Republicans, EHR vendors want ONC to take over medical app regulation

By: Brian Dolan | Mar 14, 2013        

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Brian Dolan, Editor, MobiHealthNewsThere has been a painfully slow chess game playing out in Washington DC these past two years over the fate of FDA regulation of mobile medical apps.

Last July I wrote about the largely failed attempt by some members of Congress and companies like Aetna, UnitedHealth, and Verizon Communications to insert language into the The Food and Drug Administration Safety and Innovation Act (FDASIA) to slow down the FDA’s issuance of a final guidance document for mobile medical apps. While the legislative attempts to slow the FDA down may not have worked directly, for whatever reason, the FDA has still failed to produce a final document after the draft published almost 20 months ago.

Next week the House of Representatives’ Energy and Commerce Committee, which is led by Rep. Fred Upton (R-MI), is holding a series of hearings about mobile medical app regulation to find out — among other things — why the FDA hasn’t issued final guidance yet. When the committee’s vice chair, Rep. Marsha Blackburn (R-TN), appeared on Fox News this past week to discuss the hearings, she claimed that FDA regulation of mobile medical apps will “drive up the costs of consumers, it will drive up the costs of your cell phone.”

I am very curious to hear the supporting evidence for that claim during the hearings next week.

Notably, the committee chairman, Rep. Upton, was the lead sponsor of the House version of the FDA bill discussed above that included the 18 month moratorium on medical app regulation last year. Instead of an 18 month moratorium, a section within the passed law, (Section 618) mandates that within 18 months (by January 9, 2014) the Secretary of HHS “acting through the” FDA commissioner “and in consultation with” the ONC and FCC chairman has to publish a report that includes a proposed strategy and recommendation for “an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”

It’s worth keeping in mind that the legislation calls for HHS to work through FDA to create this report with help from the others. It’s also worth remembering that the final version of this legislation curiously swept mobile medical apps under the heading of “health information technology” instead of “medical devices”.

While last year’s efforts to disintermediate the FDA on mobile medical app regulation were led by Verizon Communications and others through the Health IT Now Coalition, the most recent efforts to dispel the agency’s purview over mobile medical apps and make apps a part of some kind of new ONC-led certification process, appears to be driven by McKesson and other large health IT companies through the Bipartisan Policy Center (BPC). (For more on why mobile medical app regulation might be worrying EHR vendors, check out our previous coverage on how the FDA’s EHR exempt rule might becoming extinct.)

While last year’s legislation instructs HHS to have the FDA take the lead on creating this risk-based regulatory framework, ONC has already begun to take the reins. This past Friday applications closed for a new ONC FACA (federal advisory committee) specifically focused on the FDASIA Section 618 mandate for a report on a new risk-based regulatory framework for health IT and mobile medical apps. The FDA and FCC helped promote the new ONC group, but it’s clearly being convened by ONC.

To get a better sense of where all this is going and what the future of mobile medical app regulations might look like, be sure to read this letter from McKesson’s head lobbyist and Vice President of Public Affairs Ann Richardson Berkey. It calls on Dr. Farzad Mostashari to “clearly identify ONC as the agency to exercise appropriate oversight of health IT to support both patient safety and innovation” and to “synchronize [ONC’s] patient safety Plan with related meaningful use and other health IT requirements”.

“There are several initiatives underway to address these objectives,” Berkey writes, “including the Meaningful Use program, the Health IT Patient Safety and Surveillance Plan and a provision in FDASIA, which calls for a coordinated plan to address a risk-based regulatory framework for health IT. Since these initiatives may create additional requirements for developers, hospitals and providers, any requisites must be coordinated to avoid redundant or conflicting requirements.”

Berkey goes on to write that the ONC should serve as the “convener” of all these “patient safety” initiatives. She also “urges ONC to include any anticipated near-term patient safety requirements as it finalizes the scope of Meaningful Use Stage 3.”

Last year when the FDASIA legislation was amended to sweep mobile medical app regulation under the heading of “health IT”, it paved the way for ONC to take over from the FDA. Next week’s congressional hearings on mobile health apps will likely steer toward this idea that the FDA should not be regulating apps as medical devices, even though the FDA has been doing so for almost 20 years now. The debate will likely shift to whether ONC should lump mobile medical app regulation into some kind of certification process that is self-policed by the industry — all in the name of “patient safety”, of course.

During her Fox News interview, Rep. Blackburn also let slip that she already had drafted legislation to entirely stop the FDA from regulating mobile medical apps:

“I have draft legislation which is coming out, which would be an express prohibition, prohibiting the FDA from getting into these mobile medical applications as a healthcare medical device,” she said.

If the FDA has any interest in holding onto its regulatory purview, it should issue final guidance for mobile medical apps immediately.


Novartis offers patients two new apps, removes VaxTrak

By: Jonah Comstock | Mar 14, 2013        

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Clinical Trial SearchNovartis Oncology, a division of the Switzerland-based  pharmaceutical company, has added two new free Apple and Android apps to its catalog: My NET Manage and Clinical Trial Seek. Interestingly, one of their most high-profile apps, VaxTrak, has now disappeared from the Apple and Google Play stores.

My NET Manager is an app for patients with neuroendocrine tumors (or NET) to help them manage and learn about their condition. It provides tools for users to track their symptoms, set reminders for treatments, doctor visits, and medication refills, and review and track test results. The app also stores contact information for a patients’ healthcare team and enables the patient to share information with their team. Finally, the app can help NET patients track insurance claims.

The other new app, Clinical Trial Seek, is sourced from the National Institutes of Health’s database. The app is designed to help doctors and patients find cancer clinical trials in their area, and to help patients learn more about clinical trials. Users can search trials by location, disease type, treatment, phase of trial, trial sponsor, eligibility requirements or keywords, and can save and email their results.

Novartis has several apps on the Google Play and Apple app stores including apps for tracking sickle cell disease and myelodysplastic syndrome and a medical information app for healthcare professionals. In 2011, we wrote about Novartis’s VaxTrak app for keeping track of vaccinations, which was and still is featured both on Novartis’ site and on Apple’s corporate profile of the company. For some reason, VaxTrak is no longer available in the iOS AppStore or the Google Play store, and a spokesperson for the company couldn’t provide an explanation before deadline.

In addition to apps, the company has been active in the mobile health innovation space, most notably as an early investor in Proteus Digital Health, a company that’s developing ingestible sensors to track medication adherence.

Report: 1.7B to download health apps by 2017

By: Jonah Comstock | Mar 14, 2013        

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iPad Imaging AppsMobile industry analysts Research2Guidance have come out with a new report on health apps, predicting that in 2017, worldwide mobile health market revenue will total $26 billion.

The report categorizes the mobile health market as growing in three phases: an initial trial phase, a commercialization phase, and an integration phase. We are currently in the second phase, the report said, which is “characterized by a massive increase of offered solutions, the creation of new business models and the concentration on private, health-interested people, patients and corporations as major target groups.”

The barrier that has to be crossed to enter into the integration phase, the report says, is a lack of mobile health regulation. That third phase, according to Research2Guidance, will involve apps as an integrated part of doctors’ treatment plans, paid for by health insurance companies.

Currently, the firm said, there are about 97,000 mobile health apps in 62 app stores. The top 10 apps generate up to 4 million free and 300,000 paid downloads each day, according to the report. About 15 percent of all mobile health apps are dedicated apps for medical providers as supposed to consumers.

Getting back to the predictions for 2017, the company projects that more than 3.4 billion people will have smartphones or tablets with access to mobile health apps, and 50 percent of them will have downloaded health apps. The bulk of the $26 billion in revenue won’t be from paid downloads (which will make up 9 percent), but from mobile health hardware and services (84 percent). This is consistent with Research2Guidance’s predictions in their previous mobile health report last year.

“This growth projection is based on the assumption that private buyers will continue to be the primary spenders in the next five years,” the report says, “but that the integration of mHealth applications into traditional health care systems will become more and more common (integrated phase) during that time.”

characterized by a massive
increase of offered solutions, the creation of new business models and the concentration on
private, health-interested people, patients and corporations as major target groups

Humetrix aims to bring iBlueButton to the UK

By: Neil Versel | Mar 14, 2013        

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Humetrix iBlueButton app won the ONC's Blue Button Mashup Challenge.

Humetrix iBlueButton app won the ONC's Blue Button Mashup Challenge.

Humetrix, the Del Mar, Calif.-based maker of mobile health information exchange app iBlueButton, is demonstrating its technology for the UK’s National Health Service (NHS) this week.

Like so many healthcare entities around the world, the NHS has been struggling to make electronic health records available and accessible to patients. The NHS has a statutory deadline of 2015 to provide patients with control of their own records.

Humetrix is joining with EHR vendors Cerner and TPP to demonstrate data exchange via the iBlueButton mobile platform Thursday in London at the NHS Healthcare Innovation Expo 2013. Cerner provides inpatient EHRs for 22 NHS trusts – essentially regional integrated delivery networks – while TPP’s SystmOne is the EHR for ambulatory care in those trusts.

In the U.S., iBlueButton transforms what Humetrix President and CEO Dr. Bettina Experton has called an “ugly text file,” output from Medicare records the part of the federal government’s Blue Button initiative, into structured, machine-readable data. The task is somewhat different in the UK, and, in some ways, simpler.

There, inpatient discharge summaries and summary records from general practitioners come out as structured XML data. Experton said both Cerner and TPP have given Humetrix an application programming interface (API) to extract data from EHRs. Keep reading>>

Fitness trackers are prototypes for future mPERS products

By: Neil Versel | Mar 14, 2013        

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Neil_Versel_LargeDon’t look now, but we may have our next hot spot in mobile health: mobile personal emergency response systems, or mPERS.

You’re probably waiting for me to come down hard on the expected gold rush from venture capitalists and entrepreneurs who see dollar signs in our aging population. Nope. Come and get it, I say.

“Players in the market will enter from the security, [wireless] carrier, remote health and activity monitoring, wellness categories – and fitness technology tracking,” says a recent report on the next generation of PERS, published by research firm Aging In Place Technology Watch and Link-age Connect, an organization of senior-living communities.

Link-age Connect surveyed 1,114 Americans ages 55 and found that today’s PERS users tend to be elderly, female and living alone in fear of falling. Most use a PERS product for no more than three years, the report says, but that is changing. The “connected senior” will become reality before the end of this decade, according to report author Laurie Orlov, principal analyst at Aging In Place Technology Watch, who presented her findings this week at the What’s Next Boomer Business Summit in Chicago.

“We typically are seeing younger customers using mobile PERS devices than traditional PERS; ones that value outside activities like walking the dog, golfers and even elementary school children told by their parents, ‘If you need me, press this button,'” the report quotes Andy Schoonover, CEO of system vendor VRI, as saying.

Some of these activities certainly fall into the categories of fitness and personal safety. I’ve soured on the direct-to-consumer fitness trackers because there are so many of them and because they don’t really address the greatest source of spending in our hugely inefficient, $2.5 trillion healthcare industry, namely the elderly and chronically ill. PERS often does, even if it doesn’t seem like it in Schoonover’s examples.

Orlov, hardly a cheerleader for products targeting the worried well, said that “quantified self”-type devices like Fitbit and Jawbone’s UP will morph into products to track the “connected self” for both wellness and chronic disease management. “Devices for quantified and connected selves will saturate their fitness-oriented markets and look to expand into the ever growing world of aging boomers and seniors,” she wrote.

I sure hope she’s right.

Three months ago, I called for the end to the panic buttons that senior homes routinely give their residents. It’s simply too much to ask of elderly people who have fallen to have the presence of mind to press a button to summon help if they have dementia, have hit their heads or have become disoriented.

I don’t care if LifeAlert claims to save someone’s life from catastrophe every 11 minutes. These “active” personal emergency response systems are based on 30-year-old technology. They are no longer good enough when passive PERS with automatic fall detection, cellular connectivity and even synchronization with wall-mounted motion detectors are becoming widely available.

“The more passive (with opt-in consent) you can make the system, the better. Make it blend into the background so the elderly client doesn’t have to do anything,” Michael Dempsey, founder and CEO of mPERS vendor Independence Labs, says in the report. While the Aging In Place Technology Watch report was sponsored by a group of mPERS vendors and conduits like Intel-GE Care Innovations, Royal Philips Electronics and Verizon Wireless, GreatCall, Healthsense and Numera, author Orlov is hardly an industry shill.

Orlov mentions that future trackers should and must account for conditions such as dementia—and even help diagnose such ailments. “Because PERS devices will be capable of tracking gait and other activity changes over time, they will be used to learn behavior patterns first and then be able to identify variations that may signal dementia, increasingly frailty or other types of decline. A senior living alone may spend too much time in a chair or a worker becomes disoriented, becoming lost or endangered,” Orlov writes.

A panic button can’t help with any of that. Truly passive PERS can.

Slideshow: 8 pillboxes that connect to your phone

By: Jonah Comstock | Mar 13, 2013        

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Vitality GlowCapMedication adherence is a huge problem, and it’s one that seems solvable. People fail to take the pills prescribed to them for many reasons, but one of the biggest is forgetfulness, especially among elderly patients who take a lot of medications and can easily become confused.

Pillboxes have always been the go-to technology to improve adherence, whether it’s a simple Monday-through-Friday organizer or a locked pillbox with a daily alarm. But mobile technology has added another component to the smart pillbox: connectivity. Now your pillbox doesn’t just remind you to take your pills; it can track whether you did take them and report that information back to a doctor or caregiver.

With Vitality GlowCaps going mainstream at and new pillboxes debuting at CES in January and since then, the market for smart, connected pill bottles seems poised to explode.

“I think there will be many winners,” Josh Stein, CEO of smart pill bottle maker AdhereTech, told MobiHealthNews. “Adherence is such a big space that’s asking for technology to help it, and it’s a vastly complicated issue. There will certainly not be one winner. Many different solutions will win out. The best thing that could happen to us right now would be a large scale adaption of smart pillboxes and smart pill bottles, so that it becomes something people actually think about.”

Here’s seven companies using sensors and connectivity to help seniors remember to take their pills: Keep reading>>