What motivates an EHR to change and improve?

Posted on June 7, 2012 by Robert Rowley

A recent article in The Health Care Blog about how some Electronic Health Records (EHR) systems are poorly enough designed to where they present bad information, and thus can lead to potential patient harm, got me to thinking. What motivates an EHR to make changes? Are hospital and ambulatory EHRs to be thought of in the same way? Do they respond to change differently?

The anecdote cited in the article concerns a hospital-based EHR – Cerner, in this case. As illustrated by Meaningful Use data on the hospital side, Cerner is one of the 5 predominant EHRs used in hospitals, and “should” be pretty good at what they do. In particular, what was identified as especially heinous was the medication list for a patient:

Looking at this list, something becomes evident: this is a list of prescriptions written for the patient, not a list of the medications the patient is on. As a result, multiple instances of prescriptions for the same medication appear, and there is no way of determining which medications are current and which ones have been stopped.

I have seen this kind of mistake made elsewhere as well. One of the better ways to think of the relationship between diagnoses, medications, and prescriptions is to recognize that they are hierarchically related – a diagnosis can have several medications “under” it, and a medication (which may be active, or may be discontinued) may have multiple prescription events “under” it. Visually, it might best be displayed somewhat like this:

Ambulatory EHRs have recognized this issue and more commonly have addressed it properly (though the mistake of showing a prescriptions-filled list, instead of a medications list, is still made). So the bigger issue is this: how do EHRs make changes and what kinds of pressures motivate them to do so?

Regulation vs. market pressure
The article lambasting the Cerner “medication list” made the argument that this is a bad enough problem that regulation should be leveraged – that EHRs should be regulated like “medical devices.”

Of course, this raises the question of who should do the regulating, if EHRs are to be thought of this way. The FDA has made a case for regulating EHRs for “safety,” like they do other medical devices – but this adds tremendous cost and delay to the development process, and could squash innovation. The Institute of Medicine (IOM) recently reviewed the issue at length and took a strong stance against the FDA regulating EHRs, given their ever-changing nature and the routine individual customization done at every installation site.

Others have argued that market pressure, not regulation, should be what causes change and improvements. After all, product and delivery are the main things that determine any business’ success in a competitive arena.

Perhaps ambulatory EHRs and hospital EHRs should be considered differently. On the ambulatory side, as we have seen, there are hundreds of products competing for physician adoption, with a dozen or so taking the majority of the market share. This is a scenario that lends itself well to market competition, and is a market segment that we have seen blossom with innovation. Federal policy should encourage, not inhibit, such innovation. Best practices, novel data visualizations, and products that actually streamline the workflows that are in place in ambulatory offices are all things that emerge from the competitive landscape seen here.

Hospital products, on the other hand, are a different beast. In part due to the very complex ecosystem that is the hospital environment, EHR products for inpatient use are concentrated in a much smaller array of companies – only 58 products (not 284) were used for achievement of hospital Meaningful Use, and most of the concentration was in 5 different companies (Cerner – the one highlighted by the THCB article – is one of them). Such systems are massive, enterprise installations, and much more difficult to rip-and-replace. The large hospital EHR systems are slow to change – there is little market pressure to do so, their technology is fairly legacy-based, and they are large enough to be heavy-handed (read that “gag clauses” in their contracts preventing detailed public criticism).

Perhaps a regulatory approach is more appropriate in that setting, where market pressures are less likely to cause change. Perhaps it is appropriate to think of hospital EHRs as a different creature, with different market dynamics, than ambulatory EHRs, which exist in a much more open and competitive arena. In the ambulatory space, regulation (if it is done poorly) may severely stifle innovation, and delay the movement to a unified national health IT platform – a key goal of the Office of the National Coordinator for Health IT (ONC). A delicate balance to achieve.

Tags: FDA, hospital EHR, ONC, regulation

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