ONC sticks to basics in mobile security outreach

By: Neil Versel | Dec 13, 2012        

Tags: | | | | | |  |

ONC HIPAA videoWhile hospital CIOs and privacy officers sweat over the proliferation of smartphones, tablets and the BYOD phenomenon, federal health IT officials are trying to put their minds at ease with a series of resources to help providers safeguard patients’ protected health information.

Wednesday at its annual meeting in Washington, the Office of the National Coordinator for Health Information Technology (ONC) introduced an educational initiative for healthcare organizations to understand and manage privacy and security risks associated with laptops, tablet and smartphones.

Resources on the page include simple how-to’s on protecting health data, managing personal mobile devices used on institutional networks and dealing with lost or stolen devices. The page features basic explanatory videos and downloadable fact sheets on such topics as helping individual users understand organizational policies for using mobile technology.

CIOs also can download posters to educate and remind staff of procedures and responsibilities. “Your Patients Trust You to PROTECT and SECURE Their Health Information. TAKE THE STEPS when using a mobile device to safeguard patients’ information,” reads one.

The outreach is in response to public comments the Department of Health and Human Services received during and subsequent to a roundtable held in March.


Neurosurgeon-led “eBra” team moves to pillowcases, sheets

By: Neil Versel | Dec 13, 2012        

Tags: | | | | |  |

Varadan book cover1031212033811PMThe University of Arkansas team that developed the “e-bra” – a remote monitoring system embedded in the fabric of base layers – has big plans for unobtrusive, wearable sensing technology. Think products that can replace expensive, inconvenient diagnostic testing and even predict heart attack and stroke.

The team, led by neurosurgeon Dr. Vijay Varadan, distinguished professor of electrical engineering at the Fayetteville, Ark., school, and research scientist Linfeng Chen, has woven sensors into pillowcases and sheets so patients at sleep clinics don’t need to be wired up, have their heads shaven or even have patches stuck to their skin. “You can sleep in any position you want,” Varadan explains to MobiHealthNews.

Right now, the system, featuring six sensors in the pillowcase to track brain activity and six more in the sheet for measuring vital signs, is about 90 percent accurate. “We’re working to improve that,” Varadan says.

Varadan and Chen just published the first of about 10 volumes they plan on contributing to an American Society of Mechanical Engineers series of highly technical manuals on wireless health sensors. This book focuses on the history of textile-based sensors, health monitoring systems and mobile healthcare applications.

Two of the future volumes will look at sleep disorders and calorie burn rates to help determine the optimal mix of exercise for amateur and professional athletes. Others will examine the connection between brain and heart functioning in many medical ailments, according to Varadan, who directs Arkansas’ High Density Electronics Center and the Center for Wireless Nano-, Bio- and Info-Tech Sensors and Systems. “When your brain is happy, your heart is happy,” Varadan explains.

Wearable sensors potentially can pick up many of the signs of heart and brain disease that otherwise would require costly, uncomfortable imaging. “You can measure with a garment so you don’t need to go to the hospital for an MRI,” Varadan says. “You can do it at home.”

Or the testing can be performed during everyday activities, as the e-bra sports bra for women and vest for men does, rather than in a lab when the patient might not be in a natural situation. “Through your daily activities, you are not relaxing,” Varadan explains. Textile sensors pick up vital signs as people go about their lives.

Like the University of Southern California’s Center for Body Computing, the Arkansas researchers have tested wireless sensors on football players and other athletes. But Varadan takes the concept one step farther, putting monitors not just in undershirts, but in helmets for capturing brain waves during actual game action. “Right now, they do prescreening with the sticky stuff [patches],” Varadan says.

Inverted T-waves, which Varadan says are somewhat common in wide receivers, raise the risk for heart attack, severe angina and even death, according to published research. Varadan also notes that there has been little published research from physicians on neurogenic T-waves, an abnormality that he says  can predict the onset of a stroke up to six months in advance.

Varajan indicates that he is looking into setting up a company to market smart fabrics and garments, some of which even have embedded GSM transmitters that work over cellular network. However, he has not been able to find a U.S.-based manufacturer, which he prefers. “Every textile [he is working with now] is made in China or India,” he says.

The Arkansas researchers have applied for patents and Food and Drug Administration clearance on some of their innovations, including the sensor-laden sheets. Varadan also has applications pending for implantable devices that not only stimulate the brain of people with Parkinson’s and Alzheimer’s diseases, they can measure the effectiveness of such treatments.

SecondMarket plans fund for StartUp Health inductees

By: Jonah Comstock | Dec 12, 2012        

Tags: | | | | | | |  |

Steven Krein, co-founder of StartUp Health

Steven Krein, co-founder of StartUp Health

SecondMarket, a secondary market investment advisory company, is partnering with incubator StartUp Health this month to make small accredited investors more aware of the opportunities in the digital health space, and to give make a chance to fund some of StartUp’s inductees.

StartUp Health co-founder Steven Krein described StartUp Health as “an academy for health and wellness entrepreneurs” in an interview with MobiHealthNews earlier this year.

“We use the term academy specifically because we provide a longterm program for the life of the entrepreneur’s startup,” he said. “What we have learned — being entrepreneurs ourselves — is that the real work begins after you get customers and after you get funding.”

SecondMarket is best know for trading in private Facebook shares before the company went public this past summer. Now they’re focusing on acquainting accredited investors with what they call “next generation investments.” Part of that strategy is an education program where the company devotes each month to educating investors about a different space.

The focus for December was health tech, and SecondMarket partnered with StartUp Health to produce a webinar for interested investors that covered trends in digital health.

According to GigaOM, StartUp Health is offering SecondMarket investors the opportunity to contribute to a planned $7.5 million innovation fund to help support 100 digital health companies that will participate in StartUp Health’s accelerator program. The fund will own between 2 and 10 percent equity in the companies it supports.

In the webinar, StartUp Health co-founders Steven Krein and Unity Stoakes focused on the concept of creative destruction – a term coined by Austrian Economist Joseph Schumpeter and recently applied to healthcare by Dr. Eric Topol in his book “The Creative Destruction of Medicine.” It refers to a point of transformation that occurs when an existing market becomes too large and set in its ways to foster innovation and begins to fall apart. As StartUp Health chairman Gerald Levin put it in the webinar, “the big ships just can’t turn around fast enough.”

“There’s never been a more interesting time to invest in health and wellness,” said Stoakes. “That’s because healthcare is being completely reimagined. We are at the beginning of what we believe will be an epic decade of innovation and progress.”

Bob Kocher, a partner at Venrock, the Venture Capital arm of the Rockefeller Foundation, outlined the ways the health field is becoming ripe for innovation. He said the healthcare market is growing, because of a combination of more people qualifying for coverage under the Affordable Care Act, the population aging, and an increasing number of people with chronic conditions.

Kocher was also optimistic about a change in payment models – from a system where health care providers are paid for their time to a system where patients and providers share risks and rewards based on outcomes for patients. Kocher also talked about downward pricing pressure and physician shortages that would encourage hospitals to look for ways to increase labor productivity. Technologies that help hospitals do more with fewer people will be great places to invest, he suggested.

Finally, employers are changing their health priorities to focus on prevention, fitness, and wellness to drive down eventual health costs.

These trends have already spurred increased venture capital for health tech companies. According to StartUp Health figures presented at the webinar, more than $3.5 billion has been invested in digital health since 2010 – a figure that doesn’t include legacy medical technology, pharmaceuticals, or life sciences companies. The way that capital is distributed has also been changing in a way that suggests startups can do more with less. The average deal size in the space dropped from $10.8 million in 2011 to $5.1 million in 2012, even though the total amount invested went up. The space saw 219 seed deals in 2012, compared with 131 in 2011.

“For some time in the last several years there was a reluctance [on the part of investors] to really get involved,” said Levin. “The regulation seems daunting, the payment models seem complicated. But as you heard, it’s all coming together now.”

Mobile can replace in-person weight loss programs

By: Jonah Comstock | Dec 12, 2012        

Tags: | | | | | | | |  |
weight loss chart

Source: The Journal of the American Medical Association

A newly published randomized controlled trial study suggests that using mobile devices for self-tracking and feedback could be a cost-effective way to scale successful weight loss programs that include a face-to-face component.

The study, published in the Journal of the American Medical Association and completed in September 2010 at a Midwestern Veterans Affairs hospital, split a group of 70 older, mostly male veterans into two groups. Both groups attended biweekly MOVE! sessions for 6 months, but one group was issued Palm Pilots during that time and instructed on how to record their food intake, weight, and physical activity. They uploaded the data to a server where it could be accessed by coaches, who phoned them every two weeks for about 15 minutes to talk about their data and progress toward a 5 percent weight loss goal. After the six months were over, participants continued to record and transmit data, but less frequently, and coaches only followed up if participants failed to submit.

At every benchmark (three, six, nine, and 12 months), a larger percentage of the mobile intervention group had achieved the 5 percent goal than the standard group. At three months, 36.7 percent of the mobile users had met their goal, compared to none of the participants in the standard group. After 12 months, 29.6 percent in the mobile group had met the goal, compared with 14.8 percent in the standard group.

The current results are, to our knowledge, the first to demonstrate that use of a mobile technology system and remote coaching can significantly augment weight loss and maintenance when added to an existing standard-of-care obesity treatment program,” the authors write in the study. Though other interventions have been done with PDAs, they wrote, they have tended to also include intensive in-person treatment sessions. This study demonstrates that a mobile intervention can be a substitute for expensive, in-person sessions — an important finding for those looking to mobile health as a solution to scalability problems with proven obesity treatments.

“In general, greater weight loss [12.5 – 19.4 lbs] occurs when technology is combined with weekly in-person contact,” the study says. “However, because in-person interventionist contact is the most expensive treatment component to provide and the most burdensome to access, we substituted brief, regularly scheduled telephone coaching to which coaches came prepared by having reviewed participants’ transmitted, analyzed data. Results suggest that connective technology, like that used in the current study, can allow telephone contact to substitute efficiently for face-to-face time.”

Dr. Bonnie Spring of the Northwestern University Feinberg School of Medicine was the lead author of the study. She spoke at the mHealth Summit last week, using this data as an example of how RCT results are relevant in mobile health even when a lot of time has passed since the study was done.

Even homely, not very attractive apps can be effective when they integrate valid behavior change strategies,” she said. She said using the Palm Pilots, and teaching elderly seniors to enter their data and “hotsync” it with their personal computers, was somewhat frustrating. But the intervention was effective, she said, and translating the lessons learned to newer devices like smartphones and wireless activity trackers isn’t hard to do.

FCC accelerates text-to-911 program, RPM next?

By: Jonah Comstock | Dec 11, 2012        

Tags: | | | | | | | | | | |  |

FCCAccording to the Pew Internet and American Life Project, 85 percent of American adults own a mobile phone, and 80 percent of those mobile phone owners use their phone to send and receive text messages. Yet the only way to contact emergency services in the event of a fire, health emergency, or criminal activity is still by dialing 9-1-1 and making a phone call.

In August of last year, FCC chairman Julius Genachowski announced a plan to bring not only texting, but photo, video, and data support to what he called the Next Generation 911 service within five to ten years.

Now, Genachowski has announced that the rollout will happen much faster, with major mobile operators AT&T, Sprint, Verizon Wireless, and T-Mobile USA committed to implementing 911 texting by May 2014, with widespread deployment happening as soon as June 2013. Trials of text-to-911 are already underway, the FCC said in a statement.

“Access to 911 must catch up with how consumers communicate in the 21st century – and today, we are one step closer towards that vital goal,” Genachowski said in his announcement.

While the service is being phased in starting in 2013, all mobile operators have agreed to provide a “bounce back” service, whereby anyone texting 911 in an area where it’s not yet supported will get a message back directing them to call instead. The “bounce back” service will be in place by July 2013.

The service is intended for those situations where text messaging has a benefit over making a call, rather than to replace the traditional 911 service wholesale. For instance, it will make it easier for people with speech and hearing impediments to request emergency services, and victims in dangerous situations will be able to alert the police without drawing attention to themselves.

The FCC hasn’t said whether the roll out of photo, video, or data support is also being accelerated, or whether the 5 to 10 year timeline will hold.

In a speech to the Association of Public Safety Communication Officials (APCO) in August 2011, Genachowski talked about some of the possible health applications if video and picture messaging are supported.

“Imagine someone was in a car accident,” he said at the time. “With NG911, somebody in the car could send pictures of injuries and the scene to 911, which EMTs could review in advance. Once on scene, EMTs could send critical information back to the hospital, including on-site scans and diagnostic information, increasing odds of recovery.”

At the event last year, he also spoke about integrating the Next Generation system with remote patient monitoring technology in the future.

“If a patient wearing a 24-hour cardiac monitoring device experiences a cardiac event at home, the device could automatically send a wireless signal to the NG911 system to request aid, and also transmit the patient’s location, identifying data and relevant medical information,” he said.

Omada takes proven prediabetes intervention online

By: Jonah Comstock | Dec 11, 2012        

Tags: | | | | | | | | | |  |

Omada Health PreventDuring last week’s mHealth Summit, MobiHealthNews wrote about the relative slowness of rigorous efficacy data collection, compared to the speed of mobile development. One way to sidestep this problem is to work the other way around – to start with existing, reputable data, and build an online service that leverages it.

That’s the process that led to Omada Health‘s diabetes prevention program, Prevent. Prevent is an online, soon-to-be-mobile implementation of a 2002 NIH Diabetes Prevention Program (DPP) intervention that produced significant results for prediabetics. The landmark study found that the lifestyle intervention group, who participated in a 16-week course of intensive training in diet, physical activity, and behavior modification, reduced their risk of diabetes by 58 percent compared to the control group. A third subject group, taking weight loss drug metaformin, reduced their risk by 31 percent.

“If that trial had been a pill, it probably would have become a billion-dollar drug and the gold standard in care. But the DPP was a behavior change program — challenging and expensive to roll out,” Sean Duffy, CEO of Omada, said in a statement. He told MobiHealthNews that the ecosystem to turn effective trials into scalable interventions is just now taking shape, with help from groups like the CDC and UnitedHealth Group.

Duffy discovered the NIH study while interning at design and innovation consulting firm IDEO during a leave from Harvard Medical School.

“Where would you want to intervene if you were looking to build a business that was both economically viable and clinically relevant?” Duffy asjed. “If you look at the literature, one study stands above all the others, which is the DPP. It started to feel like there was this really rich opportunity to expand the access to this program by launching a web translation.”

With Prevent, Omada hopes to offer the success of the NIH study without the high cost. Users will receive a Bodytrace wireless scale in the mail as part of a “welcome kit.” The scale will automatically transmit readings to a private server via cellular, no setup required. Then, via the online portal, users will be matched up with a support group. A coach will guide users through 16 lessons based on the original Diabetes Prevention Program, which the CDC has offered up as an open source curriculum. At week five, users get a pedometer in the mail to start tracking their movement.

Initially, Duffy said, the portal is web-based and the pedometer is not connected; users enter their steps into the system manually. But he said native mobile apps are coming soon, and he hopes to be able to integrate the system with any activity tracker users might already have.

A key question for Omada is how much of the success of the original program was content, and how much was form? Can a remote implementation drive the same level of engagement and lead to the same results?

“The content is maybe 30 percent of the battle,” said Duffy. “If we put the PDFs of the curriculum online, we would have no results. It’s how you use the content.” He said the approach emphasizes multiple contact points: sending things through the mail, providing a support group via a message board, and providing a coach who communicates via both phone calls and messaging.

“The challenge for us is to design an experience that feels like ‘all hands on deck’ but at a cost that makes sense,” he said. “It’s a very human-based program. To create an ecosystem online where the program feels real and it feels like you’re getting a very high level of attention.”

And a 230-person pilot study conducted by Omada posted results not too far from the NIH intervention: Participants lost an average of 6.5 percent of their weight, compared to about 7 percent in the original study. Now that the product is developed, Omada plans to do more rigorous studies to prove the strength of the platform.

The program costs $120 per month for the first 4 months, then it drops to $12 per month. But in terms of cost, the timing is good for the company and prospective users: Senator Al Franken recently proposed a bill that would allow diabetes prevention programs, specifically, to be fully covered under Medicare. So, many prediabetic patients (the CDC estimates there are 79 million in the United States) might not have to pay anything for the service.

“It’s not necessary to have that bill come through for us to build a business, but it would be a wonderfully catalyzing thing,” Duffy said. “Because we’re a virtual model, we would need to show year-end weight loss in a peer-reviewed journal [in order to be covered], so we’re creating trials right now to do so. We could be the first virtual model certified. If the bill passed and the data was convincing enough to the CDC that they would certify us, you can imagine that would be quite catalyzing.”

Omada is part of Rock Health’s 2011 class and has so far raised $800,000 in seed funding. Prevent is their flagship product, but Duffy says they plan to leverage the platform for other weight loss cases, including weight loss for people who have already been diagnosed with Type 2 diabetes and adults seeking to lose weight for general wellness purposes.