EHR Regulations Need to Be Clear, Not Up for Interpretation

December 31, 2012

Here's a simple question for you: Would structured data by any other name smell as sweet?

"When I use a word,' Humpty Dumpty said in rather a scornful tone, 'it means just what I choose it to mean - neither more nor less."

"The question is," said Alice, "whether you can make words mean so many different things."

"The question is," said Humpty Dumpty, "which is to be master - that's all."

- Lewis Carroll, "Through the Looking-Glass, and What Alice Found There" (1871)

Most of us regularly use and encounter words that we understand in a gestalt sense (we grasp the essence of the meaning but would be hard pressed to define precisely). This lack of precision is, in general, not significant. Supporting information is usually provided by the context in which the word was used and having a general idea is usually sufficient - except when it is not and you commit some serious blunder because your (or the speaker's) gestalt sense was wrong. There are times when precision counts.

Writing a regulation is one of those times. Ambiguity can lead people to take actions that conflict with the goal of the regulation or which create loopholes that creative individuals can exploit.

The word "structured" appears frequently in the context of EHR. I have used the word myself in previous articles. I was, of course, certain about what I meant by it, but I wonder if you were? I didn't provide a precise definition so you had only your gestalt sense to go on - which was probably good enough since there was no penalty for not being able to read my mind.

If you start searching, you will discover that the word has several, almost diametrically opposed, meanings. One view has it that structured data refers to data in a database where specific information is stored based on a method of columns and rows, or in trees. This view also holds that unstructured data such as images, e-mail, and documents have no identifiable structure. The other view, as I have previously explained, classifies things like e-mail and certain document formats as being structured because every instance conforms to a set of rules that describe how an item's internal content is to be "marked up" to create clearly demarcated sections. Additional rules define the difference between "well-formed" structures and those that are not.

The point is that merely asserting that something is or should be structured says almost nothing at all unless it is accompanied by a precise definition of structured that is to be applied.

CMS has just released for comment "Health Information Technology: Revisions to the 2014 Edition Electronic Health Record Certification Criteria; and Medicare and Medicaid Programs; Revisions to the Electronic Health Record Incentive Program." This document is a further example of the fact that CMS' Certification Requirements and Meaningful Use Regulations are littered with undefined and thus ambiguous items like "Objective: Provide structured electronic lab results to ambulatory providers."

Do you have any idea what that is supposed to mean? I don't, beyond the obvious that they don't want the results embedded in a "five-paragraph essay" describing the patient's test. How would a developer know what to build? How would you know what to buy? How will an auditor decide whether your "structured results" comply with the unstated specification? Does it depend on their mood? Or the weather?

The regulations don't bother (as far as I can tell) to define structured. Perhaps the folks who wrote the regulations don't appreciate that regulations must be precise, even if wrong. Perhaps they don't know what structure is and just thought that it sounded good and technical. Perhaps the ambiguity is intentional, but to what end?

If you worry that this sort of imprecision could bite you in the future, the comment period is open until February 5, 2013.