AHIMA: Look at legal ramifications of mobile health information

By: Neil Versel | Jul 9, 2012        

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Mobile SecurityIn developing policies for managing data handled by and stored on mobile devices, healthcare organizations should look beyond privacy and security and consider the legal ramifications of mobile health information, the American Health Information Management Association (AHIMA) says.

“While much has been written stressing how extremely important security and privacy issues are in the use of mobile health technology, a question much less explored is how health information that is captured on mobile devices relates to the management of the health record,” Lydia Washington, a director of practice management at AHIMA, writes in the July issue of the Journal of AHIMA.

AHIMA has long been emphasizing the importance of the “legal health record” in the context of electronic health records, essentially the official documentation of healthcare services provided from an organization to an individual. Information captured by or transmitted over a mobile device is part of this, according to Washington.

“It is widely accepted that any health information captured or stored by clinicians using either a personal mobile device or one provided by the healthcare organization becomes part of the HIPAA-designated record set if that information is used to make decisions about a patient. The same is true when health information that is collected or captured by an individual or patient is transmitted or communicated to a provider who uses it in the provision of care,” Washington writes. Keep reading>>

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Proteus Biomedical tweaks branding, partners with Abilify-maker Otsuka

By: Brian Dolan | Jul 6, 2012        

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Proteus Biomedical's Raisin system

Proteus Biomedical's Raisin system

Intelligent medicine platform developer Proteus Biomedical has changed its name to Proteus Digital Health, to “better reflect” what the company does, Chief Product Officer David O’Reilly told MobiHealthNews in an email this week. Proteus also inked a deal with Japan-based Otsuka Pharmaceutical, which is known for its Abilify drug for schizophrenia and bipolar disorder, that will bring technology based on Proteus Digital Health’s Raisin platform to that country.

No financial terms of the deal were closed and neither were the two therapeutic areas which the collaboration will address. Besides its Abilify brand, Otsuka is focused on oncology and nutraceuticals. Besides the two commercial products, Otsuka plans to make use of Proteus Digital Health’s feedback system in its clinical research and development.

Proteus Digital Health’s intelligent medicine offering is called Raisin, and the basic system includes sensor-enabled pills, a peel-and-stick sensor patch worn on the body, and a mobile health app. The patch records when a pill is ingested and also tracks other things like sleep patterns and physical activity levels.

As O’Reilly suggested, the name change from “Biomedical” to “Digital Health” is fitting. In addition to building its medication adherence system, which embeds intelligence into the pills themselves so that their ingestion can be precisely tracked, Proteus has also developed wireless peel-and-stick, bandaid-like medical sensor technology that the company licenses out to other digital health companies through its partnership with Avery Dennison. That is the same technology that BodyMedia is leveraging for its peel-and-stick, disposable sensor that it announced at the beginning of the year.

Proteus has previously partnered with or licensed its technology to Novartis (which invested tens of millions into the company a few years ago), Medtronic, ON Semiconductor, Kaiser Permanente and Lloydspharmacy (which launched a modified version of Proteus’ Raisin system in the UK in January).

In mid-2009, Proteus Biomedical CEO Andrew Thompson predicted that China would likely be the first market it launched its system in — not the US or UK. In early 2010 Novartis announced that it had invested $24 million in Proteus and that it had exclusive rights to use the technology with specific types of therapies, including those used for organ transplant patients. While Proteus has yet to launch Helius or a similar technology commercially in the US yet, it did receive FDA clearance for the peel-and-stick sensor patch in early 2010. Proteus first announced that the UK’s NHS began testing its system back in mid-2010. Last July the company secured a patent for the technology.

More on the Ostuka deal in the press release below: Keep reading>>

Docomo, Omron Healthcare launch connected health venture in Japan

By: Neil Versel | Jul 5, 2012        

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Japanese telecom NTT Docomo is teaming up with medical equipment manufacturer Omron Healthcare to launch a new wireless and mobile healthcare venture.

The newly formed Docomo Healthcare will provide wireless links to various Omron devices, including blood-pressure cuffs, sleep monitors and body composition scales, allowing consumers to upload personal data to the cloud via smartphones. The data will support remote health management, according to Tokyo-based Docomo.

The venture also promises an unspecified “wide range of services to meet the needs of all lifestyles and the various stages of life by cooperating with various content providers, including companies in health-related fields,” according to a press release.

By March 2013, the two companies plan on combining Docomo’s two-year-old i-Bodymo health and wellness platform with Omron’s WellnessLINK, a similar service for self-management of wellness data that includes mobile access. WellnessLINK is aimed at the wellness market rather than older people with chronic diseases, according to a report in MobileHealthLive, an online publication of the GSM Association.

Docomo Health

“Through the establishment of this new company, Docomo and Omron Healthcare will tap the resources of both companies to make a full-scale entry into the healthcare services market and vastly advance healthcare communications,” Docomo says in the press release says.

Docomo and Omron already have built some connectivity in healthcare. Since 2009, NTT Docomo and handset manufacturer Fujitsu have offered a line of easy-to-use phones for seniors that synch with Omron medical devices.

NTT Docomo owns 66 percent of the Docomo Healthcare venture, while Omron holds 34 percent of shares. Docomo Healthcare is capitalized with 1.3 billion yen ($16.3 million) in cash reserves, according to the telecommunications company. The venture will be headed by Hajime Takebayashi, former CEO of Omron’s software division.

How Congress almost delayed the FDA’s mobile medical app guidance

By: Brian Dolan | Jul 5, 2012        

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Brian Dolan, Editor, MobiHealthNewsMuch has been written in the past few weeks about Congress’ efforts to put its mark on the FDA’s regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds of companies weighed in with their thoughts on the document, the industry widely expects a final guidance document any week now. Why did the Senate take an interest in medical app regulation this past spring? Who asked them to? And, what exactly did their conversation sound like?

The official beginnings of that conversation lasted about six minutes. It took place just before lunchtime in the Senate’s Hart building on April 25, 2012. The Senate’s HELP (Health, Education, Labor & Pensions) committee held a hearing on the Food and Drug Administration Safety and Innovation Act. Toward the end of the almost three hour hearing, Sen. Michael Bennet (D-Col.), the junior Senator from Colorado, submitted his second amendment to the FDA bill for consideration. Here’s how he framed it:

Sen. Michael Bennet (D-Col.): “Thank you, Mr. Chairman, and I appreciate your indulgence and the ranking members’ indulgence. I have two amendments that I want to talk about briefly then I’ll get out of everybody’s hair. The first one is Bennet Amendment Number Two, which I am offering with [Sen. Orrin Hatch (R-Utah)] and will withdraw. [It] concerns medical mobile applications, which are the apps that people use for their smartphones. They are growing extremely rapidly. Between 2010 and 2011 the number of medical apps available in the iTunes AppStore that could be subject to FDA evaluation under draft guidance increased by 250 percent. Estimates indicate that the number of smartphone users using medical apps will grow to 500 million by 2015.”

“There is huge potential in these devices, by the way. I have an app on this phone — thanks to a Colorado company — that can tell me as a parent where the closest places I can take my kid for a sore throat [are located], for example. This actually happened. My kids only get sick on Saturdays or Sundays, for some reason, and my wife said take her somewhere to see if she has strep. I was going to take her to the emergency room. This is why our medical costs are so high. And she said don’t go there, [because] there is an urgent care center just four blocks away. I didn’t know it was there. We were out of that place in 10 minutes. This device now can tell you where you can go to do that. Unfortunately, public clinics are not included because we have not made the information available, but the hundreds of millions of dollars you could save and the amount of time you could save just by [letting] people have access to information is going to make a huge difference.”

“This is a large and relatively new area that is potentially subject to new FDA regulations through a draft FDA guidance on medical mobile applications. I appreciate very much the work the FDA has done to receive stakeholder input, but this interaction between health information and medical devices must be handled delicately. Technology is evolving and being adopted rapidly. I think Congress must provide the proper due diligence on this issue for our constituents, including a number of startups, small businesses, and patients in my home state.”

“Rather than repeal this guidance, this amendment only puts a year-long moratorium on it so that HHS and an outside working group of various stakeholders can work together on a report to Congress to help us do the proper due diligence on this issue in this committee and in the full Senate on behalf of our constituents. Mr. Chairman, ranking member, I’d like to withdraw this bipartisan amendment and work with you on this issue moving forward before this bill goes to the floor.”

Sen. Barbara Mikulski: “Mr. Chairman, I would really like to salute the senator from Colorado along with his cosponsoring colleagues. I think the Internet offers a cornucopia of opportunity. These mobile devices that we call — in this case — the gentleman could take care of his wonderful daughter — who I happen to have had the pleasure of meeting a few weeks ago — and get her what she needed when she needed it without a ‘mega visit’ to the emergency room. I really hope that — I think that we could get this in a Manager’s [Amendment] or an acceptable version of this, because we need to get the administrative legs of government walk–running on this issue. The apps are going to explode. The apps are exploding. They provide specific information like that. Physicians are using their technology as the PDA. In a visit with my own doctor, he rapidly knew that something new we were considering would adversely interact with something I am currently taking. He didn’t have to go to a book. He didn’t have to call me three days later. Zip, zip. But also, as you know, there is great information out there from weight management to urgent care [but] there is also potential for ‘quackery’. You know, take an apricot juice and you will grow four feet, which I would have tried. I support what you are doing here, because the Internet is going to get ahead of the bureaucracy, and we want to make sure that everybody has every tool quickly at their fingertips and at the same time make sure that the guidance they give is excellent. So, I think you are really onto something here, and I am going to thank you for your forward thinking.”

Sen. Tom Harkin (D-Iowa): “I would agree with Senator Mikulski that you are on to something here. Obviously, you are. I think it needs some further looking at. It is one thing if you have an app that tells you where your local CVS is or your urgent care center is, and another [thing if it is an] app that plugs into some device that gives you your blood pressure, heart rate, and stuff like that. There is a little bit of difference there and somehow this needs to be worked on so that if it is a medical device it is a medical device and if it is an informational tool then that is something else.”

Sen. Bennet: “Well, I fully agree with that. Mr. Chairman, there is a very, very — we have no idea how big the gray area in between is going to be. That really is the purpose of the amendment, it’s just to slow things down a little bit so we can have a conversation about it and understand it better. As I said, I will withdraw it and look forward to working with you.”

Sen. Harkin: “I appreciate that and we will work with you on that. [Sen. Michael Enzi (R-Wyo.)] and our staff will work with you and see if we can come up with something that would reach an agreement here.”

That’s it. As far as I can tell the rest of the discussion, debate and negotiations that the Senate or the House of Representatives had about the FDA’s regulation of mobile medical apps took place behind closed doors.

It should be rather obvious which app Sen. Bennet referred to in his opening remarks. iTriage, formerly known as Healthagen before it was acquired by Aetna, is almost certainly the app the senator referenced. The startup was founded and based in Colorado, the senator’s home state. While Sen. Mikulski and Sen. Harkin point to a handful of other use cases, including drug interaction apps for doctors, weight management apps, and blood pressure apps, neither appear to reference a specific company’s offering. Keep reading>>

ACA presents golden opportunity for wireless, mobile health

By: Neil Versel | Jul 5, 2012        

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Neil_Versel_LargeThe Supreme Court’s decision to uphold most of the Patient Protection and Affordable Care Act certainly was stunning. Who really expected Chief Justice John Roberts to side with the liberal wing of the court? How many people thought that the reasoning would be that the individual mandate was a legal exercise of Congress’ power to levy taxes?

Similarly, the decision was polarizing. Plenty of President Obama’s supporters narrow-mindedly thought that the ruling assures that millions of currently uninsured Americans would now be guaranteed access to good healthcare. A lot of wacko detractors claimed that the Supreme Court killed freedom and set the United States upon a path to fulfill Comrade Obama’s supposed desire to turn this nation into the Soviet Union.

Neither, of course, is true. The best insurance coverage in the world doesn’t assure quality care, and the insurance expansion really is just throwing more money at a broken system. By the same token, the ACA leaves the long-established private insurance system in place for Americans of working age. This isn’t a government takeover, nor is it a silver bullet.

But it is a starting point for reform and a plea for disruptive innovation. You wouldn’t know that if you only paid attention to the national media, which have been fixated on insurance coverage, not care improvement and efficiency gains. But since you’re reading MobiHealthNews, you do know that healthcare is a lot more than just insurance. You know that the Affordable Care Act, certainly a flawed piece of legislation, contains real elements of care reform, not just insurance reform.

The ACA created the Center for Medicare and Medicaid Innovation within CMS and appropriated $10 billion to this innovation center. More importantly, this provision gives CMS the authority to ramp up pilot programs that prove successful at saving money or producing better patient outcomes. In the past, CMS would have to go back to Congress to expand successful “demonstrations,” a process that could take years. This should be great news for the many m-health innovators who have come up with low-cost, easy-to-implement ways to improve healthcare.

Likewise, mobile health will have an important role to play in Accountable Care Organizations, another key aspect of the ACA that is hard to explain to the masses in a catchy soundbite. The shift to bundled payments that ACOs herald, coupled with Medicare’s new policy of not reimbursing for certain preventable hospital readmissions within 30 days of discharge, puts the onus on providers to coordinate care and manage patients outside traditional settings.

That sounds like a golden opportunity for wireless monitoring and patient-provider communications. So get to work. Real health reform is just starting, and mobile technologies are well-positioned to shake the establishment that has stood in the way of improvements for far too long.

Verizon Wireless, Samsung tout mobile health apps, devices

By: Brian Dolan | Jul 3, 2012        

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Brian Dolan, Editor, MobiHealthNewsIn recent weeks three of the biggest technology companies have unveiled tablets to take on Apple’s iPad. Microsoft showed off Surface, which my colleague Neil Versel noted has some potential for healthcare. Google revealed the Nexus 7 at an event that included what might have been the first technology keynote to feature skydivers giving a live demo of a new device.

This week Samsung unveiled its Android-powered Galaxy S III and as part of the launch the South Korean company showed off an app it created, called S Health, that aggregates data from connected certain weight scales, blood pressure monitors and blood glucose meters. The Android app syncs with devices from Lifescan, Omron, and A&D.

The app is now available for Galaxy S III users in the UK. According to Engadget, the app will launch in the US soon along with a handful of other as yet unnamed European countries.

The S Health app will receive data from Lifescan’s OneTouch UltraMini/UltraEasy Blood Glucose Meter via a USB connection. It will also receive data from one of Omron’s blood pressure monitors and one of its body composition scales via Bluetooth. Similar devices from A&D: a Bluetooth-enabled blood pressure monitor and body composition scale from that company are also supported.

The app collects the health data and creates graphs and tables based on the results to “provide a full picture of health information in a digestible, easy-to-understand format,” according to the company. The app also enables users to manually enter data for diet, exercise, medication intake and other health-related information. S Health also makes it easy for users to share their health data with friends on Twitter.

As Glooko has learned, such an app can launch in the US as a Class 1 FDA registered devices under MDDS if it does not interpret the data that is streamed in from an FDA-regulated medical device. The charts and graphs that Samsung refers to in its press release may only refer to the app that will launch in Europe and other countries. For this reason Glooko’s newest app will have slightly more functionality in Europe than it will in US, as we reported last week, for the time being, anyway.

Currently, Apple iPhone and iPad users can connect Lifescan blood glucose meters to their phones via Glooko’s meter synch cable. A&D has an iOS app that can sync data from its blood pressure monitors via Bluetooth. The company also has an app powered by Wahoo Fitness that enables users to sync data from A&D activity monitors, weight scales, and BP monitors.

While Samsung’s S Health app doesn’t appear to be all that innovative, it is remarkable that the company decided to tout a health app as part of its new tablet’s launch announcement. Apple has done this at almost every one of its device launch events, but few other big hardware companies commit much marketing muscle to mobile health apps or peripherals.

In recent days, Verizon Wireless actually began airing a TV advertisement that shows off at least three key connected fitness apps and devices, including apps from DailyBurn, FitSync, and Withings’ WiFi weight scale.

The smartphone that the (somewhat) athletic father in the advertisement is using to show off his connected fitness regimen? A Samsung Galaxy S3. Watch the adspot here.