Medical Device Daily Contributing Writer
BERLIN — No medical device is an island. At least no medical device can much longer remain isolated from a medical community's information technology (IT).
Data captured by a heart monitor, an ultrasound scan or a glucose meter increasingly will be required for a patient's electronic medical record and at some point will be exchanged through networks to be consulted by a distant medical team providing treatment
Currently much of the data coming from different devices is incompatible with the standards used for record exchange beyond a practice group or a hospital center.
The emerging international response is a method called Integrating the Healthcare Enterprise (IHE) that after nine years is becoming a reference used for European requests for proposals that in some case can make or break sales of devices.
"Five years ago IHE was not a big deal with customers," said Uwe Spielmann, a product manager for PAC systems with Siemens Medical Solutions (Erlangen, Germany). "Today, at least in Germany, there are lots of tenders requiring specific IHE profiles so that a customer can be very sure his workflow processes are covered by new equipment."
Rick Stevens, head of the IHE Development Team for IBM (Armonk, New York) said, "For years IHE has been preaching the benefits of interoperable standards. Now it is much more customer-driven and we are seeing requests for proposals coming in with IHE specifications required." He added, "Canada, like Europe, is very much up to speed with IHE [and] the U.S. is starting to get some movement."
Stevens and a team of engineers from IBM were in Berlin for the European Connect-a-thon, a week-long event held during eHealth Week in mid-April and providing an opportunity to test the compatibility of new IBM software with products from other companies.
In an adjacent hall of the Berlin Messe, an all-German healthcare IT exhibition was held concurrently, offering massive booths from major companies displaying the most recent versions of products for medical imaging, archiving, practice management and hospital information systems.
The Connect-a-thon event offered a stark contrast, set in an unadorned warehouse space with long banquet tables where more than 300 engineers were huddled over laptop computers testing products by connecting to competitive systems.
Each new system is required to connect and interoperate with three other systems. If the product, for example, is an archiving program the engineers need to demonstrate the software can pull data from other systems and correctly organize the records. If the product is a data capture system, such as a diagnostic imaging unit, the engineers must demonstrate their software can correctly push the data for use by three other systems.
"There is a very colorful mixture here of languages, companies and products," said Dr. Marco Eichelberg, with the Offis Institute for Information Technology (Oldenburg, Germany), an eight-year veteran of IHE and one of the organizers of the Berlin Connect-a-thon.
Eichelberg assisted as a monitor for the Chicago Connect-a-thon, held in January. He also will serve as a monitor for the Asian Connect-a-thon to be held in November, although the site for that event is not yet determined.
"At the European event there are, generally, smaller companies and more niche vendors," he said. "Companies participating in Europe are developing products for a very different market from the U.S., with different country requirements for reimbursement, data protection, security and quality assurance reporting."
Yet while the systems and requirements differ, the shared parts of most programs are 98% similar, Eichelberg said. For example out of 2,000 pages in the IHE technical framework document, he said the section specific to Germany is four pages. This national extension deals with the different alphabet character set, patient registration and billing processes.
At the Berlin Connect-a-thon, a series of tests was available between virtual countries to assure cross-border interoperability for new systems
"It takes a full week for Connect-a-thon because vendors have to perform multiple tests and a single test might take all day," Eichelberg said. "Normally a new product has a series of 20 tests. One vendor here has 180 tests to perform this week."
An image archiving system, for example, "needs to talk to a printer, receive patient demographics and may need to connect to a regional system," he said. "If it is an X-ray unit, then the vendor needs to demonstrate that it displays correctly and shows the heart in the correct position."
InterComponentWare (ICW, Waldorf, Germany) was at the Connect-a-thon testing a hospital networking system using HL7 in both versions 2 and 3. Dirk Schumann, chief spokesman for ICW, said the system uses existing standards to connect legacy systems. "That's why we came," he said. "It is an opportunity to be sure our system adapts and works with other systems the way we intend it to do."
Engineers from GE Healthcare (Waukesha, Wisconsin) were huddled around a radiology imaging unit feeding source data into the laptops of competitors testing the compatibility of their systems.
"We used to have massive racks with people bringing large pieces of equipment, for example the part from a scanner that generates the image," said Eichelberg. At recent Connect-a-thons, engineers only needed to open a laptop and connect to an IP address to continue tests, either pushing or pulling data to links verified by the IHE monitors, he said.
This was the first Connect-a-thon for Paul Neururer, an information engineer with Synedra Information Technologies (Innsbruck, Austria), who said, "It was hard to get started on Monday, finding people to agree to test our product," an archiving system. On Thursday, Neururer said he had run 18 tests and was pleased. "The product works correctly, with only one test to go," he said.
"If something breaks, that is good," Eichelberg said. "These are all engineers, and they like to solve problems. Here the competitors take off the gloves and work together. Usually by the next morning the problem has been fixed.
"By comparison, if a customer discovers a bug once the system is installed in a hospital, the customer would be lucky if the problem was solved six months later," he said. "It serves as a kind of peer review to a certain point. We do not look at each other's source code, but there is an openness between competitors."
IBM's Stevens said, "In a week we test against 30 other vendors, pushing and pulling data. Where else can you do that?"
Stevens said that last year at an IHE demonstration event, he watched 51 vendors set up as three different virtual healthcare communities. "Everyone arrived for the set-up on Saturday and by Sunday all 51 were up and running," he said. "That is very impressive."
The benefit of IHE, he said, "is to give the customer more flexibility, more choices for systems as they are no longer looking at a single vendor, and it lowers the cost of deployment.
"So much of healthcare is a collection of products, and IHE is about how they are working together," he said, adding that the number of projects where vendors are being asked to share data across competing systems is increasing. "At some point this is going to extend beyond just community systems and become nationwide. That is the end-game."
Dirk de Langhe, market research manager for Agfa Healthcare (Mortsel, Belgium), said that the movement for interoperability grew out of the radiology practice and that Agfa has become an enthusiastic supporter of open standards as a result. "It is creating business," he said bluntly. "The days of a company sitting on its island are over."