Should the Feds Certify EHR Usability?

In an interesting turn, the Commerce Department’s National Institute for Standards and Technology (NIST) says it is looking to develop standards for evaluating ease-of-use of health IT systems. This raises some questions about the appropriate federal role in guiding the evolution of Electronic Health Records (EHR) systems – should the feds be specifying “usability standards” in the first place?

The NIST notice is currently very preliminary – they are simply looking for companies with expertise in quantifying and measuring Usability in health IT systems. However, the NIST has been charged with developing the specific testing and process documents that will be used (by organizations yet to be selected) to certify EHR systems. The overall policy and specification about Meaningful Use of a Certified EHR, which is needed to access ARRA stimulus moneys available beginning in 2011, have been published for open commentary. However, the specific nuts-and-bolts of certification is being hammered out by the NIST. They have already contracted with Booz Allen Hamilton to help with this process.

So, why would the NIST be interested in evaluating Usability, given that this is not one of the criteria specified in the Certification guidelines? Poor usability has been cited as one of the main impediments to EHR adoption (besides cost), and stimulating EHR adoption is one of the central goals of the Office of the National Coordinator (ONC) for health IT. Historically, CCHIT (the exclusive legacy certification body prior to ARRA) did not include Usability as a certification domain – too difficult to quantify and test. The result has been that many large, legacy health IT systems are so cumbersome – have such poor Usability – that they are prone to mistakes (not from lack of data, but from bad presentation of that data to the end-user).

Iowa Senator Charles Grassley has turned up the heat on legacy vendors for exactly these kinds of failures, sending a letter of inquiry to Cerner Corporation last fall. In a follow-up, Senator Grassley sent letters to 31 hospitals demanding an end to traditional “gag orders” and asked them to report any problems they experience with their EHR systems (or face penalties by 2013). Perhaps it is this kind of pressure that is motivating the NIST to consider developing Usability criteria for EHR certification.

Usability is certainly a factor in the selection of an EHR system – in fact, approaching EHR selection from the standpoint of “Usability, Interoperability, and Affordability” is something we have encouraged all along. However, there is a difference between Usability being something that the market will determine, and Usability being something that is specified by federal certification guidelines. The market moves quickly, and innovation is able to rapidly respond to end-user features and “usability requests” – witness Practice Fusion’s web-based EHR, which can evolve and adapt very quickly.

Granted that some legacy vendors (with a large, established install-base) may take months and millions of dollars to make an important change, but forcing such a change via regulation, as opposed to market competition, is not likely to move the market forward very effectively. Yes, one could argue that rip-and-replace of a poorly-functioning EHR with a better, newer one is more burdensome than getting the existing vendor to make improvements – but this happens all the time in every industry (painful though that process is). Should the feds be a party to such decisions?

It is our opinion that Usability is an important factor in EHR selection, and such selection is determined by the market. Market factors will result in faster development of high-quality EHRs than a process regulated by the feds. The federal rule-making process is susceptible to influence by established well-funded corporations who have an interest in the status quo. While it is interesting that the NIST is considering input from expertise around quantifying Usability, it is uncertain that a federal-regulatory approach will be effective. We will be watching this development with interest.

ROBERT ROWLEY is the chief medical officer at Practice Fusion, a San Francisco based company.

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Lavinia Gene WeissmanMargalit Gur-ArieMD as HELL Recent comment authors
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Lavinia Gene Weissman

I was heavily involved with the NIST activity in the Bay Area during the Clinton Administration that resulted in the creation of the Bay Area Regional Technology Alliance (BARTA) and the Silicon Valley Joint Venture. Here is my report card. 1. At the early stage of Silicon Valley Joint Venture, Pac Bell produced with medical staff from the Bay Area a feature presentation that promised telemedicine deployed all through the Bay Area. Score: This was 1994, I don’t believe there is such a highway in practice. 2. There were 23+ initiative authored out of the Joint Venture, by the time… Read more »

Margalit Gur-Arie
Margalit Gur-Arie

Usability is very much like beauty, and therefore it is in the eye of the beholder. Usability, just like beauty, can be approached from many directions and most are subjective. Does a great personality trump external looks? For some it does, for others, not so much. Is intelligence and vast knowledge more important than table manners? Maybe. Is blond better than brunette? If the Feds feel compelled to intervene in the look & feel of software, the most they should do is publish some commonsense guidelines and recommendations, to help vendors. The ultimate choice should be left to the market.… Read more »


No. But they should be liable for the injury they cause patients.