BlackBerry cofounders eye tricorder with new fund

By: Jonah Comstock | Mar 21, 2013        

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mike-lazaridis-300x381Mike Lazaridis and Doug Fregin, cofounders of BlackBerry (formerly Research in Motion, Inc.) have a new initiative: a $100 million, highly selective investment fund called Quantum Valley Investments. The firm will be based in Waterloo, Ontario, the area Lazaridis hopes will become a “Quantum Valley,” the next-generation answer to Silicon Valley, and will be focused on supporting “quantum breakthrough technologies,” including noninvasive medical scanners similar to Star Trek’s “tricorder.”

Waterloo already harbors three quantum physics-focused labs heavily supported by investments from Lazaridis: the Mike and Ophelia Lazaridis Quantum-Nano Centre, which Lazaridis opened in September 2012 with a $100 million donation, the Institute for Quantum Computing, and the Perimeter Institute for Theoretical Physics (where famed quantum physicist Steven Hawking holds a visiting chair). The new fund will support startups commercializing efforts from those labs, according to a report by Bloomberg News.

While the fund will support all kinds of quantum-based technologies, many media outlets have focused on Lazaridis’s avowal that quantum sensing could enable a device similar to Star Trek’s medical tricorder, the same fictional technology that inspired the Qualcomm Tricorder X Prize.

“On our journey toward a full-scale quantum computer, which is our holy grail, what we’re finding is some of the breakthroughs and some of the technologies that are necessary to build a quantum computer … have spin-off technologies, and Doug and I have decided to invest in them formally,” Lazaridis told Bloomberg News. “We see many of the devices and predictions of Star Trek come true, from the computer voice activation to communicators in today’s smartphones, but the medical tricorder that was used by Bones [Dr. Leonard McCoy, the ship’s doctor on the original Star Trek series] to diagnose and understand what was happening in the body without drawing blood, non-intrusively, we’re seeing that might be possible.”

Lazaridis isn’t saying what, if any, startups are in consideration for the fund’s support at present, or whether there will be any overlap with the more than 200 teams currently signed up for the X Prize. The fund is already accepting applicants on its website. Lazaridis told Bloomberg that the company isn’t envisioning any set number of investments. “It could be five deals, it could be a dozen,” he said.

Quantum Valley Investments might function to some extent like an incubator, as well. The website says “in addition to financial support, successful candidates will have access to the vast commercialization, science, financial and business experience and networks of the Managing Partners.” This likely includes access to the three Waterloo research institutions, and possibly networking opportunities with BlackBerry, where Lazaridis still sits on the board.

Quantum Valley Investments also has a Scientific Advisory Committee that includes distinguished physicists like Neil Turok and Raymond LaFlamme, as well as former Canadian astronaut and Canadian Space Agency director Steve MacLean.

In his prior role as co-CEO at BlackBerry, Lazaridis demonstrated an awareness of the role mobile technology can play in healthcare, stressing medical information privacy as the company’s reason for acquiring Certicom in 2009. With the BlackBerry 10 (under new CEO Thorsten Heins), the company has continued to focus on information security as a selling point for the healthcare market.

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Liveblog: Day 3 Congressional hearing on FDA regulating apps

By: Brian Dolan | Mar 21, 2013        

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We are live blogging old school today: Hit the refresh button every few minutes for updates! (Liveblogging is now concluded!)

10:26AM: The hearing is now adjourned! Apparently they cut it short to vote.

10:25AM: Final question goes to Mostashari from Burgess around why the ONC doesn’t just make interoperability happen.

10:23AM: Rep Griffith is now asking about the diagnostic device that was recently in the news that uses a smartphone to detect parasites in children. Griffith says if you regulate it how much would this $8 device cost after it was regulated? Foreman says the FDA is not in the business of pricing medical devices.

GRIFFITH

10:21AM: Rep. Griffith is now up after a lengthy EHR discussion between Tonko and Mostashari. Griffith asks Foreman if the FDA has talked to the IRS about the medical device tax in relation to medical apps. Foreman says it sent the IRS some ideas about that, Griffith asked for a copy of that letter. Griffith asks that while FDA has no plans to regulate the apps and devices that Rep. Waxman asked about, might it change its mind in the future? Foreman says only if those examples become medical devices or are causing some kind of safety risk. Keep reading>>

10 threads from Congress’ hearings on FDA regulation of medical apps

By: Brian Dolan | Mar 21, 2013        

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Brian Dolan, Editor, MobiHealthNewsThis week the US House of Representatives’ Energy and Commerce Committee is hosting a three-day series of hearings focused mostly on the FDA regulation of mobile medical apps. As of this writing two hearings have taken place, one held by the Communications and Technology subcommittee on Tuesday and another held by the Health subcommittee on Wednesday, but what could be the main event is set to take place early Thursday morning as representatives from ONC and FDA face questions from Congress.

Wednesday evening the testimonies for both the FDA’s Director of the Office of Device Evaluation Center for Devices and Radiological Health, Christy Foreman and the ONC’s National Coordinator Dr. Farzad Mostashari are now posted on the committee’s site. Neither includes any real surprises, but Foreman’s reiterates much of the FDA’s draft guidance and includes a note that any questions about the medical device tax should be directed at the IRS. The real discussion will come when Foreman and Mostashari answer the representatives questions after they read their prepared remarks.

If you have been following our live blog coverage (day one and day two) of the past two days’ events, you understand how scattered some of the discussion has been so far. It is clear, however, that a number of threads have emerged during the course of the two days. Here’s hoping there are more answers than questions following Thursday’s hearing.

In no particular order, below are the top 10 ideas and questions that have come up (repeatedly usually) during the hearings so far:

1. Will the 2.3 percent tax on medical device revenue apply to mobile medical apps? This one has also been framed as “should” the device tax apply to mobile medical apps that the FDA deems are functioning as medical devices. The answers to this question have so far been very mixed. Some witnesses have suggested it should never apply to any mobile medical apps. Others said that the way the medical device tax is explained in the health reform legislation suggests that it will not apply to medical apps. Some legislators and witnesses said the FDA should not be given the authority to decide what gets taxed. A similar point that came up a few times was that the IRS retail exemption for medical devices would protect apps from the new tax, but not everyone agreed that was a sure bet.

2. The FDA has been slow to issue its final mobile medical app guidance. Everyone agrees the FDA should have published its final guidance for mobile medical apps by now. Draft guidance published in mid-2011. The most interesting comment on this probably came from mHealth Regulatory Coalition lead Bradley Merrill Thompson, who said the FDA may have had trouble publishing final guidance because the industry keeps changing and new innovations make it question whether its guidance is ready. That’s the first time I’ve heard Thompson offer an explanation for FDA’s extreme tardiness.

3. Should ONC or some other group take over for the FDA? We predicted this last week when we wrote about McKesson’s lobbying efforts to move some of FDA’s oversight of mobile medical apps to the ONC and into a similar framework as the certification process ONC uses for Meaningful Use. Perhaps even as part of that very same process. When asked about this some witness agreed the FDA was the best place for mobile medical app regulation while others favored a different approach. Some legislators asked whether the FDA should decide who should regulate mobile medical apps or whether Congress should decide who should regulate them?

4. The difference between devices and software, between health IT and medical devices. McKesson’s and the Republicans’ argument for moving regulation of mobile medical apps to the ONC or some other regulatory body largely rested on the distinction between health IT and medical devices. McKesson argued that software that relied on a healthcare provider as an intermediary, for example, should not be considered a medical device because the provider can ensure it is being used safely. Medical devices, on the other hand, perform some kind of function without the intermediation of a healthcare provider, and therefore require FDA oversight. An interesting tangent to this discussion came on Tuesday when one legislator asked Happtique CEO Ben Chodor if his company’s certification process could be used as something of a free market substitute for FDA regulation of mobile medical apps. Chodor said: Absolutely not.

5. Are these hearings just an attempt to take a few swipes at ObamaCare? Representative Henry Waxman (D-CA) suggested that his Republican colleagues were just using these hearings to scare people and to make disparaging remarks about the health reform legislation. There were quite a few references to the possibility of the FDA regulating smartphones and tablets as medical devices, but Waxman and others repeatedly described these kinds of claims as untrue and mythical.

6. A celebration of health IT adoption. On the other hand, a good amount of time was spent — especially on Wednesday — extolling the virtues of health IT and, especially, electronic health records. While at least one Republican took time to mention that the increasing adoption of EHRs and health IT in general is likely because it is being mandated, at significant costs (in some cases) to physician practices, everyone agreed that the trend was a positive one.

7. Clarity of FDA regulation vs. complexity of FDA regulation. A number of exchanges between legislators and witness were about particular types of mobile medical apps and whether they would be regulated as medical devices under the FDA’s draft guidance. One legislator wondered whether a Bluetooth-enabled weight scale was a medical device was upset to learn that the best answer was: It depends. It seemed like most of the legislators refused to believe or failed to grasp that at least in some cases FDA regulations must be complex and nuanced. If it couldn’t be easily explained, some argued, then clarity must be lacking.

8. The exportation of jobs threat. On Tuesday a popular thread of the discussion was the idea that the slow pace of regulatory clarity or the existence of regulations in the first place was leading to job exportation. If the FDA was quicker with its final guidance document, perhaps more jobs would have been created by developers working in mobile health.

9. Fewer investment dollars because of uncertainty. A similar thread to the one above was that regulatory uncertainty bred hesitance from investors. If the FDA had been quicker with its regulatory guidance, maybe more investors would be willing to fund startups working in mobile health. Instead, those investment dollars went into other sectors or, worse, to companies based in other countries.

10. Mobile developers have avoided healthcare. Another consequence of the regulatory environment — the existence of FDA regulation of mobile apps and/or the uncertainty surrounding it — might be that mobile developers have decided not to tackle health problems and decided to build another game or music app instead. While there was no data to back up this claim, it seemed to be a trend that some of the witnesses agreed was underway.

Thursday morning is the main event. Maybe ONC and FDA will shed some light on the current state of mobile medical app regulation. Better yet: Maybe the FDA will take the opportunity to publish its final guidance?

Report: 18.2M health sensors will ship in 2017

By: Jonah Comstock | Mar 21, 2013        

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ONWorld researchAccording to a new report by research firm ON World, 18.2 million health and wellness wireless sensor networks (WSNs) will be shipped worldwide in 2017, generating $16.3 billion in annual revenue. That’s up from 1.7 million shipments and $4.9 billion in revenues in 2012.

Between 2012 and 2017, the firm reported, health and wellness WSNs that are wearable, implantable, or otherwise mobile-enabled will increase by 75 percent per year (CAGR) and will make up 57 percent of all health and wellness WSNs in 2017.

Interestingly, ON World’s numbers exclude sports and fitness trackers from the category of health and wellness wireless sensors. Other recent reports, like Juniper’s report on the wearable market last year, have had their numbers significantly bolstered by including sports and fitness trackers. Mareca Hatler, research director at ON World, said the company will cover sports and fitness trackers in a pending report.

“We just saw there were really specific business models, and in terms of the volumes of shipments it would be best served if we covered it separately,” she told MobiHealthNews.

ON World evaluated more than 100 health and wellness sensor products in compiling the report, not all of them wearable or consumer devices.

“WSN applications for health and wellness are expanding,” the firm writes in its executive summary. “These include large scale hospital operational management systems, wearable/implantable sensors and vital signs monitors as well as wellness monitoring, mobile personal emergency response systems (PERS) and growing solutions for weight management, sleep monitoring and general wellness.”

The company found that 53 percent of the companies they evaluated targeted self-management of chronic conditions. In 2017, ON World predicts, chronic condition management will make up 60 percent of WSN revenue, with 31 percent coming from heart disease and 24 percent coming from diabetes management.

The list of companies ON World evaluated, available on the firm’s website, includes a number of companies familiar to MobiHealthNews readers: remote monitoring heavies like Philips and Qualcomm, the as-yet unlaunched home health scanner Scanadu, the now-defunct sleep tracker Zeo, and quirky startups like smart toothbrush-maker Beam Technologies and posture-coaching company LumoBack. Many of these companies were counted in the category of “general wellness,” according to Hatler, a catch-all that includes devices like the Beam Brush, consumer vital sign monitors, sleep monitors, and, more than anything else, connected weight scales.

That general wellness category will expand 1,600 percent over the next five years, the report said, to make up 41 percent of shipments in 2017. As the general wellness category is primarily direct-to-consumer devices, this trend could suggest a growth of patient engagement and personal responsibility for help.

ON World also surveyed 300 early technology adopters and found that 30 percent were interested in web-connected health and wellness devices.

Cleveland Clinic offers patients iPad app, Today

By: Aditi Pai | Mar 21, 2013        

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Cleveland Clinic Today appProvider apps with a focus on patient engagement are set to be a big trend this year.

This month The Cleveland Clinic introduced its tenth app, called Cleveland Clinic Today. The app, which is only available for iPad users currently, provides patients with health and wellness tips, quizzes, and an interactive model of the human body. While anyone can download the app, Cleveland Clinic patients can access its full feature set, including resources to navigate the provider’s network to find a doctor, access contact information, or request an appointment. The app builds on Cleveland Clinic’s patient-facing MyChart software which its EHR vendor Epic developed.

Cleveland Clinic’s MyChart app also appears to still be available.

While the app’s quizzes focus on teaching patients about basic health-related facts, the interactive model of the human body allows the users to explore different human systems on their own with an option to click on related articles along the way. The health tips include videos, recipes and share buttons to send stories over Facebook, Twitter, or email.

While Today is exclusively available for iPad users for now, Cleveland Clinic announced recently that it is working with Microsoft to explore a Windows 8 launch of its mobile apps.

Most of Cleveland Clinic’s apps offer particular services. Cleveland Clinic Cancer Trials, for example, helps cancer patients find clinical trials and stay up to date on existing ones. The Heart Story app serves as an interactive newspaper series that details 26 hours inside the Cleveland Clinic Heart Center. The Cleveland Clinic Innovations app offers information about the technologies under development by the provider and also keeps users up-to-date on the progress of spin-off companies that started out as a part of Cleveland Clinic.

For more on the Today app launch, read this article over at Healthcare Communication.

Two new initiatives take gym workouts mobile

By: Jonah Comstock | Mar 20, 2013        

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Matrix 7xiTwo companies made announcements this week that would tie together the increasingly popular world of fitness apps with the increasingly high-tech workout machines found in gyms across the country — fitness startup MyFitnessPal and fitness equipment maker Precor.

MyFitnessPal, an online diet and fitness managing tool which can also be accessed via mobile apps for Apple iOS, Android, and BlackBerry and Windows, announced a partnership with NetPulse, a developer of software for fitness equipment, and Johnson Technology, makers of Matrix Fitness equipment.

NetPulse partners to provide software for eight major fitness equipment manufacturers, including Johnson. Its technology brings television channels onto workout machines as well as providing virtual workout experiences. NetPulse’s NetPulseOne web platform, which allows gym members to access their data across different machines and at home, is integrated with several apps and fitness trackers, including Fitbit, MapMyFitness, and Aetna CarePass. MyFitnessPal has already been added to that list and, will soon be linked directly into machine consoles as well. Johnson Technology’s new Matrix 7xi series of cardio equipment consoles will also integrate with MyFitnessPal, automatically syncing workout information to the user’s account.

According to a press release from MyFitnessPal, the data sharing will be two-way, so that users can both import data from their workouts into the application, and view the MyFitnessPal application while working out on machines.

Netpulse, through its acquisition of Virtual Active, has previously worked with Rock Health graduate BitGym on connecting virtual workout experiences to fitness equipment.

Another fitness equipment maker, Precor, made a number of announcements about its Preva open online fitness tracking platform, which aims to promote engagement with workout tracking, goal-setting, and achievement badges. Most notably for MobiHealthNews readers, the company announced a forthcoming iPhone app, Preva Mobile, that will allow users to track their workouts, on both Precor and non-Precor machines, as well as other kinds of exercise including group classes and hiking.

Precor is also partnering with health and fitness rewards startup EveryMove, so that users can earn EveryMove rewards points directly by working out on Precor workout machines. EveryMove incentivizes healthy behaviors by offering gift cards and merchandise in exchange for points accrued for active behavior.