The trouble with ONC’s new rule

  | November 4, 2016

If you're entrenched in the inner workings of health IT policy, you might have had the pleasure of digging through the recent Enhanced Oversight Proposal from the Office of the National Coordinator for Health IT (ONC).
If you haven't heard of it, you're not alone: It fell in the 2,398 page shadow of the MACRA final rule, released on the same day. But I read through ONC's rule — which would increase the agency's influence over health IT products — and as I did, I couldn't help but think of a scenefrom the movie Dead Poets Society.
It takes place in a prep school classroom, where a teacher played by Robin Williams instructs a student to read aloud an essay titled “Understanding Poetry," by Dr. J. Evans Pritchard. The essay lays out a scientific model for judging every poem: If its perfection is plotted on the horizontal of a graph, and its importance is plotted on the vertical, the total area yields the “measure of its greatness." Science and art unite!
The students dutifully take notes, until Williams announces that the essay is “excrement" — and instructs his class to tear it out of their books.
Poetry and EHRs, believe it or not, share a lot of similarities. Medicine is a science and an art. The tools used to improve care delivery, patient safety and patient outcomes must meet at the intersection of science and art to support each unique patient story.
But in this new proposal, ONC is trying to treat health IT as pure science. As part of its enhanced oversight, the document states, ONC would have the discretion to review complaints of non-conformities in health IT systems — and to affect the way developers implement “corrective action plans" to a product.
It's not fully clear whether ONC even has the statutory authority to do this; the agency is assuming regulatory authority from a purpose statement in the HITECH Act of 2009, declaring an aim to “improve health care quality."
And the rule is frustratingly vague; it doesn't establish a threshold for when a complaint about a health IT product becomes a public health concern, and therefore subject to review. It's hard for any business to operate under that kind of uncertainty.
But ONC's new rule could undercut the marketplace even further — in a way that should cause concern for physicians and health system executives. After all, the agency directly influences the development of health IT products. And the rule treads dangerously close to suggesting a nationwide, one-size-fits-all approach for subjective measures like usability, and even physician workflow.
As a coordinator of health IT, ONC is well-intentioned: The agency strives to make sure that every physician adopts and implements products that improve patient outcomes. But approaching the job with an eye toward standardization is like measuring Shakespeare or Byron's greatness in a bar graph. It's fine to use statistics and data on humans' interaction with technology to inform and drive usability design, or to tailor a solution to specific consumers.
But any attempt to define or measure a system as “usable" is inherently flawed. Just imagine a federal agency determining which systems were usable, down to individual pieces of functionality. If we did that with the internet, we'd still be downloading AOL disks to search “What is Y2K?" in Ask Jeeves.
The HITECH Act set ONC on a course to “promote a more effective marketplace, greater competition, greater systems analysis, [and] increased consumer choice." ONC should be sticking to its mission, and allowing health IT developers to respond directly to the demands of their physician consumers. The agency should encourage competitive market principles that improve quality, usability and innovation.
Otherwise, the health IT products of tomorrow will be no greater than the technology of today.
Greg Carey is technology standards & policy manager at athenahealth.

The trouble with ONC’s new rule