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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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Michael P. Kassner
Thinkernetter
Thursday February 28, 2013 9:11:37 AM
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If you research the medical field there are many more significant problems than certificates that need to be addressed. It is quite scary, actually: 

http://www.techrepublic.com/blog/security/vulnerable-medical-devices-a-clear-and-present-danger/8892

Alison Diana
Thinkernetter
Thursday February 28, 2013 9:44:41 AM
no ratings

Just read a blog by a doctor who, as I understand it, has been using digital tools that interface with his EMR, a step that's safer and should save his patients and insurance companies money. However, the EMR vendor is charging a large fee for that "convenience," pretty much negating the financial benefits. We need standards to ensure medical devices work together seamlessly and safely; we also need the financial side of this world to buck up and rework its existing model.

B. Krafte
IQ Crew
Thursday February 28, 2013 11:16:09 AM
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I applaud the ICSA Labs/ IHE USA initiative and confident it will be reasonably successful.

However, as important as the standards initiative is, my concern lies with the adoption and deployment of the technology. Specifically, it's the lack of adoption by physician practices, insurance companies, labs, and others in healthcare services that presents the major obstacle.

Jason Adams
IQ Crew
Thursday February 28, 2013 12:51:26 PM
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@Alison, this is unfortunate but when a company see's an opportunity to make more money, they will go for it regardless of the field or usefullness. Hopefully in time these prices will drop and actually become more financially positive for the healthcare industry.

Jason Adams
IQ Crew
Thursday February 28, 2013 12:52:34 PM
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@B. Krafte, I can see where you're coming from. I know having worked in healthcare myself that doctors and other healthcare professionals reject change and one major reason they give is due to lack of time to learn something new so they stick with what they already know and has been working even if it's not efficient.

nasimson
Thinkernetter
Thursday February 28, 2013 12:57:17 PM
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You are right Michael.The advancements in the healthcare industry,which were supposed to drive us and make our living conditions much better, have taken us a step backward due to their vulnerabilities.

 

nasimson
Thinkernetter
Thursday February 28, 2013 12:58:46 PM
no ratings

Despite of making  a product undergo different accuracy tests,Why don't they create a tool just as the CISCO has introduced to detect the imitations of its branded products?
This may help them to overcome many issues of computerized healthcare industry,I suppose.

Alison Diana
Thinkernetter
Thursday February 28, 2013 2:41:09 PM
no ratings

I hope so! But I think some patients are still getting charged $100 for two Tylenol, so who knows?! 

DHagar
Thinkernetter
Thursday February 28, 2013 3:58:06 PM
no ratings

Your points about providers adopting technology is very true, Jason.  In Sharon's article, the excellent outline for standards and interoperability would assist in building systems that can have common platforms, so that the user is learning only the unique application.  Also, standards would go a long way in building transparency against clear specifications - which could reduce the scamming events and truly make healthcare better.

DHagar

slfisher
Thinkernetter
Thursday February 28, 2013 7:56:51 PM
no ratings

oh, man, Michael, that's scary as hell! Yikes!

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