Tina Simpson, JD, MSPH
Principal
My father, a practicing physician and epidemiologist, is a pretty even mannered guy; an academic who can see many sides of any argument and accord a great deal of tolerance and grace in any debate. There is one topic though you can’t get him started on: electronic health records (EHRs) and their impact on clinical workflows and physician workload.
Introduce this topic, and, Reader, be warned: Here there be dragons – or at least a vehement discourse on their respective failings including (allegedly) cumbersome and non-intuitive design, forced task repetitions, and the impact on clinical workflows.
My father is not alone in his exasperation. EHR usability is the great, justified, bugbear of clinicians of any stripe and is a big problem in health care. This is unsurprising as physicians spend two hours working within an EHR platform for every one hour delivering care. Barriers, including, but not limited to, the lack of intuitiveness in workflows and endlessly toggling across disparate tabs, top the list of the greatest issues that providers cite. There is mounting evidence demonstrating the close association between (lack of) usability and increased task load with increased physician burnout. Poor usability also presents safety and quality risks to care delivered, as increased cognitive work load or non-intuitive pathways create opportunities for error. Indeed, a 2021 study in the Journal of the American Medical Association (JAMA) opined that EHR (lack of) usability and correlating increased task and cognitive workload on users is a leading factor in medical errors, noting that nearly 40% of the products evaluated presented an issue with “potential for patient harm.” This doesn’t surprise my father (yes, I bit the bullet and treaded warily into that conversation): “Nothing is easy [in the platform]. Everything takes time. When you add on complexity to any task you create more opportunity for error.”
Now, this is not to say that technology hasn’t presented opportunities to reduce errors and improve care. It absolutely has (I’m #teamtech here.). Technology has such a great capacity to change the way we live and relate to one another; what interests me here, however, is how one of the most fundamental components of modern health technology – EHR platforms – has been developed, implemented, and used without much attention to the human element. Meaning that the focus, particularly as it relates to EHRs and clinical decision support, data analytics, and messaging platforms geared towards clinical use, tends to be on the desired output or task, without a commensurate focus on the preferences, biases, and limitations that a human user brings to the equation. Dr. Chaitany Dahagam, a physician and member of the IBM Watson Health Team put it more succinctly: “The problem is that clinicians have been left out. They have been left out of the decision making, the design of the solution, and they have been told to just take it and use it.”
Ensuring that EHR platforms are an enhancer to clinician users in their clinical workflows and workspace – and not an inhibitor, comes down to a question of design. And if there is anything that we should take from the experience it is this: Design Matters. And you cannot have a well-designed solution, product, or environment without integrating the perspective, preferences, and limitations of the user.
That brings me, finally, to today’s topic – the integration of human-centered design principles (or Human Factors Engineering) within healthcare technology specifically.
As an industry, EHR technology developers and the regulators overseeing them have historically centered their focus on use case (or system requirements and output) of their platforms – without much reference to the user.
There are several reasons for this.
First, EHR platforms generally were designed around revenue management and optimization, and are best understood as mechanisms to capture all billable events. Consequently, optimization within existing clinical workflows is necessarily an ancillary function. The primary, initial selling point for an EHR (including during the “Meaningful Use” implementation phase), centered around revenue management – and the accurate and complete documentation of all the things a clinician did (and could bill for) throughout an interaction with a patient. And – speaking in general terms – platforms excel in that regard.
Secondly, while there is universal recognition that usability is, well, pretty important to effective and safe use, there hasn’t been a standardized, accessible, or enforced metric for measuring and comparing usability across platforms. This is a failure of regulatory oversight. As the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (“ONC”), the organization responsible for certifying EHR platforms, rather sheepishly asserts, usability is among the most difficult characteristics of a software to measure. It is also the most critical. And we haven’t done a great job of integrating usability as a meaningful, transparent, and enforced criteria for (among other things) certification of EHR Platforms.
EHR platforms must be certified by ONC. Since 2015, this process requires attesting that the platform was developed using “user-centered design” and conducting formal usability testing on eight specific EHR functions. Evaluation of the integration of “user-centered design” principles has received a super light touch regulatorily. Vendors must attest to compliance – but until very recently, there has been no requirement to conduct usability testing or user-centered design evaluations in actual clinical environments. Consequently, platforms have been designed, tested, and refined in a vacuum. Furthermore in 2017 (in an announcement that took many in the healthcare industry by surprise, but was consistent with the then Administration’s focus on de-regulation) ONC announced that it would not conduct audits to confirm compliance, relying exclusively on the complaint process.
Passage of the CURES Act and regulatory rulemaking since that time has improved the “accountability landscape” – a little. As of April 2021, vendors seeking to receive or maintain certification by ONC must attest to conducting Real World Testing and submit plans for conducting those tests in each clinical environment a product is marketed for.
This is an important (and too long delayed) step forward, creating a space at the table for the clinician-user. But, while this is progress, I know that many clinicians’ expectations are measured.
Because of course, now we have a legacy problem, illustrating the proverb that a stitch in time saves nine – nine of your metric of choice: 900,000 physicians suffering burnout, billions in redevelopment or implementation trainings or purchased updates, or preventable medical errors?
The bottom line: design matters. Human Factors Engineering, (also known as ergonomics) – it’s about more than posture-centered chairs.
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Tina Simpson was joined by AGG Attorney Lori Wright and UNC School of Medicine’s Health Engineering Department Researcher and Doctoral Candidate Karthik Adapa, whose research in Human Factors Engineering includes the development and validation of a more accurate measure of the cognitive workload associated with the EHR platform used in a clinical setting.