Should EHR usability be regulated?

Posted on June 15, 2012 by Robert Rowley

The question of “usability” of Electronic Health Records (EHR) systems continues to be a topic of discussion. A recent report in iHealthBeat gathers comments from a number of influential expert opinions on the topic.

There are many aspects to the issue of EHR “usability” – not the least of which is a consensus on what defines a system as “usable.” Mostly, it’s been defined by its opposite – we can comment on systems that show poor usability, and from that we might infer what is good usability. Poorly usable systems have been shown not only to slow down workflows and get in the way of efficient medical care, but have also been shown to actually cause patient harm. A recent anecdote from a hospital system raised the question of whether EHRs should be regulated as “medical devices,” given their potential to introduce harm. The concern about poorly designed EHR systems, and what should be done about them in order to ensure public safety, has been studied extensively – the Institute of Medicine (IOM) recently published a report on the subject and came up with a series of suggestions.

We can define “bad usability,” but can we define “good usability?” Is it an issue of standardization of features, like with automobiles that need to have certain elements present (though the details can be different) so that the experience of using one car can be transferred and applied to driving a different car with relative ease? Isn’t Meaningful Use supposed to require a minimum feature set from certified EHR products already – and is that base feature set enough (like with the car example)? Or should there be more?

Ambulatory vs. hospital systems
Most of the examples cited in the literature concerning “bad usability” are hospital-based EHRs. Is it fair to talk about hospital systems and ambulatory systems in the same way?

As we have seen from an analysis of federally-published Meaningful Use (MU) date for 2011, the patterns for ambulatory systems and hospital systems are different. Physicians who were successful Meaningful Use attesters in 2011 used 284 different products; though the top 12 products (each used by over 1,000 MU attesters) represented over 70% of the attesters, with the remaining 30% being spread across the remaining 272 products. In this scenario, there is significant room for innovation, and movement from one system to another. Anecdotes about rip-and-replace for ambulatory EHR products are common (though painful), and this ability by the market to move to “better” products can drive usability.

Hospital systems, on the other hand, are much more entrenched, enterprise systems, and the ability to rip-and-replace one system for another is much more onerous. Among MU attesting hospitals, we see from the same federal data that 59 systems were used by such hospitals, with the top 5 vendors being installed in 72.5% of MU attesting facilities; the remaining 27.5% used one of the other 54 systems. In this kind of setting, market pressures (including better “usability”) are arguably less likely to result in change. Regulatory pressures might be more important here.

Regulation vs. market competition
Another question around improving usability of EHRs is this: where should the impetus to make better products come from? Regulatory requirements, or innovation in the free marketplace?

As we’ve seen from a superficial analysis of the Meaningful Use data, there is still widespread competition among ambulatory products, and the ability of the market (in this case, physician practices) to ditch “bad” or “poorly usable” systems in favor of better ones is an important driver. And perhaps this market-based pressure, coupled with a minimum feature set required from EHRs for Meaningful Use certification, will result in a more standardized experience, like the automobile analogy. At least that can be argued for ambulatory products.

Hospital systems are really a different beast. End-users (hospitals) may be less able to exert market-based pressure (with the threat of rip-and-replace to another system), and thus influence the design and “usability” of their products, once they are installed and experience using them has accumulated. This places more importance on “getting it right the first time” – and addressing “usability” at the front end of the EHR adoption process for hospitals is very important. There are systematic ways of assessing usability, which have been reviewed in the literature.

So… should federal regulation play a role in enforcing “usability?” There is much risk in that. There is risk of stifling innovation, which has been such a large feature of the ambulatory EHR space. There is risk that large industry players will exert sufficient influence on the enforcement process that it will stifle competition (not just innovation) and make everyone “look like me.” The market can drive improvement in EHR usability in the ambulatory space – we have seen that. We should perhaps separate the discussion about usability, and consider hospital systems in a different discussion than ambulatory systems. This remains a hot topic in health IT circles, and will continue to be controversial for some time.

Tags: usability

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