iHealth to launch Bluetooth wrist-worn blood pressure monitor next

By: Brian Dolan | Jul 9, 2012        

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iHealth Blood Pressure iPhone

iHealth's original Blood Pressure Cuff for iOS users

iHealth Lab, a subsidiary of China-based Andon Health, just received 510(k) clearance from the FDA for a wrist-worn, Bluetooth-enabled blood pressure monitor called the iHealth BP7 Wireless Blood Pressure Wrist Monitor that will connect with iPhones, iPads, and iPod touch devices.

The original iOS-enabled iHealth blood pressure cuff, which the company launched at the Consumer Electronics Show at the beginning of 2011, took its measurement by wrapping around the user’s upper arm like a traditional cuff. The original device also required the user to nest their iOS device in a dock that connected to the cuff via a cable. The new device adds Bluetooth connectivity. Like the original monitor the new one will also rely exclusively on the iOS device to display readings since it has no display screen of its own.

Andon explains in the FDA clearance document that the “Fully Automatic Wireless Blood Pressure Wrist Monitor is [intended] for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm.” Unlike the original device Andon released through its iHealth Lab brand last year, the new one will take its reading as the cuff inflates rather than while it deflates like the wired version did. Keep reading>>

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Vodafone taps Exco for mobile-enabled clinical trials

By: Brian Dolan | Jul 9, 2012        

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Exco InTouch PfizerAt the DIA Annual Meeting in Philadelphia last month, Vodafone and Exco InTouch announced a deal that sees Vodafone launching a new mobile-enabled clinical trial offering that leverages Exco’s patient reported outcomes software for mobile phones. Exco made headlines last year when it inked a deal with pharmaceutical company Pfizer to determine how effective mobile-enabled clinical trials could be at saving researchers time, lowering costs, yielding more accurate results, increasing patient compliance and engagement, lowering withdrawal rates, and enabling real-time data.

Last June Pfizer inked a deal with Exco InTouch to use its eDiary technology for its mobile-enabled Participatory Patient-Centered (PPC) clinical trial, which Pfizer called the first FDA-approved clinical drug trial involving all-electronic home-based reporting. Participants in the trial received medication via the mail and used the mobile application to participate in the study. The drug “tested”, Detrol, is intended for use by patients with overactive bladders and has already been FDA-cleared.

Vodafone plans to launch its version of the offering, called Vodafone Patient Reported Outcomes (Vodafone PRO) on a global scale. Vodafone is a global mobile operator with more than 400 million mobile subscribers in 30 different countries across five different continents. Vodafone points to statistics that claim some 85 percent of the world’s population now owns a mobile phone, which makes it an important and accessible technology that can be used in clinical trials.

“[The partnership] demonstrates the extent to which mobile phone technology is increasingly being recognised by large pharmaceutical companies as an effective tool for the collection of clinical trial data,” Tim Davis, CEO, Exco InTouch, said in a written statement. “As a result of the partnership, research sponsors will be able to monitor safety and manage compliance in real time. This will make clinical trials easier and safer for patients, while enabling researchers to collect and process data quickly, accurately and reliably.”

More in the press release below: Keep reading>>

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>>

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>>