User-Centered Design and Patient Safety: The Health Information Technology for Economic and Clinical Health (HITECH) Act
Hospitals and physicians have to implement and use (as in meaningful use) a certified EHR if they want payment incentives from Medicare and Medicaid. A proposed new rule for certification and meaningful use of EHRs is now publicly available. And there is good news for us lovers of user-centered design and improved user experiences with EHRs. First, some background.
Background: Medicare and Medicaid Incentive Programs, and the ONC HIT Certification Program
A certified EHR has passed specific tests administered by CCHIT or other ONC-authorized organization, primarily functionality tests. For example, does the inpatient EHR check for drug-drug and drug-allergy interactions? Does it maintain a current problem list for the patient? Does it provide computerized provider order entry? Can it maintain confidential data and work with other systems?
None of the required testing involves usability. (though CCHIT has an optional usability evaluation process for ambulatory EHRs). Usability is about to take a leap forward for the medical profession.
Methodology for Usability
"the proposed rule proposes certification criteria that are intended to improve patient safety through the application of user-centered design processes and adherence to appropriate quality systems principles"
The ONC (Office of the National Coordinator for Health IT) wants a user-centered design methodology to be part of the development effort for certified EHRs. That's good, very good. Following a methodology that includes input from users increases the chances that the resulting EHR will be successful at decreasing errors and boosting the productivity of physicians and nurses.
"But wait" you might say. "A methodology does not guarantee that an EHR is better." Yes, you're right. Ideally we want EHRs with measurably better productivity, measurably better error rates, and measurably faster learning times. However, no EHR vendor in their right mind will publish the results of their internal tests. Any bad results would be bad for business. And we don't yet have Consumer Reports evaluating EHRs.
Someday we will have an easy-to-use scorecard for selecting an EHR that takes into account measurable outcomes, including prescribing errors, provider efficiency, and time to learn. Until then we can feel pretty comfortable knowing that our EHR vendor followed all the right steps that should lead to a better, more usable EHR – observing practitioners, creating personas and scenarios of use, conducting usability tests throughout the methodology, and iterating on the design.
Efficient and Effective Use of EHRs
Office of the National Coordinator for Health Information Technology (ONC) and the Agency for Healthcare Research and Quality (AHRQ) want to have a process for measuring and evaluating the usability of health IT systems
The proposed certification criteria are called: 2014 Edition EHR certification criteria
These certification criteria seek to enhance care coordination, patient and family engagement, interoperability, and the security, safety, and efficacy of EHR technology (The permanent certification program will be called ONC HIT Certification Program)
A new criterion for EHR certification is called 'safety-enhanced design.' This is a smart move, since everyone agrees on improving patient safety. You've probably read that medical error is a leading cause of death in the US, some say it's in fifth place at 98,000 deaths each year.
"We believe that a significant first step toward improving overall usability is to focus on the process of UCD"
but limited to eight certification criteria:
- § 170.314(a)(1) (CPOE);
- § 170.314(a)(2) (Drug-drug, drug-allergy interaction checks);
- § 170.314(a)(6) (Medication list);
- § 170.314(a)(7) (Medication allergy list);
- § 170.314(a)(8) (Clinical decision support);
- § 170.314(a)(17) (Electronic medication administration record);
- § 170.314(b)(3) (Electronic prescribing); and
- § 170.314(b)(4) (Clinical information reconciliation)
These eight areas are responsible for the most errors and offer the greatest opportunity for preventing errors and improving the users' experience with EHRs.
While there is no singular model of UCD, the instantiations embody the following principles:
- Understand user needs, workflows and work environments
- Engage users early and often
- Set user performance objectives
- Design the user interface from known human behavior principles and familiar user interface models
- Conduct usability tests to measure how well the interface meets user needs
- Adapt the design and iteratively test with users until performance objectives are met
Surprisingly, the proposed rule lets EHR vendors choose the specific UCD process(es) they will follow. This is the big fault. One EHR vendor could use just one UCD process, say understanding user needs, while another EHR vendor could use several UCD processes (usability testing, contextual inquiry, iterative design changes, designing with usability best practices, summative usability testing, and employing a usability standard). Both would meet the certification criterion. It's a pass-fail test. And if a vendor does anything, they pass. Imagine a student attending a physics class and choosing just one assignment to complete and passing the course. Not the engineer I want designing bridges, if you catch my drift.
Vendors could provide documentation showing that they have been following UCD processes. That counts as a pass for this criterion. Other vendors who had not been following UCD processes would have to prove that they had been using them before they could be certified.
Surprisingly enough, the results of any usability testing used for certification would be publicly available. That will certainly get the attention of EHR vendors who want to keep proprietary information private, and avoid opening their kimonos to the world.
Watch for screams from EHR vendors on the results of usability testing. But if that's the only requirement to be removed from the proposed rule, then it's a win for physicians and consumers. We still get a user-centered design methodology. Perhaps usability scores for EHRs are not so far away.