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Sharon Fisher

Standards Certification Critical for Healthcare Devices

Written by Sharon Fisher
2/28/2013 35 comments
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As medical equipment gets increasingly computerized and interactive, some of us may flash back in horror to the early days of computing, a time when trying to get computers to talk to each other was fraught with uncertainty.

When it's hard enough to get a couple of computers to work together, even if they're from the same vendor, how do you get a couple of pieces of completely different pieces of medical equipment from different vendors to communicate?

"Well, they'll just use standards," you say.

But anyone who's followed their mom's recipe to the letter only to find out it just doesn't taste the same knows that two vendors can follow the exact standard and still find their products don't converse. This is bad enough when you're talking about two computers, but far worse when you're discussing a couple of pieces of equipment that might well be keeping someone alive.

That's what's useful about companies like ICSA Labs, which partnered with IHE USA, a nonprofit organization that drives adoption of standards-based interoperability to improve patient care. The two are working together to test and certify medical equipment to make sure it can interoperate.

"The ability to share data across patients in an organization, and especially beyond the organization's walls, is definitely not where we want it to be," says Joyce Sensmeier, president of IHE USA as well as vice president of informatics at the Healthcare Information and Management Systems Society (HIMSS). This is particularly an issue with the recent emphasis on electronic health record (EHR) systems, she says. "The ability for any clinician to access information about patients, wherever that information resides, so there can be continuity of care, is the ideal."

The Connectathon, held in Chicago at the end of January, was set to include 150 vendors coming to test their systems against each other, Sensmeier says. Similar events have been held for the past decade.

In addition to the testing itself, what's new this year is the ability for vendors to earn a certificate that demonstrates their compliance with the standard and interoperability with other medical equipment products that support standards, says Amit Trivedi, program manager for healthcare at ICSA Labs, in Mechanicsburg, Pa. "What we're doing is overlaying our processes, accredited by the American National Standards Institute, as a certification body," he says. Once a product passes the normal Connectathon tests, it then undergoes certification testing and the results go to an independent certification body. "It's giving end users additional confidence that the product will do what it's labeled to do," he says.

Trivedi expects about 10 percent to 15 percent of these vendors to go on to become certified, which he says costs from $5,000 to $15,000 depending on how many profiles they're testing.

Now, ICSA has also been accredited to certify vendors for the 2014 Edition, Stage 2 certification program, which mandates additional requirements for organizations providing EHR services. These requirements include a strengthening of security, enhanced interoperability for facilitating health information exchange, better protection of private patient information, and new ways for providers to become "meaningful users."

Meaningful users -- that is, organizations that perform a certain amount of actual work in EHR rather than just going through the motions -- are eligible to receive incentives from the government that total up to $25 billion over several years, Trivedi says. The government is doing this to encourage vendors to support EHR.

Ironically, this all parallels the development of computer communications itself, where Dan Lynch and his company, Advanced Computing Environments, organized what became an annual conference called Interop, which featured a bake-off -- coincidentally also called Connectathon -- that allowed developers to cross-test their implementations of TCP/IP against each other. (This also led to the t-shirt, "I know it works -- I saw it at Interop," which led to the t-shirt for the Interop Network Operations Center staff, "I know it works -- I fixed it at Interop.") In 1989, for example, the fourth Interop drew almost 10,000 people.

Certification and testing hope to avoid a similar fate in the world of computerized healthcare devices.

Related posts:

— Sharon Fisher, @slfisher, is a veteran computer journalist who has been on staff at InfoWorld, CommunicationsWeek, and Computerworld. Her freelance work has appeared in numerous publications and online sites.

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Alison Diana
Thinkernetter
Monday March 4, 2013 3:19:34 PM
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This was a children's hospital - Arnold Palmer Children's Hospital - but they have a related Winnie Palmer's Women's Hospital next door that, I've been told, uses the same security procedures. Of course, it has a maternity wing so hospitals always use stringent processes for newborns. I guess they just use the same system throughout. 

slfisher
Thinkernetter
Monday March 4, 2013 1:14:25 PM
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That would make a lot of sense. I do wonder, though, how much delay that might introduce, and how it could affect patient care.

slfisher
Thinkernetter
Monday March 4, 2013 1:13:09 PM
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You know, I disagree with that. One could have said the same thing about TCP/IP in the Internet era, and it didn't take long for vendors to realize the benefits of interoperability. For one thing, not every vendor can make everything, and for another, they have to accept that most organizations are going to have a best-of-breed solution. Even IBM eventually saw the light on TCP/IP. :)

slfisher
Thinkernetter
Monday March 4, 2013 1:09:45 PM
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That's kind of what this whole ICSA effort is about -- doing the testing and doing certification. But yes, we need an IETF for medical equipment.

DHagar
Thinkernetter
Monday March 4, 2013 1:07:00 PM
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Very true, on device provider self-interest. Dr. T.  That's why if we win over the hearts and minds of the physicians and the contribution to patient care, we will build a stronger advocacy for standards and better healthcare devices.

DHagar

DrT
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Another reason why we do not have standards utilized on different devices and apps just because providers do not see any benefit for it, they want to sell their own product not the one that can work with all others.
DrT
IQ Crew
Sunday March 3, 2013 2:10:34 PM
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One way to communicate different system for EMR/EHR point of view is to have a middle tier that can do the translation. Many of those systems are written in a different platform and have different architecture, a middleware would help to interconnect them.
DrT
IQ Crew
Sunday March 3, 2013 2:07:16 PM
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There are lots of standards on different technologies but no specific body is really enforcing them properly that is why we end up with many devices and applications which are incompatible with each other.
slfisher
Thinkernetter
Friday March 1, 2013 10:06:56 PM
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Is it like that for visiting everyone, Alison, or just kids?

Alison Diana
Thinkernetter
Friday March 1, 2013 9:55:38 AM
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I was amazed at the security involved in visiting a child in the hospital. The guard scanned my license, took my photo, and printed a stick-on badge that featured my mugshot and a barcode. This was at Arnold Palmer Hospital in Orlando. The girls with me (we were visiting their friend who has leukemia) all wore the same badge that stated they were "mine." When we returned a week later, I flashed my license and the same badge printed out.

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