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EHR Design Talk with Dr. Rick 6/20/12

Special Edition: The ONC/NIST Workshop on Creating Usable EHRs — Part 2

If you ask clinicians which aspects of their EHRs drive them nuts, many can tell you in some detail. On the other hand, if you ask them how to improve those EHR designs, most cannot articulate the issues in ways that would lead to fundamental change. Relying on focus groups and implementing user requests turn out to be similarly unproductive.

If these methods don’t work, how should one design EHR software that meets the goals and needs of its users and thereby improves healthcare?

There are no simple answers. After all, EHR software is a very new cognitive tool.

An alternative to asking users for advice and feedback is to apply rational design methods collectively referred to as User-Centered Design (UCD). This was the focus of last month’s ONC/NIST Workshop.

Since my last post, I’ve been thinking a lot about the term User-Centered Design because it has two distinct definitions.

On the one hand, it can mean design based on our understanding of how the human brain best takes in, organizes, and processes information — in other words, Human-Centered Design. By this definition, UCD encompasses not just usability testing, but also the findings and methods of a number of related fields, including interaction design, data visualization, cognitive science, and human factors.

On the other hand, the term User-Centered Design can refer to a relatively codified method of software design that places emphasis on setting user performance objectives, conducting iterative user testing during development, and ultimately performing formal summative usability testing to evaluate the end product.

I prefer the first definition because it places more emphasis on the design process itself. A design process that brings together the findings and methods of several fields is more likely to foster innovative solutions. One comprehensive design approach I particularly like is Goal-Directed Design, as described by Alan Cooper, Kim Goodwin, and colleagues in their complementary books About Face 3 and Designing for the Digital Age.

The next question is what role, if any, should ONC play in regard to User-Centered Design and EHR usability. There are two basic philosophies on how to improve EHR design and safety.

One approach is to encourage innovation by allowing market forces, including those created by disruptive innovation, to work. The other approach is to regulate the evaluation process — for instance, to require summative usability testing, to have the FDA regulate EHRs as medical devices, and so forth.

While everyone wants safer EHR designs, in practice it’s not clear to me that more regulation will help. Because of the complex and interactive nature of software user interfaces, evaluating the safety of EHRs is orders of magnitude more difficult than evaluating the safety of physical devices.

An EHR can follow a long list of guidelines, pass all kinds of usability testing, and still present the user with terribly problematic interfaces. After having studied the NIST, AHRQ, and HIMSS documents related to EHR usability, I don’t see how mandating formal usability testing is going to make EHRs safer.

For one thing, one usability guideline inevitably conflicts with another. Furthermore, while summative usability testing is reliable and yields quantitative data, exactly what gets tested is highly subjective. Third, evaluating the safety of EHR software is a moving target, as the software development tools, the design patterns, and the platforms are all changing rapidly.

It is clear that ONC has been considering the role it should play in regard to EHR usability. While we don’t know what ONC’s final rules on User-Centered Design will be, we can glean some information from last month’s workshop.

In their presentations, National Coordinator Farzad Mostashari and ONC’s recently appointed acting Chief Medical Officer, Jacob Reider, made the following points:

It would appear this same perspective is reflected in ONC’s March 2012 Notice of Proposed Rule Making (pp. 13842-3). First of all, ONC proposes to limit the UCD process to eight certification criteria, all related to the high-risk area of medications. Secondly, the notice states:

… we believe that a significant first step toward improving overall usability is to focus on the process of UCD. While valid and reliable usability measurements exist … we are concerned that it would be inappropriate at this juncture for ONC to seek to measure EHR technology in this way … Presently, we believe it is best to enable EHR technology developers to choose their UCD approach and not to prescribe one or more specific UCD processes that would be required to meet this certification criterion.

Unless innovative designs are allowed to emerge, the next generation of EHR user interfaces will continue to have all the major usability problems of our current ones. From my perspective as a physician EHR user who also thinks and writes about EHR design, I’d say that ONC got its User-Centered Design policy just about right.

Rick Weinhaus MD practices clinical ophthalmology in the Boston area. He trained at Harvard Medical School, The Massachusetts Eye and Ear Infirmary, and the Neuroscience Unit of the Schepens Eye Research Institute. He writes on how to design simple, powerful, elegant user interfaces for electronic health records (EHRs) by applying our understanding of human perception and cognition. He welcomes your comments and thoughts on this post and on EHR usability issues. E-mail Dr. Rick.