Ginger.io tests passive monitoring for diabetes

By: Jonah Comstock | Jan 29, 2013        

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Ginger.ioPassive behavior monitoring and analytics company Ginger.io is now soliciting participants for a diabetes pilot study, building on the work that won them the Sanofi Data Design Diabetes Innovation Challenge in 2011.

Ginger.io, which recently raised $6.5 million in a round led by Khosla Ventures, makes passive monitoring software for smartphones, with the goal of creating profiles for how different diseases and conditions affect behavior. Ginger.io’s software monitors how often users make calls, how long they talk for, how often they text, and similar metrics, as well as location data. Eventually, the company will be able to compare their behavior to a baseline and send out alerts when it’s out of the ordinary. To make the system work for particular chronic diseases, like diabetes, the company needs to collect a lot of data to form what it calls a “Behavior Genome” for a given condition.

“The infrastructure for collecting data, the infrastructure for processing it, … all of that is similar [between conditions],” CEO Anmol Madan told MobiHealthNews late last year. “There’s one platform we use for all these conditions, but the specific models for how patients behave would depend on the specific conditions.”

The company is looking for participants with Type II diabetes between the ages of 18-65 who own an Android or Apple smartphone and speak fluent English. Pilot study participants will install the Ginger.io software on their phones, and, additionally, take occasional three- to five-question surveys about their health and mood. In exchange, users of the app will get feedback from the program — alerts, insights, and observations about their health. Down the road, the company will also let them set up the software to alert family members of behavioral red flags.

Ginger.io won the first-ever Sanofi Data Design Diabetes Innovation Challenge in November 2011 with a version of the app the company is now testing. According to the Ginger.io blog, the company has spent the intervening year on improving the interface and the user experience of the app. In May, the company launched a similar pilot in partnership with the Collaborative Chronic Care Network (C3N) for patients with Crohn’s disease or ulcerative colitis. The company appears to be launching the diabetes pilot alone, though they are turning to clinical trial-patient matching website Corengi.com to help solicit participants.

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Phone detection of Parkinson’s approaches 99 percent accuracy

By: Neil Versel | Jan 29, 2013        

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Parkinsons Voice InitiativeA British mathematician is applying “big data” algorithms to detect Parkinson’s disease from voice recordings and now claims accuracy up to 99 percent.

“We also know how to predict the severity of symptoms to within a few percentage points of clinical judgment,” Max Little, a mathematician on the faculty of Aston University in Birmingham, England, and a visiting researcher at both the Massachusetts Institute of Technology and Oxford University, wrote Friday in the Huffington Post’s TED Weekends column. He gave a TED talk in Edinburgh, Scotland, last June.

The technology has the potential to make drastic cuts to the time and cost of diagnosing Parkinson’s, a neurological disease that manifests itself not only through the telltale physical tremors but through changes in speech patterns, among half a dozen other typical symptoms.

“Current symptom tests are done in a clinic. They are expensive, time-consuming, and logistically difficult. So mostly, these tests are not done outside clinical trials,” Little wrote. “Our technology could enable some radical breakthroughs, because voice-based tests can be administered remotely, and patients can do the tests themselves. Also, they are high speed, taking less than 30 seconds, and since they don’t involve expert staff time, they are ultra low cost. That makes the technology massively scalable.”

Little founded the Parkinson’s Voice Initiative and is in the process of analyzing 10,000 phone calls he and his team collected for a current research project. He has been working on the project for seven years since a friend, spurred on by the fact that a friend, a former ballet dancer, suffers from Parkinson’s disease.

“This incredible and unique dataset will tell us whether it is possible to use something as ubiquitous as the telephone to detect and monitor the disease,” Little said. “This now becomes a ‘big data’ analysis problem, and until the analysis is done, we can’t know for sure if it will work. But if it does, we would have the technology to check out some 75 percent of the world’s population at a negligible cost.”

Little reported achieving 86 percent accuracy with mathematical algorithms he developed while working a Ph.D. at Oxford. As a professional, he said he now has algorithms that come close to 99 percent in laboratory conditions.

If the analysis does prove successful on a wide scale, Little said the technology could eliminate some physician office visits by providing a remote means of monitoring how Parkinson’s is progressing and also assist in research projects. “We could do high-frequency monitoring for individualized treatment decisions. This might allow clinicians to optimize drug timing and dosage,” Little surmised.

“For clinical trials, we could do cost-effective mass recruitment for new treatments. By recruiting very large numbers into trials we could help speed up the search for a cure. And finally, this could enable population-scale screening programs, that might allow us to search for ‘biomarkers’ that show early signs of the disease before the damage done is irreparable,” he continued.

Little also said scientists in other fields might be able to apply his algorithms outside medicine. “One particularly fascinating application is the detection of extrasolar planets — that is, planets circling other stars,” he wrote.

While the voice angle is new, this is not the first time someone has tried to bring mobile technology to Parkison’s care. Great Lakes Neurotechnologies has won FDA 510(k) clearance for Kinesia HomeView, which combines a tablet computer and wireless sensors to assess the effectiveness of treatments for Parkinsonian tremors.

NYC kicks off $50,000 innovation challenge with Health 2.0

By: Neil Versel | Jan 29, 2013        

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Care4Today app from Janssen Healthcare Innovation

Care4Today, a medication adherence app from Janssen Healthcare Innovation

The New York City Economic Development Corp. (NYCEDC), which promotes business investment in the city, is the latest to dangle cash prizes for innovation in digital health.

The contest, called Innovate Health Tech NYC and launched Monday, is offering a total $50,000 in award money and exhibition space to three winners for developing “commercially viable technologies that solve urgent healthcare problems,” the organization says. NYCEDC, which is working with the San Francisco-based Health 2.0 organization on the challenge, will be looking for such things as mobile apps, wireless health monitors, tools for clinical workflow management and healthcare analytics software.

After the contest closes May 2, judges will pick a total of 10 finalists to receive assistance from health IT veterans to refine their product pitches in time for a public demonstration scheduled for July. Three winners will emerge from that group.

Sponsors include Johnson & Johnson’s Janssen Healthcare Innovation, entrepreneurship academy StartUp Health and online technology competition platform ChallengePost.

“It’s indicative of a trend we think is really inspiring,” StartUp Health co-founder and partner Unity Stoakes tells MobiHealthNews, namely the many healthcare innovation challenges being run across the country. The hope is that winners will develop into sustainable companies that can have a real impact on healthcare in the U.S. and around the world, Stoakes says.

StartUp Health will be providing coaching, mentoring and support to the finalists and will be part of the review and selection process, according to Stoakes.

While sponsors have only committed to running Innovate Health Tech NYC contest once, there are plans to make it ongoing, Stoakes says. “It’s a model that has worked well in New York,” he says, citing the NYCEDC’s NYC BigApps competition for creating useful mobile apps from city databases and, at the federal level, the Surgeon General’s Healthy Apps Challenge.

This contest follows on the heels of the announcement last week of Pilot Health Tech NYC, also from the Economic Development Corp. and Health 2.0. That program will operate much like a business accelerator, providing $100,000 to each of 10 early-stage health IT companies for pilot programs to test technology prototypes in healthcare settings for a period of 3-6 months.

Organizers of the planned annual Pilot Health Tech NYC program are taking applications through Feb. 10 for “matchmaking” sessions with established healthcare service organizations. Matchmaking interviews will take place Feb. 20-21 and final proposals are due May 27.

StartUp Health and health incubator Blueprint Health are supporting Pilot Health Tech NYC.

Equivital uses old pill sensor for new tricks

By: Jonah Comstock | Jan 28, 2013        

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equivital sensor beltCompanies like BodyMedia, Fitbit, and Withings provide wearable trackers for customers to gather data about their health as they live their everyday lives. British company Equivital, whose CEO Anmol Sood appeared at CES on a panel with CNN’s Dr. Sanjay Gupta, is focused on using wearable body monitors in extraordinary situations. Australian firefighters and space jumper Felix Baumgartner are two high-profile examples.

The most headline-grabbing component of Equivital’s body monitoring system is an ingestible capsule sensor which measures core body temperature and transmits that result on a shortwave radio frequency. The capsule itself isn’t Equivital’s invention, nor is it new. It was first developed under the name VitalSense by Mini Mitter Co., which was acquired by Respironics, which was, in turn, acquired by Philips. Philips now licenses the technology to Equivital. Mini Mitter published a validation study of the technology in the Journal of Thermal Biology back in 2004.

But self-tracking has a considerable higher profile now, and, according to Sood, Equivital’s innovation is to use the pill in what he calls “mobile human monitoring” situations.

“Previously, [the capsule] was being used in systems that weren’t allowing mobile human monitoring,” he told MobiHealthNews. “People who were sitting, sedentary, minimal movement. We’re able to take that technology and use it in a different use case. It could be a soldier running around, it could be a firefighter, it could be Felix Baumgartner.”

Equivital makes the EQ02 system which includes a sensor belt which interfaces with a range of customizable third-party sensors, including the ingestible sensor for monitoring core body temperature. The company is marketing the whole monitoring suite to emergency workers like firefighters and hazardous condition workers in the oil and gas markets, to pharmaceutical companies for use in collecting more accurate drug trial data, and as part of their Black Ghost military training system, which allows the monitoring of health and location in real time for soldiers engaged in training exercises.

Sood says the key is not just collecting a lot of data, but making all the data synthesize into actionable information.

“We have an end-to-end mobile human monitoring system: the [capsule] and the chest belt,” he said. “That’s a multiparameter sensor, so it can monitor clinical grade EKG, heart rate, respiratory rate, three types of temperature, and movement on a tri-access accelerometer. So we can look at the raw data on that level, and we have our own algorithms to allow that data to become contextualized.”

By tracking those biometrics on people in action and under extreme stress — like firefighters, space jumpers, and military personnel — Equivital will be collecting data that doesn’t yet exist; data that could not have been collected with older technologies. Like so many companies in digital health today, exactly what Equivital will do with their data is still up in the air.

What the new HIPAA means for digital health access

By: Jonah Comstock | Jan 28, 2013        

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Mayo Clinic Patient iPad app

Mayo Clinic's Patient iPad app

“HIPAA is a valve, not a blockage.” At least, that’s what Office of Civil Rights (OCR) director Leon Rodriguez has said about the Health Insurance Portability and Accountability Act of 1996. Discussions of the national health information privacy and security act often revolve around the ways it limits access to patient health information, rather than the ways in which it makes that information available to patients themselves.

The new 563-page HIPAA omnibus final rule, released last week by the Department for Health and Human Services (HHS), clarifies and expands patients’ rights pertaining to their health information, while also toughening providers’ responsibility to keep that data safe and secure. The new rule, which is the first major update to the 15-year-old law, incorporates provisions laid out in the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act.

Easier access to electronic records for patients

For patients, the biggest difference under the new rule is a change in the process of requesting their electronic health records: the default format is changed from a hard copy to an electronic copy.

“The old rule was ‘an individual is entitled to receive a copy in the form or format requested if readily producible,'” said Adam Greene, an attorney with Davis Wright Tremaine who formerly worked at OCR. “If the requested format was not readily producible, than the old rule was ‘you get a hard copy.’ Under the new rule, you continue to have a right to choose the format if readily producible, but now, if the information is maintained electronically and the covered entity is not able to provide the requested form and format, than the default is an electronic copy.”

Greene also said patients can now request that another copy of the records be sent to a third party designee, something that, under the old rules, required a special authorization form. That third party could be a caregiver or a school, but the provision could also make it easier for health consumers to automatically send their health information to an app.

Additionally, the new rules allow individuals paying for a procedure entirely with cash to ask that the procedure not be shared with their health plan. The new rule prohibits protected health information from being sold and limits how it can be used in marketing and fundraising.

For care providers and their associates, tougher enforcement

The new rule includes a number of changes that clarify and, in some cases, increase the standards for protecting patient information. Although the amount that an organization can be fined for a security breach has not changed since 2009, changes in liability and enforcement still give the law some much-needed sharper teeth.

“My overall impression of what HHS did was to send a message to covered entities and business associates handling protected health information that HHS is going to be serious about enforcement,” said Brian Balow, a lawyer at Dickinson Wright LLC.

One major change is that liability for a breach of patient health information is now shared — not just among the covered entities (hospitals and other care providers) but also among their business associates, and subcontractors of those associates. Business associates include anyone who works with a provider in a capacity that requires them to access the protected information — for instance, cloud providers and HIPAA-secure messaging companies.

Balow said the emphasis of the new rule is on “willful neglect,” defined as “conscious violation or reckless indifference” to the law. Covered entities and business associates can be fined $50,000 per violation for cases where covered entities and business associates haven’t completed risk assessments or fail to have data safeguards in place. “Per violation” can mean “per patient with a compromised record” in some cases and “per day of noncompliance” in others, so the fines can add up very quickly.

Old “harm standard” vs. new “low probability of compromise”

As well as expanding the scope of the enforcement, the new rule changes what constitutes a breach. The breach notification threshold refers to the standard for determining whether a security breach is severe enough that a hospital or business associate should be required to report it to HHS, the affected patients and, in some cases, the media.

“The biggest surprise to the healthcare industry was the breach notification threshold, in that it went from ‘a significant risk of harm’ to ‘low probability of compromise,'” said Greene of Davis Wright. “I think not too many people, if any, were predicting that change, although everyone knew that the breach notification standard was in play. So everyone’s grappling with that. As subjective as the harm standard was before, the new standard, which OCR suggests is more objective, leaves huge question marks because people don’t know what it means to have been compromised.”

The final rule reads: “Thus, breach notification is not required under the final rule if a covered entity or business associate, as applicable, demonstrates through a risk assessment that there is a low probability that the protected health information has been compromised, rather than demonstrate that there is no significant risk of harm to the individual as was provided under the interim final rule.”

Balow said that tort law in general is designed for cases where individual harm is hard to establish. It’s hard for a patient to know his information has been breached if he isn’t told, and even if he is, it’s very difficult to seek restitution through a civil suit.

“There are, in my experience more and more people aware of this and believing that their rights are being violated,” Balow said. “I know there have been a couple of class action suits filed, but that law is not at present well developed in terms of the private right of individuals whose private health information has been disclosed. And the issue there is ‘What’s the damage?’ You have to show damage, and it’s very nebulous.”

So instead, the Office of Civil Rights conducts HIPAA audits, fining violators in amounts which could reach tens of millions of dollars. The OCR collects the money and, since the passage of the HITECH act, also receives the revenues to use for further enforcement efforts. But Greene said the department has actually been pretty conservative in leveraging the fines.

“If you look at the stats today, there are roughly 18,000 cases where HHS has investigated, found noncompliance, and closed it with productive actions, compared to only about 12 cases where they’ve brought a penalty and where money’s changed hands,” Greene said, adding that the department simply doesn’t have the resources to do a large number of settlements per year. “There’s definitely been heightened awareness, and I have expectations, but whether we’re ever going to see penalties handed out like traffic tickets, that remains to be seen.”

Greene also said a future rule facilitated by HITECH will allocate some of the money from HIPAA settlements to the patients who were directly affected by the breach.

Blue Button and apps

The provision that might have the most relevance for the Blue Button initiative is the one that facilitates easy sharing of health data to a third party by a patient. Although HIPAA might be strict on health care providers who are acting as stewards for patient information, it doesn’t put any restrictions at all on how the patient uses that data once they have it — including sharing it with an app.

It’s possible that other legislation will take over the security responsibilities at that point, however. Rep. Hank Johnson (D.-Ga.) recently posted draft legislation that would regulate how apps collect and use all kinds of user information. Called the Application Privacy, Protection, and Security Acts, or APPS Act, the draft legislation doesn’t talk about health information specifically. But it does make provisions for individuals to have more control over what information an app collects, require that apps meet a certain standard of information security and, perhaps most relevant, gives them the right to stop data collection and have any existing data deleted at any time.

If the Blue Button initiative succeeds in its mission for patients to have access to their health information in a meaningful and accessible way, then many patients will likely be storing their personal health information in apps on their mobile devices. A measure like this, that holds apps accountable for maintaining the security of that information, could be an important piece making the future ecosystem of patient information viable.

Pew: Most US adults track health data but few use digital tools

By: Brian Dolan | Jan 28, 2013        

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basis

Early screenshot of Basis Band's dashboard

Perhaps surprisingly, a majority of American adults track their own health data, however, most aren’t using digital technologies to do so.

About 69 percent of US adults track at least one health indicator, according to a national survey called Tracking for Health, conducted by Pew Research Center’s Internet & American Life Project. About 60 percent of US adults track weight, diet, or an exercise routine, while 33 percent track another health indicator like blood pressure, sleep patterns or headaches. Some 12 percent of adults track health indicators for a loved one.

Susannah Fox, an associate director of the Pew Internet Project, told MobiHealthNews that this survey was the first broad national survey to look at health data tracking and as such her team didn’t know what to expect. They made the decision to ask all adults about health tracking — not just Internet users — in part because the 65+ population is (as a group) more likely to not be online but also more likely to have (at least one) chronic condition that requires some level of tracking.

“Seven in ten American adults are tracking health data, which sounds like a huge number until we follow up with the “gotcha” question of ‘How are you tracking?'” Fox explained to MobiHealthNews. “It turns out that half of trackers say they are keeping track of progress just in their heads. They don’t write it down, they don’t use a device, they don’t keep a spreadsheet. Half are just tracking in their heads. One in three say they are tracking on paper, like in a notebook or journal. One in five say they are using some form of technology, whether a medical device like a glucometer, or a website or a spreadsheet — any kind of technology.”

Perhaps surprisingly, this digital tracking adoption rate — about 21 percent of American adults — is similar to findings from a question featured in a 2010 Pew survey: “Our survey finds that 15 percent of internet users have tracked their weight, diet, or exercise routine online. In addition, 17 percent of internet users have tracked any other health indicators or symptoms online. Fully 27 percent of adult internet users say yes to either question.” While the rates are within one percentage point when the margin of error (2.5 percent) is considered, it’s clear no matter how you interpret this data that the number of people who use digital health trackers has not increased over the course of the past two years. Keep reading>>