When How is More Important than What

William HymanWilliam A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University, w-hyman@tamu.edu
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A prevailing feature of Meaningful Use (MU) is that certain things must be done by or with the EHR. Even if we assume that at least some of these dictated things are in fact important, the need to do them within or from the EHR has replaced the merit of simply doing them. An example here is the report of a physician who could document that she gave certain written healthcare information to all appropriate patients, but she did it the old fashioned way, by thinking it was valuable to do so and always remembering. She did not need and did not have to rely on a prompt from her EHR. If her EHR did provide such a prompt, it would have been just one more prompt among many, or perhaps among too many. Such a prompt would not have improved her performance, nor improved the patient care she was providing, nor would it have been of any benefit to her patients. The MU question then is did her actually doing it, and her documentation of actually doing it, mitigate the fact that she wasn’t doing it as a result of an EHR prompt? The answer in the world of regulation, of course, is no. Actually doing is what matters. The only thing that matters in Regulationville is the process by which it was done.

In this anecdote an EHR prompt would be of no value, other than meeting meaningful use. But should we just do a collective eye-roll and make sure all of the required prompts occur just so we can say yes they are there? The practical answer unfortunately, barring changes to MU, is yes. The better answer is to remember that prompt fatigue is a recognized problem. At some level more prompts do not enhance performance and in fact may degrade performance. This degradation can spread from the specific prompt to prompts in general to overall unhappiness with, or perhaps hatred of the EHR.

I am reminded of when the FDA created the medical device Design Control regulations that dictate a specific sequence of design steps. These steps parallel what was otherwise recognized as good engineering practice. In this regard the FDA did not invent good engineering practice, but they did create a specific regimen with named components. Admittedly, unlike much of MU, the FDA regulation did say you could do it another way, if you proved that it was equivalent. However few companies decided to go this route because of the ongoing compliance and inspection burden it would create, along with always educating the inspector.

A VP of engineering for a medical device company that I knew, who did in fact practice good engineering, was concerned that converting their documented methodology to the FDA way was going to be burdensome and of no value, but of course they were going to do it because a requirement is a requirement. At risk of undoing my argument I will admit that six months after they were doing it the FDA way this VP said to me “You know Bill, we had our first Design Review meeting <a required formability under Design Controls> and it was good!”. So maybe some process regulations do bring value, but the question remains of which ones, and is there flexibility that allows effective alternatives.