EHR Usability as a corporate culture for vendors

Posted on June 20, 2012 by Robert Rowley

EHR Usability is a very important aspect influencing the utility of, and adoption of, Electronic Health Records (EHR). The use of EHR systems is moving out of the “early adopters” phase, and is reaching the tipping point where it is becoming mainstream. More often than not, some form of Health IT is being used in medical offices and hospitals across the U.S.

With this rapidly increasing adoption, partly spurred by federal efforts (Meaningful Use) and partly from encouragement from all sectors such as specialty societies, licensing agencies and health plans, experience with how effective (or ineffective) EHRs are in the practice of medicine will increase dramatically. This is a two-edged sword.

EHRs that are designed well can improve healthcare processes and outcomes, and increase patient safety. However, there are also reports in the early literature that show unexpected worsening of healthcare delivery with increased patient harm caused by EHR implementation. Clearly, EHR usability that affects patient safety is critically important.

The NIST weighs in
Numerous national bodies have looked at the question of EHR usability with respect to its impact on safety. The Institute of Medicine (IOM) issued a report on EHR safety, and proposed a way to approach this question (see the IOM report here). The FDA has recognized usability and interface design for medical devices as being an important element of device safety, and has issued guidelines as well (see the FDA guidelines here).

The National Institute of Standards and Technology (NIST), which is the organization that detailed the EHR Certification criteria for Meaningful Use, had issued a Guide to the Process Approach for Improving the Usability of EHRs in November 2012, which described an internal method for EHR vendors to approach product design. At the risk of getting too “inside baseball” on this, the product management approach was more consistent with the Agile approach, rather than the traditional Waterfall approach, stressing nimble, iterative product development cycles stemming from user workflow stories.

More recently, on March 20, 2012, NIST came out with a more comprehensive guideline document for EHR usability assessment. The NIST guidelines are an important step in setting a framework for vendors to assess their products. The guideline document can be seen here, and should be a must-read for every EHR vendor in the marketplace.

The NIST guideline describes an EHR Usability Protocol (EUP) which focuses on usability affecting safety. It does not attempt to create any kind of ease-of-use scoring system (sort of like a “rotten tomatoes” assessment of movies, but for EHRs) – instead, it creates a process for EHR vendors to look at the kinds of “human errors” that users make when they use the EHR in defined settings.

What will be the impact of the NIST guidelines?
The NIST guidelines describe a process for EHR vendors to implement when creating or updating their systems. The Stage 2 Meaningful Use final rules are not yet published (expected this summer), but it would not be surprising to see some form of “usability” testing be part of the new Stage 2 Certification criteria for vendors.

Should it be the same for ambulatory EHR vendors and hospital systems? Hospital systems are large and complex, and have been the primary source for anecdotes of poor usability has impacted patient safety. They are already have an established install base – the EUP appears to be most applicable to systems still in the development shop, and not so much for systems already out in the field.

Owing to the complexity of hospital systems, it may make sense to evaluate each of the pieces of their EHR separately – focus on the usability of the CPOE system first, for example, and then the ICU monitoring system, etc. That may break down the otherwise unwieldy beast into bite-sized pieces, each of which can be looked at individually (from a usability/safety standpoint).

Ambulatory EHRs, being smaller and arguably easier to modify (or rip-and-replace), might take an all-at-once approach to usability evaluation. Certainly, the user-centric approach to product development, seen frequently as the dominant method in web application development, is also seen ambulatory, smaller EHRs – particularly web-based EHRs.

Testing EHR usability – a new challenge
Given that an EHR Usability Process is important, and is a step forward for the industry, and may be part of Stage 2 Certification, how will we implement this? How would one test such a process from the outside? Asking a vendor to demonstrate that they have an EUP process in place might be difficult to achieve for Certification purposes. After all, ONC-ACB Certification is a one-time “pass the test and you’re Certified” step, while the NIST-described EUP is more of an ongoing development process.

Are there outside examples to help us here? Yes – there are other areas of health care where ongoing processes are evaluated: periodic accreditation of hospitals (Joint Commission), and periodic accreditation for Continuing Medical Education (CME). Each of these examples are ways where an outside body evaluates an accreditation-candidate, reviews its written processes and protocols, and makes sure that the organization is following those processes. If passed, the candidate organization is accredited for a specified period of time.

Might this model work for EHRs? A two-pronged approach where (1) ONC-ACB Certification assures that a minimum feature-set is included in the EHR product in order to be deemed Certified, and (2) a “Usability Accreditation” process, which periodically assesses a vendor’s EHR Usability Process, and makes sure the vendor is following those processes.

Who should do Usability Process accreditation, if we go down that path?
At the risk of opening up a whole new can of worms, the obvious question that comes from this proposal is: who should do “Usability Accreditation” anyway? Probably not the ONC Authorized Certifying Bodies – their focus is on ensuring inclusion of a specified feature-set as a one-time pass/fail event. Should it be the Joint Commission? Some other independent body? Should it be from a new breed of “usability consultant” organizations?

No easy answers to this question. But it is one that should be thought about carefully. The NIST guidelines are a helpful approach to guiding EHR vendors in a way that addresses EHR Usability (where it relates to safety). They encourage Usability to be part of an EHR vendor’s corporate culture. But they are hard to assess, making it hard to assure the EHR users (medical professionals) and the public at large (the patients on whom errors can result in harm) that an given vendor is following the EUP guidelines. An Accreditation approach, similar to other accreditation processes in health care, might be a useful one to consider.

Tags: NIST, regulation, usability

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