Over a year ago, we reported on a suite of cloud based mobile and desktop software by Envisionier that was bringing endoscopy video capture into the modern era.

In that article, we showed how the eGoWorks desktop app allows physicians to edit captured video, add text to make a report, and share the study securely with colleagues and patients, all from a browser based app.

A companion iPhone app allowed review of the video and stills from anywhere, pulling data from the eGoWorks server.

This was a major advance from the current state where endoscopy (including arthroscopy & laparascopy) is viewed live on video monitors but the data is lost as soon as the equipment is unplugged from the wall. By moving the video data to the cloud, Envisionier opened up new avenues for storage, collaboration and analysis of digital patient data.

Now, Envisionier is taking another leap with the introduction of its Endoscync wireless video transmitter and companion iPad app. Together, these allow any endoscope to send its video data wirelessly to a nearby iPad, which thus replaces the traditional video monitor as well as functioning as a simple report generator.

Along with their handheld EndoGo HD camera, this means that an endoscopy suite can now reside in a small briefcase instead of occupying a corner of a room.

The Endosync module is currently in beta form. iMedicalApps had exclusive access to a test version as well as the accompanying eGoPad iPad app. The Endosync module accepts “component” video input from any source and is not exclusive to the EndoGO camera. With a simple adapter, it can be plugged into any commercial video tower, such as those made by Olympus or Storz. Aside from plugging in a power source (or battery pack), that is the only set up required for the Endosync module.

The capture resolution is either standard DV (320×240) or HD (720×480), which the release model will select automatically. The EndoGo HD camera is also capable of DVI (digital video) output, however the EndoSync currently only accepts analog component video input.

Once turned on, the Endosync creates an encrypted (WPA) WiFi network, which the user joins from the iPad. Just launch the eGoPad app and start capturing video and stills. David Guy, CEO of Envisionier, explained that by having the EndoSync create its own WiFi network, it avoids having to rely on a hospital or clinic wireless network. The Endosync is able to multicast the video output, so the images can be viewed simultaneously on more than one iPhone or iPad, opening up new possibilities for teaching or collaboration.

We found that there was no lag or choppiness in the video display on the iPad. Once viewing the video stream, a simple press of a button starts the capture. Another button allows a still image to be stored.

Envisionier also provides a flexible iPad holder that can be clamped to a table top, exam chair or operating room mount, allowing for single hand use of the iPad. In typical use, the endoscope itself is the only component that is sterilized since it is the only part in contact with the patient.

In addition to capturing video, the eGoPad app also allows for dictation directly into the iPad. This can even be activated by voice by saying “start recording” to the iPad, allowing the operator’s hands to remain on the endoscope. In our trial, this did not seem to initiate reliably, although it would be a genuinely useful feature and hopefully will be improved. Envsionier is also working on direct transmission of the voice recording to on-line transcription companies so that text transcripts are automatically generated. For now, only the audio is stored.

Reports can be generated directly on the iPad from any captured stills. A separate screen allows composition of up to four stills per page and the ability to type directly below each image. Your letterhead and standard header can be included and a report to the referring physician can be totally completed directly on the iPad, another time saver.

Once the acquisition is complete, the eGoPad app can be switched to online mode (via 3G or local WiFi) to connect to the eGoWorks server. By pressing “sync”, the video and other data from this session is pushed up to the cloud and all previous stored endoscopy data becomes also becomes available on the iPad. This opens up the prospect of even more interesting functionality.

One that is immediately available is a “compare” feature. Up to four recent or old stills can be selected and displayed simultaneously for the user to see. In patients who have undergone serial endoscopy, such as following up colonic polyps or esophageal erosions, this alone is a huge advance. This type of longitudinal comparison is simply not possible with conventional video endoscopy.

The potential here for future innovations is even greater. Image analysis software is already standard in breast mammography. Here is a perfect opportunity to include tools on the iPad to compare size, shape and color of imaging findings and supplement the  physician’s diagnostic impression. According to David Guy, these are some of the same ideas they have considered. However, introducing these decision support tools would likely change the classification of the software vis the FDA, complicating its clearance, and will likely be deferred to future versions.

Once the iPad is synced, then the video and reports are also available using the eGoWorks application which works in any desktop browser. Since it currently uses the Microsoft Silverlight plugin, it cannot be accessed on a mobile device, although the plugin is available for Windows and Mac. 

Our previous review already covered many of the important features of the web application. These include the ability to add demographic characteristics to studies and to generate reports. There is a HIPAA-compliant method for sharing of endoscopic video and images with colleagues or even patients. The “compare” feature is also available online but here also allows video to be compared. Images and videos can be flagged as favorites, in order to collect examples for teaching. Images can be adjusted for sharpness, hue, saturation, brightness, and color offset. Video editing capabilities include trimming, extracting still images from video.

Conclusion

To summarize, Envisionier has built a near complete endoscopy ecosystem, including a hand held HD camera, a desktop browser based app with server back-end and, now, the Endosync – a Wi-Fi hub that accepts video input and transmits it wirelessly to any nearby iPads or iPhones. By storing the endoscopy video and image data in the cloud, Envisionier has made patients’ data mobile and unshackled it from the endoscopy suite. This means that no matter where the physician is –  office, clinic or home –  she has access to her endoscopy data.

In addition, the system is  ready to integrate easily into any electronic health record (EHR). Since the video is left on the eGoWorks server, only a link needs to be stored in the patient’s record. Video storage capability does not have to be built onto an existing EHR. In fact, Envisionier eGoWorks is already an approved vendor for the Veterans Administration (VA) and Vista Imaging systems, one of the world’s largest EHR installations.

Furthermore, this technique of storing the endoscopy data in the cloud and exporting only the reference would also work for integration with personal health records (PHRs). As more EHRs implement interfaces to PHRs, this opens up more avenues for machine to machine communication. Envisionier is hoping to take advantage of this and is planning an announcement soon regarding integration with a major PHR vendor. According to David Guy,

“One of the pain points with EHRs is moving data that is unassociated into the patient record. We think there is growth area in making something agnostic that allows any video tower system to become an integrated system.”

The iPad app, as befits a pre-release version, has several rough edges. Some of the buttons were awkwardly placed. Indicators marking the progress of syncing were not always displayed. Some typical iOS conventions regarding video and image manipulation were not yet implemented. Yet, even needing this extra polish, the promise of the platform is clearly evident.

In terms of a business model, the plan is to provide this as a software as a service (SAAS) model. The backend eGoWorks software will be available for free up to a certain amount of storage after which there will be a charge. Pricing of the iPad app is not yet determined.

Envisionier is starting to deliver on the promise of tele-endoscopy – where image capture and analysis are separated. Mid-level providers can perform endoscopy procedures, even in remote areas, and experts can review and analyze the video and images in another location. As David Guy said:

Our mantra is move data rather than patients.”

This is one of the promises of mobile medical technology – that cost and complexity go down while access to health care improves. We will be looking forward to seeing EndoSync on the market and hearing about how practitioners are actually using it to help patients.

[If you have developed a wireless health device and want our readers to know about it, drop us a line.]

iMedicalApps has launched mHealth (iMedicalApps.com/mhealth), a page dedicated to the use of mobile technologies for direct patient care. This is where you can read about great research being done on the use of mobile technologies for health & wellness, the latest in wireless health devices and about innovative digital health startups.

We will continue to write about mHealth practice and regulatory issues and cover important mHealth conferences, like our comprehensive coverage of the recent mHealth Summit in Washington DC. All  articles are written or edited by physicians.

We have some exciting features coming up, such as:

• an exclusive iMedicalApps sneak peak next week at a new wireless device that will change the way endoscopy is done
• fascinating first hand reports by investigators describing their mHealth research
• reports by physicians using remote and telehealth successfully in the care of their patients
• articles on the rapidly evolving legal issues around mobile health and social media

Drop us a line if you have developed a wireless health device and you want our readers to know about it or are starting a digital health company. We want to hear about it. We also love to hear from physicians using mobile and telehealth in caring for their patients and from researchers investigating mHealth technologies. This is a great place to share your stories.

After you’ve read the articles, Keep the conversation going on the iMedicalApps mHealth Forum. Tell us what you want to see covered or what to change. We welcome all voices – patients, physicians, investors and entrepreneurs.

Finally, we are looking for more great mHealth writers ! If you have a passion for mobile health and want to write for iMedicalApps, please contact us.

Thank you and enjoy.

Felasfa Wodajo, MD

mHealth Editor

mHealth Research Daily with Tim Bredrup

CodeHeart, a mobile application developed in conjunction with AT&T Business Solutions used to speed up the diagnosis of heart attacks, has been under development for two years but is still struggling to enlist emergency medical crews’ participation for a pilot project.

This likely reflects the complicated nature of mobile solutions for the health-care-provider market, which has generally taken a cautious approach to new technology for storing and sharing patient information.

Meanwhile, consumers are increasingly using their phones to track, manage and improve health. According to Pew Internet and American Life Project, 17 percent of cellphone owners have used their cellphones to look up health or medical information.

Washington Post | press release |   Pew Internet and American Life Project

As was covered recently, Qualcomm’s 2net Platform looks poised to make a major impact on medical device connectivity and allow for the creation for new kinds of health applications and businesses. One great example which shows the power of allowing application developers to “outsource” end-to-end connectivity is the Macaw app. It aggregates data from multiple types of devices and sensors to build an individualized “prevention” score based on accepted clinical evidence for the user.

At last week’s mHealth Summit, we had the opportunity to sit down with the Qualcomm Life leadership team, including Rick Valencia, VP & General Manager, Don Jones, VP Global Strategy & Market Development and Anthony Shimkin, Senior Director Marketing, to learn more about the evolution of their new health subsidiary, the goals for the 2net Platform and their plans for the future.

What led you to launch a new subsidiary, Qualcomm Life?

Qualcomm has been promoting the concept of bringing wireless into the medical device arena for a long time. The original efforts go back close to a decade. We think we can really make a difference and we think wireless technology can certainly make a difference in providing greater access as well as lowering the cost to healthcare.

We actually were originally part of what you could call an incubator within Qualcomm and at a certain point it didn’t fit any longer. The health division was under a separate group at Qualcomm Labs, another sub-division, and most new businesses are brought up under it. So we were brought together under this Qualcomm Labs organization and when we reached critical mass in terms of internal funding and progress towards our launch, we were graduated out, if you will, about a month ago into a separate subsidiary.

The word incubator means different things to different people. For the companies under your umbrella, are you investing in them, are you providing them with technical resources, providing space ?

Yes, to all the above, in different forms for different companies. So a number of the companies in our pavilion at the mHealth Summit are companies that we’ve made investments in. We’ve announced the Qualcomm Life Fund, which has already made five investments in later stage companies and we will continue to make more investments with a $100 million fund.

We provide a lot of technical guidance; we provide a lot of business guidance. Don [Jones] meets with one start up a day on average and advises them on different business models that we see around the world, because that’s not easy. That’s the hard part. There are a lot of great ideas, no lack for technology. It’s the business model that supports the business in this healthcare environment.

It’s been a danger for a while that there is a lot of technology looking for a problem.

Exactly.

Don Jones: Actually, we have been involved over a long period of time in getting research institutions going, in getting standards bodies going, whether it is policy, investment, education, we even have a master’s program for physicians in wireless health at the Scripps Institution. These are all components of a larger ecosystem so that when the many companies show up, and increasingly large Fortune 500 companies are showing up, we want to make sure the assets are there in the marketplace to turn to.

That makes a lot of sense. I see that you have partnered with Rock Health, what is your relationship ?

Rick Valencia: They throw great parties (laughter). We are one of the sponsors of Rock Health. We were among the first round of sponsors and we will continue sponsoring them. They focus primarily on health apps, and in our ecosystem we expect to be bringing in a number of service provider’s application developers. We hope that the developers will see the value of an open platform with all the access to these streams of environmental data and they will start writing interesting applications.

You made that job easier. Is there a particular size or type of company you are looking for to partner on 2net ?

Come one, come all. I mean, we are really looking for any size, it’s really about the need and we think we can fulfill a need that small and large companies have. Small companies don’t have the capital to do what we’ve done, to accomplish what we’ve accomplished with the 2net Platform.

Big companies in some cases already have deployed something but the operational support costs and that whole new line of business that they’ve never understood, moving from healthcare – the medical device arena – into the telecom arena, it’s not easy. So we’ve met with some of the biggest companies in the world, and they’ve told us point blank, “we are drowning in the operational support costs of managing [telecommunication], that’s because we didn’t really quite realize what we were getting ourselves into when we started.”

So, having built the 2net Hub as an FDA Class 1 MDDS Device, it makes it lot easier for these big medical device companies to simply pair their medical device [with the 2net Hub] to enable connectivity, an otherwise expensive proposition that’s not easy for anyone to do. And so we think that anyone that has that opportunity to develop the right model, to deploy a wirelessly enabled medical device, we think we can support them big or small.

Do you think this threatens any existing business models?

I don’t particularly think so, I mean, certainly there will be companies that perceive this to be competitive or that have their own ideas around some sort of similar concept and view it as competitive.

Don Jones:  I’ll tell you what it threatens. I think it threatens non-connected medical devices. Going down the road five years from now, it won’t make sense as a manufacturer of a FDA or CE class device to have to deal with the complexity of establishing a connection with an end user. There are going to be too many reasons why you want connected devices. We are at very beginning of this evolution.

Rick Valencia:  Absolutely. New business opportunities, new business models – providing this platform with these streams of biometric data will allow for business models that we can’t even dream about yet.

What types of information will be stored on the 2net Cloud ?

Well, the simple answer initially is that our customers are the device manufactures. Each one of them has their own business model, their own desire for the data and the presentation of the data, and they’re going to dictate to us where they want that data to go. And so, we can offer the data up any which way they want to and in any form they want and to any place they want it to go. It really just depends on our customers’ need.

The platform also stores data, not just passes it through. What happens if one of your partners goes belly up ?

We are passing through the patient identifiable data; we’re storing, aggregated and anonymizing data on the platform. So, the data is the patients’ data – they decide who gets to see it and for what duration of time and how it’s used. We have data rights, assuming that the patient has opted into whatever solution our customers have developed and have passed on to us. So, we’re only storing anonymized data.

Don Jones: If you jumped ahead, it is quite possible that there will be applications that will be developed that will give permanency to that consumer. That consumer will have another option for storing their data. Another way of answering the question is that we are disaggregating the data from the devices. The software industry can come in and write cool applications based on that data.

Tell me about the 2net hub. It is a cool device but it is obviously a fixed-point device. Is there still a large home-based market ?

Rick Valencia:  Yeah, we think so. And we think that also, unless there is requirement for 7/24 mobility especially for existing devices on the market, it probably makes better sense to pair [medical devices] with some sort of gateway device as opposed to embedding [cellular] technology. Embedding technology means a new development process.

Some of these devices were designed to be in the home for five, ten years. And so taking it back through a new development cycle is very expensive and time consuming. It means another FDA approval process and that’s just very expensive. This is a really quick-to-market solution for medical devices that exist today; if [devices] don’t require that 7/24 mobility, if they have store-forward capability, [users] can be up and about and [when they get home] it will upload whatever data is collected.

[The 2net Hub] is one of four gateways. The other three include embedded technologies, so we have a team that does nothing but provide engineering services to our partners to help them figure out how they get that technology in their devices, and we are also building two virtual hubs: one that would reside on the phone and pass data to our back-end platform from the phone, and another that would connect with someone else’s back end. So it’s a system to system connection. But we get all this data in one place.

What are the other goals of Qualcomm life ?

So, we are announcing launch of the 2net Platform in the U.S. at [the mHealth Summit] and the $100 million Qualcomm Life Fund. What’s coming next is that this is built to be a global platform and Qualcomm has relationships around the world with virtually every [wireless] operator. What we want to do is make this a one stop proposition for a customer, so they didn’t have to go country-by-country, carrier-by-carrier and work out their deals. So, we plan to launch in Europe in early 2012 and then basically continue to progress around the world based on our customer’s needs.

So, one device can work in New York and Shanghai, manufacturers don’t have to internationalize their devices?

Exactly. They don’t have to do anything. Let us do that.

How does Qualcomm Life make money from the 2net platform?

Don Jones:  The initial model is a relationship between 2net and the individual device manufacturer. We have a model that is basically per device. That handles the enterprise data management, the device management, data storage and the connectivity costs. In the long run, we think the value will shift to the informatics. It is not an area we have spent a lot of time on yet nor yet have a lot of expertise in. But for right now, and for a number of years to come, this is about getting devices on the net followed by new health software as connected to that medical device data.

So kind of breaking apart the traditional mode – where this software goes with this device- because this device is a data source that can supply multiple kinds of software. That will be the next stage, the evolution beyond that will be heavy duty informatics across devices, across data bases.

Has Qualcomm been in this kind of service business before ?

Rick Valencia:  Our very first business, OmniTRACS, was a truck tracking business that monitored fleets of trucks. We’re leveraging that same platform that was built 25 years ago and this is now processing 12 million transactions a day for healthcare.

Don Jones:  Another way of thinking about it is that we have been doing physiological monitoring – truck, trailers, buses and other kinds of hardware and machinery – around the world for 20 years. So now we are working with [health data]. We are building on that experience and leveraging the infrastructure that is built around the world.

We have to adapt it to a healthcare environment, which has several requirements – FDA requirements, some device requirements etc. but there is an awful lot of experience. Arguably, we are the largest enterprise service provider for end-to-end connectivity in the world. We don’t make a big deal out of it, but it turns out that’s what we are.

The web in the healthcare space is still pretty PC-centric, in terms of access. You see a lot of devices that have to plug into the USB connector in your PC or something in order to get web connectivity. That all has to be freed up.

Orca Health has had quite a year. Launching their first app in in 2010, they now have a suite of ten apps with–we are promised–even more on the way. By combining stellar art work, three-dimensional interactive graphics and high-end native programming for the iPad, they have created and may well be en route to cornering the market for perioperative patient education apps.

Recent milestones for the company include winning the startup competition at Health 2.0 Europe, having two apps, EyeDecide & FootDecide, included in the iTunes App Store’s Apps for Healthcare Professionals. Until recently, Orca Health’s EyeDecide was ranked as the #1 downloaded free medical app on the App Store, and three other other apps (FaceDecide, BreastDecide & ENTDecide) are in the Top 25. To top it off, the iTunes App Store just included EyeDecide among the best the iPad / iPhone apps in its App Store Rewind 2011. It is interesting to think about the different places, and there are many, they could go from here.

Orca Health was among those selected for the StartUp Mobile Health Pavilion at the recent mHealth Summit (check out our fullcoverage), along with about two dozen other great mobile healthcare companies. There, I got to meet CEO & founder Matt Berry and publicist whiz Jake Lybbert (follow on Twitter). I talked with Matt about the (short) history and future of Orca Health, and his thoughts on the potential for tablets to improve the patient experience.

First, I have to ask – why the name Orca ?

Yeah, the name. Well, I’m from Seattle and I was looking for something very unique and known and kind of respected globally and I just came up with Orca. I’ve always been fascinated with the ocean and the killer whale and what it represents across the globe. I thought from a marketing and branding standpoint, it could be pervasive and ubiquitous, and that people would really remember it because of the immediate visual the get upon mention.

How did the company start ?

So Orca was actually kind of an accident. My father is a spine surgeon and we were discussing some of the macro issues both US based and globally within healthcare, from information asymmetry to lack of patient education to lack of patient surgical retention and I kind of interrupted him and said “You know Dad, I really think smart phones and tablets are going to be a big deal within healthcare. Why don’t we create for you this app and we’ll put some really cool 3D anatomy that the patient can be entertained with and then we’ll break down ten to fourteen different conditions with some great visuals, great content … and we’ll see what happens.” So I just basically built it for his practice.

So we built it and we called it Spine Decide and it was a much poorer version of what’s in there right now. He started giving it to his patients while they were waiting and he started seeing that the patients were much more satisfied and entertained with the information the app was giving them. We then put it in the App Store and it went number one on the medical App Store for like 9 straight weeks.

We started getting emails from physicians in South Africa, Japan, Illinois saying, “Hey this is really great, really helpful.” “Can you do a shoulder?” “Can you do a knee ?” So we just started replicating these apps across the spectrum, and that was it really.

In that story, where did it go from a cool idea to a company ?

I was in the process of moving back from Palo Alto. I did a start up out there, got it to TechCrunch50. It was doing well but I love skiing and wanted to come back to Utah. The way that it became a company was really within that story, when we started getting these emails and seeing the actual benefit it was bringing to physicians’ lives, to professionals’ lives, to medical students’ lives and ultimately to consumers, to the patients’ lives.

And that’s when I was like “Why don’t we build upon this ? This is obviously a need, why don’t we make a company?” So we approached some other doctors, and basically built a company off of it. And there were about eight founding physicians that are part of it, and so each app has a physician that attends to it and is responsible for the content–basically responsible for best practice and scientific content in the app. So that’s really how it started.

What is your process for building these apps ?

We actually have ten apps and going on twelve by Christmas. These last two will be dental which we can talk about later. Basically, we’re a design oriented company. We want to re-design healthcare. We start with the design and get one-on-one with the physician, talk about the content and the anatomy. We redo everything, everything is original content. We don’t copy and paste or purchase anything. I want it to be all original content.

What’s fascinating about that is the doctor will be like, “Yes, you know, it kind of looks like this in Netter’s book but it’s actually really like this.” And that’s just a fascinating process to go through. So we start with the design and then we turn it over to the 3D riggers and they build that process and then it’s adding content from there, with illustrations in between.
Right now we are in the process of redoing all the applications in a much more robust, light weight way. Most of it will be server based. Everything, even the conditions, will be 3D, where you’ll be able to explore inside the condition, move it around, rather than have it just be a static image. So that’s kind of the process, and we have a pretty good expertise right now.

With the right resources, we can knock them out pretty quickly. And they’re not light apps, they’re not a little simple game app. We’re big on execution and that’s how I drive my team, everyday it’s execution, execution. It’s the velocity of what we can do at a high rate.

I’m just impressed that how you can do the quality of the content but at this rate

Yeah I mean basically within fourteen months, we’ve done twelve pretty heavy apps and I think you’ll love what our dental apps will do. It’s all about execution. The bigger companies that have ten times the resources we do but are like big aircraft carriers, they can’t really turn. We pride ourselves on being light and doing a lot of work. We’re able to do it very, very quickly and we have the process down pat now.

How much of the secret sauce is 3D ?

Pretty much everything. What we’re really waiting for is the hardware to catch up, to do what we really want with the processor. We have a heart and a brain app that we’re trying to parallel with the launch of the iPad 3. It’s going to have totally different specs and it’ll really push the limits and really wow people.
I think our apps are great right now. I think they’re OK. I think they’re some of the better stuff that’s out there. I don’t think they’re phenomenal yet. I think we’re getting to some phenomenal stuff, with some gamification, some utility and some augmented reality. That’s really going to kind of set a new bar. But we’re really kind of waiting for hardware to catch up, which is happening at a pretty amazing rate.

You’re not trying to wedge a website into a tablet. You’re actually developing something that’s entirely native.

That’s right. Although we do have a web strategy, my philosophy from day one is that we start mobile and work backwards into the web. Everybody knows that the world’s going mobile and our computing devices will be strictly mobile, whether that’s a smart phone or a tablet. That’s where we’re going. So about a year ago I told everyone on my team, we’re going to start mobile, everything starts native and then we work back in to web apps, we work back in to dot-coms and that type of thing. I feel like you start mobile and work backwards and you’ve got a pretty good recipe for success.

I think that’s a good business strategy because your native apps are a big barrier to entry.

That’s right. It’s not an easy thing. 

Who funded you at the beginning ?

We raised from those original participating physicians, eight of them. So they’re content contributors and they’re all investors, capital contributors as well as sweat equity contributors.

How are you marketing this ? The average doctor is not paying attention to Health 2.0

Yeah, that’s exactly right. You know, we haven’t done any marketing to date. We have a presence on Twitter. That’s really about it. This is kind of the first wave of what we’re doing. I want to tell people what we’re about. I wanted to get products out there and then get reception. We’re really starting the phase of doing some traditional marketing as well a social stuff, but we really haven’t done much to promote them yet. We’re going to go pretty heavy on the conferences next year and really get in front of the people. 

It’s hard to sell to doctors, how do you tackle that ?

The adaption of the iPad and iPhone within healthcare has been absolutely stunning. But you’re right, most of them are early doctors, younger guys who are just coming out of medical school and residency, and that’s fine. We’re happy that the physicians are using them but we really want to create a platform that’s kind of a next wave of patient education. Kind of a 21st century place that you go to interact with your health, and so it’s more patient based than it is physician.
 

Yes, I noticed you’re marketed as a professional app but in reality it’s consumer content.

The websites that are out there are kind of the old model. It’s content that was written by an attorney and you go there and you read this encyclopedic version while three Viagra ads are blaring in your face. It’s absurd and it needs to stop. It was cool in 1996, now it’s not. The next phase is really interacting with your condition whatever that may be and visualizing it and be entertained by it.

There are two learning curves that are going on while we’re building. Number one is smart phone adoption. My grandmother downloads apps and tells me about this Flipboard app that she uses all the time. It’s amazing. The second learning curve is healthcare apps. We’re under the assumption, and it’s obviously proven, that a doctor will prescribe you an app just like he does drugs or a medical device or something else or exercises or whatever. He will say download X app to get this information or to monitor your heart, etc.

So there’s two learning curves there, so I wasn’t over anxious to shift everybody’s paradigm but now we’re coming out of those two curves and the adaption of smart phones has been stunning and the success of everybody’s work within iTunes App Store that’s medically directed has been pretty cool.

So where do you want to go next ?

You’ve seen some of the augmented reality in the vision test that you can do with an Eye Decide. Seeing what actual macular degeneration looks like through your camera lens, ditto with floaters. It’s pretty cool stuff and possibly could be saving a trip to the optometrist or ophthalmologist and saving yourself a lot of money in the process.

The next phase that we’ll be doing is some utility based stuff that will communicate with various devices. The third one that I’m really, really excited about is our aging heart app. That will use some games where you can put various inputs into your heart. Let’s say that you smoke three packs a day or are 40 pounds overweight. Let’s see what that does to your heart over the next 20 years. Now let’s do the reverse.

Let’s say that you lose 40 pounds and you stop smoking and you go vegan, now let’s see what happens. Let’s see how that’s going to save your knees. That’s really kind of the next phase of where we’re going as far as implementing games and various inputs to hopefully influence behavior and get people healthier. If they can see what it’s going to do instead of having someone tell them, that could have a very profound impact on people

One of the major announcements at last week’s mHealth Summit was made by Qualcomm who introduced a new platform for wirelessly connecting medical devices. The 2net platform abstracts away the details of connecting a sensor to a cloud-based server.

Right now, if a company develops a great  lightweight sensor to measure, say, walking speed, it will also have to engineer a way for that information to be transferred wirelessly, sometimes across a couple of stops, to its eventual destination somewhere on a server. Although these same challenges repeat for every device, each company has to “reinvent the wheel”.

Additionally, once it arrives at the company’s servers that rich collection of data would still be isolated – in a “data silo”. If another company comes along with a terrific heart rate sensor and suggests, “why don’t we combine the two data streams and make a useful new app”, not only would they have to recreate the entire chain of communication for themselves, the two companies would have to agree to methods for their two servers to talk and share information.

2Net makes almost all of the above problems go away. It opens up a world of seamlessly connected wireless devices that allows application developers and sensor designers to concentrate on their work and “outsource” all the communication and data storage needs. Already within the Qualcomm pavilion on the exhibit floor, there were already several companies taking advantage of the new “2net” platform.

This is a big deal.

Actually, Qualcomm made three concurrent announcements. First, they are spinning off their Qualcomm Wireless Health division formally into a wholly owned subsidiary, Qualcomm Life. Also announced was the creation of a $100M venture fund for connected wireless companies called the Qualcomm Life Fund. The fund will invest in the following areas:

• Body worn or implantable biosensors or devices for vertically focused applications like chronic disease care, medication compliance and fitness or wellness
• Integrated system providers that do remote diagnosis, monitoring, or specialize in independent living
• Mobile software health IT applications
• Health Informatics/Analytics

The fund has already announced five investments; AliveCor, Air Strip Technologies, Cambridge Temperature Concepts, Telcare and WorkSmart Labs, four of which were present at the Summit.

The exciting announcement, however, is the 2net platform. The goal of the platform is to make it simple for medical devices of all kinds, whether they measure oxygen saturation, weight, blood pressure, etc., to get their data to where it belongs. We had the opportunity to learn about 2net with Chris Talbot, Senior Director, Business Development for Qualcomm Life. We will soon publish our interview with Rick Valencia, VP and General Manager and Qualcomm Life about its history, business goals and possible partners.

There are four ways that data can be transmitted using the 2net system.

1. The 2net Hub – a standalone gateway hub for the home
2. Medical devices with an embedded cellular component
3. Medical data sent from mobile phones
4. Via the internet from other servers using application programming interfaces (APIs)

The 2net hub

The 2net hub is a device which has prongs for a wall outlet, two LED lights … and that’s it. Built into it are four radios, 2g/3g cellular, WiFi, Bluetooth and Ant+ (a low power radio protocol used mostly for exercise equipment). It can communicate with any 2net aware device in the house, using any of the above radios, and transmit the data via cellular communication to the 2net platform.

Although many people do not realize this, Qualcomm is one of the largest MVNOs in the world (mobile virtual network operator). This means that it buys cellular bandwidth from the likes of AT&T and Verizon and resells or uses it on behalf of its customers, which is how the 2net hub communicates to the 2net servers. The result is that the maker of, for example, a home sphygmanometer can build into the device any kind of radio – bluetooth, WiFi, etc. and it  has to do is make it able to communicate with the 2net hub.

After that, Qualcomm Life will make sure it arrives at their server. The consumer does not have to worry about setting up a WiFi network, pairing Bluetooth, etc. It is plug-and-forget. This also accelerates advances in the device marketplace because consumers will find it easier to swap one device for another.

The 2net hub, by design, is a fixed point device. For mobile devices, there are two other methods to connect to the 2net platform. One is via a cell phone acting as a gateway. In this case, Qualcomm Life provides a set of code to be added to a health or medical app that directs sensor data to the 2net servers using the cellular network. Another method is embedded cellular chips inside devices which themselves connect to the cellular network. This is analogous to an Amazon Kindle which has an imbedded cellular chip for downloading books but (of course) does not make phone calls.

Finally, any server on the internet can feed information directly into the 2net servers using application programming interfaces (APIs). This would be useful in the case of, say, a patient health record (PHR) uploading data to 2net for the purposes of displaying it on a mobile app somewhere else. In fact, it is this bidirectional ability of the cloud based service that will allow for a wealth of yet to be imagined data mashups valuable for populations and individuals.  This is the most exciting part of this new platform.

It is this potential to aggregate all kinds of biometric and user entered data that is making possible the Macaw app which is an impressive demonstration of how a mobile device can aggregate a wide swath of biometric data and guide an individual into reducing risk of preventible illness. It is a powerful and comprehensive tool based on the Prevention Plan to decrease your health risks–which we will profile in an accompanying article.

The APIs that allow streamlined data sharing to and from other servers was also via an integration into a web based EHR, Hello Health by Myca. As can be seen below, there is a live dashboard  aggregating input from several different sensors simultaneously, including blood pressure, asthma inhaler puffs, glucose, weight, etc.

The volume of biometric data is expected to massively increase in the near future. Currently, data transmission is a patchwork of independently created proprietary solutions. Just imagine the number of  communication subsystems within any single hospital connecting medical devices. Qualcomm is stepping into this disordered marketplace, taking advantage of its global scale and multiple decades of leadership in wireless communication to offer a unifying platform.

Although the system is not based on open protocols managed by a standards body, such as the W3C for the internet, a simple and reliable system that companies large and small could subscribe to could well be the catalyst to launch the next big phase of the mHealth revolution.

The mHealth Summit 2011 is in full swing and there are many exciting booths and demonstrations available to see. We recently reported that ResolutionMD has received FDA clearance for its mobile radiology viewing system. The platform is available as a free downloadable demo “lite” version via iTunes.

Calgary Scientific, makers of ResolutionMD, are here at the mHealth Summit and were kind enough to give the imedicalapps team a live demonstration of the app, including some of its marqee features.

The video below demonstrates what the technology can do and is a live demonstration of ResolutionMD.

 Key points about their imaging solution include:

• The imaging data is NOT copied, it is left on the source PACS (i.e. hospital or imaging center)
• A temporary copy of the data is created on a dedicated server
• The server is usually housed by the specific entity that owns the PACS
• Calgary Scientific does not sell its product directly, ResolutionMD is resold by large PACS vendors such as GE and Fujitsu
• All image processing–including 2d and 3d reconstructions–are performed on the server side, saving system resources
• A session can be opened with an iPad or various Android tablets, allowing the rendered images to be displayed
• Images can also be viewed on a web browser, which currently has more capabilities and functionality than the mobile app counterparts
• For security purposes, no data is stored on the mobile device. Instead, when the session is closed nothing is retained
• Since the images are rendered remotely, two devices can view the same images simultaneously as well as share controls

This last feature is especially exciting since a radiologist can be viewing an image on his/her iPad, send an email invite to a physician inviting him to open a simultaneous session and actually go through the slices and point at the findings of interest.

At this time, it is not clear if this platform will be extended to small imaging centers and physician practices with digital radiology capabilities.

The third annual mHealth Summit kicked off today in Washington DC.

The list of keynote speakers is an all-star list of influential leaders in health and wireless medicine.

After an introduction by Robert Kaplan, PhD from the NIH and Scott Campbell, PhD from the FNIH, Patricia Mecheal, PhD, executive director of the mHealth Alliance highlighted the progress mobile health is allowing less developed countries to tackle their health problems such as malaria and other communicable diseases.

Patricia Mecheal also mentioned how mobile technologies have helped gender inequalities, explaining that she herself is now a patron of mobile apps for expectant mothers.

The two keynote speakers on the first day were Kathleen Sebelius, secretary of the US Health & Human Services and Eric Topol, MD.

Both speakers had clear messages for the attendees but it was Dr. Topol who really gave a rousing and inspirational keynote that touched on nearly every aspect of the digital revolution in medicine.

[Ed. Note: check out our recent interviews with Patty Mechael and Eric Topol. The following is excerpted from their speeches.]

Kathleen Sebelius

Virtually every American now has a cell phone with smarthphones comprising nearly half of these phones. We are used to using smartphones to get directions or choose where to eat but now we are increasingly using them to track and manage our health. The iTunes app store has 12,000 apps for health. But as technology goes, this is not big news. What is exciting is that this is happening where the rate of innovation has been slower, namely medicine.

While technology has improved the consumer experience almost everywhere, such as banks and ATMs, healthcare has stubbornly held on to “cabinets and hanging files”. Whereas we have some of the best doctors, nurses and technology in the world, and the highest spending, Americans still live with illness and die younger than in many countries. At the same time, doctors and nurses are frustrated by the demands of care. Healthcare costs have stressed families and have led to difficult choices at all levels of government.

Part of the problem is lack of information. Patients cannot access their information, which is stored in offices. They cannot find information on medications or find specialists. Doctors way too often have inadequate information on their patients, about their diabetes management, or what happened recently while they were in the emergency department.

This is why the president launched early in his term an effort to improve health IT in this country. Since 2009, the share of office electronic health records has gone from 17% to 34%, with 52% saying they plan on adopting them. We are on pace to triple the use of EHRs. This is a huge change. Mobile health is the natural extension of this change. We need to bring these advances to pockets and purses. Mobile health allows us to reach populations previously hard to reach such as African Americans, Latinos and others.

People are happy to leave some portion of their healthcare  in the hands of professionals. They are happy to leave scalpels and lasers in the hands of surgeons. However, we should be involved in diet, quitting smoking, choosing a doctor. It has been incredibly inspiring to see developers come up with tools to do this such as iTriage, which is helping consumers find health care facilities as easily as finding a restaurant as well as Pillbox, which is helping people identify pills. This is not just impacting patients. For physicians, a smartphone with Epocrates is almost as necessary as a stethoscope.

Yet, I believe we have a long way to go. We in administration ask what can do to accelerate the development of this technology. Now, we believe the biggest force for innovation is America’s entrepreneurs. Government has a role too, as  it can drive research to develop the context for this technology. It can be a catalyst. The rapid adoption of EHRs is an example. The benefits of EHRs have been well known, yet adoption was very low in 2009, even in a sector that is 17% of GDP. We helped remove obstacles.

First, we developed a national platform with interoperable systems. We built regional Health Information Exchanges (HIEs) for institutions that did not have access to IT expertise. We then put in financial incentives for doctors and hospitals. What was especially important was developing meaningful use standards that, for the first time in this country, can track the outcomes of interventions. Along the way, we created 50,000 new jobs in this field.

When government targets it resources effectively, we can make major changes. We are making vast amounts of data available to those of you in this room. Until recently it was hidden, scattered across websites and publications. We unlocked the data and built a central clearinghouse at www.healthdata.gov. There has been an incredible response, with dozens of apps built and we are just getting started. Much of this is due to the incredible ingenuity of Todd Parks, serial entrepreneur within HHS.

Earlier this year we challenged developers to develop apps for young people to avoid dating violence. One out of five women in college report some sort of assault. If young people can create a flash mob, why not use the technology to protect themselves?  Today I want to congratulate two winners of our “Apps against Abuse” challenge: Circle of 6 and OnWatch. We are also working on Text4Babies, which has helped 250,000 moms.

Today, I ask all of you to help move all health technologies forward–not just mobile. These technologies will be embraced by consumers if they feel that their information is safe. At the FDA, we are practicing safe regulation, so that mobile software keeps health information secure. We need your help in both of these areas. We are talking about using the biggest technology breakthroughs of our time and applying it to our biggest challenges. As China and India grow their middle class, they will also need these technologies for their consumers. There is no reason we cannot be the ones to provide those technologies. The future is in sight.

Thank you.

Eric Topol, MD

It is wonderful to be here, representing the West Wireless Health Institute, whose mission is to lower the cost of health care.

[shows slide of 16th century fresco] This image demonstrates the word “Kairos”, the greek word for “supreme moment”. We are at this most momentous time in medicine due to this inflection point because of the intersection of the digital & the medical world, which is sort of a cocoon. These two worlds are now merging.

There is a tremendous digital infrastructure already built [shows slide of iPod, Blackberry, iPhone, Kindle and iPad]. This affects shopping, thinking and behaviors. There is a new species “homo distractus” [shows cartoon of twins in utero texting to each other]. We have gone from zero to 800m users on Facebook since 2004, soon it will be more than a billion, and from 0 to 250m Tweets per day on Twitter in a few years. Occupy Wall Street is a street movement propelled by social networks. Why can’t there be a similar movement for health?

A patient recently posted her picture on Facebook. Somebody far away made the rare diagnosis of Kawasaki disease using just the photo. In online patient communities like PatientsLikeMe, many patients are gleaning more support and information from their peers than their doctors. We have trillions of gigabytes of data, we have supercomputers like Watson that can process 200m pages per second. Wellpoint has even contracted with Watson for challenging diagnoses.

Joseph Schumpeter, an Austrian economist from last century, coined the term “Creative Destruction”. This is the Kairos. We see it in newspapers and magazines. Johns Hopkins is closing Welch Medical Library since all their content is going digital. When I was training there, I lived in that building.

We are also seeing the beginning of wireless sensors. These include the Nike running sensor and the Jawbone UP. The Zeo sensor tracks sleep continuously, you can see I woke up many times last night as I was excited about today. The Withings weight scale can send data directly to providers, same with the Agamatrix glucometer. There is even now available continuous glucose monitoring every five minutes using a sophisticated skin patch.

The AliveCor device allows ECG measurement simply using by utilizing a case on the outside of an iPhone. [He demonstrates his own ECG live on stage by holding the phone in his hands] I used one of these recently during a plane flight to diagnose someone with a heart attack. [He places the credit card sized sensor against his chest]

You can see my heart rate is faster than it was before – look a PVC!  This will engender a culture of “e-hypochondriacs” [laughter].

You can also use Skin Scan to take a picture of a mole and get a text back saying whether it is good or bad. The Cell Scope can make a medical microscope out of a cell phone for under $50. Using microfluidics and nanoelectronics, you can now sample saliva for genetics. This is what has been termed “the incredible shrinking laboratory”.

Eyenetra.com sells a $2 app that makes it possible to diagnose near- and far-sightedness, it was invented by MIT. The Sensimed Triggerfish can monitor continuous interocular pressure. Tears can be tested to measure glucose. Today, a big announcement from Qualcomm will allow data aggregation using a cloud-based service.

The future is global non-communicable diseases– not Tb, HIV & malaria. The future is cardiovascular and cancer worldwide, which have mHealth strategies. In Isaacson’s biography of Steve Jobs, he says he is excited for his son Reed since “the biggest innovations in the 21st century will be the intersection of biology and technology”. We will soon have the complete $1000 genome in 2 hours is the future. Nicholas Volker, a child born in Milwaukee, Wisconsin was about to die due to multiple infections and sepsis. Finally, one of his doctors suggested they sequence his genome, and found the genetic source of his problem. He is now cured and healthy at age six.

DNA Electronics makes a handheld device that analyzes a portion of genome using saliva. It can tell what dose of plavix should be used or if an alternative is preferable. It can help avoid the rare and devastating side effect of Steven-Johnson syndrome which can be seen with Tegretol (carbamezapine) whose susceptibility is due to a known allele. We now have breakthrough drugs for cystic fibrosis for the 3-4% of patients with a particular gene. We also know that some fraction of the 347 million diabetics in the world are resistant to metformin.

[shows stethoscope] This is a stethoscope. It was invented in 1847. I have not used one in two years. I have a miniature ultrasound in my pocket that allows me to see the heart, why just listen to lub-dub when I can see the hear? [he demonstrates by showing his own echocardiogram live on stage]

Why do we know when something will go wrong in our cars but not in ourselves? We can’t tell if an artery is going to crack, we only can see plaques. Yet arteries that crack often only have partial blockages. This is why Tim Russert had a normal stress test just weeks before he died suddenly of a ruptured left anterior descending coronary artery. How can we tell ahead of time?

Now we can by looking at molecular expression of endothelial cells. This can be detected with a nanosensor the size of a grain of sand, connected to an app. We will be able to detect cancer cells and immune the destruction of islet cells for diabetes. Embedded nanosensors are a big part of the future. This is the superconvergence of genomics, imaging, internet, social netowrking and wireless sensors.

It is the biggest convergence of our lives.

The mHealth Summit is the largest annual gathering dedicated to mHealth in the world and convenes a global group of researchers, health professionals & industry. As a media partner for the Summit, iMedicalApps will be presenting an exclusive series of interviews with keynote and prominent speakers between now and the December meeting titled “mHealth Leaders speak to iMedicalApps”.

Joseph Kvedar, MD, is the Founder and Director of the Center for Connected Health, which was established in 1995 by Partners HealthCare.

Partners was founded by Massachusetts General Hospital and Brigham and Women’s Hospital, and is a principal teaching affiliate of Harvard Medical School.

The Center’s mission is to “develop new strategies to move health care from the hospital and doctor’s office into the day-to-day lives of patients.” Dr. Kvedar will be speaking in the Super Sessions at the Summit on “Mobile Health in the Clinical Enterprise”.

Read below to learn more about the fascinating work being done at the Center for Connected Health and his thoughts on the mHealth Summit.

Why are you participating in the mHealth Summit?

The growth in this sector has been extraordinary in the last that two or three years. From a patient perspective, the power of having mobile technology always on, always networked, in the palm of your hand and very personal just really does open up a whole new opportunity for the delivery of health care that we just have never thought about.

What do you hope to get out of it?

I think safe to say in this space the mHealth Summit is one of the biggest meetings, so there is going to be great content, and there are going to be great networking opportunities. I hope to get insights into the field, to take the pulse of what’s happening and to with colleagues working in the same area to inspire new concepts and business relationships.

Could you please share a few thoughts on the potential of mHealth to improve health?

I have been at it seventeen years and we just couldn’t conceive of the opportunity that today’s smart phones, as an example, give us in terms of just-in-time care delivery and just-in-time messaging and the opportunity to educate people when they needed the most and on and on. So I do think there is something here, I do think it’s a — it’s really profound and it is going to have an enormous effect on not just the health care industry, but all industries.

Mobile technology is with you and we are always connected so that we can use it as a tool to sense all kinds of things about you and collect them and aggregate them and then give you insight into your lifestyle which will be important for health care.

Tell me about the Center for Connected Health

We changed our name in 2006 from Partners Telemedicine because we evolved from the concept of traditional telemedicine and got into some of these other areas, so we thought we need to really have a different term for what we do. We would say that mHealth and connected health aren’t exactly the same. But mobile enables us to push our vision so much faster, in such a more compelling way that it’s incredibly exciting. Now what we do here is we are very focused on opportunities for really two things.

One is self care and insights into lifestyle change and behavior change and all those sort of things that will take your population that’s headed for chronic illness and reverse that trend. And then the second is just-in-time care or the ability of a health care provider to manage a population of patients and then reach into the moment and find you and say, “hey, look it’s me, I am just looking over your data, and it looks to me like — you know, I see this trend over the last three days of your blood glucose reading, let’s have a chat about what’s going on” and do that teaching in the moment that you just can almost never do during office visits. You’ve got an appointment at 3 pm on Friday afternoon and that’s when you show up and if you are not sick then it’s a quick visit, but if you go home in the next week you get sick, tough luck.

It seems the Center works both on the provider and the consumer side

So we are definitely a hybrid organization, that’s part of what is fun about it. We do have an academic side, true, but as a division of Information Systems at Partners Healthcare, one of our missions is to keep the organization three to five — more like five to seven – years ahead of the curve on these technologies. So, as we move into a world of accountable care and capitation, all of a sudden it’s become very, very plausible that we use a lot of these programs to extend ourselves across greater population of patients and take care of them effectively outside of the office. It’s really about creating innovative programs that get us into the care coordination world as opposed to the office visit world.

Then we have what I call our external facing side. We do some research grants, we do some cutting edge research, we have four or five things going on right now that are fairly large scale implementation trials of either an interesting technology or a care model. We are doing something with social networking and Facebook in asthma for instance.

We are doing something with an ingestible biosensor that measures certain things, and whether that’s effective for changing behavior. We are doing some things with a medication adherence device that scans pills and tells you whether you took the right pill or if you filled the bin wrong, its a very, very smart device. So we do that work and it is either funded by research grants or by the companies themselves.

And then we have a consulting practice, particularly for early stage firms. But a variety of organizations hire us to help them to either get their products sorted out and determine how they fit in the marketplace or possibly to do a feasibility trial or a clinical trial. We sometimes help people with their business plan, we connect them with funders.

We aren’t an official incubator in that sense but we do a lot of those things. We also have a close associate who can help people sort out their investment strategies. So we do bleed over into the start up world. I tell people our mission is to accelerate the adoption of connected health and that can be by moving things forward in the commercial sector or it can be right here in our own delivery system.

How can connected medical devices reduce health care costs ? Have you seen some examples?

Well, I alluded to this in the very beginning, we have this hypothesis that our patients and consumers – people don’t have to be already sick to be part of this phenomenon – they are our biggest untapped resource. And the way that we believe that we’re going to fundamentally lower the cost of care or decrease the demand in an already overtaxed system is by offloading more and more of the responsibility on to individuals. And they will be happy to do it because who cares more about your health than you do?

The statistics that I like to throw out here are that 56% of the health care expenses in this country are labor. In the last, I want to say, ten years the economy in general has increased labor productivity by 1.8% whereas health care has fallen by 0.8% creating an almost three percentage point difference in the overall productivity of workers in our economy and what’s going on in health care.

So we really have an enormous opportunity to use our healthcare labor across more individuals and keep more individuals healthy, lowering the demand and lowering the cost. We think mobile health, and of course “connected health” our brand of mobile health, has that opportunity. It has to do with feedback loops, it has to do with just in time care. We are seeing it happen, and have great data in our own patient populations that’s showing this can happen and that’s the direction we are pushing everything we are doing.

Do you think capitated and global payment structures will help or hinder adoption of these technologies?

I would say it will be a boost because providers, when they really are capitated, will very quickly realize that their most precious resource is their brick and mortar and they simply don’t need to have everybody come in for every sore throat, flu shot, blood pressure check. We did all those things for years partly because we couldn’t think any differently but also probably because the cash register rings every time you go – that’s the only way the cash register rings. So you know if you get us out of that, where you are going to get paid a flat rate to take care of this population and the goal then is to sign up more people because the more people you sign up the more you get paid and yet be more efficient, this stuff will take off like a rocket.

It seems there is an mHealth conference somewhere every other week. What do you believe sets the mHealth Summit apart?

I think the that has to do really with the fact that there’s such a heavy emphasis on the NIH side. And that brings a different crowd to the table,. You have Health 2.0, which I know is not mobile meeting but there certainly is plenty of mobile technology present there. Health 2.0 is mostly about startup land. There is also the Wireless Life Science Alliance which is really more traditional pharma and device companies and how they are moving into wireless.

We run a meeting here, the Connected Health Symposium which is really about policy and psychology around growing the connected health market. I think the reason the mHealth Summit can attract thousands of people is because it attracts people from the foundation side, it attracts people from the public health side, and it attracts people from the various institutes at NIH. So it’s a different crowd and they are thinking about the problems differently. I am a big huge believer in the whole ecosystem and I am an equal opportunity networker. There are people here that I wouldn’t necessarily get to see at other meetings.

[Ed. In addition to his role at the Center for Connected Health, Dr. Kvedar is a past President and Board member of the American Telemedicine Association (ATA) and a Past Chair of the American Academy of Dermatology (AAD) Task Force on Telemedicine. In 2009, Dr. Kvedar was honored by the ATA with its Individual Leadership Award, recognizing his significant contributions to connected health and telemedicine. Mass High Tech, The Journal of New England Technology named Dr. Kvedar an All-Star in the field of healthcare. ]

[The mHealth Summit is the largest annual gathering dedicated to mHealth in the world and convenes a global group of researchers, health professionals & industry. As a media partner for the Summit, iMedicalApps will be presenting an exclusive series of interviews with keynote and prominent speakers titled "mHealth leaders speak to iMedicalApps" between now and the December meeting.]

It is hard to easily comprehend the depth and breadth of Dr. Topol’s career. He has been a major figure in cardiology, genomics and wireless health while also assuming leadership positions in landmark institutions such as the Cleveland Clinic and the Scripps Institute in La Jolla.

As chairman of cardiology at the Cleveland Clinic, he led the program to become number one for heart care. He was lead investigator on numerous national & worldwide cardiovascular clinical trials and started a medical school at the Clinic. He was also among the first physicians nationwide to call attention to the potential cardiac dangers of Vioxx. His very public criticism of Merck and the FDA brought to light the intimate but not always visible connections between the pharmaceutical industry and academic medicine.

Later he moved to San Diego, where he currently serves as director of the Scripps Translational Science Institute, Chief Academic Officer for Scripps Health and Professor of Translational Genomics. He has been a leading proponent of wireless medicine for more than a decade. He co-founded the West Wireless Health Institute with Gary and Mary West who contributed the initial $45m gift to start the Institute and have since committed an additional $100m to found a not-for-profit venture fund for wireless health companies. He currently serves as Vice Chairman of the Institute which is dedicated to “innovating, validating, and advocating for the use of technologies including wireless medical devices to transform medicine.” Be sure to check out our recent interview of WWHI chief executive Don Casey.

Dr. Topol is delivering the opening keynote for the mHealth Summit on December 5. His new book “The Creative Destruction of Medicine” is also making its debut at the Summit as an e-book, available to meeting attendees. Read below to hear his thoughts on the mHealth Summit and wireless platforms’ potential to improve health & transform the practice of medicine.

Why are you participating in the mHealth Summit?

I am excited to be participating in the mHealth Summit because this is a gathering of the really interested people in this space from all over the world, and it is the one that is most exciting in making a vast difference in the future of medicine.

Could you please share a few thoughts on the potential of mHealth to improve health?

The story here is that a remarkable digital intrastructure has been built and yet the medical world is in a separate orbit, a cocoon of sorts. This is the beginning of a coalescence of a these two fields, where medicine can leverage this fantastic digitial infrastructure. Not just wireless but the idea that you can digitize the whole human being. We’re used to digitizing books and movies but now we can digitize people with wireless sensors, advanced medical imaging, even genomic sequencing. mHealth is a way to take this forward, because now we’re talking about a mobile platform, a way of getting that data on any individual, to individualize their care, to allow prevention of significant illnesses. This is a unique opportunity, the most exciting time in medicine ever.

There are a lot of mobile meetings out there, what makes the mHealth Summit special ?

Well, I think this is the meeting. The term “summit” is used pretty liberally but this one is the real deal. It brings together people from all over the world who are interested in fostering global health through mHealth, this is an unparalleled gathering of people and exchange of ideas.

What do you hope to get out of the mHealth Summit ?

To me, it is a great opportunity to meet so many people in this mHealth community, the thought leaders, and to try to help catalyze going forward. It is exciting for me because I have a book coming out called “The Creative Destruction of Medicine”, about how the digital revolution will create better health care. This book will be available at the mHealth Summit electronically, exclusively for the meeting. In my address, I can only cover so much but this book gets into all the nitty gritty. This is such an extraordinary time in medicine. My hope is that I can help catalyze this movement which is based not in the physician community but rather in the consumer, in the public. And it is not just United States, but rather global.

In your TED talk you said that in the last two years we have learned more about disease than in all the previous eras, what did you mean by that ?

Since 2007, due to the acceleration of knowledge of our genomic underpinning – the root causes of disease – we have advanced our knowledge so exponentially that it transcends all of the history of medicine. Now that we can sequence a human being wholly, every one of the 6 billion base pairs, we can get full disclosure on each individual. That includes the prevention of diseases that might otherwise occur in that person but also what drugs might be useful, and those that would induce a serious side effect.

And all this kind of information can be stored on someone’s smart phone. There are now prototypes of devices that look like a smartphone but that are actually capable of genetic sequencing. A handheld device will be able to sequence portions of the genome, such as a possible cancer mutation or to see if a bacteria is resistant to certain antibiotics. In the next few years, using sequencing chips, these devices will be capable of sequencing a whole genome. Really a remarkable convergence between genomics and mobile technologies.

Can mobile technologies help less wealthy countries leapfrog some of their health challenges ?

Absolutely. As a cardiologist, I can look at the cardiac rhytm of anyone in the world. I can tell them if they are in atrial fibrillation, another arrhythmia or that they don’t have an arrhythmia. And that’s just the beginning. Next year, we’ll be able to look at all their vital signs. The fact is that we have leveled the playing field for practicing medicine. We can communicate through our smartphones, these amazing mini computers, to render diagnosis and care. That extends to making the diagnosis of infectious diseases, through add-ons to the smart phone, there is limitless potential here.

You have the opportunity for any patient in the world to connect with an expert to get guidance. That is something we never had before because we could not transmit that data. We just didn’t have the data. We couldn’t capture it, much less transmit and share it. For example using the V-scan, a high resolution ultrasound device, somebody can do an ultrasound in India and put it on their phone so I can look at it. I can see every structure of that person’s heart, abdomen or fetal structures. All this is done in real time.

[Editors Note: The mHealth Summit is the largest annual gathering dedicated to mHealth in the world and convenes a global group of researchers, health professionals & industry. As a media partner for the Summit (Twitter: #mHS11), iMedicalApps will be presenting an exclusive series of interviews with keynote and prominent speakers between now and the December meeting titled "mHealth Leaders Speak to iMedicalApps".]

Patty Mechael has been actively involved in the field of international health for 15 years with field experience in over 30 countries and was recently named Executive Director of the mHealth Alliance, a key organization linking and facilitating efforts to expand mobile health across the world in low and middle income countries.

The mHealth Alliance is an important part of the conference and is actually one of the three ”Organizing Partners” of the meeting (along with HIMSS and the NIH). As such, the mHealth Alliance is not just participating in the meeting but organizing sessions around global mHealth. In fact this, as Patty Mechael explained, is one of the unique aspects of the Summit. It is the only meeting where the the four legs of mHealth are represented in the program: research, policy, business, and technology – with representation of views and experiences from both developed and developing countries.

Read more to learn how the mHealth Alliance is helping less wealthy countries and organizations develop sustainable and scalable models of mobile health where the medical infrastructure is, at best, incomplete.

[Note: Questions are in bold and the answers are below]

Why are you participating in the mHealth Summit?

For us, the Summit represents an important platform for networking among and with our stakeholders, sharing ideas and profiling the work that they are doing. Our efforts with  the Summit are to make sure that the perspectives of those working within the Global South are featured throughout the Summit program.

What do you hope to get out of the Summit?

The Summit is a wonderful learning opportunity and a platform for connecting groups that normally don’t get to interact with each other.  In addition, we will be convening a series of special sessions that the Alliance is taking a lead on related to the work that we are doing with national stakeholders, on participatory design, and monitoring and evaluation.  There has been a big push in the last year for countries to develop national mobile health strategy as part of their larger eHealth strategy. We want to bring together those stakeholders to share what has worked and how it has worked in different settings, in countries like the Phillipiines, South Africa, Kenya and Bangladesh. How do we take the collective wisdom and start to learn about the national level strategic planning processes?

One of the other events we are engaging in is around participatory design, along with Frog Design and UNICEF. The question is what is the role of design in mHealth? Not just in the applications themselves but also in program design. Applying a design approach can help set the health strategies and the selection of the best mHealth tools out there to solve specific problems.

We are also working on a research and evaluation session with the Johns Hopkins School of Public Health and the World Health Organization. A major gap area in mHealth is in impact evaluation. How do we know what works, why it works? There have been a number of collective efforts in the past year, some hosted by NIH, another meetingat the Rockefeller Foundation Estate in Italy to look at how do we become more strategic in the way we approach evaluation of mobile health to make sure the investments we make are the most informed.

We are also doing a couple of awards during the Summit. One is the “Top 11 Innovators of 2011″, co-chairing this award with the Rockefeller Foundation. We are accepting nominations now and will be going through public voting in November and then a final judging panel. We also have a partnership with the Norwegian government to issue catalytic grants to innovative mHealth programs that have a sustainable business model that is driving them.

Could you please share a few thoughts on the role of mHealth in global health?

The mHealth Alliance is actually currently going through a major strategic planning process. We have been actively engaged in global mHealth for two years and are now at an inflection point. A critical aspect of this strategy will be to facilitate the mainstreaming of mHealth into global health activities at community, district, national, and international levels. On Tuesday morning at the Summit, we are launching our 2012 mHealth Alliance Strategy publicly. At the moment we are engaging in internal development and will be vetting externally, via webinar and on-line discussions to engage the larger global mHealth community.

We have a working relationship with the World Health Organization (WHO) over the next three years building capacity in evaluating the impact of the mobile health programs. That is their core strength, they leverage impact analysis for policy making. It has been hard for anybody to drive the policy development without the evidence.

One of the things that has been challenging, and one of the places where work to convene national stakeholder comes into play, is that you have to start with the desire to align technology with health priorities. Otherwise, it is just technology for technology’s sake. I can tell you we have ten year’s experience with this – where there is a lot of technology for the sake of technology, where it is a really good idea but is not having an additive effect on health outcomes or health system strengthening. This is because it is not designed to be interoperable, standardized and directly linked to a set of health targets.

It seems there is a mHealth conference somewhere every other week. What do you believe sets the mHealth Summit apart?

One of the things I appreciate about the mHealth Summit is its size. It is the largest gathering out there. It is a nice combination of research, having the partnership with the NIH, with the NIH leading on the research agenda is really helpful; industry, having partners coming at it from an industry perspective; and having a partner like the mHealth Alliance which is trying to make sure that the voices of those from the Global South are featured within the discussion. There is so much learning from the Global South that has implications for how we do things in the United States and Europe. Imagine what you learn from trying to do things in a very resource constrained environment, and then apply those lessons where you actually have the resources.

In countries like Ethiopia, they are working their way through a national strategic process in ways the United States hasn’t even started. Yet, we have some wonderful efforts being undertaken in the United States by the FDA and FTC to look at the mHealth regulatory issues that a lot of other countries are struggling with and that can look to the United States.

If you look at the way mHealth exists in the real world, it requires that connection between industry, the policy & regulatory environment, and research. They are completely interconnected although many times we segment them out. A lot of times when I sit at meetings one of the frustrations of mine is that the NGOs, governmental institutions and maybe an academic institution or two are there but then industry gets left out. And then when you have industry meetings, they are not talking to any of these other people. At some point, none of this stuff is going to make any sense unless everyone is talking to each much more effectively to achieve commonly agreed health objectives.

Other information

The following is a description of the mHealth Alliance from its webpage:

The mHealth Alliance champions the use of mobile technologies to improve health throughout the world. Working with diverse partners to integrate mHealth into multiple sectors, the Alliance serves as a convener for the mHealth community to overcome common challenges by sharing tools, knowledge, experience, and lessons learned. The mHealth Alliance advocates for more and better quality research and evaluation to advance the evidence base;  seeks to build capacity among health and industry decision-makers, managers, and practitioners; promotes sustainable business models; and supports systems integration by advocating for standardization and interoperability of mHealth platforms.  The mHealth Alliance also hosts HUB (Health Unbound), a global online community for resource sharing and collaborative solution generation. Hosted by the United Nations Foundation, and founded by the Rockefeller Foundation, Vodafone Foundation, and UN Foundation, the Alliance now also includes PEPFAR, HP, the GSM Association, and NORAD among its founding partners. For more information, visit http://www.mhealthalliance.org.

Patty Mechael has a Masters in International Health from the Johns Hopkins School of Public Health and a PhD in Public Health and Policy from the London School of Hygiene and Tropical Medicine, where she specifically examined the role of mobile phones in relation to health in Egypt. She was also a speaker at the 2011 mHealth Summit where she presented here “Top ten lessons learned from mHealth rollouts”. Below is a recounting of the list, as reported by Brian Dolan of MobiHealthNews

1. Capitalized on what others have done, what others have learned
2. Evaluate the impact of mobile technologies to support behavior change
3. Locally-generated content is important. Be sure to appropriately contextualize information makes it more meaningful
4. Adapting materials to mobile is a challenging undertaking
5. Move away from research focus on user satisfaction and actually evaluate the impact on health outcomes
6. Be realistic and don’t get caught up in the hype. Tone it down, at least
7. Take a systems-thinking approach and move away from single-issue focus
8. Recycle, repurpose, reuse; don’t reinvent the wheel, (especially if it’s a flat tire, as another speaker quipped)
9. mHealth at scale can only come from strong leadership linking technology with health priorities and looking for most appropriate tools that exist; look for public-private partnerships
10. It’s not about technology.

As we discussed in the first of this two part series, mobile devices are already entering the world of the surgeon. Currently, it is mostly downloadable apps that promise to help surgeons with the informational portions of their tasks, such as tracking the cases they have done, e.g. Surgichart or helping in the consent process, e.g. Surgery Risk

While apps that are dedicated to the technical aspects of surgery, such as the excellent AO Surgery Reference, are becoming available, in the future we will see the iPad (or its brethren) actually in the operating room. Why ? Because the iPad has many characteristics that make it a great an advanced surgical instrument.

First is its small size. Every modern operating room has stacks of electronic equipment hanging from the ceiling or in large cabinets for patient monitoring and controlling in-field devices. Since the iPad already supports a bevy of standard wireless communication protocols, many of these large boxes’ functions could likely be off-loaded to an iPad with clever engineering. One immediate advantage would be that the iPad could be brought directly into the operative field in a small sterile bag where the touch interface makes it possible to change settings even using gloved hands. This means that the surgeon or assistant could manipulate the controls rather than asking the room staff to make every little change. The long battery life means that an iPad can make it through even a long surgical day without needing a recharge (at least not before the surgeons do !)

Even more intriguing are the possibilities for user interfaces that incorporate the built-in sensors in the iPad, specifically the accelerometer and gyroscope. These sensors have made the iPod Touch a massive success in the mobile gaming world by allowing players to interact with games by turning and twisting their devices. Could they also lead to new types of assistive surgical instruments ? Read below as we explore these ideas.

[Ed. This article, and the first part of this series, is co-published in the Journal of Surgical Radiology]

Communication

The most basic and fundamental function of mobile devices is communication. In the surgical realm, this often means sharing visual information since intraoperative observations are critical to understanding surgical options and prognosis. But this can even be extended to the preoperative setting, where the ability to quickly consult with a colleague about physical findings could help guide surgical planning. The built-in FaceTime videoconferencing feature in the iPad 2 and iPhone 4 is as simple as it gets. In fact, this is exactly what Armstrong et al showed could be one use of FaceTime, in a brief report describing its use in sharing the appearance of pre- and post-operative wounds, where two surgeons discussed the appearance of an extremity and whether surgery is indicated, as seen in the image below. If the Wi-Fi network is encrypted, the communication is likely in fact HIPAA compliant.

Sharing intraoperative images with patients and other professionals is also a feature of SurgiCharts, as our recent review showed while eGoWorks is an iOS app for sharing endoscopic images stored using Envisionier’s web-based endoscopic image server by the same name. For more robust video sharing, JEMS offers a system where multiple mobile clients can view the same video stream (image below). The stream is encrypted and mobile clients are available for both iOS Android devices. A video server is required, which can take in up to four different video inputs. This means that the same surgical procedure can be viewed in multiple locations, even in different cities, making it potentially a great tool for teaching.

Intraoperative visualization

While the iPad could be used to view a remote surgery, it may be put to even better use in the immediate operative field. One use could be to follow the patient’s vital signs. The AirStrip platform already allows for live remote monitoring of fetal heart tracings and is already deployed in multiple hospitals. Now also available is remote monitoring of vital signs, such as EKG tracing, blood pressure and oxygen saturation. While this is mostly the responsibility of the anesthesiologist, in cardiac procedures especially, the surgeon is also acutely interested in heart electrical activity and blood pressures. Thus, large and expensive plasma screens are often hung from the ceiling in cardiac operating rooms. An iPad in the operative field running AirStrip may be a far more economical alternative.

Another interesting possibility is to use an iPad as a microscope. Surgeons are used to using “loupes”, eyeglasses with built in magnification, when working on small objects such as nerves and vessels. Other times, large and expensive floor microscopes are brought sterile-wrapped into the operative field. However, there may be times when an inexpensive video microscope may be all that is needed. One university project, “CellScope” demonstrated the feasibility of attaching a magnifier to a cell phone camera to make an inexpensive 45x microscope that can be used in rural settings or less developed countries. Instead of using the built-in camera, if the image sensor was a the tip of a thin extension tube, such as seen below, it could be brought into the field and the video transmitted wirelessly to a nearby iPad. This would then function as the surgeon’s eyes, allowing her to peer into poorly lit body cavities and magnifying small objects.

Intraoperative measurement

The accelerometer inside many smartphones is sensitive to changes in position, such as rotating the device between portrait and landscape. It can also allow for software to be written to allow the device function as a sort of “level” to determine when objects are parallel to each other or to the ground, as demonstrated by the popular iPhone app “iHandy”. This capability is exploited by the “Scoliogauge” app to help orthopedic surgeons measure extent of spine curvature in scoliosis. By having the patient bend forward and placing the iPhone on their back, the angle of trunk rotation can be measured. This rotation corresponds to the degree of curvature in scoliosis. You can read more about this in our recent interview with the orthopedic surgeon and app developer Matt Ockendon.

The same concept has been used to help guide surgeons planning reconstructive eyelid surgery as reported by Mezzana et al, who used an iPhone intraoperatively to ensure that eye lids are parallel during oculoplastic surgery, as seen below.

The app is called Laser Level and it is was originally designed for home decorators to determine when wall hangings are perfectly level. The app overlays two “laser” lines in real-time onto the camera image which turn green when they are parallel, as seen in the image above. The authors reported they were able to get both 100% interobserver reliability as well as “perfect alignment of the lateral canthal position after surgery verified by manual level assessment” in all nine of their patients.

Intraoperative “navigation” refers to a group of technologies that are used to assist surgeons in locating deep anatomic structures or accurately placing implants inside patients. In orthopedics, navigation has been shown to increase the accuracy of placement of knee replacement prostheses. However, one consistent complaint among surgeons has been the inconvenience of assembling the  required transmitters and registering them onto the display sensors while in the operating room. Now Brainlabs, in partnership with implant maker Smith & Nephew, has developed a system that uses an iPod Touch to replace almost the entire device.

As can be seen in the image above, the reflectors and the user interface are incorporated into the iPod Touch which is inside a case and brought sterile into the field. The alignment of the implant is read directly off the screen. The device is awaiting FDA approval in the USA  and a demo is available in the iTunes App Store.

Augmented Reality in the Operating Room

Object recognition software is becoming increasingly sophisticated, even on mobile devices. A great example is the remarkable iPhone application MagicPlan that can almost “magically” draw the floor plan of a room by using the iPhone camera to determine the distance to each corner in a room. The user points the iPhone camera at each corner in a room and the app draws green lines, which are approved the user. Once all the corners are registered, the floor plan, with actual distances, is shown.

This type of technology is termed “augmented reality” and generally defined as the practice of combining or superimposing computer generated data onto live-obtained images. Familiar examples include televised football where a virtual first down line is superimposed onto the field or televised soccer where advertisements seem to be displayed on the walls enclosing the playing field.

The medical uses for augmented reality are just being explored. One app currently available measures the angle between bones on an xray. The app is called Hallux and it is specifically designed to guide surgeons planning reconstructive foot surgery.

In this case, the software combines readings from the iPhone accelerometer and the user determined positions of the bones, using the on-screen alignment guide, to read the angle between the first two metatarsal foot bones. You can read more about it  at our more detailed app review.

Much of surgery has to do with imagining deeper structures, such as organs and bones. Sophisticated image processing techniques make it possible to render three dimensional images, even color coded by organ. These types of images can be invaluable for identifying pathology and planning complex surgery.

The above rendering was produced by Dr. Maki Sugimoto a hepatobiliary surgeon who is pioneering methods of incorporating advanced imaging techniques and surgery. In this example, he uses an overhead projector to overlay the 3d image onto the actual patient during surgery, as seen below. In order to align the images, he uses anatomic landmarks, such as the navel and the iliac crests. to properly align and scale the image.

His group reported their findings in seven surgeries including three cholecystectomies, two gastrectomies and two colectomies. They found that live image registration helped the surgeon locate small objects and tumors introperatively that would otherwise have been difficult to find, and potentially helped avoid intraoperative injury.

An even more useful and convenient method of combining real and computer generated images during surgery, I propose, would be if this “overlay” image could be displayed on an iPad. In this concept, the three dimensional image would be manipulated in real time by pointing the iPad at different portions of the body, giving the sense of being able to peer inside the body. A method of simulating a live three-dimensional view on the iPad was demonstrated by the Engineering Human-Computer Interaction Research Group in France (below).

By using the iPad’s accelerometer, different aspects of a computer-generated 3D object are displayed as the iPad is tilted (video). This can simulate the familiar stereoscopic 3D image display which relies on polarizing glasses, without the glasses. The group even demonstrated how using the front-facing camera and face detection algorithms, the same 3D experience can even simulated when the user looks at the iPad from different angles. A demo version of the software is available for download in the iTunes App Store.

Going further, perhaps the remarkable technology developed by Microsoft for its Kinect could be incorporated into surgery. The Kinect was developed as a gaming tool to allow players to interact with objects on the screen by moving their own bodies. It works by projecting a dense yet invisible mesh of infrared dots into a room and, by rapidly reading the reflection of the infrared light, it can track the movement of people.The image below is from source Matt Cutt’s blog.

The Kinect has already been “hacked” to work inside an operating room by allowing a surgeon to manipulate the display of CT & MRI images from across the room, hands-free.

From there, it is not hard to imagine the same technology being used to track the movement of a surgeon’s hands or instruments. What could be a great leap forward would be to combine the position of the surgeon’s instruments with live-registered three dimensional anatomy images and thus simulate the instruments inside the body. A Kinect-like device could “watch” the surgeon’s hands and instruments outside the body while the iPad is pointed at different parts of the patient to virtually peer inside and show the instruments.

Conclusion

The iPad has the potential be a game changer in surgery because of its small size, built in sensors and wireless networking capabilities. The only restriction is the imagination of future surgical innovators. Even if the above predictions fail to materialize, it is safe to say what the future holds is only barely imagined today.

References

Armstrong, D. G., Giovinco, N., Mills, J. L., & Rogers, L. C. (2011). FaceTime for Physicians: Using Real Time Mobile Phone-Based Videoconferencing to Augment Diagnosis and Care in Telemedicine Eplasty, 11, e23.

Mezzana, P., Scarinci, F., & Marabottini, N. (2011). Augmented Reality in Oculoplastic Surgery: First iPhone Application. Plastic and Reconstructive Surgery, 127(3), 57e–58e.

Image overlay navigation by markerless surface registration in gastrointestinal, hepatobiliary and pancreatic surgery. Sugimoto, et al. J Hepatobiliary Pancreas Sci. 2010 Sep;17(5):629-36. Epub 2009 Oct 2.

Editors Note: iMedicalApps is live at the workshop today, stay tuned for posts later in the day — until then, make sure to give your opinion in the comments section of this post

The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.

Today and tomorrow (Sep 12-13), the FDA is holding an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps has been invited to participate as one of the panelists.

We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?

Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.

The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:

1. How to assess the risks inherent to clinical decision support software and
2. How to classify mobile software that works in concert with a medical device.

Read below to learn more about these issues.

FDA Workshop

We recently had the opportunity to speak with Bakul Patel, MSEE, MBA, the lead author at the FDA of the Draft Guidance, about the Workshop. Mr. Patel combines a focused interest in mobile software with a broad background in business and technology to bear on this issue. He pointed out that developing this particular guidance was more intricate than many others since it had to be cleared by not only our center and the larger FDA but also our parent agency, the HHS. Even the Office of Management and Budget in the White House expressed an interest due to the possible economic impact….as soon as you touch something like “mHealth”, more entities get involved.

It must be remembered, though, that this process will eventually produce a guidance, not new regulations. The distinction is an important one. A guidance provides principles on how the FDA intends to apply existing regulations. Therefore, once the Draft Guidance is finalized, medical software publishers and device makers should be able to predict what types of apps the FDA believes require pre-market clearance and whether they will likely be considered Class I, II or III devices. This will be very valuable for the continued development of mHealth devices and software.

In contrast, regulations have the force of law. The rule making process can be very time consuming since often numerous disparate outside comments are incorporated into the final rules. For example, the regulation designating Medical Device Data Systems (MDDS) as Class I devices was proposed in 2008 but finalized only in 2011 (see our previous post for details about MDDS)

Nevertheless, producing the Draft Guidance is painstaking work, as Mr. Patel explained, because you’re making national policy and that the document has to be legally sound while addressing the different audiences, including lawyers, users, doctors, manufacturers and the medical device industry. Convening a two day workshop on mobile medical apps is a sign of the importance the FDA has placed on this topic.

Mobile Apps as Accessories

As we have discussed recently, the FDA has long been regulating software as a medical device. However, when the medical device is a hybrid of separate software and hardware components, new questions arise. As an example, think of the IBG Glucometer, a device not yet cleared by the FDA. In this case, the software is a separate downloadable app and thus an “accessory” in FDA lingo, which means it is considered a medical device. The clearance process required for a device is determined in large part by the potential risk to a patient. The question the FDA is posing is to what classification should the software be assigned? Should the classification of the software be the same as the hardware or different?

As the companion apps become more sophisticated in the future and begin to offer more features than just reporting the raw data, this question will take on increasing importance. For some of their thinking, refer to the regulation docket where more details about this issue are included.

Clinical Decision Support Software

Among the most exciting developments for physicians using smartphones and tablets for patient care is the potential for improved clinical decision making due to the ready availability of vast amounts of clinical information at the point of care. Everyday physicians combine clinical findings, such as physical observations, laboratory values and imaging findings to make decisions for their patients. What if mobile software could take some of the same information, refer to the best available clinical evidence and suggest better, cheaper or safer alternative diagnoses or therapies ? This type of software is generally termed “Clinical Decision Support Software’ (CDDS). Here is the FDAs definition of CDDS from the Draft Guidance:

“Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.
Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.”

As can be seen, this is potentially very broad, from simple apps that calculate fracture risk based on osteopenia scores to sophisticated prognosis modeling software for ICU patients. Since, in the future, this may well be the most widely and frequently used class of software by primary care physicians and specialists, getting this regulation right now will help determine what new tools we physicians will have in the future.

More details of the FDAs thinking can be seen in the Workshop agenda. Again, your input will be very valuable in drafting the final guidance.

Recent FTC action

Among the first statements in the Draft Guidance is to define what types of apps the FDA intends to regulate. In doing so it offers the following definition:

“This subset, which we are calling mobile medical apps as defined in section III, includes only those that meet the statutory definition of a device; and either:

• are used as an accessory to a regulated medical device;
• or transform a mobile platform into a regulated medical device”

At iMedicalApps, we recently reported on the recent and important precedent of the Federal Trade Commission (FTC) removing a consumer health app from the iTunes and Android app stores that purported to improve acne using light from a smartphone. It is useful to remember that the FDA’s mandate is to regulate any medical device or implement that is designed or purports to diagnose or treat disease. The Draft Guidance explicitly excludes

“Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”

In this case, the FTC acting on the behalf of consumers, intervened in the “Medical” section of an App store but, according to the FDA, which does not fit the definition of a “Mobile Medical App”

The lesson for physicians is that the arrival of the FDA into the mobile software world does not and cannot mean that inaccurate or even fraudulent consumer health care apps will be eliminated or even deterred. We must remain vigilant on behalf of our patients and help them safely navigate the app stores, much as we have now become accustomed to the perils of patients consulting “Dr. Google”.

Conclusion

The increasing involvement of the FDA, and to a lesser extent, the FTC in the mobile medical software and devices arena is another sign of the maturation of this space. Like many other industries, we can predict more consistent regulation will likely lead to more entrants and a richer marketplace. In this instance, the input of clinicians into the regulatory process is not only invited but vital to its evolution.

The explosive growth of medical applications for smartphones, launched by the  debut of the innovative Apple iTunes App store in 2008, promises to fundamentally change the physician’s tool set. While many specialties have always been heavily dependent on technology, such as radiology and cardiology, the ubiquity of these small, interconnected computers means that every physician will soon have access to a broad array of software and hardware to help them perform their daily work.

At iMedicalApps.com, we have been reviewing the most interesting medical apps on the market today as well as watching for trends in mobile medical technology. The most popular categories thus far have been clinical reference and utility apps.  Some of the largest download numbers have been for apps that provide drug and disease reference information, such as the encyclopedic Medscape app, or medical calculators.

However, more targeted apps that are specialty specific are slowly coming on the market. Some early ones, not surprisingly, were reference and self-assessment apps for radiology. These include the popular Radiology 2.0: One Night in the ED, iRadiology and Radiopaedia apps. More substantively, mobile image viewing apps promise to liberate radiologists from their workstations, including the recently FDA approved Mobile MIM app for the iPad.

We are now seeing an increasing number of apps for surgeons coming to the app stores. Presently, this is primarily on the iOS platform although the popular ones will no doubt be coming to the Android platform. Below is a survey of notable apps currently available for surgeons. This article is concurrently published in the Journal of Surgical Radiology.

1. In The Office

SurgAware

Patients undergoing surgery are anxious and, even if they seem like they followed the preoperative counseling in the office, undoubtedly will have questions as soon as they leave. These two apps help patients navigate the informed consent process.

According to the developers of SurgAware, patients forget “70% of what is said in a doctor’s consulting room” within 24 hours. In order help them remember, SurgAware:

…puts all those risks into writing, in a format that can be emailed to anyone who needs to know. If you are a patient, you can either email the list to your doctor for discussion at your next appointment, or check to see that all topics have been covered. If you are a doctor or a nurse, you can use the list as a reference during the process of taking consent, email your patient, copy the email to yourself, and then have evidence of having disclosed the information.

Surge Aware itunes

Heart Surgery Risk

Coronary artery bypass grafting (CABG) is a commonly performed procedure. Despite the immense technical complexity, the risks to most patients are low. However, they are not the same for all patients. For patients to whom CABG has been recommended, HeartSurgeryRisk:

is designed to give patients and their families and friends an estimate of what the chances for complications or death are for a patient who is considering CABG surgery. The calculator is based on data from the Society of Thoracic Surgeons National Database© and the Online Risk Calculator©.

Heart Surgery Risk itunes

ShoulderDecide MD

One of the most challenging aspects of communicating surgery with patients is explaining anatomy. Whereas, the names of anatomical structures are the lingua franca of surgeons, they are almost uniformly foreign to patients. Therefore, many apps are available to help bridge this gap. One such series is available from OrcaMD  which makes patient counseling apps for orthopedics and plastic surgery. Some surgeons also use general anatomy apps, such as the well known Netter Flash Cards. According to the ShoulderDecide MD’s developers:

The purpose of ShoulderDecide is to educate the non-medically trained patient about their shoulder problems. It aims to enhance understanding of common conditions of the shoulder area while answering in an informed, practical guide which conditions may require surgical treatment.

Shoulder Decide itunes

2. Surgery Planning

PreOpEval

Once the decision for surgery is made, then the real preparation work begins. For many patients, it is important to anticipate how their existing medical conditions could possibly complicate surgery and anesthesia. Preoperative testing could range from a basic history and physical all the way to invasive cardiac testing. In many surgeons’ offices, what constitutes adequate pre-surgical testing is based more on local tradition than evidence. According to the developers of PreOpEval, it helps guide testing:

… based upon the guidelines on this topic from the American College of Cardiology & American Heart Association of 2007 and 2009, the Institute for Clinical Systems Improvement of 2006, and the American College of Chest Physicians of 2008…

The app addresses such common questions as:- who needs bloodwork before surgery?- who needs an EKG or a CXR?- how do I handle patients on Warfarin, Aspirin, and Clopidogrel?- which patients are recommended to get perioperative B-blockers or statins?- which active cardiac conditions preclude surgery?- how long after MI should a patient wait before surgery?

Pre Op Eval itunes

iTraycer

For surgical sales reps, managing inventory of implants and trays can be challenging. Although not intended for direct use by surgeons, iTraycer is an interesting solution that helps these very mobile reps manage and locate their equipment by:

providing tracking and real-time tracing of medical trays, devices and implants, including lot numbers, part numbers, from manufacturer to patient.

iTravcer itunes

3. Night Before

Zollinger

Reading up on tomorrow’s case is not just for residents, reviewing “old” texts often brings forth new appreciation even for practicing surgeons . Now, with the availability of major surgical textbooks in app format, these resources can be available anywhere. For general surgeons, the Zollinger series is a well known reference, covering almost every major abdominal procedure and hernia repairs. According to the the app publisher, the Zollinger apps:

…allow you to access step-by-step instructions and superb line drawings for numerous general surgical procedures. Many procedures also include fully-narrated, slideshow presentations outlining each step in the procedure, from Intro and Indications through Post-Operative Care.

Campbell’s Orthopedics

For orthopedic surgeons the most ubiquitous surgical technique text is undoubtedly Campbell’s Orthopedics. Now in its 10th edition and still going strong, it was one of the early textbooks to be adapted to app format. That also allowed multiple videos to be included, which contributes to the hefty 870Mb download. It does not include every procedure in the paper text but, according to the publisher,  the app format allows user to:

• Navigate through 242 techniques and more than 1000 corresponding images with the flick of a finger
• View almost 20 high quality procedure videos
• Bookmark techniques for convenient reference
• Quickly locate any technique in the entire app using the comprehensive search index

Current Diagnosis and Treatment Surgery

For residents and students preparing for surgery and even for surgeons, this large volume contains information on diseases most likely to be treated surgically. According to the app publisher, it offers:

• Wide-ranging coverage that encompasses general surgery and all the important subspecialties including otolaryngology, urology, gynecology, orthopedics, plastic and reconstructive surgery, and pediatrics
• More than 600 informative photographs and illustrations
• Detailed treatment algorithms
• Completely rewritten chapters on Wound Healing, Anesthesia, Otolaryngology/Head & Neck Surgery, The Heart, Neurosurgery, Gynecology, and Orthopedic(s)

AO Surgery Reference

For orthopedic surgeons involved in trauma care, the principles of operative fracture management developed by the “AO”of Switzerland remain the benchmark. Their fracture classification scheme and treatment algorithms have been disseminated throughout the globe. Now they are available in two free apps. The AO Surgery Reference, according to the publishers, recognizes this important fact about surgeons:

The idea behind this service is the realization that reference in daily clinical life is often difficult. Frequently, there is little time during a hospital day to consult books or journals, or even to perform a literature search in order to gather evidence for a decision. The AO Surgery Reference allows surgeons to access much of the body of surgical knowledge for reference purposes during their clinical work.

A second app, the Müller AO Classification of Fractures – Long Bones, makes the sometimes complicated AO fracture classification scheme approachable by converting it into a series of simple screens and touch controls.