Still rocky reception for latest activity tracking gadgets

By: Brian Dolan | Jul 30, 2012        

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Nike+ Fuel BandThe past year has included the launch, recall, and still-imminent-launch of a handful of activity tracking devices: Nike’s FuelBand, Jawbone’s UP, and the Basis Band, respectively. (Update: Jawbone doesn’t consider its “no questions asked” voluntary full refund offer to Jawbone UP users a “recall” since the device did not pose safety issues, a spokesperson tells MobiHealthNews.)

Jawbone made headlines last year when it recalled its buggy device and offered full refunds to anyone who purchased them. While the device is still available for purchase on some third party sites, the company has yet to officially resurrect it. In recent weeks Jawbone’s Chief Creative Officer, Yves Béhar told attendees at VentureBeat’s MobileBeat conference that the company would bring the UP back to store shelves:

“We had a hardware failure on the product, unexpected obviously. It was a heartbreak beause it was the fastest-selling product ever outside of Apple products. It’s going to relaunch. Hardware is hard, doing hardware and software is even harder. In this case it was components that were failing on the board,” Béhar said, according to a report over at VentureBeat.

While Nike’s FuelBand does not appear to be suffering from any kind of hardware malfunction, recent reviews have questioned the accuracy or usefulness of the wristworn tracker’s method. A writer over at Gizmodo found through their own experiments that the device gave them more “fuel points” for eating a slice of pizza than for walking up a flight of stairs. A columnist over at The New York Times pointed to that review but also through her own experiences with the device found that she hit her activity goals by lounging around her apartment and “barely moving.”

Despite panning the device, the Times columnist helpfully includes some perspective from a handful of health behavior experts.

BJ Fogg, Director of Stanford’s Persuasive Technology Lab, who has conducted tests with the FuelBand and similar devices, said wearing the device alone is enough to change behavior. “Simply donning it can work as a fancier version of a string tied around your finger: a reminder to complete a task or errand, he said. It could be the nudge you need, for example, to get off the subway a few stops early and walk the rest of the way home, or to jog a few extra laps around the track,” the Times writes.

Michael Kim from Kairos Labs also weighed in: “Points and badges do not lead to behavior change,” he told the Times.

Read the full New York Times piece here (reg. req.)

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Remote monitoring still seeks business models, EHR connectivity

By: Neil Versel | Jul 30, 2012        

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Dr. Mohit Kaushal

Dr. Mohit Kaushal

The move toward accountable care organizations, the ubiquity of cell phones and changing patient expectations all are contributing to the rise of mobile monitoring of chronic diseases, but it still may take years before home care becomes a routine part of medicine.

Friday morning at the 4th annual World Congress Leadership Summit on mHealth in Boston, Dr. Mohit Kaushal, executive VP of business development and chief strategy officer of the West Wireless Health Institute, La Jolla, Calif. surmised that it would take as many as five years to figure out effective business models for mobile monitoring.

In the meantime, organizations continue to experiment. “Technology is rarely a panacea,” said Kaushal, former director of connected health at the Federal Communications Commission. However, it can be an impediment, since few monitoring devices or even text-based reminder systems connect to electronic health records.

“Data by itself is not valuable. It has to be integrated into the back end of EHRs,” Kaushal said.

This is where process design comes into play.

Dr. David Judge, medical director of the Ambulatory Practice of the Future, a primary care clinic at Massachusetts General Hospital in Boston, noted that a lot of care in his practice takes place outside the physician office. He said there are still plenty of issues with integration and absorption of data.

“There are big barriers in engaging providers,” Judge said. For one thing, physicians likely do not want to see financial data when making clinical decisions. “It can’t all just flow to the doctor. How do you triage that?” he wondered.

He also said that the focus of monitoring needs to shift away from individuals. “What does it mean to take care of a population of patients?” Judge wondered during the panel discussion.

Care teams are getting smaller and smaller, according to Dr. Andy Steele, director of medical informatics at Denver Health, raising the imperative for patients to become more engaged.

Judge is not so sure physicians want to share EHR data. “Are we ready to show that to patients?” he asked.

It may not matter too much longer what healthcare professionals think about the idea, though. Consumers soon will expect access to their health information, according to Kaushal. “How come my bank can give me my information? How come I can make a [restaurant] reservation on Open Table? Why can’t I get my information from you?” Kaushal asked.

“The patient needs to be the center of the hub of information,” Judge insisted.

Patients, even those from low-income environments, appear to be ready.

“We had a lot of perceived barriers,” Steele said. Denver Health, a safety net with about half of its patients lacking insurance and many of the rest on Medicaid, found that less than 5 percent of patients in a trial of home monitoring via cell phone had broadband Internet service at home. Yet, the program had 80 percent adoption even after six months.

“Don’t underestimate what patients can do with technology,” Steele reported, adding that about a third of mobile interaction with patients is not direct, but rather through a caregiver. For example, care managers at the health system frequently find themselves texting reminders to someone in Denver, who then gets on the phone to Mexico and tells a diabetic relative who had gotten care in Colorado to check his or her blood sugar, according to Steele.

“There is a tremendous variety in the way people use these devices,” noted Jeff Bipes, senior manager of enterprise mobility design and strategy at medical device maker Medtronic. A wide choice of handsets, Bipes said, may be the reason why the Android platform leads the consumer smartphone market. The iPhone may be slick, but Apple follows the “Henry Ford model of smartphones,” according to Bipes, where you can have any model you want as long as it’s an iPhone.

Proteus gains de novo FDA clearance for ingestible biomedical sensor

By: Neil Versel | Jul 30, 2012        

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Proteus Biomedical's Raisin system

Proteus Biomedical's Raisin system

Proteus Digital Health, formerly known as Proteus Biomedical, has become the first company to receive Food and Drug Administration clearance for an ingestible biomedical sensor that monitors medication adherence.

The FDA granted 510(k) premarket approval to the Proteus Ingestible Event Marker (IEM) as a de novo medical device, meaning that there was no similar product on the market, four years after Redwood City, Calif.-based Proteus first sought clearance. A related wireless sensor patch worn on the skin gained FDA clearance in 2010 because there were predicate devices previously cleared by the FDA.

The IEM sensor, which can be embedded into a pill, is activated by stomach fluid, then transmits a signal through the body to the skin patch, indicating that a patient has ingested medication. The patch also measures patient vitals and body position, and wirelessly sends all of the data to a Proteus smartphone app.

Both the patch and the IEM secured the CE Mark in Europe in 2010, and Proteus this year inked a deal with British pharmacy chain Lloydspharmacy to sell the monitoring system in the UK and other European countries. The product will hit the European market in September, according to Arna Ionescu, director of user experience at Proteus.

The American regulatory process was more drawn-out, as Proteus first sought FDA clearance for both the IEM and the patch in 2008. “We worked very closely with the FDA to [find a regulatory pathway to] get this through,” an elated Ionescu told MobiHealthNews Thursday in Boston at the 4th annual World Congress Leadership Summit on mHealth. “It took a lot of creativity to get this through.”

A year ago, Proteus secured a patent for the ingestible sensor, which some have dubbed a “chip in a pill.”

In a Proteus press release issued Monday, Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, Calif., and author of “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare,” called the FDA clearance ” a major milestone in digital medicine,” According to Topol, “Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management.”

Ionescu said that the company is still developing its U.S. sales plans and would have more information later. All along, Proteus has been busy lining up investors.

In May, Proteus disclosed that it had raised about $17.5 million in a round of funding it hopes will eventually top $50 million. In 2010 the company received a $24 million investment from pharmaceutical maker Novartis.

Proteus also quietly raised about $25 million in late 2009.

Janssen launches Care4Today mobile medication reminder system

By: Neil Versel | Jul 26, 2012        

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Care4TodayJanssen Healthcare Innovation, an entrepreneurial unit of pharmaceutical heavyweight Johnson & Johnson, is promoting medication adherence with a new secure messaging platform and smartphone app and website.

The Care4Today Mobile Adherence program, announced on Wednesday, delivers reminders to take medications as directed, refill prescriptions and visit physicians when appropriate. Users can request reminders for any prescription – whether or not it’s a J&J drug – or for over-the-counter medications and nutritional supplements.

“The Care4Today Mobile Adherence platform can help overcome the No. 1 barrier to consumers taking their medications by providing customized reminders delivered via secure messaging directly to their cell phone, a device that most people carry with them at all times,” Janssen Healthcare Innovation boss Dr. Diego Miralles says in a press release.

Janssen Healthcare Innovation has made improving medication adherence a top priority. The San Diego-based group cites a 2009 report from the New England Healthcare Institute which found non-adherence costs the U.S. a staggering $290 billion a year and contributes to 3.5 million hospitalizations and 125,000 deaths annually.

Care4Today Mobile Adherence is available as an iPhone/iPad and Android app, but it also works with any web-enabled phone or PC. Users sign up for free on the website and register the medications they want reminders for. The reminders can be specific or discreet, with coded phrases such as “walk the dog,” Janssen says.

Each message asks for a response to indicate that the patient has taken medications. The system keeps a log for users to monitor their own adherence and, if they choose, bring a printout to share with their doctors. For the sake of privacy, Janssen Healthcare Innovation says it does not have access to user identities.

Watch a short video about Care4Today here.

Hospitals struggle with BYOD, want clarity from federal regulators

By: Neil Versel | Jul 26, 2012        

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BYODWith the bring-your-own-device trend showing no signs of abating and mixed messages coming from government regulators, healthcare organizations are struggling mightily with how to secure patient data on tablets, smartphones, laptops and even wireless medical devices.

Different federal agencies see security through different prisms. The Drug Enforcement Agency, part of the Department of Justice, regulates controlled substances, and requires two-factor authentication for physicians to write electronic prescriptions of Schedule II narcotics. Instead of using what’s referred to as a “hard token” for the second factor, Dr. John Halamka, CIO at Beth Israel Deaconess Medical Center in Boston has suggested to the Food and Drug Administration, which regulates medications themselves, the use of a technology that sends a text message to a doctor’s “known cellphone” with a code that expires in 10 minutes.

“The FDA said you need not a BlackBerry but a BarackBerry,” Halamka said Wednesday in Boston at the 4th annual World Congress Leadership Summit on mHealth. He was referring to the highly secured, heavy and expensive smartphone that President Obama and others with high-level intelligence clearance must use for communicating classified information. It’s a product made by defense contractor General Dynamics that is capable of issuing missile launch codes, Halamka said. That’s not exactly practical for healthcare.

Healthcare entities generally use HIPAA privacy and security rules developed at the Department of Health and Human Services, but there is a lot of overlap between agencies.

Deven McGraw, director of the Health Privacy Project at the Washington-based Center for Democracy and Technology called encryption “your get-out-of-jail-free card should there be a breach,” as far as HIPAA is concerned. However, if the technology is too cumbersome, users will find dangerous workarounds such as leaving passwords on sticky notes on the front of shared workstations.

On the consumer side, McGraw said the U.S. Commerce Department’s National Telecommunications and Information Administration is now convening stakeholders, as the Federal Trade Commission has called for, to help reach consensus on mobile data protection standards, not specifically for healthcare. Along the same lines, the Center for Democracy and Technology this month published best practices for mobile app development.

“It’s the intersection of these [institutional and consumer worlds] that is being driven by an increasingly engaged e-patient base,” McGraw said. Stage 2 of the “meaningful use” EHR incentive program, set to begin in 2014, also will promote consumer engagement, based on draft requirements published earlier this year that should be finalized any day now.

“I think it would be good if the regulators would provide some clarity on that,” McGraw said. The silence that the FDA, Federal Communications Commission and others have had for more than a year now on possible regulation of mobile apps as medical devices “isn’t helpful,” she added.

Dr. Joshua Lee, newly appointed CIO at University of Southern California Health, said healthcare organizations need to take “intermediate steps” to manage and secure mobile devices while various agencies work out their differences on health information privacy rules and regulation of mobile apps.

Under HIPAA, organizations are required to know who users are and manage their access. Lee, who until a month ago was CMIO at the University of California-San Diego Health System before moving up to Los Angeles, uses Active Directory, a Windows Server feature that allows network administrators to authenticate and manage users. As residents and others leave the organization, their credentials get deleted.

Portals can help “do the heavy lifting of authentication for you,” Lee recommended. He uses Citrix and USC, just as he did at UCSD. He also is a fan of native smartphone and tablet apps for access to electronic health records, in part because apps necessarily limit the amount of information delivered to the mobile device and probably won’t store data locally. “The complexity of what you get on a native application nowhere near matches what you can get on a desktop computer,” Lee said, but noted that this will change as mobile technology evolves.

One thing that is near certain is that some portable devices will disappear. Halamka discussed a recent theft of a physician’s personal laptop at Beth Israel Deaconess, publicly disclosed last week, that contained information on about 3,900 patients. The computer contained a tracking device, but the machine has not been turned on to activate the tracker; the laptop most likely has gone to a “chop shop,” where the hard drive was wiped clean so it could be illegally resold, so the risk to patients probably is small, according to Halamka.

Still, BIDMC is going ahead with a previously planned two-phase effort first to encrypt all laptops and tablets owned by the institution in the next 90 days, then to encrypt all personal mobile devices that employees and medical staff used for business purposes.

“We’re going to learn a lot over the next 90 days,” according to Halamka. What happens, for example, when someone brings in an old laptop running Windows NT, an operating system that does not support encryption? “It’s your lucky day,” Halamka said. “We’re going to buy you a new laptop.”

The second phase will present even more challenges, because tablets and smartphones running the open-source Android mobile operating system and older computers with Windows XP or the Snow Leopard version of Mac OS might require extra attention, Halamka said.

To Halamka, it just shows how BYOD at an academic medical center is pretty much a nightmare without proper institutional controls. “It would be like Toyota building a plant and then allowing people to come in and build any car they want,” he said.

Summer reading: Jody Ranck’s digital health field guide

By: Brian Dolan | Jul 26, 2012        

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Brian Dolan, Editor, MobiHealthNewsIn May GigaOm published its first ebook, called Connected Health: How mobile phones, cloud and big data will reinvent healthcare, written by longtime digital health scholar and consultant Jody Ranck. Within the book’s more than 200 pages is perhaps the most comprehensive and studied analysis of connected health that I have had the pleasure to read.

MobiHealthNews has long been a fan of Ranck’s work and he has appeared in most of our video reports from past mHealth Summit events. On the last occasion we covered a report he penned for GigaOm, Ranck helpfully explained why a looser definition for mobile health was a good thing, which likely reduced some of the widespread navel-gazing that was popular in mHealth circles at the time.

As the subtitle suggests, Ranck’s latest work focuses on a number of digital health technology trends, but chief among them is mobile. Here’s a few lines from the introduction that deftly pegs the current conversation:

“The important point here is to move beyond the mere fascination with the device and connect the device with people and data flows so that the right person gets the right care at the right time—a realization of anytime, anyplace health that puts the patient or citizen at the center of a technology. Human-centered design processes can further improve the quality of care and extend our resources through the focus on data-driven care that can optimize health outcomes,” Ranck writes.

“The connected-health story will not only be a story about technology,” he continues. “It will require innovations from service and experience-design specialists. In the eyes of most who have used the healthcare system, the sector leaves much to be desired. Based on their experience in other fields, designers could apply new ways of thinking about service delivery to the health sector.”

Ranck’s analysis is one of the better studied missives because it includes examples of digital health pilots, projects and companies on nearly every page – a good number were previously unknown to us.

The author also pulls no punches: “At the moment, there is considerable growth, but the market remains fragmented. What is missing is a framework for bringing stakeholders to the table to build the foundation of a sustainable market. The Continua Health Alliance is one model focusing on standards for Bluetooth interoperability of medical devices. The mHealth Alliance is a rather weak or failed model (extremely limited impact, absence of leadership in building cooperation) that has not lived up to expectations for those of us involved in the 2008 Bellagio summit on eHealth, and there is a growing need for an institution that could take the next steps in its place.”

Ouch.

Along with the deep contextual details and a few acerbic comments like the one above, Ranck employs an anthropological lens at various times throughout the book, which he described as a “field guide” for those working in or interested in digital health.

“There are plenty of reasons to be skeptical,” Ranck writes. “Rarely a day goes by without a new press release of a new mHealth or fitness app that promises to fundamentally change health care. Anthropologists studying technology and society often refer to the ‘political economy of hope and hype’ that has plagued biotechnology, and we’re certainly seeing the same with the so-called IT revolution. To see opportunities in a new and rapidly growing space, you need to step back and look at the structural transformation from a distance. I hope this book can contribute to the connected health discussion and debate by asking critical questions and pushing for sustainable technology policies and market approaches.”

Ranck’s Connected Health, contributes to the discussion tremendously. It is also a steal at less than $8 – get your copy from GigaOm here.