one year contract also has four more one year extension options.

Lockheed will enable providers working for the Coast Guard to access medical information from their mobile devices and tablets whether they are at a patient’s bed side, looking to review lab data remotely, or are located at a disaster recovery site. The Coast Guard’s health records system is based on Epic.

For more on the Lockheed-Coast Guard deal, read this post over at Government Health IT.

Separately, the Department of Veterans Affairs announced that it has chosen a vendor for its mobile device management (MDM) project, which has been in the works for some time. The VA’s CIO Roger Baker said that his office would notify the winning vendor on September 30. The MDM project will enable the VA to securely support more than 100,000 smartphone and tablet devices, including VA-owned devices and the personal devices that employees and medical students bring into work.

The VA first announced the MDM project a year ago and stated that its rollout would take 18 months at the time. Now, 12 months later, the VA predicts it will take about another year to roll it out.

More over at GovInfoSecurity.

First Microsoft Kinect PT app to go into clinical trials

By: Brian Dolan | Oct 2, 2012        

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ReflexionThe West Health Institute announced that it has developed technology to aid physical therapy professionals and patients using Microsoft’s Kinect for Windows motion tracking platform. The application leverages Microsoft’s Kinect for Windows motion camera and a Windows 7 personal computer and provides interactive feedback and educational materials to help providers improve patient adherence to regimens and ensure that the exercises are performed correctly. The Institute is beginning clinical research studies of the technology with the Naval Medical Center of San Diego.

While there have been previous technology demonstrations that leveraged Kinect for physical therapy, the West Health Institute’s Spencer Hutchins, who co-invented the technology and serves as the project’s lead, told InformationWeek that the application, called Reflexion Rehabilitation Measurement Tool (RMT), is the first physical therapy app leveraging Kinect to go into clinical trials. The clinical research pilot studies will review the program’s usability and participants’ adherence to therapy. Later studies will also measure clinical outcomes.

“Rehabilitation needs to happen continuously, not just when the therapist or doctor is watching, so we developed a tool to extend the expert guidance of physical therapists and make it more engaging and more effective for patients,” Dr. Ravi Komatireddy, co-inventor of the technology and a visiting fellow with West Health Institute and clinical scholar with Scripps Translational Science Institute, said in a statement.

Most physical therapy programs today instruct patients via paper pamphlets that include drawings to demonstrate prescribed exercises and the only time providers can track how well their patients are performing the exercises is during their face-to-face visits. Most physical therapy exercises are practiced when the patient is away from their provider.

“The biggest problem with physical therapy is patients not doing enough of it or not doing it properly,” Hutchins stated. “We are building a tool to help physical therapists measure progress in a fun way that could potentially help patients heal faster.”

Watch this quick demo video narrated by Hutchins for more on Reflexion.

Twice as many use tablets for health tools, information

By: Brian Dolan | Oct 2, 2012        

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WebMD iPadAccording to Manhattan Research, the number of adults in the US who used their mobile phones for health information and tools grew from 61 million in 2011 to 75 million this year. Using tablets for accessing health information and tools doubled over the past year: 15 million US adults used tablets for health information last year and 29 million used them for health activities this year.

The research firm also found that among those Americans aged 55 and older who own or use a tablet device, about half of them are using the devices for health purposes.

For those American adults who own a tablet, smartphone and a desktop or laptop — and use at least one of them for a health activity — about 60 percent are using all three of the screen for accessing online health information and tools, according to Manhattan.

“Growing ownership of connected devices and the access to digital health tools and information they provide is helping to drive the broader shift from intermittent to continuous care,” Monique Levy, Vice President of Research at Manhattan Research, stated. “This trend shows vast potential for changing key dynamics of healthcare delivery, including patient engagement, provider involvement, and how preventive care is incentivized.”

For its Cybercitizen Health US survey the research firm polled almost 9,000 US adults via landlines, mobiles, and the internet during the third quarter. More on the survey over at Manhattan’s website here.

Bam Labs app now remotely validates sleeping position

By: Neil Versel | Oct 1, 2012        

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BAM_001_300In remotely installing a software upgrade for all of its U.S. customers, the maker of a “smart bed” system for hospitals and post-acute rehab facilities, claims to have developed the country’s first application that biometrically validates bed position changes through a secure, cloud-based monitoring platform.

The new Position Change feature from BAM Labs, Campbell, Calif., an optional feature in the latest update to Bam Labs Health Monitoring app, verifies whether a patient has changed positions in bed. This helps assure that patients are turned regularly to avoid pressure ulcers and alerts staff in case of a bed exit that can lead to a fall.

The app, which supports BAM’s Touch-free Life Care, or TLC, smart bed system, is available not only though the Web, but for Apple iOS mobile devices. Users can get immediate alerts on their iPhones and iPads in case of motion that could be the precursor to a fall. Bam reports that facilities using the app have seen a 43 percent reduction in falls out of bed and an hour of daily staff time saved per bed.

“Since starting the smart bed program, we’ve had improved outcomes on those clients using the technology. It took a couple weeks to gain valuable data which allowed us to trend daily movement patterns with each client. With this data and the technical applications, we were able to develop custom programs to intervene before incidents could occur,” Eric Mock, administrator at Winter Park (Fla.) Care and Rehabilitation, says in a Bam Labs press release.

The new release now can run on wireless network connections as slow as 256 kilobytes per second, according to Bam Labs, but it also supports WPA/WPA2 security.

As MobiHealthNews has reported, the TLC system is a mattress pad that detects patient motion as well as biometric signals such as heart rate and respiration. It transmits readings over the hospital or other healthcare facility’s network to Bam’s cloud for instant analysis, and data can be exported into electronic health records.

Bill would create FDA Office of Mobile Health, HHS support for app developers

By: Neil Versel | Sep 28, 2012        

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iPhone_FDAThough the Food and Drug Administration is developing regulations for mobile medical apps, at least one member of Congress believes the federal agency is not currently equipped to handle the rapid pace of innovation in mobile technology.

Rep. Mike Honda (D-Calif.), whose district covers much of Silicon Valley, is preparing to introduce legislation that would address this perceived shortcoming by establishing an Office of Mobile Health within the FDA. The office, according to Kaiser Health News, would make recommendations to FDA regulators on issues related to mobile health apps.

The planned legislation, reportedly known as the Healthcare Innovation and Marketplace Technologies Act (HIMTA), also would set up a support program within the Department of Health and Human Services to help mobile health technology developers follow HIPAA privacy standards as they design new apps.

“Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” Honda says in a statement. “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.”

Predictably, in this divided political climate, opinions of the forthcoming bill are mixed.

Andrew Rosenthal, chief strategy officer for Massive Health, a startup developer of consumer health apps, tells Kaiser Health News that he is hopeful an FDA Office of Mobile Health could help smaller companies like his navigate the “confusing” and often expensive regulatory process. However, Joel White, executive director of the Health IT Now Coalition, a group of major corporations and the conservative U.S. Chamber of Commerce, would prefer a new agency that works outside the bureaucratic FDA framework so as not to discourage innovation.

Kaiser Health News reports that the bill would be introduced “later this month,” though September ends Sunday. As of Thursday afternoon, no bill had been introduced. Honda’s media spokesman was not immediately available for comment.