EMR safety still a concern, resulting from poor design

As Electronic Health Records (EHR) systems become more widespread, issues of poor design, and the consequences of that, take on a higher profile. This is especially true in hospital systems, which often are built using legacy, locally-installed client/server technology, geared to being self-contained (rather than interoperable).

A recent article in the Huffington Post highlighted that as hospitals shift towards EHR usage, these systems are showing signs of patient harm resulting from flaws in their design and use. In particular, Computerized Physician Order Entry (CPOE) systems have been the center of attention in these concerns.

As reports of patient harm have emerged, the Food and Drug Authority (FDA), which regulates medical devices of all sorts, has started to look at EHRs from a product-safety standpoint. As we commented previously, such potential efforts by the FDA to regulate EHR safety (and in particular, the safety of hospital-based CPOE systems) seems to run counter to the intent of the Office of the National Coordinator for Health IT (ONC) in its efforts to encourage the widespread adoption of EHRs, and grant incentives for use starting in 2011. The question of which federal agency should be responsible for the assurance that EHRs are safe and effective has yet to be worked out – we have proposed that the ONC, which is developing rules for HHS Certification, should be responsible for this, rather than the FDA.

Looking into exactly what kinds of features of CPOE systems seem to be the most common culprits, the Huffington Post article reports that most of the reports filed by physicians alleged malfunctions or poor designs of Cerner’s CPOE equipment. One criticized “user unfriendly interfaces” and screens with a small font size and “extraneous and distractive” information that had led pharmacists to overlook changes in medication orders. Another report described how health care personnel had trouble reading orders on the computer screen – causing a “life threatening acute asthma attack” in a patient given the wrong drug.

Poor user interfaces (UI) - the look of the screens, and the selection of what data is important to display to the specific user (which may be different, depending on the role of the user) – seem to be at the heart of “poorly designed software.” This is not surprising, with legacy systems as are commonly found in hospital settings.

The National Institute of Standards and Technology (NIST), having recognized that bad UI is an issue that needs addressing in order to better assure the safety of EHRs in use, has been studying this matter. The NIST has been focusing on the specifics of EHR certification criteria – the “open book test” that will be used by whichever ONC-Accredited Certification and Testing Body certifies an EHR (none have yet been certified, as the process of defining the criteria is not yet completed, and no ONC-ACTBs have yet been designated). Now the NIST has announced a summer workshop on Usability in Health IT, focusing more specifically on how to better define “acceptable UI” and minimize the kinds of risks identified which result from “bad UI.”

In the realm of ambulatory EHRs, like Practice Fusion’s EMR, the use of web-based technology, and meticulous attention to the user experience, has been more successful in overcoming UI issues (and the safety concerns that result from them). Modular, interoperable web-based products, which are the basis of all Health 2.0 technologies, are in a much better position to solve the “UI problem” than might be the case for traditional legacy technologies often found in hospitals.

The problems of safety, as noted in the Huffington Post article, are important – but also need to be put into their proper context. Complex hospital-based systems, and in particular CPOE systems that suffer from “bad UI,” need attention – our view is that the ONC, with the assistance of the NIST, is in a better position to do this effectively, rather than the FDA. And the lessons of ambulatory web-based products (both physician-facing and consumer-facing) can serve as powerful lessons on how to build better hospital systems. In the meantime, we will continue building a robust ambulatory web-based EMR that is an example of “good UI” and set the expectations of physicians in what they look for (and demand) in their health IT products.

Robert Rowley, MD
Chief Medical Officer, Practice Fusion, Inc.