After this week's big announcement from Apple that the iPhone will soon be able to connect to medical devices via Bluetooth, we thought it'd be a good idea to check-in with the Continua Health Alliance, which is working to ensure interoperability for connected personal medical devices. Earlier today, mobihealthnews caught up with Continua Health Alliance President David Whitlinger to discuss the organization's efforts to date, the iPhone 3.0, working with the FDA, the imminent first batch of Continua certified products as well as their plans to include more wireless technologies. 

What is the Continua Health Alliance?

The Continua Health Alliance is a non-profit industry consortium of 189 companies that is continuing to grow week-to-week. The effort behind Continua is to create this marketplace, or what we sometimes call an ecosystem, of interoperable, personal telehealth solutions. By bringing together all of the different companies that want to participate in delivering personal healthcare solutions, we are able to get them working together and collaborating on personal care delivery systems and from that drive the standards and connectivity components. The organization has been working now for 3 years and our version 1 guidelines were released in January. Our test and certification program is up and running and certifying products. About 15 or so products are currently in that pipeline. The first one, of course, was announced earlier this year. We are on to version 2, so we're continuing to push forward with new devices, new use cases and new user experiences as well as new care delivery systems. It's a really vibrant organization of some of the most dedicated engineers and healthcare professionals that I've ever had the opportunity to work with.

How long will it typically take for a product to complete Continua's certification process?

The certification process itself is completed by a certification lab in Barcelona, Spain that Continua has contracted. That company is called AT4 Wireless. They're our first certification lab, but as the market grows we will be putting contracts out for other certification labs around the world. It takes roughly 3 to 4 days for the certification process to take place. Right now the process is largely manual as we work through some test cases, but we are also contracting with AT4 Wireless to build an automated test tool, which will be available to [Continua Health Alliance] membership here by--roughly--the second half of the year. So companies will be able to self-certify using that test.

How did Nonin's pulse oximeter become the first certified Continua device?

Well, there product stands to benefit much more from the wireless than most of the other devices. They have been working on a Bluetooth product for a bit of time and the Continua's Bluetooth guidelines happen to fit right in line with Nonin's. The first product that Nonin announced as Continua-certified was USB enabled.

So the first product was Nonin's, what types of devices are in those 15 products currently in the pipeline?

Those 15 different devices include blood pressure cuffs, weight scales, cell phones, aggregator life boxes and so forth.

Why are those 15 products the next ones up? Is there a reason all 189 of your member companies have not submitted products yet?

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The product development of each company is independent and they are all working on their own products, on their own schedules and for their own reasons. It all varies depending on what the product might be, what its market might be and what other things the company is working on. The companies that are leaders and on the front edge of adoption Continua's guidelines are the ones who made these 15 products or so that are in the pipeline. There are other companies that are looking to bring their products toward certification later in the year or perhaps even next year.

So we should expect these 15 or so products to come out pretty soon given the short period of time it takes to get certified?

Yes, well, certification is only a couple of days for the product. Then it's up to the company to determine what else they need to do before launching the product. In some cases they may still need to get FDA clearance or in others it might be it's likely done but they're just getting ready to shrink wrap it.

Do you work alongside the FDA to help them craft their clearances for these devices?

Well, first let's say it up front: Continua's guidelines and certification are focused on the connectivity and interoperability of these products and getting things to work together. In addition to that the Continua organization does do quite a bit of market enabling activities--not just marketing--but policy work with the governments around the world. We do this in order to help lay the groundwork and open up the marketplace for these personalized healthcare solutions. To that end, the FDA, as you may be aware, is just now trying to get their heads around this marketplace--not only personal telehealth, but also the idea of a multi-vendor marketplace. You have the ability to plug different vendors' products together, whether it's a blood pressure cuff and a glucose monitor from two different companies plugging into a cell phone from a third company, which then runs on a carrier from a fourth company and then you are on top of a diabetes monitoring service from a fifth company. These collaborative kinds of solutions are not things the FDA is used to. They have been working with us very, very closely. There is an R&D group within the FDA that has tried to get in front of this type of thing in order to put together the regulatory environment. They have been very accommodating in dialogue as well as white papers with our organization. Every single conversation is: We are charged with the safety of the American people, but we also do not want to be in the position of over-regulation where we stifle innovation and stifle new care delivery to the people that need it.

Why did Continua pick Bluetooth for wireless connectivity of personal telehealth devices?

A couple of reasons. It's ubiquity for one. The cell phone is the common device for a lot of these use cases because Bluetooth is included in them in most markets around the world. Bluetooth's tolerance for a noisy world is very high; it has built-in security that is rather good; Pricepoint for the chips is right in line; It already has a great ecosystem around it already and it's one of the best, mature radios on the market for [personal-area-network] radios.

The recent Apple iPhone 3.0 announcement seemed to parallel many of Continua's goals. Did Continua have any input into that announcement?

No, Apple is not a member of Continua at this time. Johnson & Johnson's LifeScan is a member of Continua and they have been actually more active in the last year, so we could probably assume from what was announced last week that based on the timing, Apple want to show what could be on the market now and the volume of devices that are out there are not sufficient to meet their needs. As that changes over the course of this year, Apple will become more interested in becoming Continua certified going into 2010, because that volume of devices will be there to make it beneficial.

Apple has always been more likely not to wait for a standard before they adopt technology. There were one of the last to adopt Bluetooth 2 or USB even though those standards had reached a standard in the industry.

So, what we can expect from Continua in the year ahead?

Version 2 of our guidelines is well on its way. Some of the new things going on: There is another radio selection that's going on. A lot of the work toward choosing it is beginning in Barcelona at a summit this coming week. That radio selection will be predominantly geared toward the health and fitness devices that are typically body worn. The shoe pods, heart rate straps and other things that are body worn sensors. Being able to connect those to a cell phone or a fitness watch or the broader Internet. There are a number of candidates for this radio technology: Bluetooth low power is on the list; Zigbee is on the list; ANT+ is on the list; BodyLAN is on the list. There are several of these low-power radios. So that radio selection is going on this next week and then the other use cases being address via low power radio are the sensors that might be distributed throughout the home of an elder individual, for example. The bed pressure sensors, the motion detector sensors and so forth. That radio selection process is also scheduled to begin soon. It's possible they could both be the same technology, but because the use cases are different there is an option that there could be two separate radio technologies. We will make some announcement on that once the decision is made, but it will take a bit of time for us to put some messaging around that.

Finally, let's review: Why should a company that already has a product out there with Bluetooth connectivity enabled consider updating their offering so it's in-line with Continua's guidelines and has Continua certification. What's the benefit?

Continua does provide a reference source guide library, so member companies have access to and can download over a $1 million worth of source codes from our library, which can be used to get in-line with Continua's guidelines. Today, as you are well aware, each of the devices sold by individual companies have their own individual protocol and so they are largely published, not specifically proprietary, but they are still different. So it's difficult for cell phone makers or PC makers to bring these devices into a user experience because for every single device they have to write a driver and build a proprietary interface. The Continua protocol reference source codes remove that. Build one interface for the cell phone and it can talk to all the blood glucose monitors, weight scales, pulse oximeters and so forth that are also Continua certified. If a company already has a Bluetooth enabled personal health device in the market, they still have this issue of interfacing with all the different host devices with their somewhat proprietary Bluetooth interface. That can be a hard thing for a single host device to do for one, single device. Continua removes that barrier so everyone can mix and match and build on one interface.