It's more or less accepted that human behavior is so complex that any attempt to regulate it is bound to have some unintended consequences. By consequence, I mean a negative or undesirable outcome; there is generally little objection to the other kind of consequence, a serendipitous positive result. “Unintended” tends to be equated with unanticipated, but there is clearly a difference. Some consequences come as a total surprise but many are easy to imagine, hence they could have been anticipated (even if they were not) and some may be secretly desired and so, left unstated.
At the most basic level, regulation has a specific implication. Regulation, being a governmental, and hence a societal function, must aim to achieve results that will be widely recognized and accepted as social goods. It is all too easy for an individual or small group to disguise as a regulation, something that would benefit them directly if enacted. Regardless of whether it harmed society at large or had no significant impact on society at all, it would be unjustifiable to commandeer the machinery of society for private advantage.
If proposed regulations that are likely to produce easily anticipated consequences are, nevertheless, adopted, one needs either to seriously question the underlying motivations or attribute them to reckless, anti-social behavior. Perhaps the so-called unintended consequence was actually the outcome that was hoped for — being unable to convince anyone, in a straightforward manner of its desirability, a regulatory scheme is devised that “just happens” to produce as an “unintended” consequence — that which was actually sought in the first place.
If unintended consequences are possible (and when is that not the case)? and, by definition, unpredictable, convincing evidence should be required that the potential gain from a regulation will be so great that the benefit will far outweigh the potential adverse impact of the unknown — a stringent expectation rarely achieved.
Taking the regulatory requirement for the use of certified EHR as an example, how does this regulation fulfill the basic premises?
First it is necessary to identify the potential benefits of certification, or expressed another way, what is the evidence:
* that the items spelled out in the criteria are important?
* that a significant number of products exist that would fail to satisfy the customer's needs due to their absence?
* that the criteria insure that the functions are implemented in a useable fashion?
* and finally, that the criteria insure the long-term viability of the product and the medical record?
What are some of the obvious or easily anticipated consequences of regulation?
First, excellent products may be driven out of the market if they have not yet garnered sufficient market share to generate the income stream needed to offset the costs of obtaining certification.
Secondly, the cost of certified products will increase due to the vendor’s added overhead associated with obtaining and maintaining certification and, to the extent that products are driven out of the market, decreased competition will tend to result in higher prices.
Third, the process of adapting an EHR to qualify for certification may make it harder to use, modify, and maintain leading to decreased efficiency in the practice setting.
Finally, since there is no evidence to prove that products fulfilling the criteria have a lower failure rate than others, the possibility remains that adapting a product to meet the criteria may increase its likelihood of failure — not an outcome that is going to speed up adoption of EHR or allay the fears of those who have yet to adopt.
So how did these criteria originate in the first place, and why are they expressed as they are? The criteria were drawn up by a group of self-anointed experts who believe they (or their organizations) have "good" EHRs and that, therefore, the features provided by those EHRs should become the "gold standard" by which all others should be judged. The experts have not, however, informed us what percentage of implementations fail even though the product fulfilled the criteria. We are supposed to trust them when they assert that each criterion represents an essential function and that products lacking it are doomed to fail.
The sheer number of criteria alone, numbering in the hundreds, suggests that not all can be equally important or relevant for a particular setting. Even the committee recognizes this. Separate sets of criteria are being prepared for inpatient, ambulatory, ER, ICU, and long-term care settings — and given time, no doubt, there will a different set for each specialty in each setting. Early experience must have already validated the assertion that many of the criteria are irrelevant or unimportant in some settings because the number of different sets of certification criteria is growing. Once the number of different types of certification reaches a threshold, it begins to beg the question of why every practice or practice setting shouldn't have its own set of criteria (oh, I forgot, that is what we used to do before certification).
Instead of reconsidering the entire concept, the committee is taking the six-million-dollar man approach: "We can rebuild him! Make him stronger and faster than he was before." We can solve the problem of mushrooming complexity by adding yet more complexity to the certification process. It gives the appearance of being an expensive attempt to save face and to validate both the committee and the notion of certification as essential.
The most significant consequence of certification is so obvious and certain that there is no way it can be considered unexpected or unanticipated. Certification provides existing products, good or not, with an invisible shield of protection and a franchise to print money. Certification creates a significant barrier to the entry of any new or innovative technology into the marketplace. It relies on those existing vendors, the ones with the most obsolete, petrified technologies to be the source of breakthrough conceptual and technical innovation. In short, certification will set progress in EHR back by however many years it remains in effect.
The EHR certification regulations, therefore, present a conundrum. The process by which the certification criteria have become regulations does not meet the criteria by which anything should become a regulation, and yet these certification criteria are supposed to be accepted as useful and correct merely because they are now officially regulations. It may very well be that over the next few years the basic goals of EHR envisioned by healthcare reform of better quality and safety, lower cost and the practical and routine of the exchange of patient charts and data between practitioners will be achieved. The burden will still be on those who devised the certification criteria to demonstrate that the good outcome was actually a direct result of certification and not just another unanticipated consequence.
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