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mobihealthnews | February 12, 2009

FDA may regulate iPhone Health Apps

One of the last and liveliest sessions at TEPR+ last week was a presentation and Q&A with Don Witters from the FDA Center for Devices and Radiological Health. Witters repeated multiple times that he attended the show in order to begin a dialog with the mHealth industry to establish clear pathways and regulations that ensure wireless quality of service, coexistence with other medical systems, data integrity, security and electromagnetic compatibility. Witters said his goal was safe, secure and reliable deployments of wireless technology in healthcare.

What is a medical device?

"So, what is a medical device?" Witters asked. "This is an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body-that could actually include some information technologies and performance technologies-but usually it's something that is performed on the patient, touches the patient or is performed between physician and patient."

iPhones with diagnostic apps are medical devices?

At times during the session, the tension in the room was palpable. Witters declared that the FDA has jurisdiction over any device that diagnoses, treats or prevents a disease. This led to one question from the audience: "So an MRI app for an iPhone is a wireless medical device? Or a patient reporting their blood glucose level by text messaging their physician who then adjusts their insulin dosage with a return SMS?" Witters initial response was "No, I think that's getting into information exchange-that's different." After the questioner thanked him and and said that people probably just breathed a sigh of relief, Witters doubled-back. "Well, I think the real answer is 'We don't know.' That's why I'm here today to begin this dialog and see where [the FDA] fits." So, the FDA could really be interested in inspecting iPhones for use as "wireless medical devices"? You bet. read more

Last thoughts on TEPR+ 2009

If the rumors are to be believed, the TEPR+ 2009 event last week in Palm Springs, CA could have been the final Toward an Electronic Patient Record event put on by the Medical Records Institute. While the for-profit MRI has already announced the formation of a non-profit mHealth Initiative (mHI) and an associated mHealth event this December in Boston, MA, the group has not formally announced the disintegration of the TEPR+ conference either.

Speculation abounds as to the fate of TEPR+, but some industry stalwarts were quick to point out that attendance was certainly far below shows past: "The organizers tell me that about 750 people have registered, down from 1,200 at last year's meeting in Fort Lauderdale, FL, and from a peak of just under 3,000 five years ago, Neil Versel wrote on his Healthcare IT Blog last week, "I can't say that I saw 750 people here, though. I would be surprised if there were more than a couple of hundred people present at the opening session this morning, and the exhibit hall contains just four rows of booths." For the record, the MRI's official press release following the event said "close to 800 people came together" during the five days the event was held.

All that aside, last week's event was surely a boon to the emerging mHealth sector and served as a key platform for industry players to share ideas, solutions and potential barriers to market when it comes to connecting patients to care through wireless technologies. I spoke with MRI Founder and CEO Peter Waegemann today about his key takeaways from the event relating to mHealth. Waegemann said the mHI's newest project, making Boston into the first mHealth city was one subject that needed repeating as was his prediction that the U.S. could spend billions on electronic medical records (EMRs) and see no real cost savings or spend a couple hundred million on mHealth chronic disease management systems and see potentially billions of dollars in savings.

Mobihealthnews was the only publication on-site covering the mHealth Revolution track in full, so be sure to visit our numerous articles on the event, including write-ups on Google Health, Microsoft HealthVault, Kaiser Permanente and many more.

Interview: An Army of (All)One (Mobile)

AllOne Mobile is perhaps the biggest partner Microsoft HealthVault has in mHealth. The Plymouth Meeting, PA-based company has close ties to security solutions provider Diversinet, in which it is a significant investor. AllOne Mobile's HealthVault plaform, steeped in security, has become an attractive mobile PHR solution for a number of Blue Crosses as well as the U.S. Army. mobihealthnews had a chance to catch-up with AllOne Mobile's Director of Sales and Business Development Frank Avignone to discuss the company's relationship to HealthVault, the reason for the growing interest in mHealth, barriers to market for mHealth services and why he thinks an all-in-one approach is better than attacking the verticals.

mobihealthnews: Please explain AllOne Mobile and its relationship to Microsoft HealthVault. Is your relationship with Microsoft HealthVault exclusive on the mobile side?

Avignone: No, we are not exclusive to HealthVault and HealthVault is not exclusive to us as a mobile platform, but, that said right now we are the only horizontal mobile platform for healthcare. You've got BeWell, Vocel and others that are very vertical with disease management or the PDR style solution but we are very horizontal. We are actually working with some of those companies I mentioned to pull their content into AllOne Mobile. So, instead of having to have an Internet-enabled phone, what you would do is have your phone with AllOne Mobile on it and you wanted to find a pill, whether it's one you were taking and wanted to do some research on or what, from your medication list just put in the basic information. We would then send that out with some of your context information, if necessary, like your age or your location, perhaps, and pull back contextual content. That way we don't have to ask questions like, "Is it a red pill?" or "Is it a blue pill?"

It's an IP solution, but you don't need to have a browser. You do need to have a data plan to use AllOne Mobile, but better than 80 percent of phones coming out of the stores have data plans. About 30 percent of the phones sold last December had QWERTY keyboards and of that group about 70 percent were enhanced phones like the iPhone. So we work on any mobile phone as long as you aren't carrying a battery in a bag for it. Screen size is important because otherwise you are scrolling like crazy. People are replacing their phones on average every 12 to 18 months because they are making them so that they fall apart. read more

Analyst: 10M use mobiles for health info

A report from Manhattan Research has found that 10 million adults in the U.S. have used their mobile phones to look up health information in the last year. The report, penned by Manhattan Research VP Meredith Abreu Ressi is called "The Future of Mobile Health: Mobile Adoption, mHealth and Mobile Marketing."

Ressi notes that The Food Network, WebMD, Johnson & Johnson, the National Health Service in the UK and many others have all launched mobile initiatives, while many large wireless carriers and some device manufacturers are devising mHealth strategies. Ressi also points out that biopharma companies are beginning to take a hard look at how to leverage mobile phones as their next marketing channel, too.

The rise of mHealth is attributable to advancements in device memory, connection speeds, and user-interface design as well as the prospect that mobile devices will be the primary Internet access point for most consumers in the next three to five years. read more

Text message reminders sans SMS, wireless

A recent reader comment about SMS security and reliability issues, dovetails nicely with the presentation that Barbara Rapchak, CEO of Leap of Faith Technologies gave last week at the TEPR conference in Palm Springs. Her company conducted a medicine compliance pilot study that sent text messages reminding users to take their medication on-time-but the texts were not sent over a wireless carrier's network. They weren't sent at all.

The general consensus is that patients follow directions and take their medications as instructed about 50 percent of the time. To drive the point home, Rapchak reminded us of former Surgeon General Dr. Everett Koop's famous line: "Drugs don't work in people who don't take them." Even cancer patients aren't completely adherent: Compliance in cancer patients is estimated to be about 80 percent, Rapchak said. Leap of Faith Technologies found a way to increase adherence from an average of 50 percent to 96 percent. read more

First thing's first: Do you have reception?

Cellular Specialties, Inc.'s (CSI) President of Custom Solutions Kelley Carr found the mHealth Revolution program at TEPR "fascinating", especially since it means hospitals will need companies like CSI all the more.

Distributed antenna systems like the one CSI integrates into hospitals will make it possible for hospitals to offer cell phone applications to their doctors by guaranteeing those doctors and wirelessly connected patients will be able to get a signal inside the facility. Carr said a recent survey showed 87 percent of enterprise workers admitted to probems with phone coverage in their buildings.

Carr also pointed to regulatory policies that he believes are in the pipeline for the next couple years that are going to mandate that first responders (firefighters, police officers, etc.) can receive coverage inside of commercial buildings. Carr also noted that a poor wireless signal inside a hospital could become a public relations nightmare: "The last thing you want to see in a newspaper is that someone went to make a 911 call inside your hospital and they couldn't."

IBM, Continua connect Google Health to devices

As of Tuesday Google Health was finally viewable from the mobile phone-now the company is really getting its mobile act together: The Continua Health Alliance, an industry group promoting compatibility between medical devices and online health systems, has teamed up with IBM to develop a set of interface tools for Google Health that will allow wirelessly-enabled medical devices like glucose meters, blood pressure monitors and more to stream live data directly into the Web company's personal health record (PHR). Google Health enables physicians, family members or other caregivers to access the patient's health information online as the information is updated in real-time by the connected devices. IBM and Continue have, in effect, connected Google Health to the mHealth revolution... finally. Continua's two standards for connecting medical devices are Bluetooth for wireless connections and USB for old-fashioned, wired ones.

The news comes just one day after Google Health announced that its partner Anvita had created a Mobile Viewer of the PHR for Android phones like T-Mobile USA's GI handset.

IBM integrated its Information Management, Business Intelligence and WebSphere Premises Server sensor event platform into Google Health to leverage the platform to better manage chronic disease, health and wellness as well as elderly care, according to the press release. IBM aimed to leverage the power of Services-Oriented Architectures so that partners could quickly scale their solutions for healthcare consumers with modular components.

read the companies' press release here for more information

MRI: We will make Boston the first mHealth city

The founder of TEPR and CEO of the Medical Records Institute, Peter Waegemann, announced that one of the first pilot projects of his newly formed mHealth Initiative (mHI) is to create an "mHealth City" out of Boston, MA. (This is exciting news for mobihealthnews since we, too, are in Boston.)

"We want to get to a point where everyone in greater Boston has the capability to put personal health information on the mobile phone and use disease management applications-like those being discussed here for diabetes, asthma and hypertension," Waegemann announced at TEPR last week. "And do it in a way that shows the home for health data should be at the hospitals and doctors' practices. There are many students in Boston who may not have a provider, so they can go to Google Health or Microsoft HealthVault and sign up." Waegemann said one of the key goals of the project is to create a population-wide health records locator system so that emergency workers can locate the record when necessary no matter where the most up-to-date record is stored-even if it's on the patient's mobile device.

"We hope to accomplish this by next year," Waegemann said. "The basics will be in place by this summer and the end of 2009." read more

More on Mobihealthnews.com...

Jitterbug: Mobile Entertainment tech for mHealth
Calculating ROI on text message reminders
Round-up: Stimulus, Glenn Close, Stutters
Senate stimulus bill passes: $20B+ for HIT

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mobihealthnews | February 12, 2009

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