EHR certification: Getting comfortable with the concept

July 1, 2011

An understanding of what certification is and isn't,
how it differs from meaningful use and what long-term benefits it could bring.


Software certification is a relatively new concept for the healthcare industry; therefore, it's created some discomfort. Adding to the uneasiness is the fact that certification is often talked about in the same breath as the meaningful-use requirements emanating from the Health Information Technology for Economic and Clinical Health (HITECH) provisions of the government's American Recovery and Reinvestment Act (ARRA).

An understanding of what certification is and isn't, how it differs from meaningful use and what long-term benefits it could bring could help dispel some of the awkwardness, and get healthcare professionals and providers on the path toward the full realization of technology's potential in healthcare.

Certification: What it is

Plain and simple, software certification ensures that products have been tested to meet certain functionality standards. For example, certification indicates that a software product has registry functions, quality measurement and minimal assurances of interoperability and security.

With respect to electronic health records (EHRs), the Office of the National Coordinator for Health Information Technology (ONC) has defined the criteria for testing this functionality. The government, however, has passed the testing baton to authorized testing and certification bodies (ATCBs).

Currently, six ATCBs are testing software under the ONC's temporary certification program. That program will be in effect until a permanent one is established, which is expected no sooner than January 2012. These organizations will need to re-apply to continue on as testing and certifying bodies under the government's permanent program.

All six ONC-ATCBs use test procedures and criteria for EHR certification that were established by the National Institute of Standards and Technology (NIST). These requirements ensure that EHR systems are uniformly tested and meet meaningful-use requirements as approved by the U.S. Secretary of Health & Human Services (HHS). Upon certification, HHS publishes the names of the certified products on the Certified Health IT Product List.

Certification: Understanding what it is not

Under the HITECH program, certification is not intended to predict how well the software will serve various segments of the market or how well various providers will like the software. Instead, certification simply validates that the software will work in accordance with ONC specifications. Indeed, certification criteria are technical specifications, not user specifications.

As a result, healthcare providers should make sure that their evaluations of potential software solutions stretch beyond simply checking off the certification box. Providers need to make sure that they purchase a system that meets their specific needs and will help them most expediently meet the government's meaningful-use requirements.

In essence, there might be many systems that could potentially help a provider meet a specific requirement, such as clinical decision support — but only a few of these technologies might offer the interface that a provider deems user friendly and compatible with current workflow. And, of course, one system might work well for one provider while a different system could be the right choice for another. As such, providers still need to evaluate products to determine what will ultimately serve their organizations in terms of specialty-focused functionality, features, usability/workflow operations and price.

The difference:
Certification vs. meaningful use

The fact that certification is closely linked to meaningful use has caused an anxiety spike as well. Simply put, certification measures the functionality of EHR software, while meaningful use measures a provider's implementation of the said software. For example, to be certified, an EHR solution has to have the capability to maintain an active medication list. To meet meaningful-use requirements, a provider needs to leverage the active medication list so that more than 80 percent of patients have at least one entry recorded as structured data.

It is vital that providers understand how to implement their certified EHR technologies so that they can meet the CMS thresholds for meaningful use. As such, providers should ask vendors to go beyond simply ensuring that their products offer the functionality required for certification — and also insist that vendors work closely with them to ensure that they can tap into this functionality to meet meaningful-use requirements.

Of course, the issue becomes more complex when providers act as both software developer and implementer. Indeed, many hospitals are in the process of creating their own self-developed EHR systems — and are trying to get them certified under the ONC program. At the same time, they need to deploy this software in a meaningful way to meet the ARRA requirements. As such, these providers need to keep in mind that when they are developing the software, it needs to be able to meet all of the potential meaningful-use requirements, even though the provider might only use a subset of this functionality in pursuit of incentive funds. For example, a certified EHR technology must include functionality for immunization submission and be certified in this criteria even if the provider is not planning on pursuing this meaningful-use menu measure.

Certification: The long-term benefits

Although certification might be causing some unrest as the healthcare industry grapples with the concept, it eventually will bring about plenty of benefits. To start, certification is likely to take costs out of the software development process. When providers purchase a certified product, they have an assurance that the software can deliver on its promises. When providers purchase software that has not been certified, they often need to go back to the vendor to “debug” the solution and ask for modifications, which adds unnecessary costs.

In addition, certified EHR software is much more likely to evolve to be interoperable with other systems and to include security features that protect the privacy of information. Interoperability is poised to play an increasingly important role as these meaningful-use requirements continue to evolve. For example, Stage 1 meaningful use requires that providers demonstrate the capability to electronically exchange clinical information. Additional interoperability requirements are expected to follow in the Stage 2 and 3 requirements.

In the final analysis, certification could also spur additional EHR innovation. As more software vendors meet certification requirements, they will be able to move on and create the innovative features that differentiate their systems and make them ultimately more valuable to end users.

Rik Drummond is CEO and chief scientist of Drummond Group.
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